Kenneth Lam, MD

Three years after gabapentin received US Food and Drug Administration (FDA) approval in 1990 for epilepsy, case reports and animal studies emerged announcing its potential in the treatment of pain syndromes through then-novel analgesic mechanisms.¹ Fast forward 20 years to 2016: gabapentin and its close cousin, pregabalin, are internationally considered first-line agents for the treatment of neuropathic pain in guidelines from the Centers for Disease Control and Prevention, the Canadian Pain Society, and the National Institute for Health and Care Excellence. Gabapentin is the 10th most prescribed drug in the United States, and brand-name pregabalin sales were $4.4 billion USD, ranking 8th in invoice drug spending.²

The ascendancy of gabapentinoids as drugs of choice for pain, though, is fraught with controversy; yet, they were shepherded to commercial success. In 2004, the patent owner of gabapentin, Warner-Lambert (now owned by Pfizer), admitted guilt to charges that it violated federal regulations in its promotion: they encouraged off-label prescribing through paid physician-to-physician communications, publication of positive outcomes, and suppression of negative ones.³ Pfizer paid another settlement in 2009 for false claims about off-label indications for brand-name pregabalin.⁴

Mindful of historical biases, recent trials and meta-analyses have found less favorable outcomes for gabapentinoids in the treatment of off-label pain conditions and greater risks than previously reported. Cochrane reviews for gabapentin demonstrate efficacy only in postherpetic neuralgia (for which it has FDA approval) and diabetic peripheral neuropathy (for which it does not); pregabalin has efficacy in both these conditions as well as posttraumatic neuropathic pain and fibromyalgia (and FDA approval for all four). For other types of neuropathic pain, the evidence is of lower quality. Even for approved indications, the risk–benefit ratio is questionable, as the numbers needed to harm for dizziness and somnolence are similar to the numbers needed to treat for pain.^5,6 Further, case–control studies have found increased odds of opioid-related death when gabapentinoids were coprescribed with opioids,^7,8 prompting gabapentinoids to be reclassified as class C controlled substances in the UK as of April 2019.⁹

On this backdrop, Gingras and colleagues publish their retrospective cohort study on high-risk prescribing of these popular drugs in Montreal, Canada in this issue of Journal of Hospital Medicine.¹⁰ In their retrospective cohort study of 4,103 patients admitted to a clinical teaching unit, more than one in eight patients (13%) were being prescribed a gabapentinoid as an outpatient; chart review of the admission notes indicated that only 17% of them had an FDA-approved indication and 28% had no clear indication. Gabapentinoid users were more likely to be coprescribed an opioid than nonusers (28% vs 12%). There was no significant difference in length of stay or inpatient death between users and nonusers.

Gingras et al. thereby conclude that there is an opportunity to deprescribe on the basis of few gabapentinoid users having a documented indication and the recent research showing potentials for harm and abuse.¹¹ We agree. Messaging around gabapentinoids should be similar to that for opioids: these are medications with limited evidence supporting their use in the treatment of chronic pain, and prescribing them for unapproved indications risks doing greater harm than good. We offer two recommendations on how hospitalists can proceed with deprescribing them safely.

First, the urgency of deprescribing in inpatient settings should be titrated to the degree of risk. When the reason for hospitalization is potentially an adverse drug effect, culprit medications posing a substantial and near-term risk of harm should be stopped, such as when patients on gabapentinoids present with major alteration of their mental status.

In less urgent circumstances, hospitalists should speak first with outpatient prescribers because they may have important contextual information (eg, indication, patient preference, failure of alternative therapies, etc.) about previous care that the inpatient clinician lacks. For gabapentinoids, it is easy to imagine how treated pain syndromes without objective markers of disease may escape notice by a hospitalist and remain undocumented, which may encourage erroneous deprescribing. If the shared decision between the patient and providers is to deprescribe, patients on high doses warrant a tapering schedule.¹¹ Pharmacist consultation can help with this.

Second, before discharge, hospitalists should communicate their rationale for deprescribing medications to both patients and outpatient prescribers, especially if a prolonged tapering schedule is required. This type of communication occurred infrequently in this study: the reason for deprescribing a gabapentinoid was missing from the discharge summary 55% of the time. Without this, outpatient prescribers may simply reinitiate the medication after the patient is discharged.

To counter the overuse of gabapentinoids, hospitalists should look for opportunities to deprescribe them where there is concern about adverse events and when evidence-based indications do not exist. Successful deprescribing of these popular drugs will require deliberate collaboration and communication with the outpatient circle of care, as ongoing deprescribing ultimately depends on patients and outpatient prescribers agreeing to the change.

Disclosures

Dr. Steinman served as an unpaid expert witness in United States of America ex. Rel. David Franklin vs. Parke-Davis, Division of Warner-Lambert Company and Pfizer, Inc, litigation which alleged that the named pharmaceutical companies improperly marketed gabapentin for non-FDA-approved uses. Drs. Lam and Rochon have no conflicts of interest to declare.

Funding

Dr. Rochon is supported by the Retired Teachers of Ontario (RTO/ERO) Chair in Geriatric Medicine at the University of Toronto. Dr. Steinman is supported by the National Institute on Aging, US (K24AG049057 and P30AG044281).

Three years after gabapentin received US Food and Drug Administration (FDA) approval in 1990 for epilepsy, case reports and animal studies emerged announcing its potential in the treatment of pain syndromes through then-novel analgesic mechanisms.¹ Fast forward 20 years to 2016: gabapentin and its close cousin, pregabalin, are internationally considered first-line agents for the treatment of neuropathic pain in guidelines from the Centers for Disease Control and Prevention, the Canadian Pain Society, and the National Institute for Health and Care Excellence. Gabapentin is the 10th most prescribed drug in the United States, and brand-name pregabalin sales were $4.4 billion USD, ranking 8th in invoice drug spending.²

The ascendancy of gabapentinoids as drugs of choice for pain, though, is fraught with controversy; yet, they were shepherded to commercial success. In 2004, the patent owner of gabapentin, Warner-Lambert (now owned by Pfizer), admitted guilt to charges that it violated federal regulations in its promotion: they encouraged off-label prescribing through paid physician-to-physician communications, publication of positive outcomes, and suppression of negative ones.³ Pfizer paid another settlement in 2009 for false claims about off-label indications for brand-name pregabalin.⁴

Mindful of historical biases, recent trials and meta-analyses have found less favorable outcomes for gabapentinoids in the treatment of off-label pain conditions and greater risks than previously reported. Cochrane reviews for gabapentin demonstrate efficacy only in postherpetic neuralgia (for which it has FDA approval) and diabetic peripheral neuropathy (for which it does not); pregabalin has efficacy in both these conditions as well as posttraumatic neuropathic pain and fibromyalgia (and FDA approval for all four). For other types of neuropathic pain, the evidence is of lower quality. Even for approved indications, the risk–benefit ratio is questionable, as the numbers needed to harm for dizziness and somnolence are similar to the numbers needed to treat for pain.^5,6 Further, case–control studies have found increased odds of opioid-related death when gabapentinoids were coprescribed with opioids,^7,8 prompting gabapentinoids to be reclassified as class C controlled substances in the UK as of April 2019.⁹

On this backdrop, Gingras and colleagues publish their retrospective cohort study on high-risk prescribing of these popular drugs in Montreal, Canada in this issue of Journal of Hospital Medicine.¹⁰ In their retrospective cohort study of 4,103 patients admitted to a clinical teaching unit, more than one in eight patients (13%) were being prescribed a gabapentinoid as an outpatient; chart review of the admission notes indicated that only 17% of them had an FDA-approved indication and 28% had no clear indication. Gabapentinoid users were more likely to be coprescribed an opioid than nonusers (28% vs 12%). There was no significant difference in length of stay or inpatient death between users and nonusers.

