Head & Neck/Thyroid Cancers

The availability and popularity of orally administered anticancer therapy has drastically increased in recent years. Currently, there are more than 40 oral anticancer medications on the market in the U.S.; and about 40% of all newly FDA-approved anticancer agents in 2013 and 2014 have been oral agents.¹

The use of these agents is often driven by patients. In a review of 103 patients, an overwhelming 90% of patients who were to receive palliative chemotherapy chose oral chemotherapy over IV chemotherapy, assuming equivalent efficacy, toxicity, clinic visits, and blood work schedules. However, 70% of these patients were unwilling to sacrifice any efficacy between IV and oral chemotherapy.² Several other factors influenced the preference of oral chemotherapy for patients, including convenience, avoidance of central venous catheter placement or need for other IV access, control of the environment in which they receive chemotherapy, and travel considerations.² In addition to these practical benefits, patients reported a great sense of freedom with oral chemotherapy.³

Although patients may prefer oral anticancer therapies, for providers, several issues exist surrounding the shift in delivery of anticancer therapies from IV to oral therapies. The most significant concern is patient adherence, defined as “the extent to which patients take medications as prescribed by their health care providers.”⁴

Adherence rates in clinical trials are often excellent; however, real-life adherence rates tend to be less optimal.⁵ In a study of women receiving 5 years of adjuvant tamoxifen for breast cancer, the researchers determined that patients filled their prescription 87% of the time the first year of treatment. This rate of adherence dramatically decreased to only 50% by year 4.⁶

These results suggest that a longer duration of treatment can adversely affect adherence. Duration of treatment is of great concern for providers specifically when considering the need for indefinite duration of use of tyrosine kinase inhibitors for the treatment of chronic myeloid leukemia. In 2011, Ibrahim and colleagues showed that imatinib adherence rates of ’ 85% have been directly correlated to the loss of complete cytogenetic response (26.8% vs 1.5%, P = .0002) and lower probability of continuing imatinib (64.5% vs 90.6%, P = .006).⁷ Whereas several factors are known to influence adherence rates, Marin and colleagues identified the 2 main risk factors for poor adherence to imatinib: younger age and adverse effects (AEs). The median age for patients with adherence rates of ’ 90% was 43.8 years compared with 53.8 years for patients with > 90% adherence rate. Imatinib AEs, such as asthenia, nausea, muscle cramps, and bone or joint pains, also significantly decreased imatinib adherence.⁸

In addition to concerns for poor therapeutic outcomes and suboptimal toxicity management, lack of adherence to oral anticancer regimens can result in significant waste of medication and increased health care costs. In most situations, IV anticancer treatment cycles are repeated every 1 to 3 weeks and allow the patient more frequent face-to-face interaction with the oncology team. Oral chemotherapy, on the other hand, is traditionally dispensed as a 28- to 30-day supply. This practice often limits the patient’s access to the oncology team for full evaluation of adherence and toxicity, which can lead to oral anticancer therapy waste.

Khandelwal and colleagues investigated the utility of a split-fill to decrease health care costs. In the splitfill process, patients were dispensed only days 1 to 16 of their oral anticancer medication at the initial fill. If the medication was tolerated and the prescribing provider deemed no changes in treatment necessary, the remaining 12 to 14 days of the cycle were then dispensed. Unfortunately, all insurance companies did not authorize the split-fill plan, thus preventing some patients in the study to participate in this cost savings strategy. However, it was determined for the patients who discontinued therapy, about 34% could have reduced wastage had they been on the split-fill plan, resulting in an average direct savings of $934.20 per patient who discontinued use.⁹

In 2011, the Hematology/Oncology and Pharmacy divisions at the VA Pittsburgh Healthcare System (VAPHS) examined the issues surrounding dispensing and monitoring of oral anticancer therapy. Higher utilization of oral anticancer therapy was identified and in parallel, increasing rates of patient nonadherence, toxicity, and wasted medication. Originally, most providers dispensed oral anticancer therapy as a 1-month supply. However, in efforts to increase adherence, limit toxicity, and avoid medication waste, some oncologists began only dispensing a 1- to 2-week supply of medication per visit. This shift in practice led to a pilot study evaluating the utility of limiting all oral chemotherapy to a 7- to 14-day supply during the first 3 months of treatment.

Pilot Study

The goal of the pilot study was to increase adherence, decrease toxicity, and avoid medication waste. Patients who initiated a new oral anticancer therapy between August 15, 2011, and February 15, 2012, were enrolled in the pilot study. Each patient was to be provided only a 14-day supply of medication at each visit. Patients on concurrent chemoradiotherapy with capecitabine were dispensed only a 7-day supply (as they were at VAPHS daily for radiation) of medication. A pillbox designated for oral anticancer therapy was provided and filled by the clinical pharmacist before leaving the hematology/oncology clinic.

Patients were provided a calendar to record the time and date of their oral anticancer therapy selfadministration. Patients were also asked to record any missed doses and the reasons they missed taking the medication. In addition, patients were counseled on the importance of medication adherence, food-drug and drug-drug interaction, proper storage and administration of medications, and when/who to notify if AEs occurred.

Patients were asked to return the pillboxes to the hematology/oncology clinic for the next refill and meet with the clinical pharmacist. A pill count was performed at each visit in addition to screening for toxicity. If a toxicity was identified, the prescribing provider was contacted for further orders. If no changes were needed, the remaining 14-day supply was dispensed to the patient at that time. Adherence and toxicity were documented in the electronic medical record (EMR) at each visit.

Thirty patients were started on 32 different oral anticancer therapies (Table 1) over the 6 months between August 15, 2011, and February 15, 2012. Patients already initiated on oral anticancer therapy before the start date were not included in this analysis. This number also did not include patients on lenalidomide, because this medication is mailed directly to the patient from a specialty pharmacy. All patients were male; average age was 68 (45-89) years; 83.3% of patients were white; and 83% of patients had a stage IV disease.

Adherence assessments using pill counts and medication calendars demonstrated that 6% (121/2,037) of doses that were dispensed were not taken. Overall adherence rate was 94%. The average patient adherence rate was 93.2%. Adverse events contributed to 62.8% of doses omitted (Table 2). Some AEs (eg, nausea, vomiting, and hypertension) were deemed preventable or modifiable with better symptom management. However, the majority of AEs that led to dose omission were not preventable.

Ten patients had their treatments discontinued midcycle, leading to 24.7% of missed doses. Adverse events led to 70% of discontinuation, whereas 20% resulted from disease progression. In both cases of disease progression, the patient was given a 30-day supply before the restaging scan, and in both cases this led to oral anticancer therapy waste. An additional 12.3% of doses were omitted due to hospitalization of patients.

Over a 6-month period, an estimated $32,314 was saved under the 14-day dosing pilot. This number was reached by subtracting the number of pills actually dispensed under pilot protocol from the number of pills that would have been dispensed under old dispensing standards (usually 28- to 30-day supply), then multiplying the difference by the cost per pill.

The results of this study were presented to the Pharmacy and Therapeutics Committee and led to the approval  to continue with the 14-day dispensing protocol at VAPHS in March 2012. In addition, the pilot served as the backbone for the VHA Guidance on Oral Chemotherapy Dispensing and Monitoring.¹⁰ As part of the guidance, a monitoring guide for all the FDA-approved oral anticancer therapies is maintained and available for all VA practitioners to access on the PBM website under the Clinical Guidance subheading.

Current Practice

From the time the original pilot was conducted, the number of available oral anticancer therapies has increased along with the patient volume. Due to these factors and the lack of a dedicated outpatient oncology clinical pharmacist, oncology nurses in the outpatient clinic now direct the education, dispensing, and monitoring of patients on oral chemotherapy.

Treatment Plan

An oral anticancer treatment plan is developed by the oncology physician and entered in the EMR as a progress note titled Treatment Plan. The treatment plan includes, disease, stage, curative vs palliative intent, premedications, oral anticancer medication, dose, route and frequency, cycle length and number of cycles, baseline and continuous monitoring parameters, follow-up with provider, and staging follow-up. Once the oncology clinical pharmacist approves a treatment plan, the oncology nursing staff ensures that all the prechemotherapy laboratory tests are ordered and helps arrange any additional tests needed (echocardiogram, electrocardiogram, etc). After all the prechemotherapy testing is complete, the oncology nurse phones the patientto schedule a date for chemotherapy education and to pick up the first 14-day supply.

Initial Visit

The oncology nurse meets with each patient receiving oral anticancer therapy and provides them with an oncology clinic information packet, which includes chemotherapy education, a medication sheet, questions and answers about chemotherapy, common AEs and ways to manage them, as well as tips for meeting with the nurse and physician. The oncology nurse then reviews the oral anticancer treatment the patient is to receive, including how to administer the medication and timing, whether to take with or without food, common AEs, storage, safe handling, contact name if a toxicity arises, and importance of adherence.

The patient is provided with a pillbox and encouraged to track any missed doses. The oncology nurse then reschedules the patient for the next appointment at the clinic no more than 14 days later. Some treatments require more frequent monitoring and therefore are only dispensed 7 days at a time.

First Follow-up Visit (7-14 days)

At the first follow-up visit, the oncology nurse reviews adherence and toxicity with the patients. If any toxicity is identified, the oncology nurse contacts the oncology physician for additional assessment and orders. If the patient demonstrates adherence and tolerability, an additional 7- to 14-day supply is dispensed and the next appointment is scheduled 7 to 14 days later.

Subsequent Follow-up Visits

The patient continues to follow up at least every 28 days after cycle 1. The oncology nurse practices veterancentered care when trying to determine the appropriate follow-up for each patient. Continuous monitoring of toxicity and adherence occurs at each visit. If toxicity develops, monitoring may be increased at the discretion of the oncology nurse or physician.

Conclusions

Patients at VAPHS have been very receptive to the oral anticancer therapy protocol. Few patients have refused the initial biweekly visits, and many patients appreciate the special attention being focused on their treatment. The facility hopes to be able to expand its oral anticancer monitoring protocol to a telehealth clinic to help reduce the travel time of many patients. Additionally, as the program continues to expand, it is hoped it will be able to support a full-time outpatient oncology clinical pharmacist with a scope of practice to help manage toxicity and continue to improve adherence rates.

Author disclosures

The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Click here to read the digital edition.

