Practice Management

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (H.R. 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

The Senate currently appears unlikely to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.
 

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

The work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the America’s Health Insurance Plans trade association.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

AGA’s stance: This is a huge victory for patients! Advocating for prior authorization reform has been AGA’s top priority. Learn more about prior authorization and how it impacts gastroenterology on the AGA website. 

A version of this article first appeared on Medscape.com.

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (H.R. 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

The Senate currently appears unlikely to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.
 

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

The work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the America’s Health Insurance Plans trade association.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

AGA’s stance: This is a huge victory for patients! Advocating for prior authorization reform has been AGA’s top priority. Learn more about prior authorization and how it impacts gastroenterology on the AGA website. 

A version of this article first appeared on Medscape.com.

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (H.R. 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

The Senate currently appears unlikely to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.
 

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

The work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the America’s Health Insurance Plans trade association.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

AGA’s stance: This is a huge victory for patients! Advocating for prior authorization reform has been AGA’s top priority. Learn more about prior authorization and how it impacts gastroenterology on the AGA website. 

A version of this article first appeared on Medscape.com.

I don’t think I heard the term “passive income” until I was already an attending gastroenterologist.

That was no surprise. Why would I as a gastroenterologist with a focus in inflammatory bowel diseases be even remotely interested in that term?

Like most physicians, I went into medicine to take care of patients. That was my entire dream. It was a pleasant surprise to hear that gastroenterologists were relatively well paid compared to many other internal medicine specialties.

That was a bonus. I was not practicing medicine for the money. I was here to do good, only. Money was the evil one. It’s no surprise money remained a taboo topic amongst physicians.

This is reflected in the lack of financial education in our training.

I went through all my medical training without getting any financial education. In my last year of training, I wondered how I was going to not end up being a burned out, overworked physician mom. I knew I was going to work in a large hospital-based practice or academic center. I was already aware that employed physicians had a higher burnout rate compared to independent physicians. My desperation to avoid what looked like the natural history of most physicians in medicine was what led me to my financial awakening, as you could call it.

I became curious about where my money was going as it hit my bank account. Where was I investing? How was I going to ensure that I wasn’t putting all my financial eggs in one basket by relying solely on my clinical income? This road led me into a world that I didn’t know existed. It was the world of physician entrepreneurs.

I began thinking more critically of how I was spending my time outside of the hospital. As a busy physician mom, there already were a lot of competing needs and demands on the 24 hours that I was limited to within a day. How could I get things done and increase my earnability without needing to exchange more time for money in a one-to-one ratio?

Passive income!

First of all, what exactly is passive income?

It refers to money earned that does not require you to physically and actively pump in time in order to get money out. For instance, seeing patients clinically is not passive. Performing procedures is not passive.
 

What are some examples of passive income?

• Dividend paying stocks or funds

• Investing through retirement accounts

• Passive real estate investment through syndications, crowdfunding, REITs

• Book writing

• Business partnership or ownership such as surgery center co-ownership

• Peer-to-peer lending

• Affiliate marketing

• House hacking

• Rent out your car

• Rent out your backyard/ swimming pool

• Invention with royalty payment

• Podcasting

There are some myths about passive income that are worth exploring

1. Passive income is completely passive: This is relative passivity, meaning that for every investment, there is a phase of learning, acquiring knowledge, vetting, and possibly researching that is not passive. After the initial phase of set up, most passive sources of income may require some monitoring or checking in. However, what makes an investment passive is the absence of that one-to-one ratio of input to output that would normally exist in a more active income source.

2. Making passive income is lazy: If you are a physician, you are probably not lazy. Yes, we have a high standard of expectation for ourselves, but anyone that is able to withstand the rigors of medical training, residency, and fellowship is not lazy in my books. Burnout can present in various ways, including apathy. Let’s not confuse that as lazy because, if we do, that would qualify as gaslighting and self-splaining. As someone that teaches physicians how to have money, here is my opinion: In order to make money ethically, there has to be exchange in value. One person gives value, the other gives money as a thank you. Value can be physical as seen in clinical work. Value can also be monetary. For example, I could give $100,000 to a start-up company that needs that money to execute their brilliant idea, and, in return for my investment, they could give me a 15% return per year. Is that lazy? Without this, their brilliant idea may not see daylight. Value exchange is the key. Giving value comes in different ways.

3. Finding ideas for passive income is hard: Many of us are invested in the stock market, most commonly through retirement accounts. This would qualify as passive income. Typically, we have simply elected that the growth in our investment or dividends be reinvested as we are choosing to use this money long term. In other words, if you have a retirement account, you already have passive income. The question now is how you can find additional passive ways to invest.

What are the benefits to passive income as a gastroenterologist?

1. Changing landscape of medicine: Over the last few decades, we have seen a growing shift in the landscape of medicine. There has been an increase in administrations surpassing the increase in physicians. There seem to be more and more growing bodies that are wedging between physicians and patients. This has led to increasing dissatisfaction for patients and physicians alike. In order to respond to these changes and create lasting changes, there is a need for a change in the leadership. It is fair to say that when you have a more diversified source of income, there is less pressure on a single source of income to provide “food and shelter” for your family. Physician leaders that are liberated have to have a sense of financial liberation.

2. Not putting eggs in one basket: At the beginning of the COVID-19 pandemic, there was significant fear of the unknown. Elective procedures were canceled, leading to financial strain for physicians. Gastroenterologists were not spared. When your income source is diverse, it provides more peace of mind.

3. Mental resourcefulness: This is an understated benefit of passive income and diversified income. As physicians, we went through a lot of hard work to get to where we are today. An average incoming medical student has had extensive demonstration of activity, volunteerism, and problem solving. Yet, as attending physicians, because of the burden of everyday clinical responsibilities and endless paperwork, as well as the platform and “warehouse” and “administrative-type involvement” in medicine, the average physician isn’t creating avenues to expend their cognitive abilities in a way that is diverse outside of the clinical setting. Having passive income opportunities creates a gym for mental resourcefulness that increases work satisfaction and may positively impact burnout.

4. Relationship building: As physicians, we tend to stick with our own. After working 60-80 hours per week, it is no surprise that most of your social network may end up being those that you work with. Passive income opportunities expose physicians to networking and social opportunities that may be critical for relationship building. This may improve mental wellness and overall sense of well-being.

5. Longevity in medicine: As more physicians elect to be employed by larger organizations outside of academics, sabbaticals are becoming less and less available. Having passive sources of income may permit a physician who would otherwise not be able to suffer loss of income the opportunity to take a leave of absence in the short term that may provide long-term longevity in medicine, while promoting wellness.

6. Wealth building: Wealth has had a negative reputation in the world. We seem to equate wealth as bad and being the source of evil. We forget that money is simply a tool that takes the shape of the container you place it in. If you are good, money becomes a tool for more good. Having passive income can help accelerate the journey to wealth building. This can be a great resource as physicians can support unique lifesaving, community-building, and environment-protecting initiatives, as well as support political candidates who will have a positive effect on patient care and the future of medicine.

I hope you are convinced that, with weighing the benefits and the myths associated with passive income, it is of value for gastroenterologists to equip themselves financially so we can be positioned to be a critical part of the changing platform in medicine. Gastroenterologists have to do their due diligence to ensure that their finances are future proof to the best of their abilities.
 

Dr. Alli-Akintade, a gastroenterologist with Kaiser Permanente South Sacramento (Calif.) Medical Center, is founder of The MoneyFitMD and creator of The MoneyFitMD podcast (www.moneyfitmd.com).

I don’t think I heard the term “passive income” until I was already an attending gastroenterologist.

That was no surprise. Why would I as a gastroenterologist with a focus in inflammatory bowel diseases be even remotely interested in that term?

Like most physicians, I went into medicine to take care of patients. That was my entire dream. It was a pleasant surprise to hear that gastroenterologists were relatively well paid compared to many other internal medicine specialties.

That was a bonus. I was not practicing medicine for the money. I was here to do good, only. Money was the evil one. It’s no surprise money remained a taboo topic amongst physicians.

This is reflected in the lack of financial education in our training.

I went through all my medical training without getting any financial education. In my last year of training, I wondered how I was going to not end up being a burned out, overworked physician mom. I knew I was going to work in a large hospital-based practice or academic center. I was already aware that employed physicians had a higher burnout rate compared to independent physicians. My desperation to avoid what looked like the natural history of most physicians in medicine was what led me to my financial awakening, as you could call it.

I became curious about where my money was going as it hit my bank account. Where was I investing? How was I going to ensure that I wasn’t putting all my financial eggs in one basket by relying solely on my clinical income? This road led me into a world that I didn’t know existed. It was the world of physician entrepreneurs.

I began thinking more critically of how I was spending my time outside of the hospital. As a busy physician mom, there already were a lot of competing needs and demands on the 24 hours that I was limited to within a day. How could I get things done and increase my earnability without needing to exchange more time for money in a one-to-one ratio?

Passive income!

First of all, what exactly is passive income?

It refers to money earned that does not require you to physically and actively pump in time in order to get money out. For instance, seeing patients clinically is not passive. Performing procedures is not passive.
 

What are some examples of passive income?

• Dividend paying stocks or funds

• Investing through retirement accounts

• Passive real estate investment through syndications, crowdfunding, REITs

• Book writing

• Business partnership or ownership such as surgery center co-ownership

• Peer-to-peer lending

• Affiliate marketing

• House hacking

• Rent out your car

• Rent out your backyard/ swimming pool

• Invention with royalty payment

• Podcasting

There are some myths about passive income that are worth exploring

1. Passive income is completely passive: This is relative passivity, meaning that for every investment, there is a phase of learning, acquiring knowledge, vetting, and possibly researching that is not passive. After the initial phase of set up, most passive sources of income may require some monitoring or checking in. However, what makes an investment passive is the absence of that one-to-one ratio of input to output that would normally exist in a more active income source.

2. Making passive income is lazy: If you are a physician, you are probably not lazy. Yes, we have a high standard of expectation for ourselves, but anyone that is able to withstand the rigors of medical training, residency, and fellowship is not lazy in my books. Burnout can present in various ways, including apathy. Let’s not confuse that as lazy because, if we do, that would qualify as gaslighting and self-splaining. As someone that teaches physicians how to have money, here is my opinion: In order to make money ethically, there has to be exchange in value. One person gives value, the other gives money as a thank you. Value can be physical as seen in clinical work. Value can also be monetary. For example, I could give $100,000 to a start-up company that needs that money to execute their brilliant idea, and, in return for my investment, they could give me a 15% return per year. Is that lazy? Without this, their brilliant idea may not see daylight. Value exchange is the key. Giving value comes in different ways.

3. Finding ideas for passive income is hard: Many of us are invested in the stock market, most commonly through retirement accounts. This would qualify as passive income. Typically, we have simply elected that the growth in our investment or dividends be reinvested as we are choosing to use this money long term. In other words, if you have a retirement account, you already have passive income. The question now is how you can find additional passive ways to invest.

What are the benefits to passive income as a gastroenterologist?

1. Changing landscape of medicine: Over the last few decades, we have seen a growing shift in the landscape of medicine. There has been an increase in administrations surpassing the increase in physicians. There seem to be more and more growing bodies that are wedging between physicians and patients. This has led to increasing dissatisfaction for patients and physicians alike. In order to respond to these changes and create lasting changes, there is a need for a change in the leadership. It is fair to say that when you have a more diversified source of income, there is less pressure on a single source of income to provide “food and shelter” for your family. Physician leaders that are liberated have to have a sense of financial liberation.

2. Not putting eggs in one basket: At the beginning of the COVID-19 pandemic, there was significant fear of the unknown. Elective procedures were canceled, leading to financial strain for physicians. Gastroenterologists were not spared. When your income source is diverse, it provides more peace of mind.

3. Mental resourcefulness: This is an understated benefit of passive income and diversified income. As physicians, we went through a lot of hard work to get to where we are today. An average incoming medical student has had extensive demonstration of activity, volunteerism, and problem solving. Yet, as attending physicians, because of the burden of everyday clinical responsibilities and endless paperwork, as well as the platform and “warehouse” and “administrative-type involvement” in medicine, the average physician isn’t creating avenues to expend their cognitive abilities in a way that is diverse outside of the clinical setting. Having passive income opportunities creates a gym for mental resourcefulness that increases work satisfaction and may positively impact burnout.

4. Relationship building: As physicians, we tend to stick with our own. After working 60-80 hours per week, it is no surprise that most of your social network may end up being those that you work with. Passive income opportunities expose physicians to networking and social opportunities that may be critical for relationship building. This may improve mental wellness and overall sense of well-being.

5. Longevity in medicine: As more physicians elect to be employed by larger organizations outside of academics, sabbaticals are becoming less and less available. Having passive sources of income may permit a physician who would otherwise not be able to suffer loss of income the opportunity to take a leave of absence in the short term that may provide long-term longevity in medicine, while promoting wellness.

6. Wealth building: Wealth has had a negative reputation in the world. We seem to equate wealth as bad and being the source of evil. We forget that money is simply a tool that takes the shape of the container you place it in. If you are good, money becomes a tool for more good. Having passive income can help accelerate the journey to wealth building. This can be a great resource as physicians can support unique lifesaving, community-building, and environment-protecting initiatives, as well as support political candidates who will have a positive effect on patient care and the future of medicine.

I hope you are convinced that, with weighing the benefits and the myths associated with passive income, it is of value for gastroenterologists to equip themselves financially so we can be positioned to be a critical part of the changing platform in medicine. Gastroenterologists have to do their due diligence to ensure that their finances are future proof to the best of their abilities.
 

Dr. Alli-Akintade, a gastroenterologist with Kaiser Permanente South Sacramento (Calif.) Medical Center, is founder of The MoneyFitMD and creator of The MoneyFitMD podcast (www.moneyfitmd.com).

I don’t think I heard the term “passive income” until I was already an attending gastroenterologist.

That was no surprise. Why would I as a gastroenterologist with a focus in inflammatory bowel diseases be even remotely interested in that term?

Like most physicians, I went into medicine to take care of patients. That was my entire dream. It was a pleasant surprise to hear that gastroenterologists were relatively well paid compared to many other internal medicine specialties.

That was a bonus. I was not practicing medicine for the money. I was here to do good, only. Money was the evil one. It’s no surprise money remained a taboo topic amongst physicians.

This is reflected in the lack of financial education in our training.

I went through all my medical training without getting any financial education. In my last year of training, I wondered how I was going to not end up being a burned out, overworked physician mom. I knew I was going to work in a large hospital-based practice or academic center. I was already aware that employed physicians had a higher burnout rate compared to independent physicians. My desperation to avoid what looked like the natural history of most physicians in medicine was what led me to my financial awakening, as you could call it.

I became curious about where my money was going as it hit my bank account. Where was I investing? How was I going to ensure that I wasn’t putting all my financial eggs in one basket by relying solely on my clinical income? This road led me into a world that I didn’t know existed. It was the world of physician entrepreneurs.

I began thinking more critically of how I was spending my time outside of the hospital. As a busy physician mom, there already were a lot of competing needs and demands on the 24 hours that I was limited to within a day. How could I get things done and increase my earnability without needing to exchange more time for money in a one-to-one ratio?

Passive income!

First of all, what exactly is passive income?

It refers to money earned that does not require you to physically and actively pump in time in order to get money out. For instance, seeing patients clinically is not passive. Performing procedures is not passive.
 

What are some examples of passive income?

• Dividend paying stocks or funds

• Investing through retirement accounts

• Passive real estate investment through syndications, crowdfunding, REITs

• Book writing

• Business partnership or ownership such as surgery center co-ownership

• Peer-to-peer lending

• Affiliate marketing

• House hacking

• Rent out your car

• Rent out your backyard/ swimming pool

• Invention with royalty payment

• Podcasting

There are some myths about passive income that are worth exploring

1. Passive income is completely passive: This is relative passivity, meaning that for every investment, there is a phase of learning, acquiring knowledge, vetting, and possibly researching that is not passive. After the initial phase of set up, most passive sources of income may require some monitoring or checking in. However, what makes an investment passive is the absence of that one-to-one ratio of input to output that would normally exist in a more active income source.

2. Making passive income is lazy: If you are a physician, you are probably not lazy. Yes, we have a high standard of expectation for ourselves, but anyone that is able to withstand the rigors of medical training, residency, and fellowship is not lazy in my books. Burnout can present in various ways, including apathy. Let’s not confuse that as lazy because, if we do, that would qualify as gaslighting and self-splaining. As someone that teaches physicians how to have money, here is my opinion: In order to make money ethically, there has to be exchange in value. One person gives value, the other gives money as a thank you. Value can be physical as seen in clinical work. Value can also be monetary. For example, I could give $100,000 to a start-up company that needs that money to execute their brilliant idea, and, in return for my investment, they could give me a 15% return per year. Is that lazy? Without this, their brilliant idea may not see daylight. Value exchange is the key. Giving value comes in different ways.

3. Finding ideas for passive income is hard: Many of us are invested in the stock market, most commonly through retirement accounts. This would qualify as passive income. Typically, we have simply elected that the growth in our investment or dividends be reinvested as we are choosing to use this money long term. In other words, if you have a retirement account, you already have passive income. The question now is how you can find additional passive ways to invest.

What are the benefits to passive income as a gastroenterologist?

1. Changing landscape of medicine: Over the last few decades, we have seen a growing shift in the landscape of medicine. There has been an increase in administrations surpassing the increase in physicians. There seem to be more and more growing bodies that are wedging between physicians and patients. This has led to increasing dissatisfaction for patients and physicians alike. In order to respond to these changes and create lasting changes, there is a need for a change in the leadership. It is fair to say that when you have a more diversified source of income, there is less pressure on a single source of income to provide “food and shelter” for your family. Physician leaders that are liberated have to have a sense of financial liberation.

2. Not putting eggs in one basket: At the beginning of the COVID-19 pandemic, there was significant fear of the unknown. Elective procedures were canceled, leading to financial strain for physicians. Gastroenterologists were not spared. When your income source is diverse, it provides more peace of mind.

3. Mental resourcefulness: This is an understated benefit of passive income and diversified income. As physicians, we went through a lot of hard work to get to where we are today. An average incoming medical student has had extensive demonstration of activity, volunteerism, and problem solving. Yet, as attending physicians, because of the burden of everyday clinical responsibilities and endless paperwork, as well as the platform and “warehouse” and “administrative-type involvement” in medicine, the average physician isn’t creating avenues to expend their cognitive abilities in a way that is diverse outside of the clinical setting. Having passive income opportunities creates a gym for mental resourcefulness that increases work satisfaction and may positively impact burnout.

4. Relationship building: As physicians, we tend to stick with our own. After working 60-80 hours per week, it is no surprise that most of your social network may end up being those that you work with. Passive income opportunities expose physicians to networking and social opportunities that may be critical for relationship building. This may improve mental wellness and overall sense of well-being.

5. Longevity in medicine: As more physicians elect to be employed by larger organizations outside of academics, sabbaticals are becoming less and less available. Having passive sources of income may permit a physician who would otherwise not be able to suffer loss of income the opportunity to take a leave of absence in the short term that may provide long-term longevity in medicine, while promoting wellness.

6. Wealth building: Wealth has had a negative reputation in the world. We seem to equate wealth as bad and being the source of evil. We forget that money is simply a tool that takes the shape of the container you place it in. If you are good, money becomes a tool for more good. Having passive income can help accelerate the journey to wealth building. This can be a great resource as physicians can support unique lifesaving, community-building, and environment-protecting initiatives, as well as support political candidates who will have a positive effect on patient care and the future of medicine.

I hope you are convinced that, with weighing the benefits and the myths associated with passive income, it is of value for gastroenterologists to equip themselves financially so we can be positioned to be a critical part of the changing platform in medicine. Gastroenterologists have to do their due diligence to ensure that their finances are future proof to the best of their abilities.
 

Dr. Alli-Akintade, a gastroenterologist with Kaiser Permanente South Sacramento (Calif.) Medical Center, is founder of The MoneyFitMD and creator of The MoneyFitMD podcast (www.moneyfitmd.com).

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (HR 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

But the Senate appears unlikely at this time to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs, though, may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

One is the work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the trade association America’s Health Insurance Plans.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

A version of this article first appeared on Medscape.com.

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (HR 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

But the Senate appears unlikely at this time to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs, though, may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

One is the work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the trade association America’s Health Insurance Plans.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

A version of this article first appeared on Medscape.com.

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (HR 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

But the Senate appears unlikely at this time to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs, though, may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

One is the work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the trade association America’s Health Insurance Plans.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

A version of this article first appeared on Medscape.com.

PARIS – If results of phase 3, randomized clinical trials are the gold standard for cancer drug approvals, then single-arm trials are at best a bronze or even brass standard, with results that should only be used, under certain conditions, for accelerated approvals that should then be followed by confirmatory studies.

In fact, many drugs approved over the last decade based solely on data from single-arm trials have been subsequently withdrawn when put through the rigors of a head-to-head randomized controlled trial, according to Bishal Gyawali, MD, PhD, from the department of oncology at Queen’s University, Kingston, Ont.

“Single-arm trials are not meant to provide confirmatory evidence sufficient for approval; However, that ship has sailed, and we have several drugs that are approved on the basis of single-arm trials, but we need to make sure that those approvals are accelerated or conditional approvals, not regular approval,” he said in a presentation included in a special session on drug approvals at the European Society for Medical Oncology Congress.

“We should not allow premature regular approval based on single-arm trials, because once a drug gets conditional approval, access is not an issue. Patients will have access to the drug anyway, but we should ensure that robust evidence follows, and long-term follow-up data are needed to develop confidence in the efficacy outcomes that are seen in single-arm trials,” he said.

In many cases, single-arm trials are large enough or of long enough duration that investigators could have reasonably performed a randomized controlled trial (RCT) in the first place, Dr. Gyawali added.
 

Why do single-arm trials?