Gingras et al. thereby conclude that there is an opportunity to deprescribe on the basis of few gabapentinoid users having a documented indication and the recent research showing potentials for harm and abuse.¹¹ We agree. Messaging around gabapentinoids should be similar to that for opioids: these are medications with limited evidence supporting their use in the treatment of chronic pain, and prescribing them for unapproved indications risks doing greater harm than good. We offer two recommendations on how hospitalists can proceed with deprescribing them safely.

First, the urgency of deprescribing in inpatient settings should be titrated to the degree of risk. When the reason for hospitalization is potentially an adverse drug effect, culprit medications posing a substantial and near-term risk of harm should be stopped, such as when patients on gabapentinoids present with major alteration of their mental status.

In less urgent circumstances, hospitalists should speak first with outpatient prescribers because they may have important contextual information (eg, indication, patient preference, failure of alternative therapies, etc.) about previous care that the inpatient clinician lacks. For gabapentinoids, it is easy to imagine how treated pain syndromes without objective markers of disease may escape notice by a hospitalist and remain undocumented, which may encourage erroneous deprescribing. If the shared decision between the patient and providers is to deprescribe, patients on high doses warrant a tapering schedule.¹¹ Pharmacist consultation can help with this.

Second, before discharge, hospitalists should communicate their rationale for deprescribing medications to both patients and outpatient prescribers, especially if a prolonged tapering schedule is required. This type of communication occurred infrequently in this study: the reason for deprescribing a gabapentinoid was missing from the discharge summary 55% of the time. Without this, outpatient prescribers may simply reinitiate the medication after the patient is discharged.

To counter the overuse of gabapentinoids, hospitalists should look for opportunities to deprescribe them where there is concern about adverse events and when evidence-based indications do not exist. Successful deprescribing of these popular drugs will require deliberate collaboration and communication with the outpatient circle of care, as ongoing deprescribing ultimately depends on patients and outpatient prescribers agreeing to the change.

Disclosures

Dr. Steinman served as an unpaid expert witness in United States of America ex. Rel. David Franklin vs. Parke-Davis, Division of Warner-Lambert Company and Pfizer, Inc, litigation which alleged that the named pharmaceutical companies improperly marketed gabapentin for non-FDA-approved uses. Drs. Lam and Rochon have no conflicts of interest to declare.

Funding

Dr. Rochon is supported by the Retired Teachers of Ontario (RTO/ERO) Chair in Geriatric Medicine at the University of Toronto. Dr. Steinman is supported by the National Institute on Aging, US (K24AG049057 and P30AG044281).

Three years after gabapentin received US Food and Drug Administration (FDA) approval in 1990 for epilepsy, case reports and animal studies emerged announcing its potential in the treatment of pain syndromes through then-novel analgesic mechanisms.¹ Fast forward 20 years to 2016: gabapentin and its close cousin, pregabalin, are internationally considered first-line agents for the treatment of neuropathic pain in guidelines from the Centers for Disease Control and Prevention, the Canadian Pain Society, and the National Institute for Health and Care Excellence. Gabapentin is the 10th most prescribed drug in the United States, and brand-name pregabalin sales were $4.4 billion USD, ranking 8th in invoice drug spending.²

The ascendancy of gabapentinoids as drugs of choice for pain, though, is fraught with controversy; yet, they were shepherded to commercial success. In 2004, the patent owner of gabapentin, Warner-Lambert (now owned by Pfizer), admitted guilt to charges that it violated federal regulations in its promotion: they encouraged off-label prescribing through paid physician-to-physician communications, publication of positive outcomes, and suppression of negative ones.³ Pfizer paid another settlement in 2009 for false claims about off-label indications for brand-name pregabalin.⁴

Mindful of historical biases, recent trials and meta-analyses have found less favorable outcomes for gabapentinoids in the treatment of off-label pain conditions and greater risks than previously reported. Cochrane reviews for gabapentin demonstrate efficacy only in postherpetic neuralgia (for which it has FDA approval) and diabetic peripheral neuropathy (for which it does not); pregabalin has efficacy in both these conditions as well as posttraumatic neuropathic pain and fibromyalgia (and FDA approval for all four). For other types of neuropathic pain, the evidence is of lower quality. Even for approved indications, the risk–benefit ratio is questionable, as the numbers needed to harm for dizziness and somnolence are similar to the numbers needed to treat for pain.^5,6 Further, case–control studies have found increased odds of opioid-related death when gabapentinoids were coprescribed with opioids,^7,8 prompting gabapentinoids to be reclassified as class C controlled substances in the UK as of April 2019.⁹

On this backdrop, Gingras and colleagues publish their retrospective cohort study on high-risk prescribing of these popular drugs in Montreal, Canada in this issue of Journal of Hospital Medicine.¹⁰ In their retrospective cohort study of 4,103 patients admitted to a clinical teaching unit, more than one in eight patients (13%) were being prescribed a gabapentinoid as an outpatient; chart review of the admission notes indicated that only 17% of them had an FDA-approved indication and 28% had no clear indication. Gabapentinoid users were more likely to be coprescribed an opioid than nonusers (28% vs 12%). There was no significant difference in length of stay or inpatient death between users and nonusers.

Gingras et al. thereby conclude that there is an opportunity to deprescribe on the basis of few gabapentinoid users having a documented indication and the recent research showing potentials for harm and abuse.¹¹ We agree. Messaging around gabapentinoids should be similar to that for opioids: these are medications with limited evidence supporting their use in the treatment of chronic pain, and prescribing them for unapproved indications risks doing greater harm than good. We offer two recommendations on how hospitalists can proceed with deprescribing them safely.

First, the urgency of deprescribing in inpatient settings should be titrated to the degree of risk. When the reason for hospitalization is potentially an adverse drug effect, culprit medications posing a substantial and near-term risk of harm should be stopped, such as when patients on gabapentinoids present with major alteration of their mental status.

In less urgent circumstances, hospitalists should speak first with outpatient prescribers because they may have important contextual information (eg, indication, patient preference, failure of alternative therapies, etc.) about previous care that the inpatient clinician lacks. For gabapentinoids, it is easy to imagine how treated pain syndromes without objective markers of disease may escape notice by a hospitalist and remain undocumented, which may encourage erroneous deprescribing. If the shared decision between the patient and providers is to deprescribe, patients on high doses warrant a tapering schedule.¹¹ Pharmacist consultation can help with this.

Second, before discharge, hospitalists should communicate their rationale for deprescribing medications to both patients and outpatient prescribers, especially if a prolonged tapering schedule is required. This type of communication occurred infrequently in this study: the reason for deprescribing a gabapentinoid was missing from the discharge summary 55% of the time. Without this, outpatient prescribers may simply reinitiate the medication after the patient is discharged.