The availability and popularity of orally administered anticancer therapy has drastically increased in recent years. Currently, there are more than 40 oral anticancer medications on the market in the U.S.; and about 40% of all newly FDA-approved anticancer agents in 2013 and 2014 have been oral agents.¹

The use of these agents is often driven by patients. In a review of 103 patients, an overwhelming 90% of patients who were to receive palliative chemotherapy chose oral chemotherapy over IV chemotherapy, assuming equivalent efficacy, toxicity, clinic visits, and blood work schedules. However, 70% of these patients were unwilling to sacrifice any efficacy between IV and oral chemotherapy.² Several other factors influenced the preference of oral chemotherapy for patients, including convenience, avoidance of central venous catheter placement or need for other IV access, control of the environment in which they receive chemotherapy, and travel considerations.² In addition to these practical benefits, patients reported a great sense of freedom with oral chemotherapy.³

Although patients may prefer oral anticancer therapies, for providers, several issues exist surrounding the shift in delivery of anticancer therapies from IV to oral therapies. The most significant concern is patient adherence, defined as “the extent to which patients take medications as prescribed by their health care providers.”⁴

Adherence rates in clinical trials are often excellent; however, real-life adherence rates tend to be less optimal.⁵ In a study of women receiving 5 years of adjuvant tamoxifen for breast cancer, the researchers determined that patients filled their prescription 87% of the time the first year of treatment. This rate of adherence dramatically decreased to only 50% by year 4.⁶

These results suggest that a longer duration of treatment can adversely affect adherence. Duration of treatment is of great concern for providers specifically when considering the need for indefinite duration of use of tyrosine kinase inhibitors for the treatment of chronic myeloid leukemia. In 2011, Ibrahim and colleagues showed that imatinib adherence rates of ’ 85% have been directly correlated to the loss of complete cytogenetic response (26.8% vs 1.5%, P = .0002) and lower probability of continuing imatinib (64.5% vs 90.6%, P = .006).⁷ Whereas several factors are known to influence adherence rates, Marin and colleagues identified the 2 main risk factors for poor adherence to imatinib: younger age and adverse effects (AEs). The median age for patients with adherence rates of ’ 90% was 43.8 years compared with 53.8 years for patients with > 90% adherence rate. Imatinib AEs, such as asthenia, nausea, muscle cramps, and bone or joint pains, also significantly decreased imatinib adherence.⁸

In addition to concerns for poor therapeutic outcomes and suboptimal toxicity management, lack of adherence to oral anticancer regimens can result in significant waste of medication and increased health care costs. In most situations, IV anticancer treatment cycles are repeated every 1 to 3 weeks and allow the patient more frequent face-to-face interaction with the oncology team. Oral chemotherapy, on the other hand, is traditionally dispensed as a 28- to 30-day supply. This practice often limits the patient’s access to the oncology team for full evaluation of adherence and toxicity, which can lead to oral anticancer therapy waste.

Khandelwal and colleagues investigated the utility of a split-fill to decrease health care costs. In the splitfill process, patients were dispensed only days 1 to 16 of their oral anticancer medication at the initial fill. If the medication was tolerated and the prescribing provider deemed no changes in treatment necessary, the remaining 12 to 14 days of the cycle were then dispensed. Unfortunately, all insurance companies did not authorize the split-fill plan, thus preventing some patients in the study to participate in this cost savings strategy. However, it was determined for the patients who discontinued therapy, about 34% could have reduced wastage had they been on the split-fill plan, resulting in an average direct savings of $934.20 per patient who discontinued use.⁹

In 2011, the Hematology/Oncology and Pharmacy divisions at the VA Pittsburgh Healthcare System (VAPHS) examined the issues surrounding dispensing and monitoring of oral anticancer therapy. Higher utilization of oral anticancer therapy was identified and in parallel, increasing rates of patient nonadherence, toxicity, and wasted medication. Originally, most providers dispensed oral anticancer therapy as a 1-month supply. However, in efforts to increase adherence, limit toxicity, and avoid medication waste, some oncologists began only dispensing a 1- to 2-week supply of medication per visit. This shift in practice led to a pilot study evaluating the utility of limiting all oral chemotherapy to a 7- to 14-day supply during the first 3 months of treatment.

Pilot Study

The goal of the pilot study was to increase adherence, decrease toxicity, and avoid medication waste. Patients who initiated a new oral anticancer therapy between August 15, 2011, and February 15, 2012, were enrolled in the pilot study. Each patient was to be provided only a 14-day supply of medication at each visit. Patients on concurrent chemoradiotherapy with capecitabine were dispensed only a 7-day supply (as they were at VAPHS daily for radiation) of medication. A pillbox designated for oral anticancer therapy was provided and filled by the clinical pharmacist before leaving the hematology/oncology clinic.

Patients were provided a calendar to record the time and date of their oral anticancer therapy selfadministration. Patients were also asked to record any missed doses and the reasons they missed taking the medication. In addition, patients were counseled on the importance of medication adherence, food-drug and drug-drug interaction, proper storage and administration of medications, and when/who to notify if AEs occurred.

Patients were asked to return the pillboxes to the hematology/oncology clinic for the next refill and meet with the clinical pharmacist. A pill count was performed at each visit in addition to screening for toxicity. If a toxicity was identified, the prescribing provider was contacted for further orders. If no changes were needed, the remaining 14-day supply was dispensed to the patient at that time. Adherence and toxicity were documented in the electronic medical record (EMR) at each visit.

Thirty patients were started on 32 different oral anticancer therapies (Table 1) over the 6 months between August 15, 2011, and February 15, 2012. Patients already initiated on oral anticancer therapy before the start date were not included in this analysis. This number also did not include patients on lenalidomide, because this medication is mailed directly to the patient from a specialty pharmacy. All patients were male; average age was 68 (45-89) years; 83.3% of patients were white; and 83% of patients had a stage IV disease.

Adherence assessments using pill counts and medication calendars demonstrated that 6% (121/2,037) of doses that were dispensed were not taken. Overall adherence rate was 94%. The average patient adherence rate was 93.2%. Adverse events contributed to 62.8% of doses omitted (Table 2). Some AEs (eg, nausea, vomiting, and hypertension) were deemed preventable or modifiable with better symptom management. However, the majority of AEs that led to dose omission were not preventable.

Ten patients had their treatments discontinued midcycle, leading to 24.7% of missed doses. Adverse events led to 70% of discontinuation, whereas 20% resulted from disease progression. In both cases of disease progression, the patient was given a 30-day supply before the restaging scan, and in both cases this led to oral anticancer therapy waste. An additional 12.3% of doses were omitted due to hospitalization of patients.

Over a 6-month period, an estimated $32,314 was saved under the 14-day dosing pilot. This number was reached by subtracting the number of pills actually dispensed under pilot protocol from the number of pills that would have been dispensed under old dispensing standards (usually 28- to 30-day supply), then multiplying the difference by the cost per pill.

The results of this study were presented to the Pharmacy and Therapeutics Committee and led to the approval  to continue with the 14-day dispensing protocol at VAPHS in March 2012. In addition, the pilot served as the backbone for the VHA Guidance on Oral Chemotherapy Dispensing and Monitoring.¹⁰ As part of the guidance, a monitoring guide for all the FDA-approved oral anticancer therapies is maintained and available for all VA practitioners to access on the PBM website under the Clinical Guidance subheading.

Current Practice

From the time the original pilot was conducted, the number of available oral anticancer therapies has increased along with the patient volume. Due to these factors and the lack of a dedicated outpatient oncology clinical pharmacist, oncology nurses in the outpatient clinic now direct the education, dispensing, and monitoring of patients on oral chemotherapy.

Treatment Plan

An oral anticancer treatment plan is developed by the oncology physician and entered in the EMR as a progress note titled Treatment Plan. The treatment plan includes, disease, stage, curative vs palliative intent, premedications, oral anticancer medication, dose, route and frequency, cycle length and number of cycles, baseline and continuous monitoring parameters, follow-up with provider, and staging follow-up. Once the oncology clinical pharmacist approves a treatment plan, the oncology nursing staff ensures that all the prechemotherapy laboratory tests are ordered and helps arrange any additional tests needed (echocardiogram, electrocardiogram, etc). After all the prechemotherapy testing is complete, the oncology nurse phones the patientto schedule a date for chemotherapy education and to pick up the first 14-day supply.

Initial Visit

The oncology nurse meets with each patient receiving oral anticancer therapy and provides them with an oncology clinic information packet, which includes chemotherapy education, a medication sheet, questions and answers about chemotherapy, common AEs and ways to manage them, as well as tips for meeting with the nurse and physician. The oncology nurse then reviews the oral anticancer treatment the patient is to receive, including how to administer the medication and timing, whether to take with or without food, common AEs, storage, safe handling, contact name if a toxicity arises, and importance of adherence.

The patient is provided with a pillbox and encouraged to track any missed doses. The oncology nurse then reschedules the patient for the next appointment at the clinic no more than 14 days later. Some treatments require more frequent monitoring and therefore are only dispensed 7 days at a time.

First Follow-up Visit (7-14 days)

At the first follow-up visit, the oncology nurse reviews adherence and toxicity with the patients. If any toxicity is identified, the oncology nurse contacts the oncology physician for additional assessment and orders. If the patient demonstrates adherence and tolerability, an additional 7- to 14-day supply is dispensed and the next appointment is scheduled 7 to 14 days later.

Subsequent Follow-up Visits

The patient continues to follow up at least every 28 days after cycle 1. The oncology nurse practices veterancentered care when trying to determine the appropriate follow-up for each patient. Continuous monitoring of toxicity and adherence occurs at each visit. If toxicity develops, monitoring may be increased at the discretion of the oncology nurse or physician.

Conclusions

Patients at VAPHS have been very receptive to the oral anticancer therapy protocol. Few patients have refused the initial biweekly visits, and many patients appreciate the special attention being focused on their treatment. The facility hopes to be able to expand its oral anticancer monitoring protocol to a telehealth clinic to help reduce the travel time of many patients. Additionally, as the program continues to expand, it is hoped it will be able to support a full-time outpatient oncology clinical pharmacist with a scope of practice to help manage toxicity and continue to improve adherence rates.

Author disclosures

The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Click here to read the digital edition.

The availability and popularity of orally administered anticancer therapy has drastically increased in recent years. Currently, there are more than 40 oral anticancer medications on the market in the U.S.; and about 40% of all newly FDA-approved anticancer agents in 2013 and 2014 have been oral agents.¹

The use of these agents is often driven by patients. In a review of 103 patients, an overwhelming 90% of patients who were to receive palliative chemotherapy chose oral chemotherapy over IV chemotherapy, assuming equivalent efficacy, toxicity, clinic visits, and blood work schedules. However, 70% of these patients were unwilling to sacrifice any efficacy between IV and oral chemotherapy.² Several other factors influenced the preference of oral chemotherapy for patients, including convenience, avoidance of central venous catheter placement or need for other IV access, control of the environment in which they receive chemotherapy, and travel considerations.² In addition to these practical benefits, patients reported a great sense of freedom with oral chemotherapy.³

Although patients may prefer oral anticancer therapies, for providers, several issues exist surrounding the shift in delivery of anticancer therapies from IV to oral therapies. The most significant concern is patient adherence, defined as “the extent to which patients take medications as prescribed by their health care providers.”⁴

Adherence rates in clinical trials are often excellent; however, real-life adherence rates tend to be less optimal.⁵ In a study of women receiving 5 years of adjuvant tamoxifen for breast cancer, the researchers determined that patients filled their prescription 87% of the time the first year of treatment. This rate of adherence dramatically decreased to only 50% by year 4.⁶

These results suggest that a longer duration of treatment can adversely affect adherence. Duration of treatment is of great concern for providers specifically when considering the need for indefinite duration of use of tyrosine kinase inhibitors for the treatment of chronic myeloid leukemia. In 2011, Ibrahim and colleagues showed that imatinib adherence rates of ’ 85% have been directly correlated to the loss of complete cytogenetic response (26.8% vs 1.5%, P = .0002) and lower probability of continuing imatinib (64.5% vs 90.6%, P = .006).⁷ Whereas several factors are known to influence adherence rates, Marin and colleagues identified the 2 main risk factors for poor adherence to imatinib: younger age and adverse effects (AEs). The median age for patients with adherence rates of ’ 90% was 43.8 years compared with 53.8 years for patients with > 90% adherence rate. Imatinib AEs, such as asthenia, nausea, muscle cramps, and bone or joint pains, also significantly decreased imatinib adherence.⁸

In addition to concerns for poor therapeutic outcomes and suboptimal toxicity management, lack of adherence to oral anticancer regimens can result in significant waste of medication and increased health care costs. In most situations, IV anticancer treatment cycles are repeated every 1 to 3 weeks and allow the patient more frequent face-to-face interaction with the oncology team. Oral chemotherapy, on the other hand, is traditionally dispensed as a 28- to 30-day supply. This practice often limits the patient’s access to the oncology team for full evaluation of adherence and toxicity, which can lead to oral anticancer therapy waste.