The term “single-arm registration trial” is something of an oxymoron, he said, noting that the purpose of such trials should be whether to take the drug to a phase 3, randomized trial. But as authors of a 2019 study in JAMA Network Open showed, of a sample of phase 3 RCTs, 42% did not have a prior phase 2 trial, and 28% had a negative phase 2 trial. Single-arm trials may be acceptable for conditional drug approvals if all of the following conditions are met:

• A RCT is not possible because the disease is rare or randomization would be unethical.
• The safety of the drug is established and its potential benefits outweigh its risks.
• The drug is associated with a high and durable overall or objective response rate.
• The mechanism of action is supported by a strong scientific rationale, and if the drug may meet an unmet medical need.

Survival endpoints won’t do

Efficacy endpoints typically used in RCTs, such as progression-free survival (PFS) and overall survival (OS) can be misleading because they may be a result of the natural history of the disease and not the drug being tested, whereas ORRs are almost certainly reflective of the action of the drug itself, because spontaneous tumor regression is a rare phenomenon, Dr. Gyawali said.

He cautioned, however, that the ORR of placebo is not zero percent. For example in a 2018 study of sorafenib (Nexavar) versus placebo for advanced or refractory desmoid tumors, the ORR with the active drug was 33%, and the ORR for placebo was 20%.

It’s also open to question, he said, what constitutes an acceptably high ORR and duration of response, pointing to Food and Drug Administration accelerated approval of an indication for nivolumab (Opdivo) for treatment of patients with hepatocellular carcinoma (HCC) that had progressed on sorafenib. In the single-arm trial used as the basis for approval, the ORRs as assessed by an independent central review committee blinded to the results was 14.3%.

“So, nivolumab in hepatocellular cancer was approved on the basis of a response rate lower than that of placebo, albeit in a different tumor. But the point I’m trying to show here is we don’t have a good definition of what is a good response rate,” he said.

In July 2021, Bristol-Myers Squibb voluntarily withdrew the HCC indication for nivolumab, following negative results of the CheckMate 459 trial and a 5-4 vote against continuing the accelerated approval.
 

On second thought ...

Citing data compiled by Nathan I. Cherny, MD, from Shaare Zedek Medical Center, Jerusalem, Dr. Gyawali noted that 58 of 161 FDA approvals from 2017 to 2021 of drugs for adult solid tumors were based on single-arm trials. Of the 58 drugs, 39 received accelerated approvals, and 19 received regular approvals; of the 39 that received accelerated approvals, 4 were subsequently withdrawn, 8 were converted to regular approvals, and the remainder continued as accelerated approvals.

Interestingly, the median response rate among all the drugs was 40%, and did not differ between the type of approval received, suggesting that response rates are not predictive of whether a drug will receive a conditional or full-fledged go-ahead.
 

What’s rare and safe?

The definition of a rare disease in the United States is one that affects fewer than 40,000 per year, and in Europe it’s an incidence rate of less than 6 per 100,000 population, Dr. Gyawali noted. But he argued that even non–small cell lung cancer, the most common form of cancer in the world, could be considered rare if it is broken down into subtypes that are treated according to specific mutations that may occur in a relatively small number of patients.

He also noted that a specific drug’s safety, one of the most important criteria for granting approval to a drug based on a single-arm trial, can be difficult to judge without adequate controls for comparison.
 

Cherry-picking patients

Winette van der Graaf, MD, president of the European Organization for the Research and Treatment of Cancer, who attended the session where Dr. Gyawali’s presentation was played, said in an interview that clinicians should cast a critical eye on how trials are designed and conducted, including patient selection and choice of endpoints.

“One of the most obvious things to be concerned about is that we’re still having patients with good performance status enrolled, mostly PS 0 or 1, so how representative are these clinical trials for the patients we see in front of us on a daily basis?” she said.

“The other question is radiological endpoints, which we focus on with OS and PFS are most important for patients, especially if you consider that if patients may have asymptomatic disease, and we are only treating them with potentially toxic medication, what are we doing for them? Median overall survival when you look at all of these trials is only 4 months, so we really need to take into account how we affect patients in clinical trials,” she added.

Dr. van der Graaf emphasized that clinical trial investigators need to more routinely incorporate quality of life measures and other patient-reported outcomes in clinical trial results to help regulators and clinicians in practice get a better sense of the true clinical benefit of a new drug.

Dr. Gyawali did not disclose a funding source for his presentation. He reported consulting fees from Vivio Health and research grants from the American Society of Clinical Oncology. Dr. van der Graaf reported no conflicts of interest.

PARIS – If results of phase 3, randomized clinical trials are the gold standard for cancer drug approvals, then single-arm trials are at best a bronze or even brass standard, with results that should only be used, under certain conditions, for accelerated approvals that should then be followed by confirmatory studies.

In fact, many drugs approved over the last decade based solely on data from single-arm trials have been subsequently withdrawn when put through the rigors of a head-to-head randomized controlled trial, according to Bishal Gyawali, MD, PhD, from the department of oncology at Queen’s University, Kingston, Ont.

“Single-arm trials are not meant to provide confirmatory evidence sufficient for approval; However, that ship has sailed, and we have several drugs that are approved on the basis of single-arm trials, but we need to make sure that those approvals are accelerated or conditional approvals, not regular approval,” he said in a presentation included in a special session on drug approvals at the European Society for Medical Oncology Congress.

“We should not allow premature regular approval based on single-arm trials, because once a drug gets conditional approval, access is not an issue. Patients will have access to the drug anyway, but we should ensure that robust evidence follows, and long-term follow-up data are needed to develop confidence in the efficacy outcomes that are seen in single-arm trials,” he said.

In many cases, single-arm trials are large enough or of long enough duration that investigators could have reasonably performed a randomized controlled trial (RCT) in the first place, Dr. Gyawali added.
 

Why do single-arm trials?

The term “single-arm registration trial” is something of an oxymoron, he said, noting that the purpose of such trials should be whether to take the drug to a phase 3, randomized trial. But as authors of a 2019 study in JAMA Network Open showed, of a sample of phase 3 RCTs, 42% did not have a prior phase 2 trial, and 28% had a negative phase 2 trial. Single-arm trials may be acceptable for conditional drug approvals if all of the following conditions are met:

• A RCT is not possible because the disease is rare or randomization would be unethical.
• The safety of the drug is established and its potential benefits outweigh its risks.
• The drug is associated with a high and durable overall or objective response rate.
• The mechanism of action is supported by a strong scientific rationale, and if the drug may meet an unmet medical need.

Survival endpoints won’t do

Efficacy endpoints typically used in RCTs, such as progression-free survival (PFS) and overall survival (OS) can be misleading because they may be a result of the natural history of the disease and not the drug being tested, whereas ORRs are almost certainly reflective of the action of the drug itself, because spontaneous tumor regression is a rare phenomenon, Dr. Gyawali said.

He cautioned, however, that the ORR of placebo is not zero percent. For example in a 2018 study of sorafenib (Nexavar) versus placebo for advanced or refractory desmoid tumors, the ORR with the active drug was 33%, and the ORR for placebo was 20%.

It’s also open to question, he said, what constitutes an acceptably high ORR and duration of response, pointing to Food and Drug Administration accelerated approval of an indication for nivolumab (Opdivo) for treatment of patients with hepatocellular carcinoma (HCC) that had progressed on sorafenib. In the single-arm trial used as the basis for approval, the ORRs as assessed by an independent central review committee blinded to the results was 14.3%.

“So, nivolumab in hepatocellular cancer was approved on the basis of a response rate lower than that of placebo, albeit in a different tumor. But the point I’m trying to show here is we don’t have a good definition of what is a good response rate,” he said.

In July 2021, Bristol-Myers Squibb voluntarily withdrew the HCC indication for nivolumab, following negative results of the CheckMate 459 trial and a 5-4 vote against continuing the accelerated approval.
 

On second thought ...

Citing data compiled by Nathan I. Cherny, MD, from Shaare Zedek Medical Center, Jerusalem, Dr. Gyawali noted that 58 of 161 FDA approvals from 2017 to 2021 of drugs for adult solid tumors were based on single-arm trials. Of the 58 drugs, 39 received accelerated approvals, and 19 received regular approvals; of the 39 that received accelerated approvals, 4 were subsequently withdrawn, 8 were converted to regular approvals, and the remainder continued as accelerated approvals.

Interestingly, the median response rate among all the drugs was 40%, and did not differ between the type of approval received, suggesting that response rates are not predictive of whether a drug will receive a conditional or full-fledged go-ahead.
 

What’s rare and safe?

The definition of a rare disease in the United States is one that affects fewer than 40,000 per year, and in Europe it’s an incidence rate of less than 6 per 100,000 population, Dr. Gyawali noted. But he argued that even non–small cell lung cancer, the most common form of cancer in the world, could be considered rare if it is broken down into subtypes that are treated according to specific mutations that may occur in a relatively small number of patients.

He also noted that a specific drug’s safety, one of the most important criteria for granting approval to a drug based on a single-arm trial, can be difficult to judge without adequate controls for comparison.
 

Cherry-picking patients

Winette van der Graaf, MD, president of the European Organization for the Research and Treatment of Cancer, who attended the session where Dr. Gyawali’s presentation was played, said in an interview that clinicians should cast a critical eye on how trials are designed and conducted, including patient selection and choice of endpoints.

“One of the most obvious things to be concerned about is that we’re still having patients with good performance status enrolled, mostly PS 0 or 1, so how representative are these clinical trials for the patients we see in front of us on a daily basis?” she said.

“The other question is radiological endpoints, which we focus on with OS and PFS are most important for patients, especially if you consider that if patients may have asymptomatic disease, and we are only treating them with potentially toxic medication, what are we doing for them? Median overall survival when you look at all of these trials is only 4 months, so we really need to take into account how we affect patients in clinical trials,” she added.

Dr. van der Graaf emphasized that clinical trial investigators need to more routinely incorporate quality of life measures and other patient-reported outcomes in clinical trial results to help regulators and clinicians in practice get a better sense of the true clinical benefit of a new drug.

Dr. Gyawali did not disclose a funding source for his presentation. He reported consulting fees from Vivio Health and research grants from the American Society of Clinical Oncology. Dr. van der Graaf reported no conflicts of interest.

PARIS – If results of phase 3, randomized clinical trials are the gold standard for cancer drug approvals, then single-arm trials are at best a bronze or even brass standard, with results that should only be used, under certain conditions, for accelerated approvals that should then be followed by confirmatory studies.

In fact, many drugs approved over the last decade based solely on data from single-arm trials have been subsequently withdrawn when put through the rigors of a head-to-head randomized controlled trial, according to Bishal Gyawali, MD, PhD, from the department of oncology at Queen’s University, Kingston, Ont.

“Single-arm trials are not meant to provide confirmatory evidence sufficient for approval; However, that ship has sailed, and we have several drugs that are approved on the basis of single-arm trials, but we need to make sure that those approvals are accelerated or conditional approvals, not regular approval,” he said in a presentation included in a special session on drug approvals at the European Society for Medical Oncology Congress.

“We should not allow premature regular approval based on single-arm trials, because once a drug gets conditional approval, access is not an issue. Patients will have access to the drug anyway, but we should ensure that robust evidence follows, and long-term follow-up data are needed to develop confidence in the efficacy outcomes that are seen in single-arm trials,” he said.

In many cases, single-arm trials are large enough or of long enough duration that investigators could have reasonably performed a randomized controlled trial (RCT) in the first place, Dr. Gyawali added.
 

Why do single-arm trials?

The term “single-arm registration trial” is something of an oxymoron, he said, noting that the purpose of such trials should be whether to take the drug to a phase 3, randomized trial. But as authors of a 2019 study in JAMA Network Open showed, of a sample of phase 3 RCTs, 42% did not have a prior phase 2 trial, and 28% had a negative phase 2 trial. Single-arm trials may be acceptable for conditional drug approvals if all of the following conditions are met:

• A RCT is not possible because the disease is rare or randomization would be unethical.
• The safety of the drug is established and its potential benefits outweigh its risks.
• The drug is associated with a high and durable overall or objective response rate.
• The mechanism of action is supported by a strong scientific rationale, and if the drug may meet an unmet medical need.

Survival endpoints won’t do

Efficacy endpoints typically used in RCTs, such as progression-free survival (PFS) and overall survival (OS) can be misleading because they may be a result of the natural history of the disease and not the drug being tested, whereas ORRs are almost certainly reflective of the action of the drug itself, because spontaneous tumor regression is a rare phenomenon, Dr. Gyawali said.

He cautioned, however, that the ORR of placebo is not zero percent. For example in a 2018 study of sorafenib (Nexavar) versus placebo for advanced or refractory desmoid tumors, the ORR with the active drug was 33%, and the ORR for placebo was 20%.

It’s also open to question, he said, what constitutes an acceptably high ORR and duration of response, pointing to Food and Drug Administration accelerated approval of an indication for nivolumab (Opdivo) for treatment of patients with hepatocellular carcinoma (HCC) that had progressed on sorafenib. In the single-arm trial used as the basis for approval, the ORRs as assessed by an independent central review committee blinded to the results was 14.3%.

“So, nivolumab in hepatocellular cancer was approved on the basis of a response rate lower than that of placebo, albeit in a different tumor. But the point I’m trying to show here is we don’t have a good definition of what is a good response rate,” he said.

In July 2021, Bristol-Myers Squibb voluntarily withdrew the HCC indication for nivolumab, following negative results of the CheckMate 459 trial and a 5-4 vote against continuing the accelerated approval.
 

On second thought ...

Citing data compiled by Nathan I. Cherny, MD, from Shaare Zedek Medical Center, Jerusalem, Dr. Gyawali noted that 58 of 161 FDA approvals from 2017 to 2021 of drugs for adult solid tumors were based on single-arm trials. Of the 58 drugs, 39 received accelerated approvals, and 19 received regular approvals; of the 39 that received accelerated approvals, 4 were subsequently withdrawn, 8 were converted to regular approvals, and the remainder continued as accelerated approvals.

Interestingly, the median response rate among all the drugs was 40%, and did not differ between the type of approval received, suggesting that response rates are not predictive of whether a drug will receive a conditional or full-fledged go-ahead.
 

What’s rare and safe?

The definition of a rare disease in the United States is one that affects fewer than 40,000 per year, and in Europe it’s an incidence rate of less than 6 per 100,000 population, Dr. Gyawali noted. But he argued that even non–small cell lung cancer, the most common form of cancer in the world, could be considered rare if it is broken down into subtypes that are treated according to specific mutations that may occur in a relatively small number of patients.

He also noted that a specific drug’s safety, one of the most important criteria for granting approval to a drug based on a single-arm trial, can be difficult to judge without adequate controls for comparison.
 

Cherry-picking patients

Winette van der Graaf, MD, president of the European Organization for the Research and Treatment of Cancer, who attended the session where Dr. Gyawali’s presentation was played, said in an interview that clinicians should cast a critical eye on how trials are designed and conducted, including patient selection and choice of endpoints.

“One of the most obvious things to be concerned about is that we’re still having patients with good performance status enrolled, mostly PS 0 or 1, so how representative are these clinical trials for the patients we see in front of us on a daily basis?” she said.

“The other question is radiological endpoints, which we focus on with OS and PFS are most important for patients, especially if you consider that if patients may have asymptomatic disease, and we are only treating them with potentially toxic medication, what are we doing for them? Median overall survival when you look at all of these trials is only 4 months, so we really need to take into account how we affect patients in clinical trials,” she added.

Dr. van der Graaf emphasized that clinical trial investigators need to more routinely incorporate quality of life measures and other patient-reported outcomes in clinical trial results to help regulators and clinicians in practice get a better sense of the true clinical benefit of a new drug.

Dr. Gyawali did not disclose a funding source for his presentation. He reported consulting fees from Vivio Health and research grants from the American Society of Clinical Oncology. Dr. van der Graaf reported no conflicts of interest.

Maya Iyer, MD, MEd, experienced bullying as a faculty member, and she sensed that she wasn’t alone. “The best ideas for research often come from individual experiences, in both personal and the professional academic medicine setting,” she said in an interview.

“And I was correct. I was not the only one who experienced bullying. In fact, the most severe bullying experiences among ... women physician leaders occurred when they were in leadership positions,” said Dr. Iyer, a pediatric emergency medicine physician at Nationwide Children’s Hospital in Columbus, Ohio.

She is a coauthor of a study that was published in JAMA Network Open in which investigators surveyed the existence of antibullying policies for faculty at almost 100 U.S. medical schools.

The researchers defined bullying as “a severe form of mistreatment [that] occurs in the medical setting when a power differential allows offenders to consciously target individuals through persistent negative actions to impede the education or career of the target.”

The study included 91 medical schools, of which 4 schools had antibullying policies that included the reporting of procedures. Of the 87 medical schools without antibullying policies, 60 had antiharrassment policies; of those schools, 10 of the schools’ websites cited bullying and antiharassment policies. Five schools required a login to access policies, and one school’s website had a broken webpage link, per the study.

“We need to bring the silent scourge of bullying to the forefront because bullying is causing a brain drain on the medical profession,” said Dr. Iyer. “Bullying has numerous downstream negative effects, including depression, anxiety, burnout stress, decreased patient care satisfaction, increased medical errors, and job attrition.”

She added: “Through bullying, we are losing voices in medicine just at that point in time where we are trying to diversify the workforce to improve representation of all physicians.”

Dr. Iyer’s team sampled the top 25 schools for research and the top 25 schools for primary care. They also took a random sampling from 25 schools for research and a random sampling from top 25 schools for primary care. They assessed antibullying policies, antiharassment policies that mentioned bullying, antiharrassment policies that did not mention bullying, and the absence of policies addressing these issues.

Policy comprehensiveness was another focus for the researchers. They evaluated whether the relevant policies included faculty members and articulated the institution’s commitment to providing a safe and healthy workplace. Other factors included defining bullying and the roles and responsibilities of employees and procedures for reporting bullying.
 

Physicians can’t be bystanders to bullying

Dr. Iyer called on physicians to “acknowledge that bullying in academic medicine exists and [to] speak up when they witness such events. This means transitioning from being a bystander to an upstander.”

She doesn’t let medical schools off the hook, however. Instead, she advocated having institutions “provide safe spaces and opportunities for near-peer mentoring so that targets of bullying can share stories.”

Regarding who is responsible for addressing bullying, Dr. Iyer is emphatic. “I do want to be clear that the onus of disrupting does not fall on the targets. Rather, we need to fix the systems in which such behavior is tolerated.”

Her advice to leaders in academic medicine is to create comprehensive, zero-retaliation bullying policies that include detailed reporting procedures. Dr. Iyer advised leaders to partner with colleagues in human resources, offices of equity, and ombudspersons to develop, implement, and enforce these policies.

The study authors reported no conflicts of interest.

A version of this article first appeared on Medscape.com.

Maya Iyer, MD, MEd, experienced bullying as a faculty member, and she sensed that she wasn’t alone. “The best ideas for research often come from individual experiences, in both personal and the professional academic medicine setting,” she said in an interview.

“And I was correct. I was not the only one who experienced bullying. In fact, the most severe bullying experiences among ... women physician leaders occurred when they were in leadership positions,” said Dr. Iyer, a pediatric emergency medicine physician at Nationwide Children’s Hospital in Columbus, Ohio.

She is a coauthor of a study that was published in JAMA Network Open in which investigators surveyed the existence of antibullying policies for faculty at almost 100 U.S. medical schools.

The researchers defined bullying as “a severe form of mistreatment [that] occurs in the medical setting when a power differential allows offenders to consciously target individuals through persistent negative actions to impede the education or career of the target.”

The study included 91 medical schools, of which 4 schools had antibullying policies that included the reporting of procedures. Of the 87 medical schools without antibullying policies, 60 had antiharrassment policies; of those schools, 10 of the schools’ websites cited bullying and antiharassment policies. Five schools required a login to access policies, and one school’s website had a broken webpage link, per the study.

“We need to bring the silent scourge of bullying to the forefront because bullying is causing a brain drain on the medical profession,” said Dr. Iyer. “Bullying has numerous downstream negative effects, including depression, anxiety, burnout stress, decreased patient care satisfaction, increased medical errors, and job attrition.”

She added: “Through bullying, we are losing voices in medicine just at that point in time where we are trying to diversify the workforce to improve representation of all physicians.”

Dr. Iyer’s team sampled the top 25 schools for research and the top 25 schools for primary care. They also took a random sampling from 25 schools for research and a random sampling from top 25 schools for primary care. They assessed antibullying policies, antiharassment policies that mentioned bullying, antiharrassment policies that did not mention bullying, and the absence of policies addressing these issues.

Policy comprehensiveness was another focus for the researchers. They evaluated whether the relevant policies included faculty members and articulated the institution’s commitment to providing a safe and healthy workplace. Other factors included defining bullying and the roles and responsibilities of employees and procedures for reporting bullying.
 

Physicians can’t be bystanders to bullying

Dr. Iyer called on physicians to “acknowledge that bullying in academic medicine exists and [to] speak up when they witness such events. This means transitioning from being a bystander to an upstander.”

She doesn’t let medical schools off the hook, however. Instead, she advocated having institutions “provide safe spaces and opportunities for near-peer mentoring so that targets of bullying can share stories.”

Regarding who is responsible for addressing bullying, Dr. Iyer is emphatic. “I do want to be clear that the onus of disrupting does not fall on the targets. Rather, we need to fix the systems in which such behavior is tolerated.”

Her advice to leaders in academic medicine is to create comprehensive, zero-retaliation bullying policies that include detailed reporting procedures. Dr. Iyer advised leaders to partner with colleagues in human resources, offices of equity, and ombudspersons to develop, implement, and enforce these policies.

The study authors reported no conflicts of interest.

A version of this article first appeared on Medscape.com.

Maya Iyer, MD, MEd, experienced bullying as a faculty member, and she sensed that she wasn’t alone. “The best ideas for research often come from individual experiences, in both personal and the professional academic medicine setting,” she said in an interview.

“And I was correct. I was not the only one who experienced bullying. In fact, the most severe bullying experiences among ... women physician leaders occurred when they were in leadership positions,” said Dr. Iyer, a pediatric emergency medicine physician at Nationwide Children’s Hospital in Columbus, Ohio.

She is a coauthor of a study that was published in JAMA Network Open in which investigators surveyed the existence of antibullying policies for faculty at almost 100 U.S. medical schools.