To counter the overuse of gabapentinoids, hospitalists should look for opportunities to deprescribe them where there is concern about adverse events and when evidence-based indications do not exist. Successful deprescribing of these popular drugs will require deliberate collaboration and communication with the outpatient circle of care, as ongoing deprescribing ultimately depends on patients and outpatient prescribers agreeing to the change.

Disclosures

Dr. Steinman served as an unpaid expert witness in United States of America ex. Rel. David Franklin vs. Parke-Davis, Division of Warner-Lambert Company and Pfizer, Inc, litigation which alleged that the named pharmaceutical companies improperly marketed gabapentin for non-FDA-approved uses. Drs. Lam and Rochon have no conflicts of interest to declare.

Funding

Dr. Rochon is supported by the Retired Teachers of Ontario (RTO/ERO) Chair in Geriatric Medicine at the University of Toronto. Dr. Steinman is supported by the National Institute on Aging, US (K24AG049057 and P30AG044281).

Patient-centered care, defined by the Institute of Medicine as “health care that establishes a partnership among practitioners, patients, and their families to ensure that decisions respect patients’ wants, needs and preferences and that patients have the education and support they need to make decisions and participate in their own care,” has been recognized as an important factor in improving care transitions after discharge from the hospital.¹ Previous efforts to improve the discharge process for hospitalized patients and reduce avoidable readmissions have focused on improving systems surrounding the patient, such as by increasing the availability of outpatient follow-up or standardizing communication between the inpatient and outpatient care teams.^1,2 In fact, successful programs such as Project BOOST and the Care Transitions Interventions™ provide healthcare institutions with a “bundle” of evidence-based transitional care guidelines for discharge: they provide postdischarge transition coaches, assistance with medication self-management, timely follow-up tips, and improved patient records in order to improve postdischarge outcomes.^3,4 Successful interventions, however, may not provide more services, but also engage the patient in their own care.^5,6 The impact of engaging the patient in his or her own care by providing patient-friendly discharge instructions alone, however, is unknown.

A patient-centered discharge may use tools that were designed with patients, or may involve engaging patients in an interactive process of reviewing discharge instructions and empowering them to manage aspects of their own care after leaving the hospital. This endeavour may lead to more effective use of discharge instructions and reduce the need for additional or more intensive (and costly) interventions. For example, a patient-centered discharge tool could include an educational intervention that uses the “teach-back” method, in which patients are asked to restate in their own words what they thought they heard, or in which staff use additional media or a visual design tool meant to enhance comprehension of discharge instructions.^6,7 Visual aids and the use of larger fonts are particularly useful design elements for improving comprehension among non-English speakers and patients with low health literacy, who tend to have poorer recall of instructions.^8-10 What may constitute essential design elements to include in a discharge instruction tool, however, is not clear.

Moreover, whether the use of discharge tools with a specific focus on patient engagement may improve postdischarge outcomes is not known. Particularly, the ability of patient-centered discharge tools to improve outcomes beyond comprehension such as self-management, adherence to discharge instructions, a reduction in unplanned visits, and a reduction in mortality has not been studied systematically. The objective of this systematic review was to review the literature on discharge instruction tools with a focus on patient engagement and their impact among hospitalized patients.

The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Statement was followed as a guideline for reporting throughout this review.¹¹

Data Sources

A literature search was undertaken using the following databases from January 1994 or their inception date to May 2014: Medline, Embase, SIGLE, HTA, Bioethics, ASSIA, Psych Lit, CINAHL, Cochrane Library, EconLit, ERIC, and BioMed Central. We also searched relevant design-focused journals such as Design Issues, Journal of Design Research, Information Design Journal, Innovation, Design Studies, and International Journal of Design, as well as reference lists from studies obtained by electronic searching. The following key words and combination of key words were used with the assistance of a medical librarian: patient discharge, patient-centered discharge, patient-centered design, design thinking, user based design, patient education, discharge summary, education. Additional search terms were added when identified from relevant articles (Appendix).

Inclusion Criteria

We included all English-language studies with patients admitted to the hospital irrespective of age, sex, or medical condition, which included a control group or time period and which measured patient outcomes within 3 months of discharge. The 3-month period after discharge is often cited as a time when outcomes could reasonably be associated with an intervention at discharge.²

Exclusion Criteria

Studies that did not have clear implementation of a patient-centered tool, a control group, or those whose tool was used in the emergency department or as an outpatient were excluded. Studies that included postdischarge tools such as home visits or telephone calls were excluded unless independent effects of the predischarge interventions were measured. Studies with outcomes reported after 3 months were excluded unless outcomes before 3 months were also clearly noted.

All searches were entered into Endnote and duplicates were removed. A 2-stage inclusion process was used. Titles and abstracts of articles were first screened for meeting inclusion and exclusion criteria by 1 reviewer. A second reviewer independently checked a 10% random sample of all the abstracts that met the initial screening criteria. If the agreement to exclude studies was less than 95%, criteria were reviewed before checking the rest of the 90% sample. In the second stage, 2 independent reviewers examined paper copies of the full articles selected in the first stage. Disagreement between reviewers was resolved by discussion or a third reviewer if no agreement could be reached.

Data Analysis and Synthesis

The following information was extracted from the full reference: type of study, population studied, control group or time period, tool used, and outcomes measured. Based on the National Health Care Quality report’s priorities and goals on patient and/or family engagement during transitions of care, educational tools were further described based on method of teaching, involvement of the care team, involvement of the patient in the design or delivery of the tool, and/or the use of visual aids.¹² All primary outcomes were classified according to 3 categories: improved knowledge/comprehension, patient experience (patient satisfaction, self-management/efficacy such as functional status, both physical and mental), and health outcomes (unscheduled visits or readmissions, adherence with medications, diet, exercise, or follow-up, and mortality).

No quantitative pooling of results or meta-analysis was done given the variability and heterogeneity of studies reviewed. However, following guidelines for Effect Practice and Organisation of Care (EPOC) Risk of Bias criteria,¹³ studies that had a higher risk of bias such as uncontrolled before-after studies or studies with only 1 intervention or control site (historical controls, eg) were excluded from the final review because of the difficulties in attributing causation. Only primary outcomes were reported in order to minimize type II errors.

Our search revealed a total of 3699 studies after duplicates had been removed (Figure). A total of 714 references were included after initial review by title and abstract and 30 studies after full-text review. Agreement on a 10% random sample of all abstracts and full text was 79% (k=0.58) and 86% (k=0.72), respectively. Discussion was needed for fewer than 100 references, and agreement was subsequently reached for 100%.

There were 22 randomized controlled trials and 8 nonrandomized studies (5 nonrandomized controlled trials and 3 controlled before-after studies). Most of these studies were conducted in the United States (13/30 studies), followed by other European countries (5 studies), and the United Kingdom (4 studies). A large number of studies were conducted among patients with cardiovascular disease or risk factors (10 studies), followed by postsurgical patients such as coronary artery bypass graft surgery or orthopaedic surgery (5 studies). Five of 30 studies were conducted among individuals older than 65 years. Most studies excluded patients who did not speak English or the country’s official language; only 3 studies included patients with limited literacy, patients who spoke other languages, or caregivers if the patients could not communicate.