Khandelwal and colleagues investigated the utility of a split-fill to decrease health care costs. In the splitfill process, patients were dispensed only days 1 to 16 of their oral anticancer medication at the initial fill. If the medication was tolerated and the prescribing provider deemed no changes in treatment necessary, the remaining 12 to 14 days of the cycle were then dispensed. Unfortunately, all insurance companies did not authorize the split-fill plan, thus preventing some patients in the study to participate in this cost savings strategy. However, it was determined for the patients who discontinued therapy, about 34% could have reduced wastage had they been on the split-fill plan, resulting in an average direct savings of $934.20 per patient who discontinued use.⁹

In 2011, the Hematology/Oncology and Pharmacy divisions at the VA Pittsburgh Healthcare System (VAPHS) examined the issues surrounding dispensing and monitoring of oral anticancer therapy. Higher utilization of oral anticancer therapy was identified and in parallel, increasing rates of patient nonadherence, toxicity, and wasted medication. Originally, most providers dispensed oral anticancer therapy as a 1-month supply. However, in efforts to increase adherence, limit toxicity, and avoid medication waste, some oncologists began only dispensing a 1- to 2-week supply of medication per visit. This shift in practice led to a pilot study evaluating the utility of limiting all oral chemotherapy to a 7- to 14-day supply during the first 3 months of treatment.

Pilot Study

The goal of the pilot study was to increase adherence, decrease toxicity, and avoid medication waste. Patients who initiated a new oral anticancer therapy between August 15, 2011, and February 15, 2012, were enrolled in the pilot study. Each patient was to be provided only a 14-day supply of medication at each visit. Patients on concurrent chemoradiotherapy with capecitabine were dispensed only a 7-day supply (as they were at VAPHS daily for radiation) of medication. A pillbox designated for oral anticancer therapy was provided and filled by the clinical pharmacist before leaving the hematology/oncology clinic.

Patients were provided a calendar to record the time and date of their oral anticancer therapy selfadministration. Patients were also asked to record any missed doses and the reasons they missed taking the medication. In addition, patients were counseled on the importance of medication adherence, food-drug and drug-drug interaction, proper storage and administration of medications, and when/who to notify if AEs occurred.

Patients were asked to return the pillboxes to the hematology/oncology clinic for the next refill and meet with the clinical pharmacist. A pill count was performed at each visit in addition to screening for toxicity. If a toxicity was identified, the prescribing provider was contacted for further orders. If no changes were needed, the remaining 14-day supply was dispensed to the patient at that time. Adherence and toxicity were documented in the electronic medical record (EMR) at each visit.

Thirty patients were started on 32 different oral anticancer therapies (Table 1) over the 6 months between August 15, 2011, and February 15, 2012. Patients already initiated on oral anticancer therapy before the start date were not included in this analysis. This number also did not include patients on lenalidomide, because this medication is mailed directly to the patient from a specialty pharmacy. All patients were male; average age was 68 (45-89) years; 83.3% of patients were white; and 83% of patients had a stage IV disease.

Adherence assessments using pill counts and medication calendars demonstrated that 6% (121/2,037) of doses that were dispensed were not taken. Overall adherence rate was 94%. The average patient adherence rate was 93.2%. Adverse events contributed to 62.8% of doses omitted (Table 2). Some AEs (eg, nausea, vomiting, and hypertension) were deemed preventable or modifiable with better symptom management. However, the majority of AEs that led to dose omission were not preventable.

Ten patients had their treatments discontinued midcycle, leading to 24.7% of missed doses. Adverse events led to 70% of discontinuation, whereas 20% resulted from disease progression. In both cases of disease progression, the patient was given a 30-day supply before the restaging scan, and in both cases this led to oral anticancer therapy waste. An additional 12.3% of doses were omitted due to hospitalization of patients.

Over a 6-month period, an estimated $32,314 was saved under the 14-day dosing pilot. This number was reached by subtracting the number of pills actually dispensed under pilot protocol from the number of pills that would have been dispensed under old dispensing standards (usually 28- to 30-day supply), then multiplying the difference by the cost per pill.

The results of this study were presented to the Pharmacy and Therapeutics Committee and led to the approval  to continue with the 14-day dispensing protocol at VAPHS in March 2012. In addition, the pilot served as the backbone for the VHA Guidance on Oral Chemotherapy Dispensing and Monitoring.¹⁰ As part of the guidance, a monitoring guide for all the FDA-approved oral anticancer therapies is maintained and available for all VA practitioners to access on the PBM website under the Clinical Guidance subheading.

Current Practice

From the time the original pilot was conducted, the number of available oral anticancer therapies has increased along with the patient volume. Due to these factors and the lack of a dedicated outpatient oncology clinical pharmacist, oncology nurses in the outpatient clinic now direct the education, dispensing, and monitoring of patients on oral chemotherapy.

Treatment Plan

An oral anticancer treatment plan is developed by the oncology physician and entered in the EMR as a progress note titled Treatment Plan. The treatment plan includes, disease, stage, curative vs palliative intent, premedications, oral anticancer medication, dose, route and frequency, cycle length and number of cycles, baseline and continuous monitoring parameters, follow-up with provider, and staging follow-up. Once the oncology clinical pharmacist approves a treatment plan, the oncology nursing staff ensures that all the prechemotherapy laboratory tests are ordered and helps arrange any additional tests needed (echocardiogram, electrocardiogram, etc). After all the prechemotherapy testing is complete, the oncology nurse phones the patientto schedule a date for chemotherapy education and to pick up the first 14-day supply.

Initial Visit

The oncology nurse meets with each patient receiving oral anticancer therapy and provides them with an oncology clinic information packet, which includes chemotherapy education, a medication sheet, questions and answers about chemotherapy, common AEs and ways to manage them, as well as tips for meeting with the nurse and physician. The oncology nurse then reviews the oral anticancer treatment the patient is to receive, including how to administer the medication and timing, whether to take with or without food, common AEs, storage, safe handling, contact name if a toxicity arises, and importance of adherence.

The patient is provided with a pillbox and encouraged to track any missed doses. The oncology nurse then reschedules the patient for the next appointment at the clinic no more than 14 days later. Some treatments require more frequent monitoring and therefore are only dispensed 7 days at a time.

First Follow-up Visit (7-14 days)

At the first follow-up visit, the oncology nurse reviews adherence and toxicity with the patients. If any toxicity is identified, the oncology nurse contacts the oncology physician for additional assessment and orders. If the patient demonstrates adherence and tolerability, an additional 7- to 14-day supply is dispensed and the next appointment is scheduled 7 to 14 days later.

Subsequent Follow-up Visits

The patient continues to follow up at least every 28 days after cycle 1. The oncology nurse practices veterancentered care when trying to determine the appropriate follow-up for each patient. Continuous monitoring of toxicity and adherence occurs at each visit. If toxicity develops, monitoring may be increased at the discretion of the oncology nurse or physician.

Conclusions

Patients at VAPHS have been very receptive to the oral anticancer therapy protocol. Few patients have refused the initial biweekly visits, and many patients appreciate the special attention being focused on their treatment. The facility hopes to be able to expand its oral anticancer monitoring protocol to a telehealth clinic to help reduce the travel time of many patients. Additionally, as the program continues to expand, it is hoped it will be able to support a full-time outpatient oncology clinical pharmacist with a scope of practice to help manage toxicity and continue to improve adherence rates.

Author disclosures

The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

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In the United States, there will be an estimated 49,670 new cases of head and neck cancer for 2017.¹ Head and neck cancer (HNC) is a term used to describe a range of tumors that originate in the area of the body spanning from the lower neck to the upper nasal cavity.² Specifically, they are malignancies arising in the mouth, larynx, nasal cavity, sinuses, tongue, lips, and numerous glands such as the thyroid and salivary.² To clarify, HNC, despite the encompassing name, does not include growths of the bones, teeth, skin, brain parenchyma, and eye; therefore, such tumors will not be addressed in this article.

Patients with HNC often experience fragmented and uncoordinated care that leads to delays in cancer treatment, severe distress in patients and families, and dissatisfaction with care. Literature reports that these patients face numerous stressors including aggressive cancer treatments, severe symptoms, body image concerns, loss of speech, difficulty swallowing, nutritional issues, and respiratory problems that affect their quality of life and ability to function on a day-to-day basis.^3,4In addition, patients with HNC and their families are challenged to navigate the health care system and to overcome the difficulties of accessing services within the context of financial constraints. A multidisciplinary team (MDT) approach is the standard of care for HNC patients, as demonstrated in studies reporting better 5-year survival outcomes, increased completion of adjuvant therapy, and higher compliance with speech-language pathologist (SLP) recommendations.^{5, 6} Furthermore, a recent systematic review of cancer teams concluded that the MDT approach leads to improved clinical outcomes and enhanced communication between the patient and the team.⁷

The Institute of Medicine (IOM) stated in its 2013 report on cancer care that a high-quality care delivery system requires continuing measurement of cancer care and strategies to carry out performance improvement.⁸ Following the IOM premise, the cancer center at an academic medical center in Philadelphia made efforts to improve patient access to multidisciplinary services, first, by creating a multidisciplinary Cancer Appetite and Rehabilitation (CARE)clinic to address the symptoms and nutritional needs of HNC patients,⁹ and second, by using a gap analysis to conduct an assessment of the cancer care services provided to this cancer population. The need to conduct this assessment was generated by the desire to improve access to multidisciplinary care, with the goal of meeting standard benchmarks for completion of treatment while increasing the use of ancillary services. This article describes the process of conducting a gap analysis of cancer services for HNC patients, and includes discussion of the findings, recommendations for improving care, a description of the quality improvement interventions, and a report of the outcomes based on an interval re-assessment 18 months later.

Methods

Methods included a gap analysis, implementation of quality improvement recommendations, and re-assessment of indicators (Figure). A gap analysis “identifies differences between desired and actual practice conditions, including service delivery and quality patient outcomes as measured against evidence-based benchmarks while incorporating key stakeholder concerns and expectations.”¹⁰ The gap analysis of cancer care services offered to HNC patients was achieved through the step-by-step process described hereinafter. The implementation of quality improvement recommendations was accomplished by establishing two task force committees focused respectively on education and transitions in care coordination. Re-assessment of indicators related to timeliness of delivery of cancer treatments and collection of additional baseline data regarding supportive services.

Gap analysis

Identification of the scope of the problem. Members of the HNC multidisciplinary team raised concerns about unintended breaches in care for HNC patients that resulted not only in delay of the patients’ cancer treatments, but also in unnecessary distress for the patients and their families. As a result, the HNC team decided to conduct a gap analysis to identify the barriers in care for HNC patients, and by doing this, to determine possible solutions.