The researchers defined bullying as “a severe form of mistreatment [that] occurs in the medical setting when a power differential allows offenders to consciously target individuals through persistent negative actions to impede the education or career of the target.”

The study included 91 medical schools, of which 4 schools had antibullying policies that included the reporting of procedures. Of the 87 medical schools without antibullying policies, 60 had antiharrassment policies; of those schools, 10 of the schools’ websites cited bullying and antiharassment policies. Five schools required a login to access policies, and one school’s website had a broken webpage link, per the study.

“We need to bring the silent scourge of bullying to the forefront because bullying is causing a brain drain on the medical profession,” said Dr. Iyer. “Bullying has numerous downstream negative effects, including depression, anxiety, burnout stress, decreased patient care satisfaction, increased medical errors, and job attrition.”

She added: “Through bullying, we are losing voices in medicine just at that point in time where we are trying to diversify the workforce to improve representation of all physicians.”

Dr. Iyer’s team sampled the top 25 schools for research and the top 25 schools for primary care. They also took a random sampling from 25 schools for research and a random sampling from top 25 schools for primary care. They assessed antibullying policies, antiharassment policies that mentioned bullying, antiharrassment policies that did not mention bullying, and the absence of policies addressing these issues.

Policy comprehensiveness was another focus for the researchers. They evaluated whether the relevant policies included faculty members and articulated the institution’s commitment to providing a safe and healthy workplace. Other factors included defining bullying and the roles and responsibilities of employees and procedures for reporting bullying.
 

Physicians can’t be bystanders to bullying

Dr. Iyer called on physicians to “acknowledge that bullying in academic medicine exists and [to] speak up when they witness such events. This means transitioning from being a bystander to an upstander.”

She doesn’t let medical schools off the hook, however. Instead, she advocated having institutions “provide safe spaces and opportunities for near-peer mentoring so that targets of bullying can share stories.”

Regarding who is responsible for addressing bullying, Dr. Iyer is emphatic. “I do want to be clear that the onus of disrupting does not fall on the targets. Rather, we need to fix the systems in which such behavior is tolerated.”

Her advice to leaders in academic medicine is to create comprehensive, zero-retaliation bullying policies that include detailed reporting procedures. Dr. Iyer advised leaders to partner with colleagues in human resources, offices of equity, and ombudspersons to develop, implement, and enforce these policies.

The study authors reported no conflicts of interest.

A version of this article first appeared on Medscape.com.

From the Department of Medicine, The George Washington University School of Medicine and Health Sciences, Washington, DC.

Abstract

Objective: Inpatient vaccination initiatives are well described in the literature. During the COVID-19 pandemic, hospitals began administering COVID-19 vaccines to hospitalized patients. Although vaccination rates increased, there remained many unvaccinated patients despite community efforts. This quality improvement project aimed to increase the COVID-19 vaccination rates of hospitalized patients on the medicine service at the George Washington University Hospital (GWUH).

Methods: From November 2021 through February 2022, we conducted a Plan-Do-Study-Act (PDSA) cycle with 3 phases. Initial steps included gathering baseline data from the electronic health record and consulting stakeholders. The first 2 phases focused on educating housestaff on the availability, ordering process, and administration of the Pfizer vaccine. The third phase consisted of developing educational pamphlets for patients to be included in their admission packets.

Results: The baseline mean COVID-19 vaccination rate (August to October 2021) of eligible patients on the medicine service was 10.7%. In the months after we implemented the PDSA cycle (November 2021 to February 2022), the mean vaccination rate increased to 15.4%.

Conclusion: This quality improvement project implemented measures to increase administration of the Pfizer vaccine to eligible patients admitted to the medicine service at GWUH. The mean vaccination rate increased from 10.7% in the 3 months prior to implementation to 15.4% during the 4 months post implementation. Other measures to consider in the future include increasing the availability of other COVID-19 vaccines at our hospital and incorporating the vaccine into the admission order set to help facilitate vaccination early in the hospital course.

Keywords: housestaff, quality improvement, PDSA, COVID-19, BNT162b2 vaccine, patient education

Throughout the COVID-19 pandemic, case rates in the United States have fluctuated considerably, corresponding to epidemic waves. In 2021, US daily cases of COVID-19 peaked at nearly 300,000 in early January and reached a nadir of 8000 cases in mid-June.¹ In September 2021, new cases had increased to 200,000 per day due to the prevalence of the Delta variant.¹ Particularly with the emergence of new variants of SARS-CoV-2, vaccination efforts to limit the spread of infection and severity of illness are critical. Data have shown that 2 doses of the BNT162b2 vaccine (Pfizer-BioNTech) were largely protective against severe infection for approximately 6 months.^2,3 When we began this quality improvement (QI) project in September 2021, only 179 million Americans had been fully vaccinated, according to data from the Centers for Disease Control and Prevention, which is just over half of the US population.⁴ An electronic survey conducted in the United States with more than 5 million responses found that, of those who were hesitant about receiving the vaccine, 49% reported a fear of adverse effects and 48% reported a lack of trust in the vaccine.⁵

This QI project sought to target unvaccinated individuals admitted to the internal medicine inpatient service. Vaccinating hospitalized patients is especially important since they are sicker than the general population and at higher risk of having poor outcomes from COVID-19. Inpatient vaccine initiatives, such as administering influenza vaccine prior to discharge, have been successfully implemented in the past.⁶ One large COVID-19 vaccination program featured an admission order set to increase the rates of vaccination among hospitalized patients.⁷ Our QI project piloted a multidisciplinary approach involving the nursing staff, pharmacy, information technology (IT) department, and internal medicine housestaff to increase COVID-19 vaccination rates among hospitalized patients on the medical service. This project aimed to increase inpatient vaccination rates through interventions targeting both primary providers as well as the patients themselves.

Methods

Setting and Interventions

This project was conducted at the George Washington University Hospital (GWUH) in Washington, DC. The clinicians involved in the study were the internal medicine housestaff, and the patients included were adults admitted to the resident medicine ward teams. The project was exempt by the institutional review board and did not require informed consent.

The quality improvement initiative had 3 phases, each featuring a different intervention (Table 1). The first phase involved sending a weekly announcement (via email and a secure health care messaging app) to current residents rotating on the inpatient medicine service. The announcement contained information regarding COVID-19 vaccine availability at the hospital, instructions on ordering the vaccine, and the process of coordinating with pharmacy to facilitate vaccine administration. Thereafter, residents were educated on the process of giving a COVID-19 vaccine to a patient from start to finish. Due to the nature of the residency schedule, different housestaff members rotated in and out of the medicine wards during the intervention periods. The weekly email was sent to the entire internal medicine housestaff, informing all residents about the QI project, while the weekly secure messages served as reminders and were only sent to residents currently on the medicine wards.

In the second phase, we posted paper flyers throughout the hospital to remind housestaff to give the vaccine and again educate them on the process of ordering the vaccine. For the third intervention, a COVID-19 vaccine educational pamphlet was developed for distribution to inpatients at GWUH. The pamphlet included information on vaccine efficacy, safety, side effects, and eligibility. The pamphlet was incorporated in the admission packet that every patient receives upon admission to the hospital. The patients reviewed the pamphlets with nursing staff, who would answer any questions, with residents available to discuss any outstanding concerns.

Measures and Data Gathering

The primary endpoint of the study was inpatient vaccination rate, defined as the number of COVID-19 vaccines administered divided by the number of patients eligible to receive a vaccine (not fully vaccinated). During initial triage, nursing staff documented vaccination status in the electronic health record (EHR), checking a box in a data entry form if a patient had received 0, 1, or 2 doses of the COVID-19 vaccine. The GWUH IT department generated data from this form to determine the number of patients eligible to receive a COVID-19 vaccine. Data were extracted from the medication administration record in the EHR to determine the number of vaccines that were administered to patients during their hospitalization on the inpatient medical service. Each month, the IT department extracted data for the number of eligible patients and the number of vaccines administered. This yielded the monthly vaccination rates. The monthly vaccination rates in the period prior to starting the QI initiative were compared to the rates in the period after the interventions were implemented.

Of note, during the course of this project, patients became eligible for a third COVID-19 vaccine (booster). We decided to continue with the original aim of vaccinating adults who had only received 0 or 1 dose of the vaccine. Therefore, the eligibility criteria remained the same throughout the study. We obtained retrospective data to ensure that the vaccines being counted toward the vaccination rate were vaccines given to patients not yet fully vaccinated and not vaccines given as boosters.

Results

From August to October 2021, the baseline average monthly vaccination rate of patients on the medicine service who were eligible to receive a COVID-19 vaccine was 10.7%. After the first intervention, the vaccination rate increased to 19.7% in November 2021 (Table 2). The second intervention yielded vaccination rates of 11.4% and 11.8% in December 2021 and January 2022, respectively. During the final phase in February 2022, the vaccination rate was 19.0%. At the conclusion of the study, the mean vaccination rate for the intervention months was 15.4% (Figure 1). Process stability and variation are demonstrated with a statistical process control chart (Figure 2).

For this housestaff-driven QI project, we implemented an inpatient COVID-19 vaccination campaign consisting of 3 phases that targeted both providers and patients. During the intervention period, we observed an increased vaccination rate compared to the period just prior to implementation of the QI project. While our interventions may certainly have boosted vaccination rates, we understand other variables could have contributed to increased rates as well. The emergence of variants in the United States, such as omicron in December 2021,⁸ could have precipitated a demand for vaccinations among patients. Holidays in November and December may also have increased patients’ desire to get vaccinated before travel.

We encountered a number of roadblocks that challenged our project, including difficulty identifying patients who were eligible for the vaccine, logistical vaccine administration challenges, and hesitancy among the inpatient population. Accurately identifying patients who were eligible for a vaccine in the EHR was especially challenging in the setting of rapidly changing guidelines regarding COVID-19 vaccination. In September 2021, the US Food and Drug Administration authorized the Pfizer booster for certain populations and later, in November 2021, for all adults. This meant that some fully vaccinated hospitalized patients (those with 2 doses) then qualified for an additional dose of the vaccine and received a dose during hospitalization. To determine the true vaccination rate, we obtained retrospective data that allowed us to track each vaccine administered. If a patient had already received 2 doses of the COVID-19 vaccine, the vaccine administered was counted as a booster and excluded from the calculation of the vaccination rate. Future PDSA cycles could include updating the EHR to capture the whole range of COVID-19 vaccination status (unvaccinated, partially vaccinated, fully vaccinated, fully vaccinated with 1 booster, fully vaccinated with 2 boosters).

We also encountered logistical challenges with the administration of the COVID-19 vaccine to hospitalized patients. During the intervention period, our pharmacy department required 5 COVID-19 vaccination orders before opening a vial and administering the vaccine doses in order to reduce waste. This policy may have limited our ability to vaccinate eligible inpatients because we were not always able to identify 5 patients simultaneously on the service who were eligible and consented to the vaccine.

The majority of patients who were interested in receiving COVID-19 vaccination had already been vaccinated in the outpatient setting. This fact made the inpatient internal medicine subset of patients a particularly challenging population to target, given their possible hesitancy regarding vaccination. By utilizing a multidisciplinary team and increasing communication of providers and nursing staff, we helped to increase the COVID-19 vaccination rates at our hospital from 10.7% to 15.4%.

Future Directions

Future interventions to consider include increasing the availability of other approved COVID-19 vaccines at our hospital besides the Pfizer-BioNTech vaccine. Furthermore, incorporating the vaccine into the admission order set would help initiate the vaccination process early in the hospital course. We encourage other institutions to utilize similar approaches to not only remind providers about inpatient vaccination, but also educate and encourage patients to receive the vaccine. These measures will help institutions increase inpatient COVID-19 vaccination rates in a high-risk population.

Corresponding author: Anna Rubin, MD, Department of Medicine, The George Washington University School of Medicine and Health Sciences, Washington, DC; [email protected]

Disclosures: None reported.

From the Department of Medicine, The George Washington University School of Medicine and Health Sciences, Washington, DC.

Abstract

Objective: Inpatient vaccination initiatives are well described in the literature. During the COVID-19 pandemic, hospitals began administering COVID-19 vaccines to hospitalized patients. Although vaccination rates increased, there remained many unvaccinated patients despite community efforts. This quality improvement project aimed to increase the COVID-19 vaccination rates of hospitalized patients on the medicine service at the George Washington University Hospital (GWUH).

Methods: From November 2021 through February 2022, we conducted a Plan-Do-Study-Act (PDSA) cycle with 3 phases. Initial steps included gathering baseline data from the electronic health record and consulting stakeholders. The first 2 phases focused on educating housestaff on the availability, ordering process, and administration of the Pfizer vaccine. The third phase consisted of developing educational pamphlets for patients to be included in their admission packets.

Results: The baseline mean COVID-19 vaccination rate (August to October 2021) of eligible patients on the medicine service was 10.7%. In the months after we implemented the PDSA cycle (November 2021 to February 2022), the mean vaccination rate increased to 15.4%.

Conclusion: This quality improvement project implemented measures to increase administration of the Pfizer vaccine to eligible patients admitted to the medicine service at GWUH. The mean vaccination rate increased from 10.7% in the 3 months prior to implementation to 15.4% during the 4 months post implementation. Other measures to consider in the future include increasing the availability of other COVID-19 vaccines at our hospital and incorporating the vaccine into the admission order set to help facilitate vaccination early in the hospital course.

Keywords: housestaff, quality improvement, PDSA, COVID-19, BNT162b2 vaccine, patient education

Throughout the COVID-19 pandemic, case rates in the United States have fluctuated considerably, corresponding to epidemic waves. In 2021, US daily cases of COVID-19 peaked at nearly 300,000 in early January and reached a nadir of 8000 cases in mid-June.¹ In September 2021, new cases had increased to 200,000 per day due to the prevalence of the Delta variant.¹ Particularly with the emergence of new variants of SARS-CoV-2, vaccination efforts to limit the spread of infection and severity of illness are critical. Data have shown that 2 doses of the BNT162b2 vaccine (Pfizer-BioNTech) were largely protective against severe infection for approximately 6 months.^2,3 When we began this quality improvement (QI) project in September 2021, only 179 million Americans had been fully vaccinated, according to data from the Centers for Disease Control and Prevention, which is just over half of the US population.⁴ An electronic survey conducted in the United States with more than 5 million responses found that, of those who were hesitant about receiving the vaccine, 49% reported a fear of adverse effects and 48% reported a lack of trust in the vaccine.⁵

This QI project sought to target unvaccinated individuals admitted to the internal medicine inpatient service. Vaccinating hospitalized patients is especially important since they are sicker than the general population and at higher risk of having poor outcomes from COVID-19. Inpatient vaccine initiatives, such as administering influenza vaccine prior to discharge, have been successfully implemented in the past.⁶ One large COVID-19 vaccination program featured an admission order set to increase the rates of vaccination among hospitalized patients.⁷ Our QI project piloted a multidisciplinary approach involving the nursing staff, pharmacy, information technology (IT) department, and internal medicine housestaff to increase COVID-19 vaccination rates among hospitalized patients on the medical service. This project aimed to increase inpatient vaccination rates through interventions targeting both primary providers as well as the patients themselves.

Methods

Setting and Interventions

This project was conducted at the George Washington University Hospital (GWUH) in Washington, DC. The clinicians involved in the study were the internal medicine housestaff, and the patients included were adults admitted to the resident medicine ward teams. The project was exempt by the institutional review board and did not require informed consent.

The quality improvement initiative had 3 phases, each featuring a different intervention (Table 1). The first phase involved sending a weekly announcement (via email and a secure health care messaging app) to current residents rotating on the inpatient medicine service. The announcement contained information regarding COVID-19 vaccine availability at the hospital, instructions on ordering the vaccine, and the process of coordinating with pharmacy to facilitate vaccine administration. Thereafter, residents were educated on the process of giving a COVID-19 vaccine to a patient from start to finish. Due to the nature of the residency schedule, different housestaff members rotated in and out of the medicine wards during the intervention periods. The weekly email was sent to the entire internal medicine housestaff, informing all residents about the QI project, while the weekly secure messages served as reminders and were only sent to residents currently on the medicine wards.

In the second phase, we posted paper flyers throughout the hospital to remind housestaff to give the vaccine and again educate them on the process of ordering the vaccine. For the third intervention, a COVID-19 vaccine educational pamphlet was developed for distribution to inpatients at GWUH. The pamphlet included information on vaccine efficacy, safety, side effects, and eligibility. The pamphlet was incorporated in the admission packet that every patient receives upon admission to the hospital. The patients reviewed the pamphlets with nursing staff, who would answer any questions, with residents available to discuss any outstanding concerns.

Measures and Data Gathering

The primary endpoint of the study was inpatient vaccination rate, defined as the number of COVID-19 vaccines administered divided by the number of patients eligible to receive a vaccine (not fully vaccinated). During initial triage, nursing staff documented vaccination status in the electronic health record (EHR), checking a box in a data entry form if a patient had received 0, 1, or 2 doses of the COVID-19 vaccine. The GWUH IT department generated data from this form to determine the number of patients eligible to receive a COVID-19 vaccine. Data were extracted from the medication administration record in the EHR to determine the number of vaccines that were administered to patients during their hospitalization on the inpatient medical service. Each month, the IT department extracted data for the number of eligible patients and the number of vaccines administered. This yielded the monthly vaccination rates. The monthly vaccination rates in the period prior to starting the QI initiative were compared to the rates in the period after the interventions were implemented.

Of note, during the course of this project, patients became eligible for a third COVID-19 vaccine (booster). We decided to continue with the original aim of vaccinating adults who had only received 0 or 1 dose of the vaccine. Therefore, the eligibility criteria remained the same throughout the study. We obtained retrospective data to ensure that the vaccines being counted toward the vaccination rate were vaccines given to patients not yet fully vaccinated and not vaccines given as boosters.

Results

From August to October 2021, the baseline average monthly vaccination rate of patients on the medicine service who were eligible to receive a COVID-19 vaccine was 10.7%. After the first intervention, the vaccination rate increased to 19.7% in November 2021 (Table 2). The second intervention yielded vaccination rates of 11.4% and 11.8% in December 2021 and January 2022, respectively. During the final phase in February 2022, the vaccination rate was 19.0%. At the conclusion of the study, the mean vaccination rate for the intervention months was 15.4% (Figure 1). Process stability and variation are demonstrated with a statistical process control chart (Figure 2).

For this housestaff-driven QI project, we implemented an inpatient COVID-19 vaccination campaign consisting of 3 phases that targeted both providers and patients. During the intervention period, we observed an increased vaccination rate compared to the period just prior to implementation of the QI project. While our interventions may certainly have boosted vaccination rates, we understand other variables could have contributed to increased rates as well. The emergence of variants in the United States, such as omicron in December 2021,⁸ could have precipitated a demand for vaccinations among patients. Holidays in November and December may also have increased patients’ desire to get vaccinated before travel.

We encountered a number of roadblocks that challenged our project, including difficulty identifying patients who were eligible for the vaccine, logistical vaccine administration challenges, and hesitancy among the inpatient population. Accurately identifying patients who were eligible for a vaccine in the EHR was especially challenging in the setting of rapidly changing guidelines regarding COVID-19 vaccination. In September 2021, the US Food and Drug Administration authorized the Pfizer booster for certain populations and later, in November 2021, for all adults. This meant that some fully vaccinated hospitalized patients (those with 2 doses) then qualified for an additional dose of the vaccine and received a dose during hospitalization. To determine the true vaccination rate, we obtained retrospective data that allowed us to track each vaccine administered. If a patient had already received 2 doses of the COVID-19 vaccine, the vaccine administered was counted as a booster and excluded from the calculation of the vaccination rate. Future PDSA cycles could include updating the EHR to capture the whole range of COVID-19 vaccination status (unvaccinated, partially vaccinated, fully vaccinated, fully vaccinated with 1 booster, fully vaccinated with 2 boosters).

We also encountered logistical challenges with the administration of the COVID-19 vaccine to hospitalized patients. During the intervention period, our pharmacy department required 5 COVID-19 vaccination orders before opening a vial and administering the vaccine doses in order to reduce waste. This policy may have limited our ability to vaccinate eligible inpatients because we were not always able to identify 5 patients simultaneously on the service who were eligible and consented to the vaccine.

The majority of patients who were interested in receiving COVID-19 vaccination had already been vaccinated in the outpatient setting. This fact made the inpatient internal medicine subset of patients a particularly challenging population to target, given their possible hesitancy regarding vaccination. By utilizing a multidisciplinary team and increasing communication of providers and nursing staff, we helped to increase the COVID-19 vaccination rates at our hospital from 10.7% to 15.4%.

Future Directions

Future interventions to consider include increasing the availability of other approved COVID-19 vaccines at our hospital besides the Pfizer-BioNTech vaccine. Furthermore, incorporating the vaccine into the admission order set would help initiate the vaccination process early in the hospital course. We encourage other institutions to utilize similar approaches to not only remind providers about inpatient vaccination, but also educate and encourage patients to receive the vaccine. These measures will help institutions increase inpatient COVID-19 vaccination rates in a high-risk population.

Corresponding author: Anna Rubin, MD, Department of Medicine, The George Washington University School of Medicine and Health Sciences, Washington, DC; [email protected]

Disclosures: None reported.

From the Department of Medicine, The George Washington University School of Medicine and Health Sciences, Washington, DC.

Abstract

Objective: Inpatient vaccination initiatives are well described in the literature. During the COVID-19 pandemic, hospitals began administering COVID-19 vaccines to hospitalized patients. Although vaccination rates increased, there remained many unvaccinated patients despite community efforts. This quality improvement project aimed to increase the COVID-19 vaccination rates of hospitalized patients on the medicine service at the George Washington University Hospital (GWUH).

Methods: From November 2021 through February 2022, we conducted a Plan-Do-Study-Act (PDSA) cycle with 3 phases. Initial steps included gathering baseline data from the electronic health record and consulting stakeholders. The first 2 phases focused on educating housestaff on the availability, ordering process, and administration of the Pfizer vaccine. The third phase consisted of developing educational pamphlets for patients to be included in their admission packets.