Most studies tested the impact of educational discharge interventions (28 of 30 studies) (Table 1). Quite often, it was a member of the research team who carried out the patient education. Only 3 studies involved multiple members of the care team in designing or reviewing the discharge tool with the patient. Almost half (12 studies) targeted multiple aspects of postdischarge care, including medications and side effects, signs and symptoms to consider, plans for follow-up, dietary restrictions, and/or exercise modifications. Many (19 studies) provided education using one-on-one teaching in association with a discharge tool, accompanied by a written handout (13 studies), audiotape (2 studies), or video (3 studies). While 13 studies had patients involved in creating what content was discussed and 14 studies had patients involved in the delivery of the tool, only 6 studies had patients involved in both design and delivery of the tool. Nine studies also used visual aids such as pictures, larger font, or use of a tool enhanced for patients with language barriers or limited health literacy.

Our systematic review found 30 studies that engaged patients during the design or the delivery of a discharge instruction tool and that tested the effect of the tool on postdischarge outcomes.^6-10,14–38 Our review suggests that there is sufficient evidence that patient-centered discharge tools improve comprehension. However, evidence is currently insufficient to determine if patient-centered tools improve adherence with discharge instructions. Moreover, though limited studies show promising results, more studies are needed to determine if patient engagement improves self-efficacy and healthcare utilization after discharge.

A major limitation of current studies is the variability in the level of patient engagement in tool design or delivery. Patients were involved in the design mostly through targeted development of a discharge management plan and the delivery by encouraging them to ask questions. Few studies involved patients in the design of the tool such that patients were responsible for coming up with content that was of interest to them. The few that did, often with the additional use of video media, demonstrated significant outcomes. Only a minority of studies used an interactive process to assess understanding such as “teach-back” or maximize patient comprehension such as visual aids. Even fewer studies engaged patients in both developing the discharge tool and providing discharge instructions.

Several previous studies have demonstrated that most complications after discharge are the result of ineffective communication, which can be exacerbated by lack of fluency in English or by limited health literacy.^2,39-43 As a result, poor understanding of discharge instructions by patients and their caregivers can create an important care gap.⁴⁴ Therefore, the use of patient-centered tools to engage patients at discharge in their own care is needed. How to engage patients consistently and effectively is perhaps less evident, as demonstrated in this review of the literature in which different levels of patient engagement were found. Many of the tools tested placed attention on patient education, sometimes in the context of bundled care along with home visits or follow-up, all of which can require extensive resources and time. Providing patients with information that the patients themselves state is of value may be the easiest refinement to a discharge educational tool, although this was surprisingly uncommon.^{6,9,10,17,23,33,37} Only 2 studies were found that engaged patients in the initial stage of design of the discharge tool, by incorporating information of interest to them.^23,32 For example, a study testing the impact of a computer-generated written education package on poststroke outcomes designed the information by asking patients to identify which topics they would like to receive information about (along with the amount of information and font size).²³ Secondly, although most of the discharge tools reviewed included the use of one-on-one teaching and the use of media such as patient handouts, these tools were often used in such a way that patients were passive recipients. In fact, studies that used additional video media that incorporated personalized content were the most likely to demonstrate positive outcomes.^17,34 The next level of patient engagement may therefore be to involve the patient as an interactive partner when delivering the tool in order to empower patients to self-care. For example, 1 study designed a structured education program by first assessing lifestyle risk factors related to hypertension that were modifiable along with preconceived notions through open-ended questions during a one-on-one interview.³⁷ Patients were subsequently educated on any knowledge deficits regarding the management of their lifestyle. Another level of patient engagement may be to use visual aids during discussions, as a well-known complement to verbal instructions.^45,46 For example, in a controlled study that randomized a ward of elderly patients with 4 or more prescriptions to predischarge counseling, the counseling session aimed to review reasons for their prescriptions along with corresponding side effects, doses, and dosage times with the help of a medicine reminder card. Other uses of visual aid tools identified in our review included the use of pictograms or illustrations or, at minimum, attention to font size.^{7,8,16,29,33,35} In the absence of a visual aid, asking the patient to repeat or demonstrate what was just communicated can be used to assess the amount of information retained.^18,33

An important result discovered in our review of the literature was also the lack of studies that tested the impact of discharge tools on usability of discharge information once at home. Conducting an evaluation of the benefits to patients after discharge can help objectify vague outcomes like health gains or qualify benefits in patient’s views. This might also explain why many studies with documented patient engagement at the time of discharge were able to demonstrate improvements in comprehension but not adherence to instructions. Although patients and caregivers may understand the information, this comprehension does not necessarily mean they will find the information useful or adhere to it once at home. For example, in 1 study, patients discharged with at least 1 medication were randomized to a structured discharge interview during which the treatment plan was reviewed verbally and questions clarified along with a visually enhanced treatment card.²⁶ Although knowledge of medications increased, no effect was found on adherence at 1 week postdischarge. However, use of the treatment card at home was not assessed. Similarly, another study tested the effect of an individualized video of exercises and failed to find a difference in patient adherence at 4 weeks.²⁸ The authors suggested that the lack of benefit may have been because patients were not using the video once at home. This is in contrast to 2 studies that involved patients in their own care by requiring them to request their medication as part of a self-medication tool predischarge.^16,30 Patients were engaged in the process such that increasing independence was given to patients based on their demonstration of understanding and adherence to their treatment while still in the hospital, a learning tool that can be applied once at home. Feeling knowledgeable and involved, as others have suggested, may be the intermediary outcomes that led to improved adherence.⁴⁷ It is also possible that adherence to discharge instructions may vary based on complexity of the information provided, such that instructions focusing solely on medication use may require less patient engagement than discharge instructions that include information on medications, diet, exercise modifications, and follow-up.⁴⁸

Our review has a few limitations. Previous systematic reviews have demonstrated that bundled discharge interventions that include patient-centered education have a positive effect on outcomes postdischarge.^2,5 However, we sought to describe and study the individual and distinct impact of patient engagement in the creation and delivery of discharge tools on outcomes postdischarge. We hoped that this may provide others with key information regarding elements of patient engagement that were particularly useful when designing a new discharge tool. The variability of the studies we identified, however, made it difficult to ascertain what level of patient engagement is required to observe improvements in health outcomes. It is also possible that a higher level of patient engagement may have been used but not described in the studies we reviewed. As only primary outcomes were included, we may have underestimated the effect of patient-centered discharge tools on outcomes that were reported as secondary outcomes. As we were interested in reviewing as many studies of patient-centered discharge tools as possible, we did not assess the quality of the studies and cannot comment on the role of bias in these studies. However, we excluded studies with study designs known to have the highest risk of bias. Lastly, we also cannot comment on whether patient-centered tools may have an effect on outcomes more than 3 months after a hospital discharge. However, several studies included in this review suggest a sustained effect beyond this time period.^8,25,32,37

Patient-centered discharge tools in which patients were engaged in the design or the delivery were found to improve comprehension of but not adherence with discharge instructions. The perceived lack of improved adherence may be due to a lack of studies that measured the usefulness and utilization of information for patients once at home. There was also substantial variability in the extent of patient involvement in designing the style and content of information provided to patients at discharge, as well as the extent of patient engagement when receiving discharge instructions. Future studies would benefit from detailing the level of patient engagement needed in designing and delivery of discharge tools. This information may lead to the discovery of barriers and facilitators to utilization of discharge information once at home and lead to a better understanding of the patient’s journey from hospital to home and onwards.