Identification of best practice care indicators. The indicators of best practice care (benchmarks) for HNC patients were identified after exhaustive review of the literature^11-22(Table 1). For this gap analysis, the indicators focused on waiting time to treatment (surgery, chemotherapy, radiation therapy) and to supportive care interventions (nutrition, speech and language pathology) as follows:

• 9.2Futura StdInitial ear-nose-throat (ENT) visit to surgery: <30 days
• Biopsy to start radiation therapy (RT) for nonsurgical patients: 40 days
• Surgery to RT start: 42 days
• Surgery to nutrition consultation (outpatient), start RT to nutrition: Pretreatment
• Surgery to outpatient SLP, initial ENT visit to SLP referral, surgery to SLP referral, RT start to outpatient SLP start: Pretreatment

Measure gaps against benchmarks. To Gap analysis of measure gaps against benchmarks, the authors used the Agency for Health Care Research and Quality tool that provides a systematic method to compare current practice with best practices and determine the barriers to best practice and the feasibility of implementing best practices by the institution²³ (Table 1). For this project, a process map of waiting time to treatment and supportive care interventions was created, so that real-world conditions could be measured against benchmarks.

Process map. The authors identified 67 newly diagnosed HNC patients during January-July 2014 from the surgery, radiation therapy, and nutrition departments, but only 33 patients were able to be tracked from their initial visit at the cancer center until the completion of their treatment through the electronic medical record (EMR) system. Their information was compiled in a spreadsheet based on the EMR information. Data included patient access to supportive services and number of days between important treatment benchmarks. Tracking data was used to create a treatment flow chart and determine average treatment intervals.

To map the typical patient process, the patients were split into two groups: surgical (n = 22) and nonsurgical (n = 11). Surgical patients underwent surgery as their primary treatment and received adjuvant radiation therapy or concurrent chemotherapy. Nonsurgical patients did not require surgery other than biopsy as a part of their treatment. Most of the nonsurgical patients received chemotherapy, and 1 patient received palliative radiation therapy.

SWOT analysis. The SWOT analysis is used to chart institution performance in relation to benchmarks while describing stakeholders’ perceptions.²⁴The stakeholder perspective for this project focused on the views of the health care providers from all disciplines regarding the quality of care provided to the HNC population. In addition, a patient survey was conducted to assess their perception of the care they received.

Clinician survey. We surveyed 25 clinicians, including physicians, advanced practice providers, nurses, and allied health professionals, from the surgical (n = 3), hospitalization (n = 6), radiation (n = 3), chemotherapy (n = 3) and supportive services teams (n = 10). The survey was conducted face to face and included 7 open-ended questions designed to gain insight about problems encountered with coordination of care, suggestions to improve coordination of care, factors in treatment delays, suggestions to decrease treatment delays, factors in excellent patient outcomes, rate overall patient care, and suggestions for improvement of service. Initial survey responses were filtered by recurring themes in each question among the different patient service teams.

Patient satisfaction survey. The sample of patients was obtained from the surgery, radiation therapy, and nutrition departments during January-July 2014. Sixty-seven initial patients were identified but only 43 were eligible for interview because they had a listed phone number. A six-question nonvalidated survey was developed by the authors to measure patient satisfaction with the scheduling process, waiting time, information provided about treatment and their medical status, emotional support, the coordination of care, and the payment process. Satisfaction was rated on a scale from 1 to 5 (1 = Poor, 2 = Fair, 3 = Satisfactory, 5 = Great).

Analysis and final report. See Results section.

Quality improvement implementation. The transitions and the education committees were created to address the gaps identified during the analysis. The transitions committee developed strategies to improve the coordination of care of HNC patients throughout their cancer treatment and the education committee elaborated new ways to enhance patient education while meeting treatment timeline standards. The implementation of the interventions was developed by the inpatient and outpatient MTD teams caring for the HNC population.

Re-assessment of indicators. During January-December 2015, a total of 58 patients diagnosed with HNC were identified. Of those, 40 patients with recurrent disease were eliminated, leaving 18 patients (10 surgical, 8 nonsurgical). Similar to the initial assessment for the gap analysis, data included patient access to supportive services and number of days between important treatment benchmarks. Tracking data was used to create a treatment flow chart and determine average treatment intervals.

Results

Most of the patients were men (70%), white (70%), and 60% were within the 50-69 years age range at the time of diagnosis.

Clinician survey

The clinicians were surveyed and their responses analyzed by two people, the project leader and the project assistant. The most commonly identified weaknesses in care that the clinicians identified were delayed access to dental referrals, insufficient preoperative patient education, and inefficient discharge planning and/or home care coordination. Dental referrals were identified as a major cause of delay in starting radiation therapy because of scheduling issues, a lack of patient motivation, limited insurance coverage, and difficulty identifying reliable dentists in the patient’s geographic area. Clinicians also identified problems coordinating smoking cessation referrals for patients.

In addition, they identified the hospitalization and/or home care phases as areas for potential improvement. During hospitalization, patients often expressed surprise upon learning that they had a feeding tube and/or tracheostomy despite having received pre-operative education. This misunderstanding by the patient was likely related to the clinicians’ assumptions about the best timing for patient education and the amount of time needed for education before the surgical procedure. The surgical team provided patient education based on individual needs, and it has not been standardized because they felt that patients’ education needs vary from person to person. In contrast, patient education prior radiation therapy is standardized, and all patients received a comprehensive package of information that is re-enforced by direct patient education by the clinicians.

Another gap in care identified by the inpatient team was a prolonged intensive care unit (ICU) stay for the HNC patients. These patients remained in the ICU for the entirety of their stay. Not only was this causing overuse of resources, but patients also felt unprepared for an independent discharge home given the high level of care received in the ICU.

A range of suggestions were made to solve these problems. The most prevalent suggestion was to use a nurse navigator to coordinate referrals, schedule appointments, facilitate interdisciplinary communication, and to address social, financial, and transport needs for HNC patients. Several other suggestions referred to standardizing treatment procedures and pre-operative patient education.

Patient survey

Forty-three patients were identified for the patient satisfaction survey. Each patient was contacted at least three times over the course of 3 weeks. Of the 43 patients, 20 had an invalid phone number, 10 were not available for participation, and 1 declined to participate. A total of 12 patients completed the survey.

Although the sample size was small, the patients surveyed were very satisfied with their care. Of the 12 patients, 5 patients rated all of the services relevant to their treatment as a 5 (Great). Areas of particular concern for the patients included the waiting time to see a physician in the ENT clinic, the explanation/collection of charges, and the accessibility of support groups. Services rated 3 (Satisfactory) included waiting time to schedule appointments; the amount of information and patient education provided by about radiation, nutrition, physical therapy (PT), occupational therapy (OT), and SLP; and overall satisfaction with care.

Surgical patients. The Danish Head and Neck Society guidelines state that the interval between the initial visit diagnosis and surgery should be within 30 days.¹²A comparison of the average intervals between important treatment points for the surgical sample patients with the benchmark timing recommended in the literature are shown in Table 2. The mean time from initial visit to surgery was 28 days in the cancer center sample; 67% of patients (n = 14) had surgery within 30 days, and 33% of patients (n = 7) had surgery beyond 30 days. The interval re-assessment showed improvements in this area: the mean time from initial visit to surgery went from 28 to 18 days, and 100% of patients
n = 10) had surgery within 30 days.

Huang and colleagues have indicated that postoperative radiation therapy should ideally occur within 42 days of surgery;¹³ however, in the present study, 79% (n = 11) of the sample surgical patients undergoing radiation began their therapy on average more than 63 days after surgery. The interval re-assessment found the same results with 80% of patients starting radiation over 42 days after surgery although the average time lag decreased from 68 days to 53 days.

Nonsurgical patients. Huang and colleagues have indicated that for patients undergoing radiation as their primary form of treatment, an interval of 40 days between biopsy and the start of radiation is ideal.¹³ The average intervals between important time points of treatment for patients who did not require surgery in their treatment are shown in Table 2. The cancer center met the benchmark at baseline with an average of 38 days (n = 11 patients). The re-assessment showed improvement in this area with 100% of cases (n = 10) meeting the benchmark with an average of 32 days. Likewise, the benchmark waiting time from RT consultation to RT start of less than 30 days¹¹ was met by the cancer center for the nonsurgical group (n = 11).

Access to supportive services

Nutrition care. Studies have shown that standard nutritional care for HNC patients should start before treatment.^18,19 In the present study, the waiting time from surgery to outpatient nutrition assessment improved from 61 days to 50 days (Table 2). For patients in the surgical group, the time interval between the initial ENT visit to the outpatient nutrition assessment decreased from 85 days at baseline to 66 days at reassessment, and 82 days to 35 days, respectively, for the nonsurgical group. The time interval from surgery to nutrition assessment has not reached the recommended pretreatment benchmark, but data showed a trend of improvement from 61 days at baseline to 50 days at reassessment for patients in the group.

Patients were typically referred to outpatient nutrition at the start of radiation therapy. In the initial assessment, all patients (n = 33) had access to nutrition services, but 21% (n = 7) never spoke to the nutritionist. The re-assessment found all but one (n = 7) of the patients had been seen by a nutritionist at some point during the treatment period. The benchmark of preradiation nutrition assessment was met by 2 postsurgical patients, with the remainder of the patients being seen within 3 days of the initiation of radiation.

Speech-language pathology management. The literature recommends that patients receive SLP management before the surgery.^14-17 In this gap analysis, a difference in access to SLP services was identified between inpatient and outpatient settings. On average, patients within the sample were referred to outpatient SLP over a month after their surgery. In contrast, inpatient surgical patients had access to rapid consultations with SLP (eg, 1 day after surgery for total laryngectomy, and 4 days after surgery for oropharyngeal and oral surgery patients; T Hogan, unpublished data, June 2014). Overall, the benchmark was not met, as patients were not seen by the SPL prior to treatment.

New baseline data was collected about SLP services and showed that 70% of patients had contact with the outpatient SLP at some point during their treatment. Of those, only 29% of patients saw SLP before surgery, meeting the benchmark. The baseline waiting time was an average of 15 days before surgery and 43 days after surgery. Overall, the trend is moving toward the benchmark of care.

Similarly, studies determined that the gold standard of care for nonsurgical patients is that SLPs begin pretreatment management of HNC.¹⁶Patients in the baseline sample were typically referred to outpatient SLP about a month after biopsy (presumably diagnosis), but before the start of chemo-radiation. There were no data available for the number of patients who were actually seen by the outpatient SLP before the start of chemo-radiation.

The new baseline data found that 100% of nonsurgical patients were referred to SLP, but only25% (n = 2) were seen before they started chemo-radiation therapy (an average 5 days before) and 75% (n = 6) were seen after starting chemo-radiation therapy (an average 23 days after).

SWOT analysis

The SWOT analysis included strengths, weaknesses, opportunities and threats of the care provided to HNC patients at the cancer center. The gap analysis based on the results of the clinician surveys, process mapping, and patient satisfaction survey is summarized in Table 3. Three main gaps were identified: waiting time to treatment, education, and coordination of and transitions in care.

Quality improvement actions

Interventions by the outpatient MTD team included changing the process of scheduling dental appointments, creating a new approach to outpatient nutrition by proactively meeting patients in the ENT clinic, and conducting PT and SLP assessments to patients in the chemotherapy unit while receiving their treatment. A nurse navigator position for this patient population was approved and an expedited referral system was initiated. At the same time, the inpatient team implemented a specialized HNC unit in the medical-surgical floor, developed the protocols for the management of postsurgery HNC patients, educated nursing staff, and standardized patient education to facilitate transition to the next level of care (Table 3).

Discussion

The gap analysis of services provided to HNC patients at the cancer center identified three gaps in care: delay in treatment and supportive services, nonstandardized patient education, and lack of care coordination.