Results: The baseline mean COVID-19 vaccination rate (August to October 2021) of eligible patients on the medicine service was 10.7%. In the months after we implemented the PDSA cycle (November 2021 to February 2022), the mean vaccination rate increased to 15.4%.

Conclusion: This quality improvement project implemented measures to increase administration of the Pfizer vaccine to eligible patients admitted to the medicine service at GWUH. The mean vaccination rate increased from 10.7% in the 3 months prior to implementation to 15.4% during the 4 months post implementation. Other measures to consider in the future include increasing the availability of other COVID-19 vaccines at our hospital and incorporating the vaccine into the admission order set to help facilitate vaccination early in the hospital course.

Keywords: housestaff, quality improvement, PDSA, COVID-19, BNT162b2 vaccine, patient education

Throughout the COVID-19 pandemic, case rates in the United States have fluctuated considerably, corresponding to epidemic waves. In 2021, US daily cases of COVID-19 peaked at nearly 300,000 in early January and reached a nadir of 8000 cases in mid-June.¹ In September 2021, new cases had increased to 200,000 per day due to the prevalence of the Delta variant.¹ Particularly with the emergence of new variants of SARS-CoV-2, vaccination efforts to limit the spread of infection and severity of illness are critical. Data have shown that 2 doses of the BNT162b2 vaccine (Pfizer-BioNTech) were largely protective against severe infection for approximately 6 months.^2,3 When we began this quality improvement (QI) project in September 2021, only 179 million Americans had been fully vaccinated, according to data from the Centers for Disease Control and Prevention, which is just over half of the US population.⁴ An electronic survey conducted in the United States with more than 5 million responses found that, of those who were hesitant about receiving the vaccine, 49% reported a fear of adverse effects and 48% reported a lack of trust in the vaccine.⁵

This QI project sought to target unvaccinated individuals admitted to the internal medicine inpatient service. Vaccinating hospitalized patients is especially important since they are sicker than the general population and at higher risk of having poor outcomes from COVID-19. Inpatient vaccine initiatives, such as administering influenza vaccine prior to discharge, have been successfully implemented in the past.⁶ One large COVID-19 vaccination program featured an admission order set to increase the rates of vaccination among hospitalized patients.⁷ Our QI project piloted a multidisciplinary approach involving the nursing staff, pharmacy, information technology (IT) department, and internal medicine housestaff to increase COVID-19 vaccination rates among hospitalized patients on the medical service. This project aimed to increase inpatient vaccination rates through interventions targeting both primary providers as well as the patients themselves.

Methods

Setting and Interventions

This project was conducted at the George Washington University Hospital (GWUH) in Washington, DC. The clinicians involved in the study were the internal medicine housestaff, and the patients included were adults admitted to the resident medicine ward teams. The project was exempt by the institutional review board and did not require informed consent.

The quality improvement initiative had 3 phases, each featuring a different intervention (Table 1). The first phase involved sending a weekly announcement (via email and a secure health care messaging app) to current residents rotating on the inpatient medicine service. The announcement contained information regarding COVID-19 vaccine availability at the hospital, instructions on ordering the vaccine, and the process of coordinating with pharmacy to facilitate vaccine administration. Thereafter, residents were educated on the process of giving a COVID-19 vaccine to a patient from start to finish. Due to the nature of the residency schedule, different housestaff members rotated in and out of the medicine wards during the intervention periods. The weekly email was sent to the entire internal medicine housestaff, informing all residents about the QI project, while the weekly secure messages served as reminders and were only sent to residents currently on the medicine wards.

In the second phase, we posted paper flyers throughout the hospital to remind housestaff to give the vaccine and again educate them on the process of ordering the vaccine. For the third intervention, a COVID-19 vaccine educational pamphlet was developed for distribution to inpatients at GWUH. The pamphlet included information on vaccine efficacy, safety, side effects, and eligibility. The pamphlet was incorporated in the admission packet that every patient receives upon admission to the hospital. The patients reviewed the pamphlets with nursing staff, who would answer any questions, with residents available to discuss any outstanding concerns.

Measures and Data Gathering

The primary endpoint of the study was inpatient vaccination rate, defined as the number of COVID-19 vaccines administered divided by the number of patients eligible to receive a vaccine (not fully vaccinated). During initial triage, nursing staff documented vaccination status in the electronic health record (EHR), checking a box in a data entry form if a patient had received 0, 1, or 2 doses of the COVID-19 vaccine. The GWUH IT department generated data from this form to determine the number of patients eligible to receive a COVID-19 vaccine. Data were extracted from the medication administration record in the EHR to determine the number of vaccines that were administered to patients during their hospitalization on the inpatient medical service. Each month, the IT department extracted data for the number of eligible patients and the number of vaccines administered. This yielded the monthly vaccination rates. The monthly vaccination rates in the period prior to starting the QI initiative were compared to the rates in the period after the interventions were implemented.

Of note, during the course of this project, patients became eligible for a third COVID-19 vaccine (booster). We decided to continue with the original aim of vaccinating adults who had only received 0 or 1 dose of the vaccine. Therefore, the eligibility criteria remained the same throughout the study. We obtained retrospective data to ensure that the vaccines being counted toward the vaccination rate were vaccines given to patients not yet fully vaccinated and not vaccines given as boosters.

Results

From August to October 2021, the baseline average monthly vaccination rate of patients on the medicine service who were eligible to receive a COVID-19 vaccine was 10.7%. After the first intervention, the vaccination rate increased to 19.7% in November 2021 (Table 2). The second intervention yielded vaccination rates of 11.4% and 11.8% in December 2021 and January 2022, respectively. During the final phase in February 2022, the vaccination rate was 19.0%. At the conclusion of the study, the mean vaccination rate for the intervention months was 15.4% (Figure 1). Process stability and variation are demonstrated with a statistical process control chart (Figure 2).

For this housestaff-driven QI project, we implemented an inpatient COVID-19 vaccination campaign consisting of 3 phases that targeted both providers and patients. During the intervention period, we observed an increased vaccination rate compared to the period just prior to implementation of the QI project. While our interventions may certainly have boosted vaccination rates, we understand other variables could have contributed to increased rates as well. The emergence of variants in the United States, such as omicron in December 2021,⁸ could have precipitated a demand for vaccinations among patients. Holidays in November and December may also have increased patients’ desire to get vaccinated before travel.

We encountered a number of roadblocks that challenged our project, including difficulty identifying patients who were eligible for the vaccine, logistical vaccine administration challenges, and hesitancy among the inpatient population. Accurately identifying patients who were eligible for a vaccine in the EHR was especially challenging in the setting of rapidly changing guidelines regarding COVID-19 vaccination. In September 2021, the US Food and Drug Administration authorized the Pfizer booster for certain populations and later, in November 2021, for all adults. This meant that some fully vaccinated hospitalized patients (those with 2 doses) then qualified for an additional dose of the vaccine and received a dose during hospitalization. To determine the true vaccination rate, we obtained retrospective data that allowed us to track each vaccine administered. If a patient had already received 2 doses of the COVID-19 vaccine, the vaccine administered was counted as a booster and excluded from the calculation of the vaccination rate. Future PDSA cycles could include updating the EHR to capture the whole range of COVID-19 vaccination status (unvaccinated, partially vaccinated, fully vaccinated, fully vaccinated with 1 booster, fully vaccinated with 2 boosters).

We also encountered logistical challenges with the administration of the COVID-19 vaccine to hospitalized patients. During the intervention period, our pharmacy department required 5 COVID-19 vaccination orders before opening a vial and administering the vaccine doses in order to reduce waste. This policy may have limited our ability to vaccinate eligible inpatients because we were not always able to identify 5 patients simultaneously on the service who were eligible and consented to the vaccine.

The majority of patients who were interested in receiving COVID-19 vaccination had already been vaccinated in the outpatient setting. This fact made the inpatient internal medicine subset of patients a particularly challenging population to target, given their possible hesitancy regarding vaccination. By utilizing a multidisciplinary team and increasing communication of providers and nursing staff, we helped to increase the COVID-19 vaccination rates at our hospital from 10.7% to 15.4%.

Future Directions

Future interventions to consider include increasing the availability of other approved COVID-19 vaccines at our hospital besides the Pfizer-BioNTech vaccine. Furthermore, incorporating the vaccine into the admission order set would help initiate the vaccination process early in the hospital course. We encourage other institutions to utilize similar approaches to not only remind providers about inpatient vaccination, but also educate and encourage patients to receive the vaccine. These measures will help institutions increase inpatient COVID-19 vaccination rates in a high-risk population.

Corresponding author: Anna Rubin, MD, Department of Medicine, The George Washington University School of Medicine and Health Sciences, Washington, DC; [email protected]

Disclosures: None reported.

From the T1D Exchange, Boston, MA (Ann Mungmode, Nicole Rioles, Jesse Cases, Dr. Ebekozien); The Leona M. and Harry B. Hemsley Charitable Trust, New York, NY (Laurel Koester); and the University of Mississippi School of Population Health, Jackson, MS (Dr. Ebekozien).

Abstract

There have been remarkable innovations in diabetes management since the start of the COVID-19 pandemic, but these groundbreaking innovations are drawing limited focus as the field focuses on the adverse impact of the pandemic on patients with diabetes. This article reviews select population health innovations in diabetes management that have become available over the past 2 years of the COVID-19 pandemic from the perspective of the T1D Exchange Quality Improvement Collaborative, a learning health network that focuses on improving care and outcomes for individuals with type 1 diabetes (T1D). Such innovations include expanded telemedicine access, collection of real-world data, machine learning and artificial intelligence, and new diabetes medications and devices. In addition, multiple innovative studies have been undertaken to explore contributors to health inequities in diabetes, and advocacy efforts for specific populations have been successful. Looking to the future, work is required to explore additional health equity successes that do not further exacerbate inequities and to look for additional innovative ways to engage people with T1D in their health care through conversations on social determinants of health and societal structures.

Keywords: type 1 diabetes, learning health network, continuous glucose monitoring, health equity

One in 10 people in the United States has diabetes.¹ Diabetes is the nation’s second leading cause of death, costing the US health system more than $300 billion annually.² The COVID-19 pandemic presented additional health burdens for people living with diabetes. For example, preexisting diabetes was identified as a risk factor for COVID-19–associated morbidity and mortality.^3,4 Over the past 2 years, there have been remarkable innovations in diabetes management, including stem cell therapy and new medication options. Additionally, improved technology solutions have aided in diabetes management through continuous glucose monitors (CGM), smart insulin pens, advanced hybrid closed-loop systems, and continuous subcutaneous insulin injections.^5,6 Unfortunately, these groundbreaking innovations are drawing limited focus, as the field is rightfully focused on the adverse impact of the pandemic on patients with diabetes.

Learning health networks like the T1D Exchange Quality Improvement Collaborative (T1DX-QI) have implemented some of these innovative solutions to improve care for people with diabetes.⁷ T1DX-QI has more than 50 data-sharing endocrinology centers that care for over 75,000 people with diabetes across the United States (Figure 1). Centers participating in the T1DX-QI use quality improvement (QI) and implementation science methods to quickly translate research into evidence-based clinical practice. T1DX-QI leads diabetes population health and health system research and supports widespread transferability across health care organizations through regular collaborative calls, conferences, and case study documentation.⁸

In this review, we summarize impactful population health innovations in diabetes management that have become available over the past 2 years of the COVID-19 pandemic from the perspective of T1DX-QI (see Figure 2 for relevant definitions). This review is limited in scope and is not meant to be an exhaustive list of innovations. The review also reflects significant changes from the perspective of academic diabetes centers, which may not apply to rural or primary care diabetes practices.

The first (A.M.), second (H.H.), and senior (O.E.) authors conducted a scoping review of published literature using terms related to diabetes, population health, and innovation on PubMed Central and Google Scholar for the period March 2020 to June 2022. To complement the review, A.M. and O.E. also reviewed abstracts from presentations at major international diabetes conferences, including the American Diabetes Association (ADA), the International Society for Pediatric and Adolescent Diabetes (ISPAD), the T1DX-QI Learning Session Conference, and the Advanced Technologies & Treatments for Diabetes (ATTD) 2020 to 2022 conferences.^9-14 The authors also searched FDA.gov and ClinicalTrials.gov for relevant insights. A.M. and O.E. sorted the reviewed literature into major themes (Figure 3) from the population health improvement perspective of the T1DX-QI.

Population Health Innovations in Diabetes Management

Expansion of Telemedicine Access

Telemedicine is cost-effective for patients with diabetes,¹⁵ including those with complex cases.¹⁶ Before the COVID-19 pandemic, telemedicine and virtual care were rare in diabetes management. However, the pandemic offered a new opportunity to expand the practice of telemedicine in diabetes management. A study from the T1DX-QI showed that telemedicine visits grew from comprising <1% of visits pre-pandemic (December 2019) to 95.2% during the pandemic (August 2020).¹⁷ Additional studies, like those conducted by Phillip et al,¹⁸ confirmed the noninferiority of telemedicine practice for patients with diabetes.Telemedicine was also found to be an effective strategy to educate patients on the use of diabetes technologies.¹⁹

Real-World Data and Disease Surveillance

As the COVID-19 pandemic exacerbated outcomes for people with type 1 diabetes (T1D), a need arose to understand the immediate effects of the pandemic on people with T1D through real-world data and disease surveillance. In April 2020, the T1DX-QI initiated a multicenter surveillance study to collect data and analyze the impact of COVID-19 on people with T1D. The existing health collaborative served as a springboard for robust surveillance study, documenting numerous works on the effects of COVID-19.^3,4,20-28 Other investigators also embraced the power of real-world surveillance and real-world data.^29,30

Big Data, Machine Learning, and Artificial Intelligence

The past 2 years have seen a shift toward embracing the incredible opportunity to tap the large volume of data generated from routine care for practical insights.³¹ In particular, researchers have demonstrated the widespread application of machine learning and artificial intelligence to improve diabetes management.³² The T1DX-QI also harnessed the growing power of big data by expanding the functionality of innovative benchmarking software. The T1DX QI Portal uses electronic medical record data of diabetes patients for clinic-to-clinic benchmarking and data analysis, using business intelligence solutions.³³

Health Equity

While inequities across various health outcomes have been well documented for years,³⁴ the COVID-19 pandemic further exaggerated racial/ethnic health inequities in T1D.^23,35 In response, several organizations have outlined specific strategies to address these health inequities. Emboldened by the pandemic, the T1DX-QI announced a multipronged approach to address health inequities among patients with T1D through the Health Equity Advancement Lab (HEAL).³⁶ One of HEAL’s main components is using real-world data to champion population-level insights and demonstrate progress in QI efforts.

Multiple innovative studies have been undertaken to explore contributors to health inequities in diabetes, and these studies are expanding our understanding of the chasm.³⁷ There have also been innovative solutions to addressing these inequities, with multiple studies published over the past 2 years.³⁸ A source of inequity among patients with T1D is the lack of representation of racial/ethnic minorities with T1D in clinical trials.³⁹ The T1DX-QI suggests that the equity-adapted framework for QI can be applied by research leaders to support trial diversity and representation, ensuring future device innovations are meaningful for all people with T1D.⁴⁰

Diabetes Devices

Glucose monitoring and insulin therapy are vital tools to support individuals living with T1D, and devices such as CGM and insulin pumps have become the standard of care for diabetes management (Table).⁴¹ Innovations in diabetes technology and device access are imperative for a chronic disease with no cure.

The COVID-19 pandemic created an opportunity to increase access to diabetes devices in inpatient settings. In 2020, the US Food and Drug Administration expanded the use of CGM to support remote monitoring of patients in inpatient hospital settings, simultaneously supporting the glucose monitoring needs of patients with T1D and reducing COVID-19 transmission through reduced patient-clinician contact.⁴² This effort has been expanded and will continue in 2022 and beyond,⁴³ and aligns with the growing consensus that supports patients wearing both CGMs and insulin pumps in ambulatory settings to improve patient health outcomes.⁴⁴

Since 2020, innovations in diabetes technology have improved and increased the variety of options available to people with T1D and made them easier to use (Table). New, advanced hybrid closed-loop systems have progressed to offer Bluetooth features, including automatic software upgrades, tubeless systems, and the ability to allow parents to use their smartphones to bolus for children.^45-47 The next big step in insulin delivery innovation is the release of functioning, fully closed loop systems, of which several are currently in clinical trials.⁴⁸ These systems support reduced hypoglycemia and improved time in range.⁴⁹

Additional innovations in insulin delivery have improved the user experience and expanded therapeutic options, including a variety of smart insulin pens complete with dosing logs^50,51 and even a patch to deliver insulin without the burden of injections.⁵² As barriers to diabetes technology persist,⁵³ innovations in alternate insulin delivery provide people with T1D more options to align with their personal access and technology preferences.

Innovations in CGM address cited barriers to their use, including size or overall wear.^53-55 CGMs released in the past few years are smaller in physical size, have longer durations of time between changings, are more accurate, and do not require calibrations for accuracy.

New Diabetes Medications

Many new medications and therapeutic advances have become available in the past 2 years.⁵⁶ Additionally, more medications are being tested as adjunct therapies to support glycemic management in patients with T1D, including metformin, sodium-glucose cotransporter 1 and 2 inhibitors, pramlintide, glucagon-like polypeptide-1 analogs, and glucagon receptor agonists.⁵⁷ Other recent advances include stem cell replacement therapy for patients with T1D.⁵⁸ The ultra-long-acting biosimilar insulins are one medical innovation that has been stalled, rather than propelled, during the COVID-19 pandemic.⁵⁹

Diabetes Policy Advocacy

People with T1D require insulin to survive. The cost of insulin has increased in recent years, with some studies citing a 64% to 100% increase in the past decade.^60,61 In fact, 1 in 4 insulin users report that cost has impacted their insulin use, including rationing their insulin.⁶² Lockdowns during the COVID-19 pandemic stressed US families financially, increasing the urgency for insulin cost caps.

Although the COVID-19 pandemic halted national conversations on drug financing,⁶³ advocacy efforts have succeeded for specific populations. The new Medicare Part D Senior Savings Model will cap the cost of insulin at $35 for a 30-day supply,⁶⁴ and 20 states passed legislation capping insulin pricing.⁶² Efforts to codify national cost caps are under debate, including the passage of the Affordable Insulin Now Act, which passed the House in March 2022 and is currently under review in the Senate.⁶⁵

Funders and industry partners play a crucial role in leading and supporting innovations that improve the lives of people with T1D and reduce society’s costs of living with the disease. Data infrastructure is critical to supporting population health. While building the data infrastructure to support population health is both time- and resource-intensive, private foundations such as Helmsley are uniquely positioned—and have a responsibility—to take large, informed risks to help reach all communities with T1D.

The T1DX-QI is the largest source of population health data on T1D in the United States and is becoming the premiere data authority on its incidence, prevalence, and outcomes. The T1DX-QI enables a robust understanding of T1D-related health trends at the population level, as well as trends among clinics and providers. Pilot centers in the T1DX-QI have reported reductions in patients’ A1c and acute diabetes-related events, as well as improvements in device usage and depression screening. The ability to capture changes speaks to the promise and power of these data to demonstrate the clinical impact of QI interventions and to support the spread of best practices and learnings across health systems.

Additional philanthropic efforts have supported innovation in the last 2 years. For example, the JDRF, a nonprofit philanthropic equity firm, has supported efforts in developing artificial pancreas systems and cell therapies currently in clinical trials like teplizumab, a drug that has demonstrated delayed onset of T1D through JDRF’s T1D Fund.⁶⁶ Industry partners also have an opportunity for significant influence in this area, as they continue to fund meaningful projects to advance care for people with T1D.⁶⁷

Conclusion

We are optimistic that the innovations summarized here describe a shift in the tide of equitable T1D outcomes; however, future work is required to explore additional health equity successes that do not further exacerbate inequities. We also see further opportunities for innovative ways to engage people with T1D in their health care through conversations on social determinants of health and societal structures.

Corresponding author: Ann Mungmode, MPH, T1D Exchange, 11 Avenue de Lafayette, Boston, MA 02111; Email: [email protected]

Disclosures: Dr. Ebekozien serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for the Medtronic Advisory Board and received research grants from Medtronic Diabetes, Eli Lilly, and Dexcom.

Funding: The T1DX-QI is funded by The Leona M. and Harry B. Hemsley Charitable Trust.

From the T1D Exchange, Boston, MA (Ann Mungmode, Nicole Rioles, Jesse Cases, Dr. Ebekozien); The Leona M. and Harry B. Hemsley Charitable Trust, New York, NY (Laurel Koester); and the University of Mississippi School of Population Health, Jackson, MS (Dr. Ebekozien).

Abstract

There have been remarkable innovations in diabetes management since the start of the COVID-19 pandemic, but these groundbreaking innovations are drawing limited focus as the field focuses on the adverse impact of the pandemic on patients with diabetes. This article reviews select population health innovations in diabetes management that have become available over the past 2 years of the COVID-19 pandemic from the perspective of the T1D Exchange Quality Improvement Collaborative, a learning health network that focuses on improving care and outcomes for individuals with type 1 diabetes (T1D). Such innovations include expanded telemedicine access, collection of real-world data, machine learning and artificial intelligence, and new diabetes medications and devices. In addition, multiple innovative studies have been undertaken to explore contributors to health inequities in diabetes, and advocacy efforts for specific populations have been successful. Looking to the future, work is required to explore additional health equity successes that do not further exacerbate inequities and to look for additional innovative ways to engage people with T1D in their health care through conversations on social determinants of health and societal structures.

Keywords: type 1 diabetes, learning health network, continuous glucose monitoring, health equity

One in 10 people in the United States has diabetes.¹ Diabetes is the nation’s second leading cause of death, costing the US health system more than $300 billion annually.² The COVID-19 pandemic presented additional health burdens for people living with diabetes. For example, preexisting diabetes was identified as a risk factor for COVID-19–associated morbidity and mortality.^3,4 Over the past 2 years, there have been remarkable innovations in diabetes management, including stem cell therapy and new medication options. Additionally, improved technology solutions have aided in diabetes management through continuous glucose monitors (CGM), smart insulin pens, advanced hybrid closed-loop systems, and continuous subcutaneous insulin injections.^5,6 Unfortunately, these groundbreaking innovations are drawing limited focus, as the field is rightfully focused on the adverse impact of the pandemic on patients with diabetes.