C.M.B. and this work were funded by a CIHR Canadian Patient Safety Institute Chair in Patient Safety and Continuity of Care. Funding was provided to cover fees to obtain articles from the Donald J. Matthews Complex Care Fund of the University Health Network in Toronto, Canada. The Toronto Central Local Health Integration Network provided funding for the design and implementation of a patient-oriented discharge summary. None of the funding or supportive agencies were involved in the design or conduct of the present study, analysis, or interpretation of the data, or approval of the manuscript.

Disclosures

The authors report no conflicts of interest.

Patient-centered care, defined by the Institute of Medicine as “health care that establishes a partnership among practitioners, patients, and their families to ensure that decisions respect patients’ wants, needs and preferences and that patients have the education and support they need to make decisions and participate in their own care,” has been recognized as an important factor in improving care transitions after discharge from the hospital.¹ Previous efforts to improve the discharge process for hospitalized patients and reduce avoidable readmissions have focused on improving systems surrounding the patient, such as by increasing the availability of outpatient follow-up or standardizing communication between the inpatient and outpatient care teams.^1,2 In fact, successful programs such as Project BOOST and the Care Transitions Interventions™ provide healthcare institutions with a “bundle” of evidence-based transitional care guidelines for discharge: they provide postdischarge transition coaches, assistance with medication self-management, timely follow-up tips, and improved patient records in order to improve postdischarge outcomes.^3,4 Successful interventions, however, may not provide more services, but also engage the patient in their own care.^5,6 The impact of engaging the patient in his or her own care by providing patient-friendly discharge instructions alone, however, is unknown.

A patient-centered discharge may use tools that were designed with patients, or may involve engaging patients in an interactive process of reviewing discharge instructions and empowering them to manage aspects of their own care after leaving the hospital. This endeavour may lead to more effective use of discharge instructions and reduce the need for additional or more intensive (and costly) interventions. For example, a patient-centered discharge tool could include an educational intervention that uses the “teach-back” method, in which patients are asked to restate in their own words what they thought they heard, or in which staff use additional media or a visual design tool meant to enhance comprehension of discharge instructions.^6,7 Visual aids and the use of larger fonts are particularly useful design elements for improving comprehension among non-English speakers and patients with low health literacy, who tend to have poorer recall of instructions.^8-10 What may constitute essential design elements to include in a discharge instruction tool, however, is not clear.

Moreover, whether the use of discharge tools with a specific focus on patient engagement may improve postdischarge outcomes is not known. Particularly, the ability of patient-centered discharge tools to improve outcomes beyond comprehension such as self-management, adherence to discharge instructions, a reduction in unplanned visits, and a reduction in mortality has not been studied systematically. The objective of this systematic review was to review the literature on discharge instruction tools with a focus on patient engagement and their impact among hospitalized patients.

The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Statement was followed as a guideline for reporting throughout this review.¹¹

Data Sources

A literature search was undertaken using the following databases from January 1994 or their inception date to May 2014: Medline, Embase, SIGLE, HTA, Bioethics, ASSIA, Psych Lit, CINAHL, Cochrane Library, EconLit, ERIC, and BioMed Central. We also searched relevant design-focused journals such as Design Issues, Journal of Design Research, Information Design Journal, Innovation, Design Studies, and International Journal of Design, as well as reference lists from studies obtained by electronic searching. The following key words and combination of key words were used with the assistance of a medical librarian: patient discharge, patient-centered discharge, patient-centered design, design thinking, user based design, patient education, discharge summary, education. Additional search terms were added when identified from relevant articles (Appendix).

Inclusion Criteria

We included all English-language studies with patients admitted to the hospital irrespective of age, sex, or medical condition, which included a control group or time period and which measured patient outcomes within 3 months of discharge. The 3-month period after discharge is often cited as a time when outcomes could reasonably be associated with an intervention at discharge.²

Exclusion Criteria

Studies that did not have clear implementation of a patient-centered tool, a control group, or those whose tool was used in the emergency department or as an outpatient were excluded. Studies that included postdischarge tools such as home visits or telephone calls were excluded unless independent effects of the predischarge interventions were measured. Studies with outcomes reported after 3 months were excluded unless outcomes before 3 months were also clearly noted.

All searches were entered into Endnote and duplicates were removed. A 2-stage inclusion process was used. Titles and abstracts of articles were first screened for meeting inclusion and exclusion criteria by 1 reviewer. A second reviewer independently checked a 10% random sample of all the abstracts that met the initial screening criteria. If the agreement to exclude studies was less than 95%, criteria were reviewed before checking the rest of the 90% sample. In the second stage, 2 independent reviewers examined paper copies of the full articles selected in the first stage. Disagreement between reviewers was resolved by discussion or a third reviewer if no agreement could be reached.

Data Analysis and Synthesis

The following information was extracted from the full reference: type of study, population studied, control group or time period, tool used, and outcomes measured. Based on the National Health Care Quality report’s priorities and goals on patient and/or family engagement during transitions of care, educational tools were further described based on method of teaching, involvement of the care team, involvement of the patient in the design or delivery of the tool, and/or the use of visual aids.¹² All primary outcomes were classified according to 3 categories: improved knowledge/comprehension, patient experience (patient satisfaction, self-management/efficacy such as functional status, both physical and mental), and health outcomes (unscheduled visits or readmissions, adherence with medications, diet, exercise, or follow-up, and mortality).

No quantitative pooling of results or meta-analysis was done given the variability and heterogeneity of studies reviewed. However, following guidelines for Effect Practice and Organisation of Care (EPOC) Risk of Bias criteria,¹³ studies that had a higher risk of bias such as uncontrolled before-after studies or studies with only 1 intervention or control site (historical controls, eg) were excluded from the final review because of the difficulties in attributing causation. Only primary outcomes were reported in order to minimize type II errors.

Our search revealed a total of 3699 studies after duplicates had been removed (Figure). A total of 714 references were included after initial review by title and abstract and 30 studies after full-text review. Agreement on a 10% random sample of all abstracts and full text was 79% (k=0.58) and 86% (k=0.72), respectively. Discussion was needed for fewer than 100 references, and agreement was subsequently reached for 100%.

There were 22 randomized controlled trials and 8 nonrandomized studies (5 nonrandomized controlled trials and 3 controlled before-after studies). Most of these studies were conducted in the United States (13/30 studies), followed by other European countries (5 studies), and the United Kingdom (4 studies). A large number of studies were conducted among patients with cardiovascular disease or risk factors (10 studies), followed by postsurgical patients such as coronary artery bypass graft surgery or orthopaedic surgery (5 studies). Five of 30 studies were conducted among individuals older than 65 years. Most studies excluded patients who did not speak English or the country’s official language; only 3 studies included patients with limited literacy, patients who spoke other languages, or caregivers if the patients could not communicate.