All patients should have access to a timely treatment initiation. In this analysis, surgical patients encountered a delay between surgery and the start of radiation therapy, about 3 weeks beyond the recommended in the literature.¹² Clinicians mentioned delays in ensuring preradiation dental consultations as a significant issue affecting the patient treatment process. Re-assessment data reported that despite interventions for early dental referrals, 80% of patients still started radiation over 6 weeks after surgery; however, the average time lag decreased from 68 days to 53 days.

RT delays in HNC patients not only affect patients’ emotional state but may also impact clinical outcomes. Treatment delays have the potential to harm patients by: allowing tumor growth that impact on the curative outcomes of RT; postponing the benefits of palliative RT on symptom relief; and causing psychological distress.²⁵ In addition, delay in starting treatment has shown to increase the risk for local recurrence,^13,26 and decrease survival.²⁷

Higher demand for advanced RT modalities has been linked to treatment delays. Waiting times from initial RT evaluation to start RT have increased over time, from <14 days in 1989 to 31 days in 1997.¹¹ This is explained by the complexity of the pretreatment evaluations and the increasing demand of radiation services, especially in high volume institutions.^25,27A fast-track program to reduce waiting time in the treatment of HNC patients reported to be effective.²² This program includes a patient coordinator, a hotline for referral procedures, prebooked slots for ENT and RT clinics, faster pathology and imaging reports, and the establishment of an MTD team.

The clinician survey identified patient needs classified in three categories: pre-operative education, hospitalization process, and access to support services. Regarding pre-operative education, clinicians acknowledged that although patients were educated about their surgical options and possible outcomes prior to hospitalization, they often could not fully understand this information at the time of the instruction. The high need for education particularly in the pretreatment phase was documented in a needs assessment survey for HNC patients conducted at the cancer center D DeMille, RD, unpublished data, August 2013).

Studies have looked at the effectiveness of education in cancer patients. The use of teaching interventions (written information, audiotapes, videotapes, and computer programs) has proven to be valuable for educating patients prior to experiencing cancer treatments.²⁰Further, a systematic review of preparatory education for cancer patients undergoing surgery reported that face-to-face discussions appear to be effective at improving patient outcomes with regards to increasing knowledge and decreasing anxiety.²¹ However, it was stated that the timing of the delivery of education is critical to be efficient. For example, an education session provided one day prior the day of surgery is not useful as it may place additional stress on a patient who is already highly anxious and decreases the likelihood for the information to be managed. It is recommended to deliver education early enough prior surgery to allow time for the patient to process the information. Also, a study reported that presurgical education on potential side effects; the assessment of patients’ needs by an SLP, physical therapist, nutritionist, and social worker; and pre-operative nutritional support decrease postoperative complications.⁴

The education committee was created in response to the gap on patient education. The inpatient team took the lead and provided intense education on the care of HNC patients to the nursing staff and to HNC patients and their families about postoperative care at home. Education was also extended to rehabilitation facilities caring for this cancer population at discharge from the hospital.

Clinicians identified a gap during the hospitalization process. The gap included prolonged stay of patients in the ICU postsurgery, inefficient interclinician communication, lack of standardization of postsurgical care, and difficulty communicating with external home care teams. A major intervention was implemented that included the creation of a HNC specialized unit that offered a structured setting for standardized care and communication between patients and clinicians. Dedicated units for the management of HNC patients highly enhance the quality of care provided because it enables the MTD team to work properly by clearly defining roles and responsibilities, delineating evidence-based clinical interventions, and promoting expert care for this patient population.²³In addition, several key steps have been recommended to reduce the fragmentation of care for hospital patients, including developing a referral/transition tracking system, organizing and training staff members to coordinate transition/referrals, and identifying and creating agreements with key care providers.²⁸

Early patient access to supportive services was a concern to most clinicians. HNC providers were not consulting the CARE clinic about patients’ nutritional, physical and SLP needs until the patient was having serious problems. Patient tracking found that the minority of patients met the standard of having a presurgical speech referral. Most patients had access to outpatient nutrition services during radiation therapy but the majority of patients in the sample did not attend CARE clinic. The literature strongly supports early management of HNC patients by the SPL and nutrition counselor. Van der Molen and colleagues demonstrated that a pretreatment SPL rehabilitation program is feasible and offers reasonable patient compliance despite of the burden caused by ongoing chemo-radiation therapy for HNC patients.¹⁶Similarly, early nutrition counseling for HNC patients undergoing RT has reported to decrease unintended weight loss and malnutrition compared with late nutrition intervention.¹⁹

Although there are clear gaps in care for HNC patients from the clinicians’ perspective, the patients surveyed indicated a clear satisfaction with their care at the cancer center. Almost all patients were satisfied with their relationships with clinicians in the team. Some patients mentioned complaints of insufficient pre-operative education and waiting time, but there were not significant complaints about coordination, which clinicians had identified as a major issue. This is likely explained by the small sample size and the patients’ inability to see the background interclinician communication.

A crucial suggestion to address all of these gaps in care was the implementation of a nurse navigator. With the support of hospital and cancer center administration, a nurse navigator was hired to address the needs of HNC patients throughout their disease trajectory. The team agreed that the nurse navigator should make contact with HNC patients during their initial appointment at the surgical ENT office. This initial contact allows the nurse navigator to provide support and connection to resources. Thereafter, early contact with this patient population allows the nurse navigator to follow the patient through the continuum of care from biopsy and diagnosis to survivorship. The nurse navigator facilitates communication between clinicians, patients and their families; and provides emotional support to patients while helping to manage their financial and transportation needs.²⁹

Limitations

This is a quality improvement project with a small sample size of HNC cases. Data from this gap analysis are not statistically significant; yet, are clinically relevant in the management of the HNC population at the cancer center. Likewise, the patient sample size was small, making definitive generalizations about patient experience difficult; however, the data are helpful in highlighting possible problems for patients.

In the United States, there will be an estimated 49,670 new cases of head and neck cancer for 2017.¹ Head and neck cancer (HNC) is a term used to describe a range of tumors that originate in the area of the body spanning from the lower neck to the upper nasal cavity.² Specifically, they are malignancies arising in the mouth, larynx, nasal cavity, sinuses, tongue, lips, and numerous glands such as the thyroid and salivary.² To clarify, HNC, despite the encompassing name, does not include growths of the bones, teeth, skin, brain parenchyma, and eye; therefore, such tumors will not be addressed in this article.

Patients with HNC often experience fragmented and uncoordinated care that leads to delays in cancer treatment, severe distress in patients and families, and dissatisfaction with care. Literature reports that these patients face numerous stressors including aggressive cancer treatments, severe symptoms, body image concerns, loss of speech, difficulty swallowing, nutritional issues, and respiratory problems that affect their quality of life and ability to function on a day-to-day basis.^3,4In addition, patients with HNC and their families are challenged to navigate the health care system and to overcome the difficulties of accessing services within the context of financial constraints. A multidisciplinary team (MDT) approach is the standard of care for HNC patients, as demonstrated in studies reporting better 5-year survival outcomes, increased completion of adjuvant therapy, and higher compliance with speech-language pathologist (SLP) recommendations.^{5, 6} Furthermore, a recent systematic review of cancer teams concluded that the MDT approach leads to improved clinical outcomes and enhanced communication between the patient and the team.⁷

The Institute of Medicine (IOM) stated in its 2013 report on cancer care that a high-quality care delivery system requires continuing measurement of cancer care and strategies to carry out performance improvement.⁸ Following the IOM premise, the cancer center at an academic medical center in Philadelphia made efforts to improve patient access to multidisciplinary services, first, by creating a multidisciplinary Cancer Appetite and Rehabilitation (CARE)clinic to address the symptoms and nutritional needs of HNC patients,⁹ and second, by using a gap analysis to conduct an assessment of the cancer care services provided to this cancer population. The need to conduct this assessment was generated by the desire to improve access to multidisciplinary care, with the goal of meeting standard benchmarks for completion of treatment while increasing the use of ancillary services. This article describes the process of conducting a gap analysis of cancer services for HNC patients, and includes discussion of the findings, recommendations for improving care, a description of the quality improvement interventions, and a report of the outcomes based on an interval re-assessment 18 months later.

Methods

Methods included a gap analysis, implementation of quality improvement recommendations, and re-assessment of indicators (Figure). A gap analysis “identifies differences between desired and actual practice conditions, including service delivery and quality patient outcomes as measured against evidence-based benchmarks while incorporating key stakeholder concerns and expectations.”¹⁰ The gap analysis of cancer care services offered to HNC patients was achieved through the step-by-step process described hereinafter. The implementation of quality improvement recommendations was accomplished by establishing two task force committees focused respectively on education and transitions in care coordination. Re-assessment of indicators related to timeliness of delivery of cancer treatments and collection of additional baseline data regarding supportive services.

Gap analysis

Identification of the scope of the problem. Members of the HNC multidisciplinary team raised concerns about unintended breaches in care for HNC patients that resulted not only in delay of the patients’ cancer treatments, but also in unnecessary distress for the patients and their families. As a result, the HNC team decided to conduct a gap analysis to identify the barriers in care for HNC patients, and by doing this, to determine possible solutions.

Identification of best practice care indicators. The indicators of best practice care (benchmarks) for HNC patients were identified after exhaustive review of the literature^11-22(Table 1). For this gap analysis, the indicators focused on waiting time to treatment (surgery, chemotherapy, radiation therapy) and to supportive care interventions (nutrition, speech and language pathology) as follows:

• 9.2Futura StdInitial ear-nose-throat (ENT) visit to surgery: <30 days
• Biopsy to start radiation therapy (RT) for nonsurgical patients: 40 days
• Surgery to RT start: 42 days
• Surgery to nutrition consultation (outpatient), start RT to nutrition: Pretreatment
• Surgery to outpatient SLP, initial ENT visit to SLP referral, surgery to SLP referral, RT start to outpatient SLP start: Pretreatment

Measure gaps against benchmarks. To Gap analysis of measure gaps against benchmarks, the authors used the Agency for Health Care Research and Quality tool that provides a systematic method to compare current practice with best practices and determine the barriers to best practice and the feasibility of implementing best practices by the institution²³ (Table 1). For this project, a process map of waiting time to treatment and supportive care interventions was created, so that real-world conditions could be measured against benchmarks.

Process map. The authors identified 67 newly diagnosed HNC patients during January-July 2014 from the surgery, radiation therapy, and nutrition departments, but only 33 patients were able to be tracked from their initial visit at the cancer center until the completion of their treatment through the electronic medical record (EMR) system. Their information was compiled in a spreadsheet based on the EMR information. Data included patient access to supportive services and number of days between important treatment benchmarks. Tracking data was used to create a treatment flow chart and determine average treatment intervals.

To map the typical patient process, the patients were split into two groups: surgical (n = 22) and nonsurgical (n = 11). Surgical patients underwent surgery as their primary treatment and received adjuvant radiation therapy or concurrent chemotherapy. Nonsurgical patients did not require surgery other than biopsy as a part of their treatment. Most of the nonsurgical patients received chemotherapy, and 1 patient received palliative radiation therapy.

SWOT analysis. The SWOT analysis is used to chart institution performance in relation to benchmarks while describing stakeholders’ perceptions.²⁴The stakeholder perspective for this project focused on the views of the health care providers from all disciplines regarding the quality of care provided to the HNC population. In addition, a patient survey was conducted to assess their perception of the care they received.