Learning health networks like the T1D Exchange Quality Improvement Collaborative (T1DX-QI) have implemented some of these innovative solutions to improve care for people with diabetes.⁷ T1DX-QI has more than 50 data-sharing endocrinology centers that care for over 75,000 people with diabetes across the United States (Figure 1). Centers participating in the T1DX-QI use quality improvement (QI) and implementation science methods to quickly translate research into evidence-based clinical practice. T1DX-QI leads diabetes population health and health system research and supports widespread transferability across health care organizations through regular collaborative calls, conferences, and case study documentation.⁸

In this review, we summarize impactful population health innovations in diabetes management that have become available over the past 2 years of the COVID-19 pandemic from the perspective of T1DX-QI (see Figure 2 for relevant definitions). This review is limited in scope and is not meant to be an exhaustive list of innovations. The review also reflects significant changes from the perspective of academic diabetes centers, which may not apply to rural or primary care diabetes practices.

The first (A.M.), second (H.H.), and senior (O.E.) authors conducted a scoping review of published literature using terms related to diabetes, population health, and innovation on PubMed Central and Google Scholar for the period March 2020 to June 2022. To complement the review, A.M. and O.E. also reviewed abstracts from presentations at major international diabetes conferences, including the American Diabetes Association (ADA), the International Society for Pediatric and Adolescent Diabetes (ISPAD), the T1DX-QI Learning Session Conference, and the Advanced Technologies & Treatments for Diabetes (ATTD) 2020 to 2022 conferences.^9-14 The authors also searched FDA.gov and ClinicalTrials.gov for relevant insights. A.M. and O.E. sorted the reviewed literature into major themes (Figure 3) from the population health improvement perspective of the T1DX-QI.

Population Health Innovations in Diabetes Management

Expansion of Telemedicine Access

Telemedicine is cost-effective for patients with diabetes,¹⁵ including those with complex cases.¹⁶ Before the COVID-19 pandemic, telemedicine and virtual care were rare in diabetes management. However, the pandemic offered a new opportunity to expand the practice of telemedicine in diabetes management. A study from the T1DX-QI showed that telemedicine visits grew from comprising <1% of visits pre-pandemic (December 2019) to 95.2% during the pandemic (August 2020).¹⁷ Additional studies, like those conducted by Phillip et al,¹⁸ confirmed the noninferiority of telemedicine practice for patients with diabetes.Telemedicine was also found to be an effective strategy to educate patients on the use of diabetes technologies.¹⁹

Real-World Data and Disease Surveillance

As the COVID-19 pandemic exacerbated outcomes for people with type 1 diabetes (T1D), a need arose to understand the immediate effects of the pandemic on people with T1D through real-world data and disease surveillance. In April 2020, the T1DX-QI initiated a multicenter surveillance study to collect data and analyze the impact of COVID-19 on people with T1D. The existing health collaborative served as a springboard for robust surveillance study, documenting numerous works on the effects of COVID-19.^3,4,20-28 Other investigators also embraced the power of real-world surveillance and real-world data.^29,30

Big Data, Machine Learning, and Artificial Intelligence

The past 2 years have seen a shift toward embracing the incredible opportunity to tap the large volume of data generated from routine care for practical insights.³¹ In particular, researchers have demonstrated the widespread application of machine learning and artificial intelligence to improve diabetes management.³² The T1DX-QI also harnessed the growing power of big data by expanding the functionality of innovative benchmarking software. The T1DX QI Portal uses electronic medical record data of diabetes patients for clinic-to-clinic benchmarking and data analysis, using business intelligence solutions.³³

Health Equity

While inequities across various health outcomes have been well documented for years,³⁴ the COVID-19 pandemic further exaggerated racial/ethnic health inequities in T1D.^23,35 In response, several organizations have outlined specific strategies to address these health inequities. Emboldened by the pandemic, the T1DX-QI announced a multipronged approach to address health inequities among patients with T1D through the Health Equity Advancement Lab (HEAL).³⁶ One of HEAL’s main components is using real-world data to champion population-level insights and demonstrate progress in QI efforts.

Multiple innovative studies have been undertaken to explore contributors to health inequities in diabetes, and these studies are expanding our understanding of the chasm.³⁷ There have also been innovative solutions to addressing these inequities, with multiple studies published over the past 2 years.³⁸ A source of inequity among patients with T1D is the lack of representation of racial/ethnic minorities with T1D in clinical trials.³⁹ The T1DX-QI suggests that the equity-adapted framework for QI can be applied by research leaders to support trial diversity and representation, ensuring future device innovations are meaningful for all people with T1D.⁴⁰

Diabetes Devices

Glucose monitoring and insulin therapy are vital tools to support individuals living with T1D, and devices such as CGM and insulin pumps have become the standard of care for diabetes management (Table).⁴¹ Innovations in diabetes technology and device access are imperative for a chronic disease with no cure.

The COVID-19 pandemic created an opportunity to increase access to diabetes devices in inpatient settings. In 2020, the US Food and Drug Administration expanded the use of CGM to support remote monitoring of patients in inpatient hospital settings, simultaneously supporting the glucose monitoring needs of patients with T1D and reducing COVID-19 transmission through reduced patient-clinician contact.⁴² This effort has been expanded and will continue in 2022 and beyond,⁴³ and aligns with the growing consensus that supports patients wearing both CGMs and insulin pumps in ambulatory settings to improve patient health outcomes.⁴⁴

Since 2020, innovations in diabetes technology have improved and increased the variety of options available to people with T1D and made them easier to use (Table). New, advanced hybrid closed-loop systems have progressed to offer Bluetooth features, including automatic software upgrades, tubeless systems, and the ability to allow parents to use their smartphones to bolus for children.^45-47 The next big step in insulin delivery innovation is the release of functioning, fully closed loop systems, of which several are currently in clinical trials.⁴⁸ These systems support reduced hypoglycemia and improved time in range.⁴⁹

Additional innovations in insulin delivery have improved the user experience and expanded therapeutic options, including a variety of smart insulin pens complete with dosing logs^50,51 and even a patch to deliver insulin without the burden of injections.⁵² As barriers to diabetes technology persist,⁵³ innovations in alternate insulin delivery provide people with T1D more options to align with their personal access and technology preferences.

Innovations in CGM address cited barriers to their use, including size or overall wear.^53-55 CGMs released in the past few years are smaller in physical size, have longer durations of time between changings, are more accurate, and do not require calibrations for accuracy.

New Diabetes Medications

Many new medications and therapeutic advances have become available in the past 2 years.⁵⁶ Additionally, more medications are being tested as adjunct therapies to support glycemic management in patients with T1D, including metformin, sodium-glucose cotransporter 1 and 2 inhibitors, pramlintide, glucagon-like polypeptide-1 analogs, and glucagon receptor agonists.⁵⁷ Other recent advances include stem cell replacement therapy for patients with T1D.⁵⁸ The ultra-long-acting biosimilar insulins are one medical innovation that has been stalled, rather than propelled, during the COVID-19 pandemic.⁵⁹

Diabetes Policy Advocacy

People with T1D require insulin to survive. The cost of insulin has increased in recent years, with some studies citing a 64% to 100% increase in the past decade.^60,61 In fact, 1 in 4 insulin users report that cost has impacted their insulin use, including rationing their insulin.⁶² Lockdowns during the COVID-19 pandemic stressed US families financially, increasing the urgency for insulin cost caps.

Although the COVID-19 pandemic halted national conversations on drug financing,⁶³ advocacy efforts have succeeded for specific populations. The new Medicare Part D Senior Savings Model will cap the cost of insulin at $35 for a 30-day supply,⁶⁴ and 20 states passed legislation capping insulin pricing.⁶² Efforts to codify national cost caps are under debate, including the passage of the Affordable Insulin Now Act, which passed the House in March 2022 and is currently under review in the Senate.⁶⁵

Funders and industry partners play a crucial role in leading and supporting innovations that improve the lives of people with T1D and reduce society’s costs of living with the disease. Data infrastructure is critical to supporting population health. While building the data infrastructure to support population health is both time- and resource-intensive, private foundations such as Helmsley are uniquely positioned—and have a responsibility—to take large, informed risks to help reach all communities with T1D.

The T1DX-QI is the largest source of population health data on T1D in the United States and is becoming the premiere data authority on its incidence, prevalence, and outcomes. The T1DX-QI enables a robust understanding of T1D-related health trends at the population level, as well as trends among clinics and providers. Pilot centers in the T1DX-QI have reported reductions in patients’ A1c and acute diabetes-related events, as well as improvements in device usage and depression screening. The ability to capture changes speaks to the promise and power of these data to demonstrate the clinical impact of QI interventions and to support the spread of best practices and learnings across health systems.

Additional philanthropic efforts have supported innovation in the last 2 years. For example, the JDRF, a nonprofit philanthropic equity firm, has supported efforts in developing artificial pancreas systems and cell therapies currently in clinical trials like teplizumab, a drug that has demonstrated delayed onset of T1D through JDRF’s T1D Fund.⁶⁶ Industry partners also have an opportunity for significant influence in this area, as they continue to fund meaningful projects to advance care for people with T1D.⁶⁷

Conclusion

We are optimistic that the innovations summarized here describe a shift in the tide of equitable T1D outcomes; however, future work is required to explore additional health equity successes that do not further exacerbate inequities. We also see further opportunities for innovative ways to engage people with T1D in their health care through conversations on social determinants of health and societal structures.

Corresponding author: Ann Mungmode, MPH, T1D Exchange, 11 Avenue de Lafayette, Boston, MA 02111; Email: [email protected]

Disclosures: Dr. Ebekozien serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for the Medtronic Advisory Board and received research grants from Medtronic Diabetes, Eli Lilly, and Dexcom.

Funding: The T1DX-QI is funded by The Leona M. and Harry B. Hemsley Charitable Trust.

From the T1D Exchange, Boston, MA (Ann Mungmode, Nicole Rioles, Jesse Cases, Dr. Ebekozien); The Leona M. and Harry B. Hemsley Charitable Trust, New York, NY (Laurel Koester); and the University of Mississippi School of Population Health, Jackson, MS (Dr. Ebekozien).

Abstract

There have been remarkable innovations in diabetes management since the start of the COVID-19 pandemic, but these groundbreaking innovations are drawing limited focus as the field focuses on the adverse impact of the pandemic on patients with diabetes. This article reviews select population health innovations in diabetes management that have become available over the past 2 years of the COVID-19 pandemic from the perspective of the T1D Exchange Quality Improvement Collaborative, a learning health network that focuses on improving care and outcomes for individuals with type 1 diabetes (T1D). Such innovations include expanded telemedicine access, collection of real-world data, machine learning and artificial intelligence, and new diabetes medications and devices. In addition, multiple innovative studies have been undertaken to explore contributors to health inequities in diabetes, and advocacy efforts for specific populations have been successful. Looking to the future, work is required to explore additional health equity successes that do not further exacerbate inequities and to look for additional innovative ways to engage people with T1D in their health care through conversations on social determinants of health and societal structures.

Keywords: type 1 diabetes, learning health network, continuous glucose monitoring, health equity

One in 10 people in the United States has diabetes.¹ Diabetes is the nation’s second leading cause of death, costing the US health system more than $300 billion annually.² The COVID-19 pandemic presented additional health burdens for people living with diabetes. For example, preexisting diabetes was identified as a risk factor for COVID-19–associated morbidity and mortality.^3,4 Over the past 2 years, there have been remarkable innovations in diabetes management, including stem cell therapy and new medication options. Additionally, improved technology solutions have aided in diabetes management through continuous glucose monitors (CGM), smart insulin pens, advanced hybrid closed-loop systems, and continuous subcutaneous insulin injections.^5,6 Unfortunately, these groundbreaking innovations are drawing limited focus, as the field is rightfully focused on the adverse impact of the pandemic on patients with diabetes.

Learning health networks like the T1D Exchange Quality Improvement Collaborative (T1DX-QI) have implemented some of these innovative solutions to improve care for people with diabetes.⁷ T1DX-QI has more than 50 data-sharing endocrinology centers that care for over 75,000 people with diabetes across the United States (Figure 1). Centers participating in the T1DX-QI use quality improvement (QI) and implementation science methods to quickly translate research into evidence-based clinical practice. T1DX-QI leads diabetes population health and health system research and supports widespread transferability across health care organizations through regular collaborative calls, conferences, and case study documentation.⁸

In this review, we summarize impactful population health innovations in diabetes management that have become available over the past 2 years of the COVID-19 pandemic from the perspective of T1DX-QI (see Figure 2 for relevant definitions). This review is limited in scope and is not meant to be an exhaustive list of innovations. The review also reflects significant changes from the perspective of academic diabetes centers, which may not apply to rural or primary care diabetes practices.

The first (A.M.), second (H.H.), and senior (O.E.) authors conducted a scoping review of published literature using terms related to diabetes, population health, and innovation on PubMed Central and Google Scholar for the period March 2020 to June 2022. To complement the review, A.M. and O.E. also reviewed abstracts from presentations at major international diabetes conferences, including the American Diabetes Association (ADA), the International Society for Pediatric and Adolescent Diabetes (ISPAD), the T1DX-QI Learning Session Conference, and the Advanced Technologies & Treatments for Diabetes (ATTD) 2020 to 2022 conferences.^9-14 The authors also searched FDA.gov and ClinicalTrials.gov for relevant insights. A.M. and O.E. sorted the reviewed literature into major themes (Figure 3) from the population health improvement perspective of the T1DX-QI.

Population Health Innovations in Diabetes Management

Expansion of Telemedicine Access

Telemedicine is cost-effective for patients with diabetes,¹⁵ including those with complex cases.¹⁶ Before the COVID-19 pandemic, telemedicine and virtual care were rare in diabetes management. However, the pandemic offered a new opportunity to expand the practice of telemedicine in diabetes management. A study from the T1DX-QI showed that telemedicine visits grew from comprising <1% of visits pre-pandemic (December 2019) to 95.2% during the pandemic (August 2020).¹⁷ Additional studies, like those conducted by Phillip et al,¹⁸ confirmed the noninferiority of telemedicine practice for patients with diabetes.Telemedicine was also found to be an effective strategy to educate patients on the use of diabetes technologies.¹⁹

Real-World Data and Disease Surveillance

As the COVID-19 pandemic exacerbated outcomes for people with type 1 diabetes (T1D), a need arose to understand the immediate effects of the pandemic on people with T1D through real-world data and disease surveillance. In April 2020, the T1DX-QI initiated a multicenter surveillance study to collect data and analyze the impact of COVID-19 on people with T1D. The existing health collaborative served as a springboard for robust surveillance study, documenting numerous works on the effects of COVID-19.^3,4,20-28 Other investigators also embraced the power of real-world surveillance and real-world data.^29,30

Big Data, Machine Learning, and Artificial Intelligence

The past 2 years have seen a shift toward embracing the incredible opportunity to tap the large volume of data generated from routine care for practical insights.³¹ In particular, researchers have demonstrated the widespread application of machine learning and artificial intelligence to improve diabetes management.³² The T1DX-QI also harnessed the growing power of big data by expanding the functionality of innovative benchmarking software. The T1DX QI Portal uses electronic medical record data of diabetes patients for clinic-to-clinic benchmarking and data analysis, using business intelligence solutions.³³

Health Equity

While inequities across various health outcomes have been well documented for years,³⁴ the COVID-19 pandemic further exaggerated racial/ethnic health inequities in T1D.^23,35 In response, several organizations have outlined specific strategies to address these health inequities. Emboldened by the pandemic, the T1DX-QI announced a multipronged approach to address health inequities among patients with T1D through the Health Equity Advancement Lab (HEAL).³⁶ One of HEAL’s main components is using real-world data to champion population-level insights and demonstrate progress in QI efforts.

Multiple innovative studies have been undertaken to explore contributors to health inequities in diabetes, and these studies are expanding our understanding of the chasm.³⁷ There have also been innovative solutions to addressing these inequities, with multiple studies published over the past 2 years.³⁸ A source of inequity among patients with T1D is the lack of representation of racial/ethnic minorities with T1D in clinical trials.³⁹ The T1DX-QI suggests that the equity-adapted framework for QI can be applied by research leaders to support trial diversity and representation, ensuring future device innovations are meaningful for all people with T1D.⁴⁰

Diabetes Devices

Glucose monitoring and insulin therapy are vital tools to support individuals living with T1D, and devices such as CGM and insulin pumps have become the standard of care for diabetes management (Table).⁴¹ Innovations in diabetes technology and device access are imperative for a chronic disease with no cure.

The COVID-19 pandemic created an opportunity to increase access to diabetes devices in inpatient settings. In 2020, the US Food and Drug Administration expanded the use of CGM to support remote monitoring of patients in inpatient hospital settings, simultaneously supporting the glucose monitoring needs of patients with T1D and reducing COVID-19 transmission through reduced patient-clinician contact.⁴² This effort has been expanded and will continue in 2022 and beyond,⁴³ and aligns with the growing consensus that supports patients wearing both CGMs and insulin pumps in ambulatory settings to improve patient health outcomes.⁴⁴

Since 2020, innovations in diabetes technology have improved and increased the variety of options available to people with T1D and made them easier to use (Table). New, advanced hybrid closed-loop systems have progressed to offer Bluetooth features, including automatic software upgrades, tubeless systems, and the ability to allow parents to use their smartphones to bolus for children.^45-47 The next big step in insulin delivery innovation is the release of functioning, fully closed loop systems, of which several are currently in clinical trials.⁴⁸ These systems support reduced hypoglycemia and improved time in range.⁴⁹

Additional innovations in insulin delivery have improved the user experience and expanded therapeutic options, including a variety of smart insulin pens complete with dosing logs^50,51 and even a patch to deliver insulin without the burden of injections.⁵² As barriers to diabetes technology persist,⁵³ innovations in alternate insulin delivery provide people with T1D more options to align with their personal access and technology preferences.

Innovations in CGM address cited barriers to their use, including size or overall wear.^53-55 CGMs released in the past few years are smaller in physical size, have longer durations of time between changings, are more accurate, and do not require calibrations for accuracy.

New Diabetes Medications

Many new medications and therapeutic advances have become available in the past 2 years.⁵⁶ Additionally, more medications are being tested as adjunct therapies to support glycemic management in patients with T1D, including metformin, sodium-glucose cotransporter 1 and 2 inhibitors, pramlintide, glucagon-like polypeptide-1 analogs, and glucagon receptor agonists.⁵⁷ Other recent advances include stem cell replacement therapy for patients with T1D.⁵⁸ The ultra-long-acting biosimilar insulins are one medical innovation that has been stalled, rather than propelled, during the COVID-19 pandemic.⁵⁹

Diabetes Policy Advocacy

People with T1D require insulin to survive. The cost of insulin has increased in recent years, with some studies citing a 64% to 100% increase in the past decade.^60,61 In fact, 1 in 4 insulin users report that cost has impacted their insulin use, including rationing their insulin.⁶² Lockdowns during the COVID-19 pandemic stressed US families financially, increasing the urgency for insulin cost caps.

Although the COVID-19 pandemic halted national conversations on drug financing,⁶³ advocacy efforts have succeeded for specific populations. The new Medicare Part D Senior Savings Model will cap the cost of insulin at $35 for a 30-day supply,⁶⁴ and 20 states passed legislation capping insulin pricing.⁶² Efforts to codify national cost caps are under debate, including the passage of the Affordable Insulin Now Act, which passed the House in March 2022 and is currently under review in the Senate.⁶⁵

Funders and industry partners play a crucial role in leading and supporting innovations that improve the lives of people with T1D and reduce society’s costs of living with the disease. Data infrastructure is critical to supporting population health. While building the data infrastructure to support population health is both time- and resource-intensive, private foundations such as Helmsley are uniquely positioned—and have a responsibility—to take large, informed risks to help reach all communities with T1D.

The T1DX-QI is the largest source of population health data on T1D in the United States and is becoming the premiere data authority on its incidence, prevalence, and outcomes. The T1DX-QI enables a robust understanding of T1D-related health trends at the population level, as well as trends among clinics and providers. Pilot centers in the T1DX-QI have reported reductions in patients’ A1c and acute diabetes-related events, as well as improvements in device usage and depression screening. The ability to capture changes speaks to the promise and power of these data to demonstrate the clinical impact of QI interventions and to support the spread of best practices and learnings across health systems.

Additional philanthropic efforts have supported innovation in the last 2 years. For example, the JDRF, a nonprofit philanthropic equity firm, has supported efforts in developing artificial pancreas systems and cell therapies currently in clinical trials like teplizumab, a drug that has demonstrated delayed onset of T1D through JDRF’s T1D Fund.⁶⁶ Industry partners also have an opportunity for significant influence in this area, as they continue to fund meaningful projects to advance care for people with T1D.⁶⁷

Conclusion

We are optimistic that the innovations summarized here describe a shift in the tide of equitable T1D outcomes; however, future work is required to explore additional health equity successes that do not further exacerbate inequities. We also see further opportunities for innovative ways to engage people with T1D in their health care through conversations on social determinants of health and societal structures.

Corresponding author: Ann Mungmode, MPH, T1D Exchange, 11 Avenue de Lafayette, Boston, MA 02111; Email: [email protected]

Disclosures: Dr. Ebekozien serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for the Medtronic Advisory Board and received research grants from Medtronic Diabetes, Eli Lilly, and Dexcom.

Funding: The T1DX-QI is funded by The Leona M. and Harry B. Hemsley Charitable Trust.

Study 1 Overview (Bayliss et al)

Objective: To examine the effect of a deprescribing educational intervention on medication use in older adults with cognitive impairment.

Design: This was a pragmatic, cluster randomized trial conducted in 8 primary care clinics that are part of a nonprofit health care system.