Most studies tested the impact of educational discharge interventions (28 of 30 studies) (Table 1). Quite often, it was a member of the research team who carried out the patient education. Only 3 studies involved multiple members of the care team in designing or reviewing the discharge tool with the patient. Almost half (12 studies) targeted multiple aspects of postdischarge care, including medications and side effects, signs and symptoms to consider, plans for follow-up, dietary restrictions, and/or exercise modifications. Many (19 studies) provided education using one-on-one teaching in association with a discharge tool, accompanied by a written handout (13 studies), audiotape (2 studies), or video (3 studies). While 13 studies had patients involved in creating what content was discussed and 14 studies had patients involved in the delivery of the tool, only 6 studies had patients involved in both design and delivery of the tool. Nine studies also used visual aids such as pictures, larger font, or use of a tool enhanced for patients with language barriers or limited health literacy.

Our systematic review found 30 studies that engaged patients during the design or the delivery of a discharge instruction tool and that tested the effect of the tool on postdischarge outcomes.^6-10,14–38 Our review suggests that there is sufficient evidence that patient-centered discharge tools improve comprehension. However, evidence is currently insufficient to determine if patient-centered tools improve adherence with discharge instructions. Moreover, though limited studies show promising results, more studies are needed to determine if patient engagement improves self-efficacy and healthcare utilization after discharge.

A major limitation of current studies is the variability in the level of patient engagement in tool design or delivery. Patients were involved in the design mostly through targeted development of a discharge management plan and the delivery by encouraging them to ask questions. Few studies involved patients in the design of the tool such that patients were responsible for coming up with content that was of interest to them. The few that did, often with the additional use of video media, demonstrated significant outcomes. Only a minority of studies used an interactive process to assess understanding such as “teach-back” or maximize patient comprehension such as visual aids. Even fewer studies engaged patients in both developing the discharge tool and providing discharge instructions.

Several previous studies have demonstrated that most complications after discharge are the result of ineffective communication, which can be exacerbated by lack of fluency in English or by limited health literacy.^2,39-43 As a result, poor understanding of discharge instructions by patients and their caregivers can create an important care gap.⁴⁴ Therefore, the use of patient-centered tools to engage patients at discharge in their own care is needed. How to engage patients consistently and effectively is perhaps less evident, as demonstrated in this review of the literature in which different levels of patient engagement were found. Many of the tools tested placed attention on patient education, sometimes in the context of bundled care along with home visits or follow-up, all of which can require extensive resources and time. Providing patients with information that the patients themselves state is of value may be the easiest refinement to a discharge educational tool, although this was surprisingly uncommon.^{6,9,10,17,23,33,37} Only 2 studies were found that engaged patients in the initial stage of design of the discharge tool, by incorporating information of interest to them.^23,32 For example, a study testing the impact of a computer-generated written education package on poststroke outcomes designed the information by asking patients to identify which topics they would like to receive information about (along with the amount of information and font size).²³ Secondly, although most of the discharge tools reviewed included the use of one-on-one teaching and the use of media such as patient handouts, these tools were often used in such a way that patients were passive recipients. In fact, studies that used additional video media that incorporated personalized content were the most likely to demonstrate positive outcomes.^17,34 The next level of patient engagement may therefore be to involve the patient as an interactive partner when delivering the tool in order to empower patients to self-care. For example, 1 study designed a structured education program by first assessing lifestyle risk factors related to hypertension that were modifiable along with preconceived notions through open-ended questions during a one-on-one interview.³⁷ Patients were subsequently educated on any knowledge deficits regarding the management of their lifestyle. Another level of patient engagement may be to use visual aids during discussions, as a well-known complement to verbal instructions.^45,46 For example, in a controlled study that randomized a ward of elderly patients with 4 or more prescriptions to predischarge counseling, the counseling session aimed to review reasons for their prescriptions along with corresponding side effects, doses, and dosage times with the help of a medicine reminder card. Other uses of visual aid tools identified in our review included the use of pictograms or illustrations or, at minimum, attention to font size.^{7,8,16,29,33,35} In the absence of a visual aid, asking the patient to repeat or demonstrate what was just communicated can be used to assess the amount of information retained.^18,33

An important result discovered in our review of the literature was also the lack of studies that tested the impact of discharge tools on usability of discharge information once at home. Conducting an evaluation of the benefits to patients after discharge can help objectify vague outcomes like health gains or qualify benefits in patient’s views. This might also explain why many studies with documented patient engagement at the time of discharge were able to demonstrate improvements in comprehension but not adherence to instructions. Although patients and caregivers may understand the information, this comprehension does not necessarily mean they will find the information useful or adhere to it once at home. For example, in 1 study, patients discharged with at least 1 medication were randomized to a structured discharge interview during which the treatment plan was reviewed verbally and questions clarified along with a visually enhanced treatment card.²⁶ Although knowledge of medications increased, no effect was found on adherence at 1 week postdischarge. However, use of the treatment card at home was not assessed. Similarly, another study tested the effect of an individualized video of exercises and failed to find a difference in patient adherence at 4 weeks.²⁸ The authors suggested that the lack of benefit may have been because patients were not using the video once at home. This is in contrast to 2 studies that involved patients in their own care by requiring them to request their medication as part of a self-medication tool predischarge.^16,30 Patients were engaged in the process such that increasing independence was given to patients based on their demonstration of understanding and adherence to their treatment while still in the hospital, a learning tool that can be applied once at home. Feeling knowledgeable and involved, as others have suggested, may be the intermediary outcomes that led to improved adherence.⁴⁷ It is also possible that adherence to discharge instructions may vary based on complexity of the information provided, such that instructions focusing solely on medication use may require less patient engagement than discharge instructions that include information on medications, diet, exercise modifications, and follow-up.⁴⁸

Our review has a few limitations. Previous systematic reviews have demonstrated that bundled discharge interventions that include patient-centered education have a positive effect on outcomes postdischarge.^2,5 However, we sought to describe and study the individual and distinct impact of patient engagement in the creation and delivery of discharge tools on outcomes postdischarge. We hoped that this may provide others with key information regarding elements of patient engagement that were particularly useful when designing a new discharge tool. The variability of the studies we identified, however, made it difficult to ascertain what level of patient engagement is required to observe improvements in health outcomes. It is also possible that a higher level of patient engagement may have been used but not described in the studies we reviewed. As only primary outcomes were included, we may have underestimated the effect of patient-centered discharge tools on outcomes that were reported as secondary outcomes. As we were interested in reviewing as many studies of patient-centered discharge tools as possible, we did not assess the quality of the studies and cannot comment on the role of bias in these studies. However, we excluded studies with study designs known to have the highest risk of bias. Lastly, we also cannot comment on whether patient-centered tools may have an effect on outcomes more than 3 months after a hospital discharge. However, several studies included in this review suggest a sustained effect beyond this time period.^8,25,32,37

Patient-centered discharge tools in which patients were engaged in the design or the delivery were found to improve comprehension of but not adherence with discharge instructions. The perceived lack of improved adherence may be due to a lack of studies that measured the usefulness and utilization of information for patients once at home. There was also substantial variability in the extent of patient involvement in designing the style and content of information provided to patients at discharge, as well as the extent of patient engagement when receiving discharge instructions. Future studies would benefit from detailing the level of patient engagement needed in designing and delivery of discharge tools. This information may lead to the discovery of barriers and facilitators to utilization of discharge information once at home and lead to a better understanding of the patient’s journey from hospital to home and onwards.