Clinician survey. We surveyed 25 clinicians, including physicians, advanced practice providers, nurses, and allied health professionals, from the surgical (n = 3), hospitalization (n = 6), radiation (n = 3), chemotherapy (n = 3) and supportive services teams (n = 10). The survey was conducted face to face and included 7 open-ended questions designed to gain insight about problems encountered with coordination of care, suggestions to improve coordination of care, factors in treatment delays, suggestions to decrease treatment delays, factors in excellent patient outcomes, rate overall patient care, and suggestions for improvement of service. Initial survey responses were filtered by recurring themes in each question among the different patient service teams.

Patient satisfaction survey. The sample of patients was obtained from the surgery, radiation therapy, and nutrition departments during January-July 2014. Sixty-seven initial patients were identified but only 43 were eligible for interview because they had a listed phone number. A six-question nonvalidated survey was developed by the authors to measure patient satisfaction with the scheduling process, waiting time, information provided about treatment and their medical status, emotional support, the coordination of care, and the payment process. Satisfaction was rated on a scale from 1 to 5 (1 = Poor, 2 = Fair, 3 = Satisfactory, 5 = Great).

Analysis and final report. See Results section.

Quality improvement implementation. The transitions and the education committees were created to address the gaps identified during the analysis. The transitions committee developed strategies to improve the coordination of care of HNC patients throughout their cancer treatment and the education committee elaborated new ways to enhance patient education while meeting treatment timeline standards. The implementation of the interventions was developed by the inpatient and outpatient MTD teams caring for the HNC population.

Re-assessment of indicators. During January-December 2015, a total of 58 patients diagnosed with HNC were identified. Of those, 40 patients with recurrent disease were eliminated, leaving 18 patients (10 surgical, 8 nonsurgical). Similar to the initial assessment for the gap analysis, data included patient access to supportive services and number of days between important treatment benchmarks. Tracking data was used to create a treatment flow chart and determine average treatment intervals.

Results

Most of the patients were men (70%), white (70%), and 60% were within the 50-69 years age range at the time of diagnosis.

Clinician survey

The clinicians were surveyed and their responses analyzed by two people, the project leader and the project assistant. The most commonly identified weaknesses in care that the clinicians identified were delayed access to dental referrals, insufficient preoperative patient education, and inefficient discharge planning and/or home care coordination. Dental referrals were identified as a major cause of delay in starting radiation therapy because of scheduling issues, a lack of patient motivation, limited insurance coverage, and difficulty identifying reliable dentists in the patient’s geographic area. Clinicians also identified problems coordinating smoking cessation referrals for patients.

In addition, they identified the hospitalization and/or home care phases as areas for potential improvement. During hospitalization, patients often expressed surprise upon learning that they had a feeding tube and/or tracheostomy despite having received pre-operative education. This misunderstanding by the patient was likely related to the clinicians’ assumptions about the best timing for patient education and the amount of time needed for education before the surgical procedure. The surgical team provided patient education based on individual needs, and it has not been standardized because they felt that patients’ education needs vary from person to person. In contrast, patient education prior radiation therapy is standardized, and all patients received a comprehensive package of information that is re-enforced by direct patient education by the clinicians.

Another gap in care identified by the inpatient team was a prolonged intensive care unit (ICU) stay for the HNC patients. These patients remained in the ICU for the entirety of their stay. Not only was this causing overuse of resources, but patients also felt unprepared for an independent discharge home given the high level of care received in the ICU.

A range of suggestions were made to solve these problems. The most prevalent suggestion was to use a nurse navigator to coordinate referrals, schedule appointments, facilitate interdisciplinary communication, and to address social, financial, and transport needs for HNC patients. Several other suggestions referred to standardizing treatment procedures and pre-operative patient education.

Patient survey

Forty-three patients were identified for the patient satisfaction survey. Each patient was contacted at least three times over the course of 3 weeks. Of the 43 patients, 20 had an invalid phone number, 10 were not available for participation, and 1 declined to participate. A total of 12 patients completed the survey.

Although the sample size was small, the patients surveyed were very satisfied with their care. Of the 12 patients, 5 patients rated all of the services relevant to their treatment as a 5 (Great). Areas of particular concern for the patients included the waiting time to see a physician in the ENT clinic, the explanation/collection of charges, and the accessibility of support groups. Services rated 3 (Satisfactory) included waiting time to schedule appointments; the amount of information and patient education provided by about radiation, nutrition, physical therapy (PT), occupational therapy (OT), and SLP; and overall satisfaction with care.

Surgical patients. The Danish Head and Neck Society guidelines state that the interval between the initial visit diagnosis and surgery should be within 30 days.¹²A comparison of the average intervals between important treatment points for the surgical sample patients with the benchmark timing recommended in the literature are shown in Table 2. The mean time from initial visit to surgery was 28 days in the cancer center sample; 67% of patients (n = 14) had surgery within 30 days, and 33% of patients (n = 7) had surgery beyond 30 days. The interval re-assessment showed improvements in this area: the mean time from initial visit to surgery went from 28 to 18 days, and 100% of patients
n = 10) had surgery within 30 days.

Huang and colleagues have indicated that postoperative radiation therapy should ideally occur within 42 days of surgery;¹³ however, in the present study, 79% (n = 11) of the sample surgical patients undergoing radiation began their therapy on average more than 63 days after surgery. The interval re-assessment found the same results with 80% of patients starting radiation over 42 days after surgery although the average time lag decreased from 68 days to 53 days.

Nonsurgical patients. Huang and colleagues have indicated that for patients undergoing radiation as their primary form of treatment, an interval of 40 days between biopsy and the start of radiation is ideal.¹³ The average intervals between important time points of treatment for patients who did not require surgery in their treatment are shown in Table 2. The cancer center met the benchmark at baseline with an average of 38 days (n = 11 patients). The re-assessment showed improvement in this area with 100% of cases (n = 10) meeting the benchmark with an average of 32 days. Likewise, the benchmark waiting time from RT consultation to RT start of less than 30 days¹¹ was met by the cancer center for the nonsurgical group (n = 11).

Access to supportive services

Nutrition care. Studies have shown that standard nutritional care for HNC patients should start before treatment.^18,19 In the present study, the waiting time from surgery to outpatient nutrition assessment improved from 61 days to 50 days (Table 2). For patients in the surgical group, the time interval between the initial ENT visit to the outpatient nutrition assessment decreased from 85 days at baseline to 66 days at reassessment, and 82 days to 35 days, respectively, for the nonsurgical group. The time interval from surgery to nutrition assessment has not reached the recommended pretreatment benchmark, but data showed a trend of improvement from 61 days at baseline to 50 days at reassessment for patients in the group.

Patients were typically referred to outpatient nutrition at the start of radiation therapy. In the initial assessment, all patients (n = 33) had access to nutrition services, but 21% (n = 7) never spoke to the nutritionist. The re-assessment found all but one (n = 7) of the patients had been seen by a nutritionist at some point during the treatment period. The benchmark of preradiation nutrition assessment was met by 2 postsurgical patients, with the remainder of the patients being seen within 3 days of the initiation of radiation.

Speech-language pathology management. The literature recommends that patients receive SLP management before the surgery.^14-17 In this gap analysis, a difference in access to SLP services was identified between inpatient and outpatient settings. On average, patients within the sample were referred to outpatient SLP over a month after their surgery. In contrast, inpatient surgical patients had access to rapid consultations with SLP (eg, 1 day after surgery for total laryngectomy, and 4 days after surgery for oropharyngeal and oral surgery patients; T Hogan, unpublished data, June 2014). Overall, the benchmark was not met, as patients were not seen by the SPL prior to treatment.

New baseline data was collected about SLP services and showed that 70% of patients had contact with the outpatient SLP at some point during their treatment. Of those, only 29% of patients saw SLP before surgery, meeting the benchmark. The baseline waiting time was an average of 15 days before surgery and 43 days after surgery. Overall, the trend is moving toward the benchmark of care.

Similarly, studies determined that the gold standard of care for nonsurgical patients is that SLPs begin pretreatment management of HNC.¹⁶Patients in the baseline sample were typically referred to outpatient SLP about a month after biopsy (presumably diagnosis), but before the start of chemo-radiation. There were no data available for the number of patients who were actually seen by the outpatient SLP before the start of chemo-radiation.

The new baseline data found that 100% of nonsurgical patients were referred to SLP, but only25% (n = 2) were seen before they started chemo-radiation therapy (an average 5 days before) and 75% (n = 6) were seen after starting chemo-radiation therapy (an average 23 days after).

SWOT analysis

The SWOT analysis included strengths, weaknesses, opportunities and threats of the care provided to HNC patients at the cancer center. The gap analysis based on the results of the clinician surveys, process mapping, and patient satisfaction survey is summarized in Table 3. Three main gaps were identified: waiting time to treatment, education, and coordination of and transitions in care.

Quality improvement actions

Interventions by the outpatient MTD team included changing the process of scheduling dental appointments, creating a new approach to outpatient nutrition by proactively meeting patients in the ENT clinic, and conducting PT and SLP assessments to patients in the chemotherapy unit while receiving their treatment. A nurse navigator position for this patient population was approved and an expedited referral system was initiated. At the same time, the inpatient team implemented a specialized HNC unit in the medical-surgical floor, developed the protocols for the management of postsurgery HNC patients, educated nursing staff, and standardized patient education to facilitate transition to the next level of care (Table 3).

Discussion

The gap analysis of services provided to HNC patients at the cancer center identified three gaps in care: delay in treatment and supportive services, nonstandardized patient education, and lack of care coordination.

All patients should have access to a timely treatment initiation. In this analysis, surgical patients encountered a delay between surgery and the start of radiation therapy, about 3 weeks beyond the recommended in the literature.¹² Clinicians mentioned delays in ensuring preradiation dental consultations as a significant issue affecting the patient treatment process. Re-assessment data reported that despite interventions for early dental referrals, 80% of patients still started radiation over 6 weeks after surgery; however, the average time lag decreased from 68 days to 53 days.

RT delays in HNC patients not only affect patients’ emotional state but may also impact clinical outcomes. Treatment delays have the potential to harm patients by: allowing tumor growth that impact on the curative outcomes of RT; postponing the benefits of palliative RT on symptom relief; and causing psychological distress.²⁵ In addition, delay in starting treatment has shown to increase the risk for local recurrence,^13,26 and decrease survival.²⁷

Higher demand for advanced RT modalities has been linked to treatment delays. Waiting times from initial RT evaluation to start RT have increased over time, from <14 days in 1989 to 31 days in 1997.¹¹ This is explained by the complexity of the pretreatment evaluations and the increasing demand of radiation services, especially in high volume institutions.^25,27A fast-track program to reduce waiting time in the treatment of HNC patients reported to be effective.²² This program includes a patient coordinator, a hotline for referral procedures, prebooked slots for ENT and RT clinics, faster pathology and imaging reports, and the establishment of an MTD team.

The clinician survey identified patient needs classified in three categories: pre-operative education, hospitalization process, and access to support services. Regarding pre-operative education, clinicians acknowledged that although patients were educated about their surgical options and possible outcomes prior to hospitalization, they often could not fully understand this information at the time of the instruction. The high need for education particularly in the pretreatment phase was documented in a needs assessment survey for HNC patients conducted at the cancer center D DeMille, RD, unpublished data, August 2013).