Setting and participants: The primary care clinic populations ranged from 170 to 1125 patients per clinic. The primary care clinics were randomly assigned to intervention or control using a uniform distribution in blocks by clinic size. Eligibility criteria for participants at those practices included age 65 years or older; health plan enrollment at least 1 year prior to intervention; diagnosis of Alzheimer disease and related dementia (ADRD) or mild cognitive impairment (MCI) by International Statistical Classification of Diseases and Related Health Problems, Tenth Revision code or from problem list; 1 or more chronic conditions from those in the Chronic Conditions Warehouse; and 5 or more long-term medications. Those who scheduled a visit at their primary care clinic in advance were eligible for the intervention. Primary care clinicians in intervention clinics were eligible to receive the clinician portion of the intervention. A total of 1433 participants were enrolled in the intervention group, and 1579 participants were enrolled in the control group.

Intervention: The intervention included 2 components: a patient and family component with materials mailed in advance of their primary care visits and a clinician component comprising monthly educational materials on deprescribing and notification in the electronic health record about visits with patient participants. The patient and family component consisted of a brochure titled “Managing Medication” and a questionnaire on attitudes toward deprescribing intended to educate patients and family about deprescribing. Clinicians at intervention clinics received an educational presentation at a monthly clinician meeting as well as tip sheets and a poster on deprescribing topics, and they also were notified of upcoming appointments with patients who received the patient component of the intervention. For the control group, patients and family did not receive any materials, and clinicians did not receive intervention materials or notification of participants enrolled in the trial. Usual care in both intervention and control groups included medication reconciliation and electronic health record alerts for potentially high-risk medications.

Main outcome measures: The primary outcomes of the study were the number of long-term medications per individual and the proportion of patients prescribed 1 or more potentially inappropriate medications. Outcome measurements were extracted from the electronic clinical data, and outcomes were assessed at 6 months, which involved comparing counts of medications at baseline with medications at 6 months. Long-term medications were defined as medications that are prescribed for 28 days or more based on pharmacy dispensing data. Potentially inappropriate medications (PIMs) were defined using the Beers list of medications to avoid in those with cognitive impairment and opioid medications. Analyses were conducted as intention to treat.

Main results: In the intervention group and control group, 56.2% and 54.4% of participants were women, and the mean age was 80.1 years (SD, 7.2) and 79.9 years (SD, 7.5), respectively. At baseline, the mean number of long-term medications was 7.0 (SD, 2.1) in the intervention group and 7.0 (SD, 2.2) in the control group. The proportion of patients taking any PIMs was 30.5% in the intervention group and 29.6% in the control group. At 6 months, the mean number of long-term medications was 6.4 in the intervention group and 6.5 in the control group, with an adjusted difference of –0.1 (95% CI, –0.2 to 0.04; P = .14); the proportion of patients with any PIMs was 17.8% in the intervention group and 20.9% in the control group, with an adjusted difference of –3.2% (95% CI, –6.2 to 0.4; P = .08). Preplanned analyses to examine subgroup differences for those with a higher number of medications (7+ vs 5 or 6 medications) did not find different effects of the intervention.

Conclusion: This educational intervention on deprescribing did not result in reductions in the number of medications or the use of PIMs in patients with cognitive impairment.

Study 2 Overview (Gedde et al)

Objective: To examine the effect of a deprescribing intervention (COSMOS) on medication use for nursing home residents.

Design: This was a randomized clinical trial.

Setting and participants: This trial was conducted in 67 units in 33 nursing homes in Norway. Participants were nursing home residents recruited from August 2014 to March 2015. Inclusion criteria included adults aged 65 years and older with at least 2 years of residency in nursing homes. Exclusion criteria included diagnosis of schizophrenia and a life expectancy of 6 months or less. Participants were followed for 4 months; participants were considered lost to follow-up if they died or moved from the nursing home unit. The analyses were per protocol and did not include those lost to follow-up or those who did not undergo a medication review in the intervention group. A total of 217 and 211 residents were included in the intervention and control groups, respectively.

Intervention: The intervention contained 5 components: communication and advance care planning, systematic pain management, medication reviews with collegial mentoring, organization of activities adjusted to needs and preferences, and safety. For medication review, the nursing home physician reviewed medications together with a nurse and study physicians who provided mentoring. The medication review involved a structured process that used assessment tools for behavioral and psychological symptoms of dementia (BPSD), activities of daily living (ADL), pain, cognitive status, well-being and quality of life, and clinical metrics of blood pressure, pulse, and body mass index. The study utilized the START/STOPP criteria¹ for medication use in addition to a list of medications with anticholinergic properties for the medication review. In addition, drug interactions were documented through a drug interaction database; the team also incorporated patient wishes and concerns in the medication reviews. The nursing home physician made final decisions on medications. For the control group, nursing home residents received usual care without this intervention.

Main outcome measures: The primary outcome of the study was the mean change in the number of prescribed psychotropic medications, both regularly scheduled and total medications (which also included on-demand drugs) received at 4 months when compared to baseline. Psychotropic medications included antipsychotics, anxiolytics, hypnotics or sedatives, antidepressants, and antidementia drugs. Secondary outcomes included mean changes in BPSD using the Neuropsychiatric Inventory-Nursing home version (NPI-NH) and the Cornell Scale for Depression for Dementia (CSDD) and ADL using the Physical Self Maintenance Scale (PSMS).

Main results: In both the intervention and control groups, 76% of participants were women, and mean age was 86.3 years (SD, 7.95) in the intervention group and 86.6 years (SD, 7.21) in the control group. At baseline, the mean number of total medications was 10.9 (SD, 4.6) in the intervention group and 10.9 (SD, 4.7) in the control group, and the mean number of psychotropic medications was 2.2 (SD, 1.6) and 2.2 (SD, 1.7) in the intervention and control groups, respectively. At 4 months, the mean change from baseline of total psychotropic medications was –0.34 in the intervention group and 0.01 in the control group (P < .001), and the mean change of regularly scheduled psychotropic medications was –0.21 in the intervention group and 0.02 in the control group (P < .001). Measures of BPSD and depression did not differ between intervention and control groups, and ADL showed a small improvement in the intervention group.

Conclusion: This intervention reduced the use of psychotropic medications in nursing home residents without worsening BPSD or depression and may have yielded improvements in ADL.

Commentary

Polypharmacy is common among older adults, as many of them have multiple chronic conditions and often take multiple medications for managing them. Polypharmacy increases the risk of drug interactions and adverse effects from medications; older adults who are frail and/or who have cognitive impairment are especially at risk. Reducing medication use, especially medications likely to cause adverse effects such as those with anticholinergic properties, has the potential to yield beneficial effects while reducing the burden of taking medications. A large randomized trial found that a pharmacist-led education intervention can be effective in reducing PIM use in community-dwelling older adults,² and that targeting patient motivation and capacity to deprescribe could be effective.³ This study by Bayliss and colleagues (Study 1), however, fell short of the effects seen in the earlier D-PRESCRIBE trial. One of the reasons for these findings may be that the clinician portion of the intervention was less intensive than that used in the earlier trial; specifically, in the present study, clinicians were not provided with or expected to utilize tools for structured medication review or deprescribing. Although the intervention primes the patient and family for discussions around deprescribing through the use of a brochure and questionnaire, the clinician portion of the intervention was less structured. Another example of an effective intervention that provided a more structured deprescribing intervention beyond education of clinicians utilized electronic decision-support to assist with deprescribing.⁴

The findings from the Gedde et al study (Study 2) are comparable to those of prior studies in the nursing home population,⁵ where participants are likely to take a large number of medications, including psychotropic medications, and are more likely to be frail. However, Gedde and colleagues employed a bundled intervention⁶ that included other components besides medication review, and thus it is unclear whether the effect on ADL can be attributed to the deprescribing of medications alone. Gedde et al’s finding that deprescribing can reduce the use of psychotropic medications while not leading to differences in behavioral and psychologic symptoms or depression is an important contribution to our knowledge about polypharmacy and deprescribing in older patients. Thus, nursing home residents, their families, and clinicians could expect that the deprescribing of psychotropic medications does not lead to worsening symptoms. Of note, the clinician portion of the intervention in the Gedde et al study was quite structured, and this structure may have contributed to the observed effects.

Applications for Clinical Practice and System Implementation

Both studies add to the literature on deprescribing and may offer options for researchers and clinicians who are considering potential components of an effective deprescribing intervention. Patient activation for deprescribing via the methods used in these 2 studies may help to prime patients for conversations about deprescribing; however, as shown by the Bayliss et al study, a more structured approach to clinical encounters may be needed when deprescribing, such as the use of tools in the electronic health record, in order to reduce the use of medication deemed unnecessary or potentially harmful. Further studies should examine the effect of deprescribing on medication use, but perhaps even more importantly, how deprescribing impacts patient outcomes both in terms of risks and benefits.

Practice Points

• A more structured approach to clinical encounters (eg, the use of tools in the electronic health record) may be needed when deprescribing unnecessary or potentially harmful medications in older patients in community settings.
• In the nursing home setting, structured deprescribing intervention can reduce the use of psychotropic medications while not leading to differences in behavioral and psychologic symptoms or depression.

–William W. Hung, MD, MPH

Study 1 Overview (Bayliss et al)

Objective: To examine the effect of a deprescribing educational intervention on medication use in older adults with cognitive impairment.

Design: This was a pragmatic, cluster randomized trial conducted in 8 primary care clinics that are part of a nonprofit health care system.

Setting and participants: The primary care clinic populations ranged from 170 to 1125 patients per clinic. The primary care clinics were randomly assigned to intervention or control using a uniform distribution in blocks by clinic size. Eligibility criteria for participants at those practices included age 65 years or older; health plan enrollment at least 1 year prior to intervention; diagnosis of Alzheimer disease and related dementia (ADRD) or mild cognitive impairment (MCI) by International Statistical Classification of Diseases and Related Health Problems, Tenth Revision code or from problem list; 1 or more chronic conditions from those in the Chronic Conditions Warehouse; and 5 or more long-term medications. Those who scheduled a visit at their primary care clinic in advance were eligible for the intervention. Primary care clinicians in intervention clinics were eligible to receive the clinician portion of the intervention. A total of 1433 participants were enrolled in the intervention group, and 1579 participants were enrolled in the control group.

Intervention: The intervention included 2 components: a patient and family component with materials mailed in advance of their primary care visits and a clinician component comprising monthly educational materials on deprescribing and notification in the electronic health record about visits with patient participants. The patient and family component consisted of a brochure titled “Managing Medication” and a questionnaire on attitudes toward deprescribing intended to educate patients and family about deprescribing. Clinicians at intervention clinics received an educational presentation at a monthly clinician meeting as well as tip sheets and a poster on deprescribing topics, and they also were notified of upcoming appointments with patients who received the patient component of the intervention. For the control group, patients and family did not receive any materials, and clinicians did not receive intervention materials or notification of participants enrolled in the trial. Usual care in both intervention and control groups included medication reconciliation and electronic health record alerts for potentially high-risk medications.

Main outcome measures: The primary outcomes of the study were the number of long-term medications per individual and the proportion of patients prescribed 1 or more potentially inappropriate medications. Outcome measurements were extracted from the electronic clinical data, and outcomes were assessed at 6 months, which involved comparing counts of medications at baseline with medications at 6 months. Long-term medications were defined as medications that are prescribed for 28 days or more based on pharmacy dispensing data. Potentially inappropriate medications (PIMs) were defined using the Beers list of medications to avoid in those with cognitive impairment and opioid medications. Analyses were conducted as intention to treat.

Main results: In the intervention group and control group, 56.2% and 54.4% of participants were women, and the mean age was 80.1 years (SD, 7.2) and 79.9 years (SD, 7.5), respectively. At baseline, the mean number of long-term medications was 7.0 (SD, 2.1) in the intervention group and 7.0 (SD, 2.2) in the control group. The proportion of patients taking any PIMs was 30.5% in the intervention group and 29.6% in the control group. At 6 months, the mean number of long-term medications was 6.4 in the intervention group and 6.5 in the control group, with an adjusted difference of –0.1 (95% CI, –0.2 to 0.04; P = .14); the proportion of patients with any PIMs was 17.8% in the intervention group and 20.9% in the control group, with an adjusted difference of –3.2% (95% CI, –6.2 to 0.4; P = .08). Preplanned analyses to examine subgroup differences for those with a higher number of medications (7+ vs 5 or 6 medications) did not find different effects of the intervention.

Conclusion: This educational intervention on deprescribing did not result in reductions in the number of medications or the use of PIMs in patients with cognitive impairment.

Study 2 Overview (Gedde et al)

Objective: To examine the effect of a deprescribing intervention (COSMOS) on medication use for nursing home residents.

Design: This was a randomized clinical trial.

Setting and participants: This trial was conducted in 67 units in 33 nursing homes in Norway. Participants were nursing home residents recruited from August 2014 to March 2015. Inclusion criteria included adults aged 65 years and older with at least 2 years of residency in nursing homes. Exclusion criteria included diagnosis of schizophrenia and a life expectancy of 6 months or less. Participants were followed for 4 months; participants were considered lost to follow-up if they died or moved from the nursing home unit. The analyses were per protocol and did not include those lost to follow-up or those who did not undergo a medication review in the intervention group. A total of 217 and 211 residents were included in the intervention and control groups, respectively.

Intervention: The intervention contained 5 components: communication and advance care planning, systematic pain management, medication reviews with collegial mentoring, organization of activities adjusted to needs and preferences, and safety. For medication review, the nursing home physician reviewed medications together with a nurse and study physicians who provided mentoring. The medication review involved a structured process that used assessment tools for behavioral and psychological symptoms of dementia (BPSD), activities of daily living (ADL), pain, cognitive status, well-being and quality of life, and clinical metrics of blood pressure, pulse, and body mass index. The study utilized the START/STOPP criteria¹ for medication use in addition to a list of medications with anticholinergic properties for the medication review. In addition, drug interactions were documented through a drug interaction database; the team also incorporated patient wishes and concerns in the medication reviews. The nursing home physician made final decisions on medications. For the control group, nursing home residents received usual care without this intervention.

Main outcome measures: The primary outcome of the study was the mean change in the number of prescribed psychotropic medications, both regularly scheduled and total medications (which also included on-demand drugs) received at 4 months when compared to baseline. Psychotropic medications included antipsychotics, anxiolytics, hypnotics or sedatives, antidepressants, and antidementia drugs. Secondary outcomes included mean changes in BPSD using the Neuropsychiatric Inventory-Nursing home version (NPI-NH) and the Cornell Scale for Depression for Dementia (CSDD) and ADL using the Physical Self Maintenance Scale (PSMS).

Main results: In both the intervention and control groups, 76% of participants were women, and mean age was 86.3 years (SD, 7.95) in the intervention group and 86.6 years (SD, 7.21) in the control group. At baseline, the mean number of total medications was 10.9 (SD, 4.6) in the intervention group and 10.9 (SD, 4.7) in the control group, and the mean number of psychotropic medications was 2.2 (SD, 1.6) and 2.2 (SD, 1.7) in the intervention and control groups, respectively. At 4 months, the mean change from baseline of total psychotropic medications was –0.34 in the intervention group and 0.01 in the control group (P < .001), and the mean change of regularly scheduled psychotropic medications was –0.21 in the intervention group and 0.02 in the control group (P < .001). Measures of BPSD and depression did not differ between intervention and control groups, and ADL showed a small improvement in the intervention group.

Conclusion: This intervention reduced the use of psychotropic medications in nursing home residents without worsening BPSD or depression and may have yielded improvements in ADL.

Commentary

Polypharmacy is common among older adults, as many of them have multiple chronic conditions and often take multiple medications for managing them. Polypharmacy increases the risk of drug interactions and adverse effects from medications; older adults who are frail and/or who have cognitive impairment are especially at risk. Reducing medication use, especially medications likely to cause adverse effects such as those with anticholinergic properties, has the potential to yield beneficial effects while reducing the burden of taking medications. A large randomized trial found that a pharmacist-led education intervention can be effective in reducing PIM use in community-dwelling older adults,² and that targeting patient motivation and capacity to deprescribe could be effective.³ This study by Bayliss and colleagues (Study 1), however, fell short of the effects seen in the earlier D-PRESCRIBE trial. One of the reasons for these findings may be that the clinician portion of the intervention was less intensive than that used in the earlier trial; specifically, in the present study, clinicians were not provided with or expected to utilize tools for structured medication review or deprescribing. Although the intervention primes the patient and family for discussions around deprescribing through the use of a brochure and questionnaire, the clinician portion of the intervention was less structured. Another example of an effective intervention that provided a more structured deprescribing intervention beyond education of clinicians utilized electronic decision-support to assist with deprescribing.⁴

The findings from the Gedde et al study (Study 2) are comparable to those of prior studies in the nursing home population,⁵ where participants are likely to take a large number of medications, including psychotropic medications, and are more likely to be frail. However, Gedde and colleagues employed a bundled intervention⁶ that included other components besides medication review, and thus it is unclear whether the effect on ADL can be attributed to the deprescribing of medications alone. Gedde et al’s finding that deprescribing can reduce the use of psychotropic medications while not leading to differences in behavioral and psychologic symptoms or depression is an important contribution to our knowledge about polypharmacy and deprescribing in older patients. Thus, nursing home residents, their families, and clinicians could expect that the deprescribing of psychotropic medications does not lead to worsening symptoms. Of note, the clinician portion of the intervention in the Gedde et al study was quite structured, and this structure may have contributed to the observed effects.

Applications for Clinical Practice and System Implementation

Both studies add to the literature on deprescribing and may offer options for researchers and clinicians who are considering potential components of an effective deprescribing intervention. Patient activation for deprescribing via the methods used in these 2 studies may help to prime patients for conversations about deprescribing; however, as shown by the Bayliss et al study, a more structured approach to clinical encounters may be needed when deprescribing, such as the use of tools in the electronic health record, in order to reduce the use of medication deemed unnecessary or potentially harmful. Further studies should examine the effect of deprescribing on medication use, but perhaps even more importantly, how deprescribing impacts patient outcomes both in terms of risks and benefits.

Practice Points

• A more structured approach to clinical encounters (eg, the use of tools in the electronic health record) may be needed when deprescribing unnecessary or potentially harmful medications in older patients in community settings.
• In the nursing home setting, structured deprescribing intervention can reduce the use of psychotropic medications while not leading to differences in behavioral and psychologic symptoms or depression.

–William W. Hung, MD, MPH

Study 1 Overview (Bayliss et al)

Objective: To examine the effect of a deprescribing educational intervention on medication use in older adults with cognitive impairment.

Design: This was a pragmatic, cluster randomized trial conducted in 8 primary care clinics that are part of a nonprofit health care system.

Setting and participants: The primary care clinic populations ranged from 170 to 1125 patients per clinic. The primary care clinics were randomly assigned to intervention or control using a uniform distribution in blocks by clinic size. Eligibility criteria for participants at those practices included age 65 years or older; health plan enrollment at least 1 year prior to intervention; diagnosis of Alzheimer disease and related dementia (ADRD) or mild cognitive impairment (MCI) by International Statistical Classification of Diseases and Related Health Problems, Tenth Revision code or from problem list; 1 or more chronic conditions from those in the Chronic Conditions Warehouse; and 5 or more long-term medications. Those who scheduled a visit at their primary care clinic in advance were eligible for the intervention. Primary care clinicians in intervention clinics were eligible to receive the clinician portion of the intervention. A total of 1433 participants were enrolled in the intervention group, and 1579 participants were enrolled in the control group.

Intervention: The intervention included 2 components: a patient and family component with materials mailed in advance of their primary care visits and a clinician component comprising monthly educational materials on deprescribing and notification in the electronic health record about visits with patient participants. The patient and family component consisted of a brochure titled “Managing Medication” and a questionnaire on attitudes toward deprescribing intended to educate patients and family about deprescribing. Clinicians at intervention clinics received an educational presentation at a monthly clinician meeting as well as tip sheets and a poster on deprescribing topics, and they also were notified of upcoming appointments with patients who received the patient component of the intervention. For the control group, patients and family did not receive any materials, and clinicians did not receive intervention materials or notification of participants enrolled in the trial. Usual care in both intervention and control groups included medication reconciliation and electronic health record alerts for potentially high-risk medications.

Main outcome measures: The primary outcomes of the study were the number of long-term medications per individual and the proportion of patients prescribed 1 or more potentially inappropriate medications. Outcome measurements were extracted from the electronic clinical data, and outcomes were assessed at 6 months, which involved comparing counts of medications at baseline with medications at 6 months. Long-term medications were defined as medications that are prescribed for 28 days or more based on pharmacy dispensing data. Potentially inappropriate medications (PIMs) were defined using the Beers list of medications to avoid in those with cognitive impairment and opioid medications. Analyses were conducted as intention to treat.

Main results: In the intervention group and control group, 56.2% and 54.4% of participants were women, and the mean age was 80.1 years (SD, 7.2) and 79.9 years (SD, 7.5), respectively. At baseline, the mean number of long-term medications was 7.0 (SD, 2.1) in the intervention group and 7.0 (SD, 2.2) in the control group. The proportion of patients taking any PIMs was 30.5% in the intervention group and 29.6% in the control group. At 6 months, the mean number of long-term medications was 6.4 in the intervention group and 6.5 in the control group, with an adjusted difference of –0.1 (95% CI, –0.2 to 0.04; P = .14); the proportion of patients with any PIMs was 17.8% in the intervention group and 20.9% in the control group, with an adjusted difference of –3.2% (95% CI, –6.2 to 0.4; P = .08). Preplanned analyses to examine subgroup differences for those with a higher number of medications (7+ vs 5 or 6 medications) did not find different effects of the intervention.

Conclusion: This educational intervention on deprescribing did not result in reductions in the number of medications or the use of PIMs in patients with cognitive impairment.

Study 2 Overview (Gedde et al)

Objective: To examine the effect of a deprescribing intervention (COSMOS) on medication use for nursing home residents.

Design: This was a randomized clinical trial.