C.M.B. and this work were funded by a CIHR Canadian Patient Safety Institute Chair in Patient Safety and Continuity of Care. Funding was provided to cover fees to obtain articles from the Donald J. Matthews Complex Care Fund of the University Health Network in Toronto, Canada. The Toronto Central Local Health Integration Network provided funding for the design and implementation of a patient-oriented discharge summary. None of the funding or supportive agencies were involved in the design or conduct of the present study, analysis, or interpretation of the data, or approval of the manuscript.

Disclosures

The authors report no conflicts of interest.

Patient-centered care, defined by the Institute of Medicine as “health care that establishes a partnership among practitioners, patients, and their families to ensure that decisions respect patients’ wants, needs and preferences and that patients have the education and support they need to make decisions and participate in their own care,” has been recognized as an important factor in improving care transitions after discharge from the hospital.¹ Previous efforts to improve the discharge process for hospitalized patients and reduce avoidable readmissions have focused on improving systems surrounding the patient, such as by increasing the availability of outpatient follow-up or standardizing communication between the inpatient and outpatient care teams.^1,2 In fact, successful programs such as Project BOOST and the Care Transitions Interventions™ provide healthcare institutions with a “bundle” of evidence-based transitional care guidelines for discharge: they provide postdischarge transition coaches, assistance with medication self-management, timely follow-up tips, and improved patient records in order to improve postdischarge outcomes.^3,4 Successful interventions, however, may not provide more services, but also engage the patient in their own care.^5,6 The impact of engaging the patient in his or her own care by providing patient-friendly discharge instructions alone, however, is unknown.

A patient-centered discharge may use tools that were designed with patients, or may involve engaging patients in an interactive process of reviewing discharge instructions and empowering them to manage aspects of their own care after leaving the hospital. This endeavour may lead to more effective use of discharge instructions and reduce the need for additional or more intensive (and costly) interventions. For example, a patient-centered discharge tool could include an educational intervention that uses the “teach-back” method, in which patients are asked to restate in their own words what they thought they heard, or in which staff use additional media or a visual design tool meant to enhance comprehension of discharge instructions.^6,7 Visual aids and the use of larger fonts are particularly useful design elements for improving comprehension among non-English speakers and patients with low health literacy, who tend to have poorer recall of instructions.^8-10 What may constitute essential design elements to include in a discharge instruction tool, however, is not clear.

Moreover, whether the use of discharge tools with a specific focus on patient engagement may improve postdischarge outcomes is not known. Particularly, the ability of patient-centered discharge tools to improve outcomes beyond comprehension such as self-management, adherence to discharge instructions, a reduction in unplanned visits, and a reduction in mortality has not been studied systematically. The objective of this systematic review was to review the literature on discharge instruction tools with a focus on patient engagement and their impact among hospitalized patients.

The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Statement was followed as a guideline for reporting throughout this review.¹¹

Data Sources

A literature search was undertaken using the following databases from January 1994 or their inception date to May 2014: Medline, Embase, SIGLE, HTA, Bioethics, ASSIA, Psych Lit, CINAHL, Cochrane Library, EconLit, ERIC, and BioMed Central. We also searched relevant design-focused journals such as Design Issues, Journal of Design Research, Information Design Journal, Innovation, Design Studies, and International Journal of Design, as well as reference lists from studies obtained by electronic searching. The following key words and combination of key words were used with the assistance of a medical librarian: patient discharge, patient-centered discharge, patient-centered design, design thinking, user based design, patient education, discharge summary, education. Additional search terms were added when identified from relevant articles (Appendix).

Inclusion Criteria

We included all English-language studies with patients admitted to the hospital irrespective of age, sex, or medical condition, which included a control group or time period and which measured patient outcomes within 3 months of discharge. The 3-month period after discharge is often cited as a time when outcomes could reasonably be associated with an intervention at discharge.²

Exclusion Criteria

Studies that did not have clear implementation of a patient-centered tool, a control group, or those whose tool was used in the emergency department or as an outpatient were excluded. Studies that included postdischarge tools such as home visits or telephone calls were excluded unless independent effects of the predischarge interventions were measured. Studies with outcomes reported after 3 months were excluded unless outcomes before 3 months were also clearly noted.

All searches were entered into Endnote and duplicates were removed. A 2-stage inclusion process was used. Titles and abstracts of articles were first screened for meeting inclusion and exclusion criteria by 1 reviewer. A second reviewer independently checked a 10% random sample of all the abstracts that met the initial screening criteria. If the agreement to exclude studies was less than 95%, criteria were reviewed before checking the rest of the 90% sample. In the second stage, 2 independent reviewers examined paper copies of the full articles selected in the first stage. Disagreement between reviewers was resolved by discussion or a third reviewer if no agreement could be reached.

Data Analysis and Synthesis

The following information was extracted from the full reference: type of study, population studied, control group or time period, tool used, and outcomes measured. Based on the National Health Care Quality report’s priorities and goals on patient and/or family engagement during transitions of care, educational tools were further described based on method of teaching, involvement of the care team, involvement of the patient in the design or delivery of the tool, and/or the use of visual aids.¹² All primary outcomes were classified according to 3 categories: improved knowledge/comprehension, patient experience (patient satisfaction, self-management/efficacy such as functional status, both physical and mental), and health outcomes (unscheduled visits or readmissions, adherence with medications, diet, exercise, or follow-up, and mortality).

No quantitative pooling of results or meta-analysis was done given the variability and heterogeneity of studies reviewed. However, following guidelines for Effect Practice and Organisation of Care (EPOC) Risk of Bias criteria,¹³ studies that had a higher risk of bias such as uncontrolled before-after studies or studies with only 1 intervention or control site (historical controls, eg) were excluded from the final review because of the difficulties in attributing causation. Only primary outcomes were reported in order to minimize type II errors.

Our search revealed a total of 3699 studies after duplicates had been removed (Figure). A total of 714 references were included after initial review by title and abstract and 30 studies after full-text review. Agreement on a 10% random sample of all abstracts and full text was 79% (k=0.58) and 86% (k=0.72), respectively. Discussion was needed for fewer than 100 references, and agreement was subsequently reached for 100%.

There were 22 randomized controlled trials and 8 nonrandomized studies (5 nonrandomized controlled trials and 3 controlled before-after studies). Most of these studies were conducted in the United States (13/30 studies), followed by other European countries (5 studies), and the United Kingdom (4 studies). A large number of studies were conducted among patients with cardiovascular disease or risk factors (10 studies), followed by postsurgical patients such as coronary artery bypass graft surgery or orthopaedic surgery (5 studies). Five of 30 studies were conducted among individuals older than 65 years. Most studies excluded patients who did not speak English or the country’s official language; only 3 studies included patients with limited literacy, patients who spoke other languages, or caregivers if the patients could not communicate.

Most studies tested the impact of educational discharge interventions (28 of 30 studies) (Table 1). Quite often, it was a member of the research team who carried out the patient education. Only 3 studies involved multiple members of the care team in designing or reviewing the discharge tool with the patient. Almost half (12 studies) targeted multiple aspects of postdischarge care, including medications and side effects, signs and symptoms to consider, plans for follow-up, dietary restrictions, and/or exercise modifications. Many (19 studies) provided education using one-on-one teaching in association with a discharge tool, accompanied by a written handout (13 studies), audiotape (2 studies), or video (3 studies). While 13 studies had patients involved in creating what content was discussed and 14 studies had patients involved in the delivery of the tool, only 6 studies had patients involved in both design and delivery of the tool. Nine studies also used visual aids such as pictures, larger font, or use of a tool enhanced for patients with language barriers or limited health literacy.