Studies have looked at the effectiveness of education in cancer patients. The use of teaching interventions (written information, audiotapes, videotapes, and computer programs) has proven to be valuable for educating patients prior to experiencing cancer treatments.²⁰Further, a systematic review of preparatory education for cancer patients undergoing surgery reported that face-to-face discussions appear to be effective at improving patient outcomes with regards to increasing knowledge and decreasing anxiety.²¹ However, it was stated that the timing of the delivery of education is critical to be efficient. For example, an education session provided one day prior the day of surgery is not useful as it may place additional stress on a patient who is already highly anxious and decreases the likelihood for the information to be managed. It is recommended to deliver education early enough prior surgery to allow time for the patient to process the information. Also, a study reported that presurgical education on potential side effects; the assessment of patients’ needs by an SLP, physical therapist, nutritionist, and social worker; and pre-operative nutritional support decrease postoperative complications.⁴

The education committee was created in response to the gap on patient education. The inpatient team took the lead and provided intense education on the care of HNC patients to the nursing staff and to HNC patients and their families about postoperative care at home. Education was also extended to rehabilitation facilities caring for this cancer population at discharge from the hospital.

Clinicians identified a gap during the hospitalization process. The gap included prolonged stay of patients in the ICU postsurgery, inefficient interclinician communication, lack of standardization of postsurgical care, and difficulty communicating with external home care teams. A major intervention was implemented that included the creation of a HNC specialized unit that offered a structured setting for standardized care and communication between patients and clinicians. Dedicated units for the management of HNC patients highly enhance the quality of care provided because it enables the MTD team to work properly by clearly defining roles and responsibilities, delineating evidence-based clinical interventions, and promoting expert care for this patient population.²³In addition, several key steps have been recommended to reduce the fragmentation of care for hospital patients, including developing a referral/transition tracking system, organizing and training staff members to coordinate transition/referrals, and identifying and creating agreements with key care providers.²⁸

Early patient access to supportive services was a concern to most clinicians. HNC providers were not consulting the CARE clinic about patients’ nutritional, physical and SLP needs until the patient was having serious problems. Patient tracking found that the minority of patients met the standard of having a presurgical speech referral. Most patients had access to outpatient nutrition services during radiation therapy but the majority of patients in the sample did not attend CARE clinic. The literature strongly supports early management of HNC patients by the SPL and nutrition counselor. Van der Molen and colleagues demonstrated that a pretreatment SPL rehabilitation program is feasible and offers reasonable patient compliance despite of the burden caused by ongoing chemo-radiation therapy for HNC patients.¹⁶Similarly, early nutrition counseling for HNC patients undergoing RT has reported to decrease unintended weight loss and malnutrition compared with late nutrition intervention.¹⁹

Although there are clear gaps in care for HNC patients from the clinicians’ perspective, the patients surveyed indicated a clear satisfaction with their care at the cancer center. Almost all patients were satisfied with their relationships with clinicians in the team. Some patients mentioned complaints of insufficient pre-operative education and waiting time, but there were not significant complaints about coordination, which clinicians had identified as a major issue. This is likely explained by the small sample size and the patients’ inability to see the background interclinician communication.

A crucial suggestion to address all of these gaps in care was the implementation of a nurse navigator. With the support of hospital and cancer center administration, a nurse navigator was hired to address the needs of HNC patients throughout their disease trajectory. The team agreed that the nurse navigator should make contact with HNC patients during their initial appointment at the surgical ENT office. This initial contact allows the nurse navigator to provide support and connection to resources. Thereafter, early contact with this patient population allows the nurse navigator to follow the patient through the continuum of care from biopsy and diagnosis to survivorship. The nurse navigator facilitates communication between clinicians, patients and their families; and provides emotional support to patients while helping to manage their financial and transportation needs.²⁹

Limitations

This is a quality improvement project with a small sample size of HNC cases. Data from this gap analysis are not statistically significant; yet, are clinically relevant in the management of the HNC population at the cancer center. Likewise, the patient sample size was small, making definitive generalizations about patient experience difficult; however, the data are helpful in highlighting possible problems for patients.

In the United States, there will be an estimated 49,670 new cases of head and neck cancer for 2017.¹ Head and neck cancer (HNC) is a term used to describe a range of tumors that originate in the area of the body spanning from the lower neck to the upper nasal cavity.² Specifically, they are malignancies arising in the mouth, larynx, nasal cavity, sinuses, tongue, lips, and numerous glands such as the thyroid and salivary.² To clarify, HNC, despite the encompassing name, does not include growths of the bones, teeth, skin, brain parenchyma, and eye; therefore, such tumors will not be addressed in this article.

Patients with HNC often experience fragmented and uncoordinated care that leads to delays in cancer treatment, severe distress in patients and families, and dissatisfaction with care. Literature reports that these patients face numerous stressors including aggressive cancer treatments, severe symptoms, body image concerns, loss of speech, difficulty swallowing, nutritional issues, and respiratory problems that affect their quality of life and ability to function on a day-to-day basis.^3,4In addition, patients with HNC and their families are challenged to navigate the health care system and to overcome the difficulties of accessing services within the context of financial constraints. A multidisciplinary team (MDT) approach is the standard of care for HNC patients, as demonstrated in studies reporting better 5-year survival outcomes, increased completion of adjuvant therapy, and higher compliance with speech-language pathologist (SLP) recommendations.^{5, 6} Furthermore, a recent systematic review of cancer teams concluded that the MDT approach leads to improved clinical outcomes and enhanced communication between the patient and the team.⁷

The Institute of Medicine (IOM) stated in its 2013 report on cancer care that a high-quality care delivery system requires continuing measurement of cancer care and strategies to carry out performance improvement.⁸ Following the IOM premise, the cancer center at an academic medical center in Philadelphia made efforts to improve patient access to multidisciplinary services, first, by creating a multidisciplinary Cancer Appetite and Rehabilitation (CARE)clinic to address the symptoms and nutritional needs of HNC patients,⁹ and second, by using a gap analysis to conduct an assessment of the cancer care services provided to this cancer population. The need to conduct this assessment was generated by the desire to improve access to multidisciplinary care, with the goal of meeting standard benchmarks for completion of treatment while increasing the use of ancillary services. This article describes the process of conducting a gap analysis of cancer services for HNC patients, and includes discussion of the findings, recommendations for improving care, a description of the quality improvement interventions, and a report of the outcomes based on an interval re-assessment 18 months later.

Methods

Methods included a gap analysis, implementation of quality improvement recommendations, and re-assessment of indicators (Figure). A gap analysis “identifies differences between desired and actual practice conditions, including service delivery and quality patient outcomes as measured against evidence-based benchmarks while incorporating key stakeholder concerns and expectations.”¹⁰ The gap analysis of cancer care services offered to HNC patients was achieved through the step-by-step process described hereinafter. The implementation of quality improvement recommendations was accomplished by establishing two task force committees focused respectively on education and transitions in care coordination. Re-assessment of indicators related to timeliness of delivery of cancer treatments and collection of additional baseline data regarding supportive services.

Gap analysis

Identification of the scope of the problem. Members of the HNC multidisciplinary team raised concerns about unintended breaches in care for HNC patients that resulted not only in delay of the patients’ cancer treatments, but also in unnecessary distress for the patients and their families. As a result, the HNC team decided to conduct a gap analysis to identify the barriers in care for HNC patients, and by doing this, to determine possible solutions.

Identification of best practice care indicators. The indicators of best practice care (benchmarks) for HNC patients were identified after exhaustive review of the literature^11-22(Table 1). For this gap analysis, the indicators focused on waiting time to treatment (surgery, chemotherapy, radiation therapy) and to supportive care interventions (nutrition, speech and language pathology) as follows:

• 9.2Futura StdInitial ear-nose-throat (ENT) visit to surgery: <30 days
• Biopsy to start radiation therapy (RT) for nonsurgical patients: 40 days
• Surgery to RT start: 42 days
• Surgery to nutrition consultation (outpatient), start RT to nutrition: Pretreatment
• Surgery to outpatient SLP, initial ENT visit to SLP referral, surgery to SLP referral, RT start to outpatient SLP start: Pretreatment

Measure gaps against benchmarks. To Gap analysis of measure gaps against benchmarks, the authors used the Agency for Health Care Research and Quality tool that provides a systematic method to compare current practice with best practices and determine the barriers to best practice and the feasibility of implementing best practices by the institution²³ (Table 1). For this project, a process map of waiting time to treatment and supportive care interventions was created, so that real-world conditions could be measured against benchmarks.

Process map. The authors identified 67 newly diagnosed HNC patients during January-July 2014 from the surgery, radiation therapy, and nutrition departments, but only 33 patients were able to be tracked from their initial visit at the cancer center until the completion of their treatment through the electronic medical record (EMR) system. Their information was compiled in a spreadsheet based on the EMR information. Data included patient access to supportive services and number of days between important treatment benchmarks. Tracking data was used to create a treatment flow chart and determine average treatment intervals.

To map the typical patient process, the patients were split into two groups: surgical (n = 22) and nonsurgical (n = 11). Surgical patients underwent surgery as their primary treatment and received adjuvant radiation therapy or concurrent chemotherapy. Nonsurgical patients did not require surgery other than biopsy as a part of their treatment. Most of the nonsurgical patients received chemotherapy, and 1 patient received palliative radiation therapy.

SWOT analysis. The SWOT analysis is used to chart institution performance in relation to benchmarks while describing stakeholders’ perceptions.²⁴The stakeholder perspective for this project focused on the views of the health care providers from all disciplines regarding the quality of care provided to the HNC population. In addition, a patient survey was conducted to assess their perception of the care they received.

Clinician survey. We surveyed 25 clinicians, including physicians, advanced practice providers, nurses, and allied health professionals, from the surgical (n = 3), hospitalization (n = 6), radiation (n = 3), chemotherapy (n = 3) and supportive services teams (n = 10). The survey was conducted face to face and included 7 open-ended questions designed to gain insight about problems encountered with coordination of care, suggestions to improve coordination of care, factors in treatment delays, suggestions to decrease treatment delays, factors in excellent patient outcomes, rate overall patient care, and suggestions for improvement of service. Initial survey responses were filtered by recurring themes in each question among the different patient service teams.

Patient satisfaction survey. The sample of patients was obtained from the surgery, radiation therapy, and nutrition departments during January-July 2014. Sixty-seven initial patients were identified but only 43 were eligible for interview because they had a listed phone number. A six-question nonvalidated survey was developed by the authors to measure patient satisfaction with the scheduling process, waiting time, information provided about treatment and their medical status, emotional support, the coordination of care, and the payment process. Satisfaction was rated on a scale from 1 to 5 (1 = Poor, 2 = Fair, 3 = Satisfactory, 5 = Great).

Analysis and final report. See Results section.

Quality improvement implementation. The transitions and the education committees were created to address the gaps identified during the analysis. The transitions committee developed strategies to improve the coordination of care of HNC patients throughout their cancer treatment and the education committee elaborated new ways to enhance patient education while meeting treatment timeline standards. The implementation of the interventions was developed by the inpatient and outpatient MTD teams caring for the HNC population.

Re-assessment of indicators. During January-December 2015, a total of 58 patients diagnosed with HNC were identified. Of those, 40 patients with recurrent disease were eliminated, leaving 18 patients (10 surgical, 8 nonsurgical). Similar to the initial assessment for the gap analysis, data included patient access to supportive services and number of days between important treatment benchmarks. Tracking data was used to create a treatment flow chart and determine average treatment intervals.

Results

Most of the patients were men (70%), white (70%), and 60% were within the 50-69 years age range at the time of diagnosis.