Setting and participants: This trial was conducted in 67 units in 33 nursing homes in Norway. Participants were nursing home residents recruited from August 2014 to March 2015. Inclusion criteria included adults aged 65 years and older with at least 2 years of residency in nursing homes. Exclusion criteria included diagnosis of schizophrenia and a life expectancy of 6 months or less. Participants were followed for 4 months; participants were considered lost to follow-up if they died or moved from the nursing home unit. The analyses were per protocol and did not include those lost to follow-up or those who did not undergo a medication review in the intervention group. A total of 217 and 211 residents were included in the intervention and control groups, respectively.

Intervention: The intervention contained 5 components: communication and advance care planning, systematic pain management, medication reviews with collegial mentoring, organization of activities adjusted to needs and preferences, and safety. For medication review, the nursing home physician reviewed medications together with a nurse and study physicians who provided mentoring. The medication review involved a structured process that used assessment tools for behavioral and psychological symptoms of dementia (BPSD), activities of daily living (ADL), pain, cognitive status, well-being and quality of life, and clinical metrics of blood pressure, pulse, and body mass index. The study utilized the START/STOPP criteria¹ for medication use in addition to a list of medications with anticholinergic properties for the medication review. In addition, drug interactions were documented through a drug interaction database; the team also incorporated patient wishes and concerns in the medication reviews. The nursing home physician made final decisions on medications. For the control group, nursing home residents received usual care without this intervention.

Main outcome measures: The primary outcome of the study was the mean change in the number of prescribed psychotropic medications, both regularly scheduled and total medications (which also included on-demand drugs) received at 4 months when compared to baseline. Psychotropic medications included antipsychotics, anxiolytics, hypnotics or sedatives, antidepressants, and antidementia drugs. Secondary outcomes included mean changes in BPSD using the Neuropsychiatric Inventory-Nursing home version (NPI-NH) and the Cornell Scale for Depression for Dementia (CSDD) and ADL using the Physical Self Maintenance Scale (PSMS).

Main results: In both the intervention and control groups, 76% of participants were women, and mean age was 86.3 years (SD, 7.95) in the intervention group and 86.6 years (SD, 7.21) in the control group. At baseline, the mean number of total medications was 10.9 (SD, 4.6) in the intervention group and 10.9 (SD, 4.7) in the control group, and the mean number of psychotropic medications was 2.2 (SD, 1.6) and 2.2 (SD, 1.7) in the intervention and control groups, respectively. At 4 months, the mean change from baseline of total psychotropic medications was –0.34 in the intervention group and 0.01 in the control group (P < .001), and the mean change of regularly scheduled psychotropic medications was –0.21 in the intervention group and 0.02 in the control group (P < .001). Measures of BPSD and depression did not differ between intervention and control groups, and ADL showed a small improvement in the intervention group.

Conclusion: This intervention reduced the use of psychotropic medications in nursing home residents without worsening BPSD or depression and may have yielded improvements in ADL.

Commentary

Polypharmacy is common among older adults, as many of them have multiple chronic conditions and often take multiple medications for managing them. Polypharmacy increases the risk of drug interactions and adverse effects from medications; older adults who are frail and/or who have cognitive impairment are especially at risk. Reducing medication use, especially medications likely to cause adverse effects such as those with anticholinergic properties, has the potential to yield beneficial effects while reducing the burden of taking medications. A large randomized trial found that a pharmacist-led education intervention can be effective in reducing PIM use in community-dwelling older adults,² and that targeting patient motivation and capacity to deprescribe could be effective.³ This study by Bayliss and colleagues (Study 1), however, fell short of the effects seen in the earlier D-PRESCRIBE trial. One of the reasons for these findings may be that the clinician portion of the intervention was less intensive than that used in the earlier trial; specifically, in the present study, clinicians were not provided with or expected to utilize tools for structured medication review or deprescribing. Although the intervention primes the patient and family for discussions around deprescribing through the use of a brochure and questionnaire, the clinician portion of the intervention was less structured. Another example of an effective intervention that provided a more structured deprescribing intervention beyond education of clinicians utilized electronic decision-support to assist with deprescribing.⁴

The findings from the Gedde et al study (Study 2) are comparable to those of prior studies in the nursing home population,⁵ where participants are likely to take a large number of medications, including psychotropic medications, and are more likely to be frail. However, Gedde and colleagues employed a bundled intervention⁶ that included other components besides medication review, and thus it is unclear whether the effect on ADL can be attributed to the deprescribing of medications alone. Gedde et al’s finding that deprescribing can reduce the use of psychotropic medications while not leading to differences in behavioral and psychologic symptoms or depression is an important contribution to our knowledge about polypharmacy and deprescribing in older patients. Thus, nursing home residents, their families, and clinicians could expect that the deprescribing of psychotropic medications does not lead to worsening symptoms. Of note, the clinician portion of the intervention in the Gedde et al study was quite structured, and this structure may have contributed to the observed effects.

Applications for Clinical Practice and System Implementation

Both studies add to the literature on deprescribing and may offer options for researchers and clinicians who are considering potential components of an effective deprescribing intervention. Patient activation for deprescribing via the methods used in these 2 studies may help to prime patients for conversations about deprescribing; however, as shown by the Bayliss et al study, a more structured approach to clinical encounters may be needed when deprescribing, such as the use of tools in the electronic health record, in order to reduce the use of medication deemed unnecessary or potentially harmful. Further studies should examine the effect of deprescribing on medication use, but perhaps even more importantly, how deprescribing impacts patient outcomes both in terms of risks and benefits.

Practice Points

• A more structured approach to clinical encounters (eg, the use of tools in the electronic health record) may be needed when deprescribing unnecessary or potentially harmful medications in older patients in community settings.
• In the nursing home setting, structured deprescribing intervention can reduce the use of psychotropic medications while not leading to differences in behavioral and psychologic symptoms or depression.

–William W. Hung, MD, MPH

Study 1 Overview (Oberhaus et al)

Objective: To compare the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM) to the long-form Confusion Assessment Method (CAM) in detecting postoperative delirium.

Design: Prospective concurrent comparison of 3D-CAM and CAM evaluations in a cohort of postoperative geriatric patients.

Setting and participants: Eligible participants were patients aged 60 years or older undergoing major elective surgery at Barnes Jewish Hospital (St. Louis, Missouri) who were enrolled in ongoing clinical trials (PODCAST, ENGAGES, SATISFY-SOS) between 2015 and 2018. Surgeries were at least 2 hours in length and required general anesthesia, planned extubation, and a minimum 2-day hospital stay. Investigators were extensively trained in administering 3D-CAM and CAM instruments. Participants were evaluated 2 hours after the end of anesthesia care on the day of surgery, then daily until follow-up was completed per clinical trial protocol or until the participant was determined by CAM to be nondelirious for 3 consecutive days. For each evaluation, both 3D-CAM and CAM assessors approached the participant together, but the evaluation was conducted such that the 3D-CAM assessor was masked to the additional questions ascertained by the long-form CAM assessment. The 3D-CAM or CAM assessor independently scored their respective assessments blinded to the results of the other assessor.

Main outcome measures: Participants were concurrently evaluated for postoperative delirium by both 3D-CAM and long-form CAM assessments. Comparisons between 3D-CAM and CAM scores were made using Cohen κ with repeated measures, generalized linear mixed-effects model, and Bland-Altman analysis.

Main results: Sixteen raters performed 471 concurrent 3D-CAM and CAM assessments in 299 participants (mean [SD] age, 69 [6.5] years). Of these participants, 152 (50.8%) were men, 263 (88.0%) were White, and 211 (70.6%) underwent noncardiac surgery. Both instruments showed good intraclass correlation (0.98 for 3D-CAM, 0.84 for CAM) with good overall agreement (Cohen κ = 0.71; 95% CI, 0.58-0.83). The mixed-effects model indicated a significant disagreement between the 3D-CAM and CAM assessments (estimated difference in fixed effect, –0.68; 95% CI, –1.32 to –0.05; P = .04). The Bland-Altman analysis showed that the probability of a delirium diagnosis with the 3D-CAM was more than twice that with the CAM (probability ratio, 2.78; 95% CI, 2.44-3.23).

Conclusion: The high degree of agreement between 3D-CAM and long-form CAM assessments suggests that the former may be a pragmatic and easy-to-administer clinical tool to screen for postoperative delirium in vulnerable older surgical patients.

Study 2 Overview (Shenkin et al)

Objective: To assess the accuracy of the 4 ‘A’s Test (4AT) for delirium detection in the medical inpatient setting and to compare the 4AT to the CAM.

Design: Prospective randomized diagnostic test accuracy study.

Setting and participants: This study was conducted in emergency departments and acute medical wards at 3 UK sites (Edinburgh, Bradford, and Sheffield) and enrolled acute medical patients aged 70 years or older without acute life-threatening illnesses and/or coma. Assessors administering the delirium evaluation were nurses or graduate clinical research associates who underwent systematic training in delirium and delirium assessment. Additional training was provided to those administering the CAM but not to those administering the 4AT as the latter is designed to be administered without special training. First, all participants underwent a reference standard delirium assessment using Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) criteria to derive a final definitive diagnosis of delirium via expert consensus (1 psychiatrist and 2 geriatricians). Then, the participants were randomized to either the 4AT or the comparator CAM group using computer-generated pseudo-random numbers, stratified by study site, with block allocation. All assessments were performed by pairs of independent assessors blinded to the results of the other assessment.

Main outcome measures: All participants were evaluated by the reference standard (DSM-IV criteria for delirium) and by either 4AT or CAM instruments for delirium. The accuracy of the 4AT instrument was evaluated by comparing its positive and negative predictive values, sensitivity, and specificity to the reference standard and analyzed via the area under the receiver operating characteristic curve. The diagnostic accuracy of 4AT, compared to the CAM, was evaluated by comparing positive and negative predictive values, sensitivity, and specificity using Fisher’s exact test. The overall performance of 4AT and CAM was summarized using Youden’s Index and the diagnostic odds ratio of sensitivity to specificity.

Results: All 843 individuals enrolled in the study were randomized and 785 were included in the analysis (23 withdrew, 3 lost contact, 32 indeterminate diagnosis, 2 missing outcome). Of the participants analyzed, the mean age was 81.4 [6.4] years, and 12.1% (95/785) had delirium by reference standard assessment, 14.3% (56/392) by 4AT, and 4.7% (18/384) by CAM. The 4AT group had an area under the receiver operating characteristic curve of 0.90 (95% CI, 0.84-0.96), a sensitivity of 76% (95% CI, 61%-87%), and a specificity of 94% (95% CI, 92%-97%). In comparison, the CAM group had a sensitivity of 40% (95% CI, 26%-57%) and a specificity of 100% (95% CI, 98%-100%).

Conclusions: The 4AT is a pragmatic screening test for delirium in a medical space that does not require special training to administer. The use of this instrument may help to improve delirium detection as a part of routine clinical care in hospitalized older adults.

Delirium is an acute confusional state marked by fluctuating mental status, inattention, disorganized thinking, and altered level of consciousness. It is exceedingly common in older patients in both surgical and medical settings and is associated with increased morbidity, mortality, hospital length of stay, institutionalization, and health care costs. Delirium is frequently underdiagnosed in the hospitalized setting, perhaps due to a combination of its waxing and waning nature and a lack of pragmatic and easily implementable screening tools that can be readily administered by clinicians and nonclinicians alike.¹ While the CAM is a well-validated instrument to diagnose delirium, it requires specific training in the rating of each of the cardinal features ascertained through a brief cognitive assessment and takes 5 to 10 minutes to complete. Taken together, given the high patient load for clinicians in the hospital setting, the validation and application of brief delirium screening instruments that can be reliably administered by nonphysicians and nonclinicians may enhance delirium detection in vulnerable patients and consequently improve their outcomes.

In Study 1, Oberhaus et al approach the challenge of underdiagnosing delirium in the postoperative setting by investigating whether the widely accepted long-form CAM and an abbreviated 3-minute version, the 3D-CAM, provide similar delirium detection in older surgical patients. The authors found that both instruments were reliable tests individually (high interrater reliability) and had good overall agreement. However, the 3D-CAM was more likely to yield a positive diagnosis of delirium compared to the long-form CAM, consistent with its purpose as a screening tool with a high sensitivity. It is important to emphasize that the 3D-CAM takes less time to administer, but also requires less extensive training and clinical knowledge than the long-form CAM. Therefore, this instrument meets the prerequisite of a brief screening test that can be rapidly administered by nonclinicians, and if affirmative, followed by a more extensive confirmatory test performed by a clinician. Limitations of this study include a lack of a reference standard structured interview conducted by a physician-rater to better determine the true diagnostic accuracy of both 3D-CAM and CAM assessments, and the use of convenience sampling at a single center, which reduces the generalizability of its findings.

In a similar vein, Shenkin et al in Study 2 attempt to evaluate the utility of the 4AT instrument in diagnosing delirium in older medical inpatients by testing the diagnostic accuracy of the 4AT against a reference standard (ie, DSM-IV–based evaluation by physicians) as well as comparing it to CAM. The 4AT takes less time (~2 minutes) and requires less knowledge and training to administer as compared to the CAM. The study showed that the abbreviated 4AT, compared to CAM, had a higher sensitivity (76% vs 40%) and lower specificity (94% vs 100%) in delirium detection. Thus, akin to the application of 3D-CAM in the postoperative setting, 4AT possesses key characteristics of a brief delirium screening test for older patients in the acute medical setting. In contrast to the Oberhaus et al study, a major strength of this study was the utilization of a reference standard that was validated by expert consensus. This allowed the 4AT and CAM assessments to be compared to a more objective standard, thereby directly testing their diagnostic performance in detecting delirium.

Application for Clinical Practice and System Implementation

The findings from both Study 1 and 2 suggest that using an abbreviated delirium instrument in both surgical and acute medical settings may provide a pragmatic and sensitive method to detect delirium in older patients. The brevity of administration of 3D-CAM (~3 minutes) and 4AT (~2 minutes), combined with their higher sensitivity for detecting delirium compared to CAM, make these instruments potentially effective rapid screening tests for delirium in hospitalized older patients. Importantly, the utilization of such instruments might be a feasible way to mitigate the issue of underdiagnosing delirium in the hospital.

Several additional aspects of these abbreviated delirium instruments increase their suitability for clinical application. Specifically, the 3D-CAM and 4AT require less extensive training and clinical knowledge to both administer and interpret the results than the CAM.² For instance, a multistage, multiday training for CAM is a key factor in maintaining its diagnostic accuracy.^3,4 In contrast, the 3D-CAM requires only a 1- to 2-hour training session, and the 4AT can be administered by a nonclinician without the need for instrument-specific training. Thus, implementation of these instruments can be particularly pragmatic in clinical settings in which the staff involved in delirium screening cannot undergo the substantial training required to administer CAM. Moreover, these abbreviated tests enable nonphysician care team members to assume the role of delirium screener in the hospital. Taken together, the adoption of these abbreviated instruments may facilitate brief screenings of delirium in older patients by caregivers who see them most often—nurses and certified nursing assistants—thereby improving early detection and prevention of delirium-related complications in the hospital.

The feasibility of using abbreviated delirium screening instruments in the hospital setting raises a system implementation question—if these instruments are designed to be administered by those with limited to no training, could nonclinicians, such as hospital volunteers, effectively take on delirium screening roles in the hospital? If volunteers are able to take on this role, the integration of hospital volunteers into the clinical team can greatly expand the capacity for delirium screening in the hospital setting. Further research is warranted to validate the diagnostic accuracy of 3D-CAM and 4AT by nonclinician administrators in order to more broadly adopt this approach to delirium screening.

Practice Points

• Abbreviated delirium screening tools such as 3D-CAM and 4AT may be pragmatic instruments to improve delirium detection in surgical and hospitalized older patients, respectively.
• Further studies are warranted to validate the diagnostic accuracy of 3D-CAM and 4AT by nonclinician administrators in order to more broadly adopt this approach to delirium screening.

Jared Doan, BS, and Fred Ko, MD
Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai

Study 1 Overview (Oberhaus et al)

Objective: To compare the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM) to the long-form Confusion Assessment Method (CAM) in detecting postoperative delirium.

Design: Prospective concurrent comparison of 3D-CAM and CAM evaluations in a cohort of postoperative geriatric patients.

Setting and participants: Eligible participants were patients aged 60 years or older undergoing major elective surgery at Barnes Jewish Hospital (St. Louis, Missouri) who were enrolled in ongoing clinical trials (PODCAST, ENGAGES, SATISFY-SOS) between 2015 and 2018. Surgeries were at least 2 hours in length and required general anesthesia, planned extubation, and a minimum 2-day hospital stay. Investigators were extensively trained in administering 3D-CAM and CAM instruments. Participants were evaluated 2 hours after the end of anesthesia care on the day of surgery, then daily until follow-up was completed per clinical trial protocol or until the participant was determined by CAM to be nondelirious for 3 consecutive days. For each evaluation, both 3D-CAM and CAM assessors approached the participant together, but the evaluation was conducted such that the 3D-CAM assessor was masked to the additional questions ascertained by the long-form CAM assessment. The 3D-CAM or CAM assessor independently scored their respective assessments blinded to the results of the other assessor.

Main outcome measures: Participants were concurrently evaluated for postoperative delirium by both 3D-CAM and long-form CAM assessments. Comparisons between 3D-CAM and CAM scores were made using Cohen κ with repeated measures, generalized linear mixed-effects model, and Bland-Altman analysis.

Main results: Sixteen raters performed 471 concurrent 3D-CAM and CAM assessments in 299 participants (mean [SD] age, 69 [6.5] years). Of these participants, 152 (50.8%) were men, 263 (88.0%) were White, and 211 (70.6%) underwent noncardiac surgery. Both instruments showed good intraclass correlation (0.98 for 3D-CAM, 0.84 for CAM) with good overall agreement (Cohen κ = 0.71; 95% CI, 0.58-0.83). The mixed-effects model indicated a significant disagreement between the 3D-CAM and CAM assessments (estimated difference in fixed effect, –0.68; 95% CI, –1.32 to –0.05; P = .04). The Bland-Altman analysis showed that the probability of a delirium diagnosis with the 3D-CAM was more than twice that with the CAM (probability ratio, 2.78; 95% CI, 2.44-3.23).

Conclusion: The high degree of agreement between 3D-CAM and long-form CAM assessments suggests that the former may be a pragmatic and easy-to-administer clinical tool to screen for postoperative delirium in vulnerable older surgical patients.

Study 2 Overview (Shenkin et al)

Objective: To assess the accuracy of the 4 ‘A’s Test (4AT) for delirium detection in the medical inpatient setting and to compare the 4AT to the CAM.

Design: Prospective randomized diagnostic test accuracy study.

Setting and participants: This study was conducted in emergency departments and acute medical wards at 3 UK sites (Edinburgh, Bradford, and Sheffield) and enrolled acute medical patients aged 70 years or older without acute life-threatening illnesses and/or coma. Assessors administering the delirium evaluation were nurses or graduate clinical research associates who underwent systematic training in delirium and delirium assessment. Additional training was provided to those administering the CAM but not to those administering the 4AT as the latter is designed to be administered without special training. First, all participants underwent a reference standard delirium assessment using Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) criteria to derive a final definitive diagnosis of delirium via expert consensus (1 psychiatrist and 2 geriatricians). Then, the participants were randomized to either the 4AT or the comparator CAM group using computer-generated pseudo-random numbers, stratified by study site, with block allocation. All assessments were performed by pairs of independent assessors blinded to the results of the other assessment.

Main outcome measures: All participants were evaluated by the reference standard (DSM-IV criteria for delirium) and by either 4AT or CAM instruments for delirium. The accuracy of the 4AT instrument was evaluated by comparing its positive and negative predictive values, sensitivity, and specificity to the reference standard and analyzed via the area under the receiver operating characteristic curve. The diagnostic accuracy of 4AT, compared to the CAM, was evaluated by comparing positive and negative predictive values, sensitivity, and specificity using Fisher’s exact test. The overall performance of 4AT and CAM was summarized using Youden’s Index and the diagnostic odds ratio of sensitivity to specificity.

Results: All 843 individuals enrolled in the study were randomized and 785 were included in the analysis (23 withdrew, 3 lost contact, 32 indeterminate diagnosis, 2 missing outcome). Of the participants analyzed, the mean age was 81.4 [6.4] years, and 12.1% (95/785) had delirium by reference standard assessment, 14.3% (56/392) by 4AT, and 4.7% (18/384) by CAM. The 4AT group had an area under the receiver operating characteristic curve of 0.90 (95% CI, 0.84-0.96), a sensitivity of 76% (95% CI, 61%-87%), and a specificity of 94% (95% CI, 92%-97%). In comparison, the CAM group had a sensitivity of 40% (95% CI, 26%-57%) and a specificity of 100% (95% CI, 98%-100%).

Conclusions: The 4AT is a pragmatic screening test for delirium in a medical space that does not require special training to administer. The use of this instrument may help to improve delirium detection as a part of routine clinical care in hospitalized older adults.

Delirium is an acute confusional state marked by fluctuating mental status, inattention, disorganized thinking, and altered level of consciousness. It is exceedingly common in older patients in both surgical and medical settings and is associated with increased morbidity, mortality, hospital length of stay, institutionalization, and health care costs. Delirium is frequently underdiagnosed in the hospitalized setting, perhaps due to a combination of its waxing and waning nature and a lack of pragmatic and easily implementable screening tools that can be readily administered by clinicians and nonclinicians alike.¹ While the CAM is a well-validated instrument to diagnose delirium, it requires specific training in the rating of each of the cardinal features ascertained through a brief cognitive assessment and takes 5 to 10 minutes to complete. Taken together, given the high patient load for clinicians in the hospital setting, the validation and application of brief delirium screening instruments that can be reliably administered by nonphysicians and nonclinicians may enhance delirium detection in vulnerable patients and consequently improve their outcomes.