Our systematic review found 30 studies that engaged patients during the design or the delivery of a discharge instruction tool and that tested the effect of the tool on postdischarge outcomes.^6-10,14–38 Our review suggests that there is sufficient evidence that patient-centered discharge tools improve comprehension. However, evidence is currently insufficient to determine if patient-centered tools improve adherence with discharge instructions. Moreover, though limited studies show promising results, more studies are needed to determine if patient engagement improves self-efficacy and healthcare utilization after discharge.

A major limitation of current studies is the variability in the level of patient engagement in tool design or delivery. Patients were involved in the design mostly through targeted development of a discharge management plan and the delivery by encouraging them to ask questions. Few studies involved patients in the design of the tool such that patients were responsible for coming up with content that was of interest to them. The few that did, often with the additional use of video media, demonstrated significant outcomes. Only a minority of studies used an interactive process to assess understanding such as “teach-back” or maximize patient comprehension such as visual aids. Even fewer studies engaged patients in both developing the discharge tool and providing discharge instructions.

Several previous studies have demonstrated that most complications after discharge are the result of ineffective communication, which can be exacerbated by lack of fluency in English or by limited health literacy.^2,39-43 As a result, poor understanding of discharge instructions by patients and their caregivers can create an important care gap.⁴⁴ Therefore, the use of patient-centered tools to engage patients at discharge in their own care is needed. How to engage patients consistently and effectively is perhaps less evident, as demonstrated in this review of the literature in which different levels of patient engagement were found. Many of the tools tested placed attention on patient education, sometimes in the context of bundled care along with home visits or follow-up, all of which can require extensive resources and time. Providing patients with information that the patients themselves state is of value may be the easiest refinement to a discharge educational tool, although this was surprisingly uncommon.^{6,9,10,17,23,33,37} Only 2 studies were found that engaged patients in the initial stage of design of the discharge tool, by incorporating information of interest to them.^23,32 For example, a study testing the impact of a computer-generated written education package on poststroke outcomes designed the information by asking patients to identify which topics they would like to receive information about (along with the amount of information and font size).²³ Secondly, although most of the discharge tools reviewed included the use of one-on-one teaching and the use of media such as patient handouts, these tools were often used in such a way that patients were passive recipients. In fact, studies that used additional video media that incorporated personalized content were the most likely to demonstrate positive outcomes.^17,34 The next level of patient engagement may therefore be to involve the patient as an interactive partner when delivering the tool in order to empower patients to self-care. For example, 1 study designed a structured education program by first assessing lifestyle risk factors related to hypertension that were modifiable along with preconceived notions through open-ended questions during a one-on-one interview.³⁷ Patients were subsequently educated on any knowledge deficits regarding the management of their lifestyle. Another level of patient engagement may be to use visual aids during discussions, as a well-known complement to verbal instructions.^45,46 For example, in a controlled study that randomized a ward of elderly patients with 4 or more prescriptions to predischarge counseling, the counseling session aimed to review reasons for their prescriptions along with corresponding side effects, doses, and dosage times with the help of a medicine reminder card. Other uses of visual aid tools identified in our review included the use of pictograms or illustrations or, at minimum, attention to font size.^{7,8,16,29,33,35} In the absence of a visual aid, asking the patient to repeat or demonstrate what was just communicated can be used to assess the amount of information retained.^18,33

An important result discovered in our review of the literature was also the lack of studies that tested the impact of discharge tools on usability of discharge information once at home. Conducting an evaluation of the benefits to patients after discharge can help objectify vague outcomes like health gains or qualify benefits in patient’s views. This might also explain why many studies with documented patient engagement at the time of discharge were able to demonstrate improvements in comprehension but not adherence to instructions. Although patients and caregivers may understand the information, this comprehension does not necessarily mean they will find the information useful or adhere to it once at home. For example, in 1 study, patients discharged with at least 1 medication were randomized to a structured discharge interview during which the treatment plan was reviewed verbally and questions clarified along with a visually enhanced treatment card.²⁶ Although knowledge of medications increased, no effect was found on adherence at 1 week postdischarge. However, use of the treatment card at home was not assessed. Similarly, another study tested the effect of an individualized video of exercises and failed to find a difference in patient adherence at 4 weeks.²⁸ The authors suggested that the lack of benefit may have been because patients were not using the video once at home. This is in contrast to 2 studies that involved patients in their own care by requiring them to request their medication as part of a self-medication tool predischarge.^16,30 Patients were engaged in the process such that increasing independence was given to patients based on their demonstration of understanding and adherence to their treatment while still in the hospital, a learning tool that can be applied once at home. Feeling knowledgeable and involved, as others have suggested, may be the intermediary outcomes that led to improved adherence.⁴⁷ It is also possible that adherence to discharge instructions may vary based on complexity of the information provided, such that instructions focusing solely on medication use may require less patient engagement than discharge instructions that include information on medications, diet, exercise modifications, and follow-up.⁴⁸

Our review has a few limitations. Previous systematic reviews have demonstrated that bundled discharge interventions that include patient-centered education have a positive effect on outcomes postdischarge.^2,5 However, we sought to describe and study the individual and distinct impact of patient engagement in the creation and delivery of discharge tools on outcomes postdischarge. We hoped that this may provide others with key information regarding elements of patient engagement that were particularly useful when designing a new discharge tool. The variability of the studies we identified, however, made it difficult to ascertain what level of patient engagement is required to observe improvements in health outcomes. It is also possible that a higher level of patient engagement may have been used but not described in the studies we reviewed. As only primary outcomes were included, we may have underestimated the effect of patient-centered discharge tools on outcomes that were reported as secondary outcomes. As we were interested in reviewing as many studies of patient-centered discharge tools as possible, we did not assess the quality of the studies and cannot comment on the role of bias in these studies. However, we excluded studies with study designs known to have the highest risk of bias. Lastly, we also cannot comment on whether patient-centered tools may have an effect on outcomes more than 3 months after a hospital discharge. However, several studies included in this review suggest a sustained effect beyond this time period.^8,25,32,37

Patient-centered discharge tools in which patients were engaged in the design or the delivery were found to improve comprehension of but not adherence with discharge instructions. The perceived lack of improved adherence may be due to a lack of studies that measured the usefulness and utilization of information for patients once at home. There was also substantial variability in the extent of patient involvement in designing the style and content of information provided to patients at discharge, as well as the extent of patient engagement when receiving discharge instructions. Future studies would benefit from detailing the level of patient engagement needed in designing and delivery of discharge tools. This information may lead to the discovery of barriers and facilitators to utilization of discharge information once at home and lead to a better understanding of the patient’s journey from hospital to home and onwards.

C.M.B. and this work were funded by a CIHR Canadian Patient Safety Institute Chair in Patient Safety and Continuity of Care. Funding was provided to cover fees to obtain articles from the Donald J. Matthews Complex Care Fund of the University Health Network in Toronto, Canada. The Toronto Central Local Health Integration Network provided funding for the design and implementation of a patient-oriented discharge summary. None of the funding or supportive agencies were involved in the design or conduct of the present study, analysis, or interpretation of the data, or approval of the manuscript.

Disclosures

The authors report no conflicts of interest.