In Study 1, Oberhaus et al approach the challenge of underdiagnosing delirium in the postoperative setting by investigating whether the widely accepted long-form CAM and an abbreviated 3-minute version, the 3D-CAM, provide similar delirium detection in older surgical patients. The authors found that both instruments were reliable tests individually (high interrater reliability) and had good overall agreement. However, the 3D-CAM was more likely to yield a positive diagnosis of delirium compared to the long-form CAM, consistent with its purpose as a screening tool with a high sensitivity. It is important to emphasize that the 3D-CAM takes less time to administer, but also requires less extensive training and clinical knowledge than the long-form CAM. Therefore, this instrument meets the prerequisite of a brief screening test that can be rapidly administered by nonclinicians, and if affirmative, followed by a more extensive confirmatory test performed by a clinician. Limitations of this study include a lack of a reference standard structured interview conducted by a physician-rater to better determine the true diagnostic accuracy of both 3D-CAM and CAM assessments, and the use of convenience sampling at a single center, which reduces the generalizability of its findings.

In a similar vein, Shenkin et al in Study 2 attempt to evaluate the utility of the 4AT instrument in diagnosing delirium in older medical inpatients by testing the diagnostic accuracy of the 4AT against a reference standard (ie, DSM-IV–based evaluation by physicians) as well as comparing it to CAM. The 4AT takes less time (~2 minutes) and requires less knowledge and training to administer as compared to the CAM. The study showed that the abbreviated 4AT, compared to CAM, had a higher sensitivity (76% vs 40%) and lower specificity (94% vs 100%) in delirium detection. Thus, akin to the application of 3D-CAM in the postoperative setting, 4AT possesses key characteristics of a brief delirium screening test for older patients in the acute medical setting. In contrast to the Oberhaus et al study, a major strength of this study was the utilization of a reference standard that was validated by expert consensus. This allowed the 4AT and CAM assessments to be compared to a more objective standard, thereby directly testing their diagnostic performance in detecting delirium.

Application for Clinical Practice and System Implementation

The findings from both Study 1 and 2 suggest that using an abbreviated delirium instrument in both surgical and acute medical settings may provide a pragmatic and sensitive method to detect delirium in older patients. The brevity of administration of 3D-CAM (~3 minutes) and 4AT (~2 minutes), combined with their higher sensitivity for detecting delirium compared to CAM, make these instruments potentially effective rapid screening tests for delirium in hospitalized older patients. Importantly, the utilization of such instruments might be a feasible way to mitigate the issue of underdiagnosing delirium in the hospital.

Several additional aspects of these abbreviated delirium instruments increase their suitability for clinical application. Specifically, the 3D-CAM and 4AT require less extensive training and clinical knowledge to both administer and interpret the results than the CAM.² For instance, a multistage, multiday training for CAM is a key factor in maintaining its diagnostic accuracy.^3,4 In contrast, the 3D-CAM requires only a 1- to 2-hour training session, and the 4AT can be administered by a nonclinician without the need for instrument-specific training. Thus, implementation of these instruments can be particularly pragmatic in clinical settings in which the staff involved in delirium screening cannot undergo the substantial training required to administer CAM. Moreover, these abbreviated tests enable nonphysician care team members to assume the role of delirium screener in the hospital. Taken together, the adoption of these abbreviated instruments may facilitate brief screenings of delirium in older patients by caregivers who see them most often—nurses and certified nursing assistants—thereby improving early detection and prevention of delirium-related complications in the hospital.

The feasibility of using abbreviated delirium screening instruments in the hospital setting raises a system implementation question—if these instruments are designed to be administered by those with limited to no training, could nonclinicians, such as hospital volunteers, effectively take on delirium screening roles in the hospital? If volunteers are able to take on this role, the integration of hospital volunteers into the clinical team can greatly expand the capacity for delirium screening in the hospital setting. Further research is warranted to validate the diagnostic accuracy of 3D-CAM and 4AT by nonclinician administrators in order to more broadly adopt this approach to delirium screening.

Practice Points

• Abbreviated delirium screening tools such as 3D-CAM and 4AT may be pragmatic instruments to improve delirium detection in surgical and hospitalized older patients, respectively.
• Further studies are warranted to validate the diagnostic accuracy of 3D-CAM and 4AT by nonclinician administrators in order to more broadly adopt this approach to delirium screening.

Jared Doan, BS, and Fred Ko, MD
Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai

Study 1 Overview (Oberhaus et al)

Objective: To compare the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM) to the long-form Confusion Assessment Method (CAM) in detecting postoperative delirium.

Design: Prospective concurrent comparison of 3D-CAM and CAM evaluations in a cohort of postoperative geriatric patients.

Setting and participants: Eligible participants were patients aged 60 years or older undergoing major elective surgery at Barnes Jewish Hospital (St. Louis, Missouri) who were enrolled in ongoing clinical trials (PODCAST, ENGAGES, SATISFY-SOS) between 2015 and 2018. Surgeries were at least 2 hours in length and required general anesthesia, planned extubation, and a minimum 2-day hospital stay. Investigators were extensively trained in administering 3D-CAM and CAM instruments. Participants were evaluated 2 hours after the end of anesthesia care on the day of surgery, then daily until follow-up was completed per clinical trial protocol or until the participant was determined by CAM to be nondelirious for 3 consecutive days. For each evaluation, both 3D-CAM and CAM assessors approached the participant together, but the evaluation was conducted such that the 3D-CAM assessor was masked to the additional questions ascertained by the long-form CAM assessment. The 3D-CAM or CAM assessor independently scored their respective assessments blinded to the results of the other assessor.

Main outcome measures: Participants were concurrently evaluated for postoperative delirium by both 3D-CAM and long-form CAM assessments. Comparisons between 3D-CAM and CAM scores were made using Cohen κ with repeated measures, generalized linear mixed-effects model, and Bland-Altman analysis.

Main results: Sixteen raters performed 471 concurrent 3D-CAM and CAM assessments in 299 participants (mean [SD] age, 69 [6.5] years). Of these participants, 152 (50.8%) were men, 263 (88.0%) were White, and 211 (70.6%) underwent noncardiac surgery. Both instruments showed good intraclass correlation (0.98 for 3D-CAM, 0.84 for CAM) with good overall agreement (Cohen κ = 0.71; 95% CI, 0.58-0.83). The mixed-effects model indicated a significant disagreement between the 3D-CAM and CAM assessments (estimated difference in fixed effect, –0.68; 95% CI, –1.32 to –0.05; P = .04). The Bland-Altman analysis showed that the probability of a delirium diagnosis with the 3D-CAM was more than twice that with the CAM (probability ratio, 2.78; 95% CI, 2.44-3.23).

Conclusion: The high degree of agreement between 3D-CAM and long-form CAM assessments suggests that the former may be a pragmatic and easy-to-administer clinical tool to screen for postoperative delirium in vulnerable older surgical patients.

Study 2 Overview (Shenkin et al)

Objective: To assess the accuracy of the 4 ‘A’s Test (4AT) for delirium detection in the medical inpatient setting and to compare the 4AT to the CAM.

Design: Prospective randomized diagnostic test accuracy study.

Setting and participants: This study was conducted in emergency departments and acute medical wards at 3 UK sites (Edinburgh, Bradford, and Sheffield) and enrolled acute medical patients aged 70 years or older without acute life-threatening illnesses and/or coma. Assessors administering the delirium evaluation were nurses or graduate clinical research associates who underwent systematic training in delirium and delirium assessment. Additional training was provided to those administering the CAM but not to those administering the 4AT as the latter is designed to be administered without special training. First, all participants underwent a reference standard delirium assessment using Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) criteria to derive a final definitive diagnosis of delirium via expert consensus (1 psychiatrist and 2 geriatricians). Then, the participants were randomized to either the 4AT or the comparator CAM group using computer-generated pseudo-random numbers, stratified by study site, with block allocation. All assessments were performed by pairs of independent assessors blinded to the results of the other assessment.

Main outcome measures: All participants were evaluated by the reference standard (DSM-IV criteria for delirium) and by either 4AT or CAM instruments for delirium. The accuracy of the 4AT instrument was evaluated by comparing its positive and negative predictive values, sensitivity, and specificity to the reference standard and analyzed via the area under the receiver operating characteristic curve. The diagnostic accuracy of 4AT, compared to the CAM, was evaluated by comparing positive and negative predictive values, sensitivity, and specificity using Fisher’s exact test. The overall performance of 4AT and CAM was summarized using Youden’s Index and the diagnostic odds ratio of sensitivity to specificity.

Results: All 843 individuals enrolled in the study were randomized and 785 were included in the analysis (23 withdrew, 3 lost contact, 32 indeterminate diagnosis, 2 missing outcome). Of the participants analyzed, the mean age was 81.4 [6.4] years, and 12.1% (95/785) had delirium by reference standard assessment, 14.3% (56/392) by 4AT, and 4.7% (18/384) by CAM. The 4AT group had an area under the receiver operating characteristic curve of 0.90 (95% CI, 0.84-0.96), a sensitivity of 76% (95% CI, 61%-87%), and a specificity of 94% (95% CI, 92%-97%). In comparison, the CAM group had a sensitivity of 40% (95% CI, 26%-57%) and a specificity of 100% (95% CI, 98%-100%).

Conclusions: The 4AT is a pragmatic screening test for delirium in a medical space that does not require special training to administer. The use of this instrument may help to improve delirium detection as a part of routine clinical care in hospitalized older adults.

Delirium is an acute confusional state marked by fluctuating mental status, inattention, disorganized thinking, and altered level of consciousness. It is exceedingly common in older patients in both surgical and medical settings and is associated with increased morbidity, mortality, hospital length of stay, institutionalization, and health care costs. Delirium is frequently underdiagnosed in the hospitalized setting, perhaps due to a combination of its waxing and waning nature and a lack of pragmatic and easily implementable screening tools that can be readily administered by clinicians and nonclinicians alike.¹ While the CAM is a well-validated instrument to diagnose delirium, it requires specific training in the rating of each of the cardinal features ascertained through a brief cognitive assessment and takes 5 to 10 minutes to complete. Taken together, given the high patient load for clinicians in the hospital setting, the validation and application of brief delirium screening instruments that can be reliably administered by nonphysicians and nonclinicians may enhance delirium detection in vulnerable patients and consequently improve their outcomes.

In Study 1, Oberhaus et al approach the challenge of underdiagnosing delirium in the postoperative setting by investigating whether the widely accepted long-form CAM and an abbreviated 3-minute version, the 3D-CAM, provide similar delirium detection in older surgical patients. The authors found that both instruments were reliable tests individually (high interrater reliability) and had good overall agreement. However, the 3D-CAM was more likely to yield a positive diagnosis of delirium compared to the long-form CAM, consistent with its purpose as a screening tool with a high sensitivity. It is important to emphasize that the 3D-CAM takes less time to administer, but also requires less extensive training and clinical knowledge than the long-form CAM. Therefore, this instrument meets the prerequisite of a brief screening test that can be rapidly administered by nonclinicians, and if affirmative, followed by a more extensive confirmatory test performed by a clinician. Limitations of this study include a lack of a reference standard structured interview conducted by a physician-rater to better determine the true diagnostic accuracy of both 3D-CAM and CAM assessments, and the use of convenience sampling at a single center, which reduces the generalizability of its findings.

In a similar vein, Shenkin et al in Study 2 attempt to evaluate the utility of the 4AT instrument in diagnosing delirium in older medical inpatients by testing the diagnostic accuracy of the 4AT against a reference standard (ie, DSM-IV–based evaluation by physicians) as well as comparing it to CAM. The 4AT takes less time (~2 minutes) and requires less knowledge and training to administer as compared to the CAM. The study showed that the abbreviated 4AT, compared to CAM, had a higher sensitivity (76% vs 40%) and lower specificity (94% vs 100%) in delirium detection. Thus, akin to the application of 3D-CAM in the postoperative setting, 4AT possesses key characteristics of a brief delirium screening test for older patients in the acute medical setting. In contrast to the Oberhaus et al study, a major strength of this study was the utilization of a reference standard that was validated by expert consensus. This allowed the 4AT and CAM assessments to be compared to a more objective standard, thereby directly testing their diagnostic performance in detecting delirium.

Application for Clinical Practice and System Implementation

The findings from both Study 1 and 2 suggest that using an abbreviated delirium instrument in both surgical and acute medical settings may provide a pragmatic and sensitive method to detect delirium in older patients. The brevity of administration of 3D-CAM (~3 minutes) and 4AT (~2 minutes), combined with their higher sensitivity for detecting delirium compared to CAM, make these instruments potentially effective rapid screening tests for delirium in hospitalized older patients. Importantly, the utilization of such instruments might be a feasible way to mitigate the issue of underdiagnosing delirium in the hospital.

Several additional aspects of these abbreviated delirium instruments increase their suitability for clinical application. Specifically, the 3D-CAM and 4AT require less extensive training and clinical knowledge to both administer and interpret the results than the CAM.² For instance, a multistage, multiday training for CAM is a key factor in maintaining its diagnostic accuracy.^3,4 In contrast, the 3D-CAM requires only a 1- to 2-hour training session, and the 4AT can be administered by a nonclinician without the need for instrument-specific training. Thus, implementation of these instruments can be particularly pragmatic in clinical settings in which the staff involved in delirium screening cannot undergo the substantial training required to administer CAM. Moreover, these abbreviated tests enable nonphysician care team members to assume the role of delirium screener in the hospital. Taken together, the adoption of these abbreviated instruments may facilitate brief screenings of delirium in older patients by caregivers who see them most often—nurses and certified nursing assistants—thereby improving early detection and prevention of delirium-related complications in the hospital.

The feasibility of using abbreviated delirium screening instruments in the hospital setting raises a system implementation question—if these instruments are designed to be administered by those with limited to no training, could nonclinicians, such as hospital volunteers, effectively take on delirium screening roles in the hospital? If volunteers are able to take on this role, the integration of hospital volunteers into the clinical team can greatly expand the capacity for delirium screening in the hospital setting. Further research is warranted to validate the diagnostic accuracy of 3D-CAM and 4AT by nonclinician administrators in order to more broadly adopt this approach to delirium screening.

Practice Points

• Abbreviated delirium screening tools such as 3D-CAM and 4AT may be pragmatic instruments to improve delirium detection in surgical and hospitalized older patients, respectively.
• Further studies are warranted to validate the diagnostic accuracy of 3D-CAM and 4AT by nonclinician administrators in order to more broadly adopt this approach to delirium screening.

Jared Doan, BS, and Fred Ko, MD
Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; [email protected]

Process improvement in any industry sector aims to increase the efficiency of resource utilization and delivery methods (cost) and the quality of the product (outcomes), with the goal of ultimately achieving continuous development.¹ In the health care industry, variation in processes and outcomes along with inefficiency in resource use that result in changes in value (the product of outcomes/costs) are the general targets of quality improvement (QI) efforts employing various implementation methodologies.² When the ultimate aim is to serve the patient (customer), best clinical practice includes both maintaining high quality (individual care delivery) and controlling costs (efficient care system delivery), leading to optimal delivery (value-based care). High-quality individual care and efficient care delivery are not competing concepts, but when working to improve both health care outcomes and cost, traditional and nontraditional barriers to system QI often arise.³

The possible scenarios after a QI intervention include backsliding (regression to the mean over time), steady-state (minimal fixed improvement that could sustain), and continuous improvement (tangible enhancement after completing the intervention with legacy effect).⁴ The scalability of results can be considered during the process measurement and the intervention design phases of all QI projects; however, the complex nature of barriers in the health care environment during each level of implementation should be accounted for to prevent failure in the scalability phase.⁵

The barriers to optimal QI outcomes leading to continuous improvement are multifactorial and are related to intrinsic and extrinsic factors.⁶ These factors include 3 fundamental levels: (1) individual level inertia/beliefs, prior personal knowledge, and team-related factors^7,8; (2) intervention-related and process-specific barriers and clinical practice obstacles; and (3) organizational level challenges and macro-level and population-level barriers (Figure). The obstacles faced during the implementation phase will likely include 2 of these levels simultaneously, which could add complexity and hinder or prevent the implementation of a tangible successful QI process and eventually lead to backsliding or minimal fixed improvement rather than continuous improvement. Furthermore, a patient-centered approach to QI would contribute to further complexity in design and execution, given the importance of reaching sustainable, meaningful improvement by adding elements of patient’s preferences, caregiver engagement, and the shared decision-making processes.⁹

Overcoming these multidomain barriers and reaching resilience and sustainability requires thoughtful planning and execution through a multifaceted approach.¹⁰ A meaningful start could include addressing the clinical inertia for the individual and the team by promoting open innovation and allowing outside institutional collaborations and ideas through networks.¹¹ On the individual level, encouraging participation and motivating health care workers in QI to reach a multidisciplinary operation approach will lead to harmony in collaboration. Concurrently, the organization should support the QI capability and scalability by removing competing priorities and establishing effective leadership that ensures resource allocation, communicates clear value-based principles, and engenders a psychological safety environment.

A continuous improvement state is the optimal QI target, a target that can be attained by removing obstacles and paving a clear pathway to implementation. Focusing on the 3 levels of barriers will position the organization for meaningful and successful QI phases to achieve continuous improvement.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; [email protected]

Process improvement in any industry sector aims to increase the efficiency of resource utilization and delivery methods (cost) and the quality of the product (outcomes), with the goal of ultimately achieving continuous development.¹ In the health care industry, variation in processes and outcomes along with inefficiency in resource use that result in changes in value (the product of outcomes/costs) are the general targets of quality improvement (QI) efforts employing various implementation methodologies.² When the ultimate aim is to serve the patient (customer), best clinical practice includes both maintaining high quality (individual care delivery) and controlling costs (efficient care system delivery), leading to optimal delivery (value-based care). High-quality individual care and efficient care delivery are not competing concepts, but when working to improve both health care outcomes and cost, traditional and nontraditional barriers to system QI often arise.³

The possible scenarios after a QI intervention include backsliding (regression to the mean over time), steady-state (minimal fixed improvement that could sustain), and continuous improvement (tangible enhancement after completing the intervention with legacy effect).⁴ The scalability of results can be considered during the process measurement and the intervention design phases of all QI projects; however, the complex nature of barriers in the health care environment during each level of implementation should be accounted for to prevent failure in the scalability phase.⁵

The barriers to optimal QI outcomes leading to continuous improvement are multifactorial and are related to intrinsic and extrinsic factors.⁶ These factors include 3 fundamental levels: (1) individual level inertia/beliefs, prior personal knowledge, and team-related factors^7,8; (2) intervention-related and process-specific barriers and clinical practice obstacles; and (3) organizational level challenges and macro-level and population-level barriers (Figure). The obstacles faced during the implementation phase will likely include 2 of these levels simultaneously, which could add complexity and hinder or prevent the implementation of a tangible successful QI process and eventually lead to backsliding or minimal fixed improvement rather than continuous improvement. Furthermore, a patient-centered approach to QI would contribute to further complexity in design and execution, given the importance of reaching sustainable, meaningful improvement by adding elements of patient’s preferences, caregiver engagement, and the shared decision-making processes.⁹

Overcoming these multidomain barriers and reaching resilience and sustainability requires thoughtful planning and execution through a multifaceted approach.¹⁰ A meaningful start could include addressing the clinical inertia for the individual and the team by promoting open innovation and allowing outside institutional collaborations and ideas through networks.¹¹ On the individual level, encouraging participation and motivating health care workers in QI to reach a multidisciplinary operation approach will lead to harmony in collaboration. Concurrently, the organization should support the QI capability and scalability by removing competing priorities and establishing effective leadership that ensures resource allocation, communicates clear value-based principles, and engenders a psychological safety environment.

A continuous improvement state is the optimal QI target, a target that can be attained by removing obstacles and paving a clear pathway to implementation. Focusing on the 3 levels of barriers will position the organization for meaningful and successful QI phases to achieve continuous improvement.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; [email protected]

Process improvement in any industry sector aims to increase the efficiency of resource utilization and delivery methods (cost) and the quality of the product (outcomes), with the goal of ultimately achieving continuous development.¹ In the health care industry, variation in processes and outcomes along with inefficiency in resource use that result in changes in value (the product of outcomes/costs) are the general targets of quality improvement (QI) efforts employing various implementation methodologies.² When the ultimate aim is to serve the patient (customer), best clinical practice includes both maintaining high quality (individual care delivery) and controlling costs (efficient care system delivery), leading to optimal delivery (value-based care). High-quality individual care and efficient care delivery are not competing concepts, but when working to improve both health care outcomes and cost, traditional and nontraditional barriers to system QI often arise.³

The possible scenarios after a QI intervention include backsliding (regression to the mean over time), steady-state (minimal fixed improvement that could sustain), and continuous improvement (tangible enhancement after completing the intervention with legacy effect).⁴ The scalability of results can be considered during the process measurement and the intervention design phases of all QI projects; however, the complex nature of barriers in the health care environment during each level of implementation should be accounted for to prevent failure in the scalability phase.⁵

The barriers to optimal QI outcomes leading to continuous improvement are multifactorial and are related to intrinsic and extrinsic factors.⁶ These factors include 3 fundamental levels: (1) individual level inertia/beliefs, prior personal knowledge, and team-related factors^7,8; (2) intervention-related and process-specific barriers and clinical practice obstacles; and (3) organizational level challenges and macro-level and population-level barriers (Figure). The obstacles faced during the implementation phase will likely include 2 of these levels simultaneously, which could add complexity and hinder or prevent the implementation of a tangible successful QI process and eventually lead to backsliding or minimal fixed improvement rather than continuous improvement. Furthermore, a patient-centered approach to QI would contribute to further complexity in design and execution, given the importance of reaching sustainable, meaningful improvement by adding elements of patient’s preferences, caregiver engagement, and the shared decision-making processes.⁹

Overcoming these multidomain barriers and reaching resilience and sustainability requires thoughtful planning and execution through a multifaceted approach.¹⁰ A meaningful start could include addressing the clinical inertia for the individual and the team by promoting open innovation and allowing outside institutional collaborations and ideas through networks.¹¹ On the individual level, encouraging participation and motivating health care workers in QI to reach a multidisciplinary operation approach will lead to harmony in collaboration. Concurrently, the organization should support the QI capability and scalability by removing competing priorities and establishing effective leadership that ensures resource allocation, communicates clear value-based principles, and engenders a psychological safety environment.

A continuous improvement state is the optimal QI target, a target that can be attained by removing obstacles and paving a clear pathway to implementation. Focusing on the 3 levels of barriers will position the organization for meaningful and successful QI phases to achieve continuous improvement.