Clinician survey

The clinicians were surveyed and their responses analyzed by two people, the project leader and the project assistant. The most commonly identified weaknesses in care that the clinicians identified were delayed access to dental referrals, insufficient preoperative patient education, and inefficient discharge planning and/or home care coordination. Dental referrals were identified as a major cause of delay in starting radiation therapy because of scheduling issues, a lack of patient motivation, limited insurance coverage, and difficulty identifying reliable dentists in the patient’s geographic area. Clinicians also identified problems coordinating smoking cessation referrals for patients.

In addition, they identified the hospitalization and/or home care phases as areas for potential improvement. During hospitalization, patients often expressed surprise upon learning that they had a feeding tube and/or tracheostomy despite having received pre-operative education. This misunderstanding by the patient was likely related to the clinicians’ assumptions about the best timing for patient education and the amount of time needed for education before the surgical procedure. The surgical team provided patient education based on individual needs, and it has not been standardized because they felt that patients’ education needs vary from person to person. In contrast, patient education prior radiation therapy is standardized, and all patients received a comprehensive package of information that is re-enforced by direct patient education by the clinicians.

Another gap in care identified by the inpatient team was a prolonged intensive care unit (ICU) stay for the HNC patients. These patients remained in the ICU for the entirety of their stay. Not only was this causing overuse of resources, but patients also felt unprepared for an independent discharge home given the high level of care received in the ICU.

A range of suggestions were made to solve these problems. The most prevalent suggestion was to use a nurse navigator to coordinate referrals, schedule appointments, facilitate interdisciplinary communication, and to address social, financial, and transport needs for HNC patients. Several other suggestions referred to standardizing treatment procedures and pre-operative patient education.

Patient survey

Forty-three patients were identified for the patient satisfaction survey. Each patient was contacted at least three times over the course of 3 weeks. Of the 43 patients, 20 had an invalid phone number, 10 were not available for participation, and 1 declined to participate. A total of 12 patients completed the survey.

Although the sample size was small, the patients surveyed were very satisfied with their care. Of the 12 patients, 5 patients rated all of the services relevant to their treatment as a 5 (Great). Areas of particular concern for the patients included the waiting time to see a physician in the ENT clinic, the explanation/collection of charges, and the accessibility of support groups. Services rated 3 (Satisfactory) included waiting time to schedule appointments; the amount of information and patient education provided by about radiation, nutrition, physical therapy (PT), occupational therapy (OT), and SLP; and overall satisfaction with care.

Surgical patients. The Danish Head and Neck Society guidelines state that the interval between the initial visit diagnosis and surgery should be within 30 days.¹²A comparison of the average intervals between important treatment points for the surgical sample patients with the benchmark timing recommended in the literature are shown in Table 2. The mean time from initial visit to surgery was 28 days in the cancer center sample; 67% of patients (n = 14) had surgery within 30 days, and 33% of patients (n = 7) had surgery beyond 30 days. The interval re-assessment showed improvements in this area: the mean time from initial visit to surgery went from 28 to 18 days, and 100% of patients
n = 10) had surgery within 30 days.

Huang and colleagues have indicated that postoperative radiation therapy should ideally occur within 42 days of surgery;¹³ however, in the present study, 79% (n = 11) of the sample surgical patients undergoing radiation began their therapy on average more than 63 days after surgery. The interval re-assessment found the same results with 80% of patients starting radiation over 42 days after surgery although the average time lag decreased from 68 days to 53 days.

Nonsurgical patients. Huang and colleagues have indicated that for patients undergoing radiation as their primary form of treatment, an interval of 40 days between biopsy and the start of radiation is ideal.¹³ The average intervals between important time points of treatment for patients who did not require surgery in their treatment are shown in Table 2. The cancer center met the benchmark at baseline with an average of 38 days (n = 11 patients). The re-assessment showed improvement in this area with 100% of cases (n = 10) meeting the benchmark with an average of 32 days. Likewise, the benchmark waiting time from RT consultation to RT start of less than 30 days¹¹ was met by the cancer center for the nonsurgical group (n = 11).

Access to supportive services

Nutrition care. Studies have shown that standard nutritional care for HNC patients should start before treatment.^18,19 In the present study, the waiting time from surgery to outpatient nutrition assessment improved from 61 days to 50 days (Table 2). For patients in the surgical group, the time interval between the initial ENT visit to the outpatient nutrition assessment decreased from 85 days at baseline to 66 days at reassessment, and 82 days to 35 days, respectively, for the nonsurgical group. The time interval from surgery to nutrition assessment has not reached the recommended pretreatment benchmark, but data showed a trend of improvement from 61 days at baseline to 50 days at reassessment for patients in the group.

Patients were typically referred to outpatient nutrition at the start of radiation therapy. In the initial assessment, all patients (n = 33) had access to nutrition services, but 21% (n = 7) never spoke to the nutritionist. The re-assessment found all but one (n = 7) of the patients had been seen by a nutritionist at some point during the treatment period. The benchmark of preradiation nutrition assessment was met by 2 postsurgical patients, with the remainder of the patients being seen within 3 days of the initiation of radiation.

Speech-language pathology management. The literature recommends that patients receive SLP management before the surgery.^14-17 In this gap analysis, a difference in access to SLP services was identified between inpatient and outpatient settings. On average, patients within the sample were referred to outpatient SLP over a month after their surgery. In contrast, inpatient surgical patients had access to rapid consultations with SLP (eg, 1 day after surgery for total laryngectomy, and 4 days after surgery for oropharyngeal and oral surgery patients; T Hogan, unpublished data, June 2014). Overall, the benchmark was not met, as patients were not seen by the SPL prior to treatment.

New baseline data was collected about SLP services and showed that 70% of patients had contact with the outpatient SLP at some point during their treatment. Of those, only 29% of patients saw SLP before surgery, meeting the benchmark. The baseline waiting time was an average of 15 days before surgery and 43 days after surgery. Overall, the trend is moving toward the benchmark of care.

Similarly, studies determined that the gold standard of care for nonsurgical patients is that SLPs begin pretreatment management of HNC.¹⁶Patients in the baseline sample were typically referred to outpatient SLP about a month after biopsy (presumably diagnosis), but before the start of chemo-radiation. There were no data available for the number of patients who were actually seen by the outpatient SLP before the start of chemo-radiation.

The new baseline data found that 100% of nonsurgical patients were referred to SLP, but only25% (n = 2) were seen before they started chemo-radiation therapy (an average 5 days before) and 75% (n = 6) were seen after starting chemo-radiation therapy (an average 23 days after).

SWOT analysis

The SWOT analysis included strengths, weaknesses, opportunities and threats of the care provided to HNC patients at the cancer center. The gap analysis based on the results of the clinician surveys, process mapping, and patient satisfaction survey is summarized in Table 3. Three main gaps were identified: waiting time to treatment, education, and coordination of and transitions in care.

Quality improvement actions

Interventions by the outpatient MTD team included changing the process of scheduling dental appointments, creating a new approach to outpatient nutrition by proactively meeting patients in the ENT clinic, and conducting PT and SLP assessments to patients in the chemotherapy unit while receiving their treatment. A nurse navigator position for this patient population was approved and an expedited referral system was initiated. At the same time, the inpatient team implemented a specialized HNC unit in the medical-surgical floor, developed the protocols for the management of postsurgery HNC patients, educated nursing staff, and standardized patient education to facilitate transition to the next level of care (Table 3).

Discussion

The gap analysis of services provided to HNC patients at the cancer center identified three gaps in care: delay in treatment and supportive services, nonstandardized patient education, and lack of care coordination.

All patients should have access to a timely treatment initiation. In this analysis, surgical patients encountered a delay between surgery and the start of radiation therapy, about 3 weeks beyond the recommended in the literature.¹² Clinicians mentioned delays in ensuring preradiation dental consultations as a significant issue affecting the patient treatment process. Re-assessment data reported that despite interventions for early dental referrals, 80% of patients still started radiation over 6 weeks after surgery; however, the average time lag decreased from 68 days to 53 days.

RT delays in HNC patients not only affect patients’ emotional state but may also impact clinical outcomes. Treatment delays have the potential to harm patients by: allowing tumor growth that impact on the curative outcomes of RT; postponing the benefits of palliative RT on symptom relief; and causing psychological distress.²⁵ In addition, delay in starting treatment has shown to increase the risk for local recurrence,^13,26 and decrease survival.²⁷

Higher demand for advanced RT modalities has been linked to treatment delays. Waiting times from initial RT evaluation to start RT have increased over time, from <14 days in 1989 to 31 days in 1997.¹¹ This is explained by the complexity of the pretreatment evaluations and the increasing demand of radiation services, especially in high volume institutions.^25,27A fast-track program to reduce waiting time in the treatment of HNC patients reported to be effective.²² This program includes a patient coordinator, a hotline for referral procedures, prebooked slots for ENT and RT clinics, faster pathology and imaging reports, and the establishment of an MTD team.

The clinician survey identified patient needs classified in three categories: pre-operative education, hospitalization process, and access to support services. Regarding pre-operative education, clinicians acknowledged that although patients were educated about their surgical options and possible outcomes prior to hospitalization, they often could not fully understand this information at the time of the instruction. The high need for education particularly in the pretreatment phase was documented in a needs assessment survey for HNC patients conducted at the cancer center D DeMille, RD, unpublished data, August 2013).

Studies have looked at the effectiveness of education in cancer patients. The use of teaching interventions (written information, audiotapes, videotapes, and computer programs) has proven to be valuable for educating patients prior to experiencing cancer treatments.²⁰Further, a systematic review of preparatory education for cancer patients undergoing surgery reported that face-to-face discussions appear to be effective at improving patient outcomes with regards to increasing knowledge and decreasing anxiety.²¹ However, it was stated that the timing of the delivery of education is critical to be efficient. For example, an education session provided one day prior the day of surgery is not useful as it may place additional stress on a patient who is already highly anxious and decreases the likelihood for the information to be managed. It is recommended to deliver education early enough prior surgery to allow time for the patient to process the information. Also, a study reported that presurgical education on potential side effects; the assessment of patients’ needs by an SLP, physical therapist, nutritionist, and social worker; and pre-operative nutritional support decrease postoperative complications.⁴

The education committee was created in response to the gap on patient education. The inpatient team took the lead and provided intense education on the care of HNC patients to the nursing staff and to HNC patients and their families about postoperative care at home. Education was also extended to rehabilitation facilities caring for this cancer population at discharge from the hospital.

Clinicians identified a gap during the hospitalization process. The gap included prolonged stay of patients in the ICU postsurgery, inefficient interclinician communication, lack of standardization of postsurgical care, and difficulty communicating with external home care teams. A major intervention was implemented that included the creation of a HNC specialized unit that offered a structured setting for standardized care and communication between patients and clinicians. Dedicated units for the management of HNC patients highly enhance the quality of care provided because it enables the MTD team to work properly by clearly defining roles and responsibilities, delineating evidence-based clinical interventions, and promoting expert care for this patient population.²³In addition, several key steps have been recommended to reduce the fragmentation of care for hospital patients, including developing a referral/transition tracking system, organizing and training staff members to coordinate transition/referrals, and identifying and creating agreements with key care providers.²⁸

Early patient access to supportive services was a concern to most clinicians. HNC providers were not consulting the CARE clinic about patients’ nutritional, physical and SLP needs until the patient was having serious problems. Patient tracking found that the minority of patients met the standard of having a presurgical speech referral. Most patients had access to outpatient nutrition services during radiation therapy but the majority of patients in the sample did not attend CARE clinic. The literature strongly supports early management of HNC patients by the SPL and nutrition counselor. Van der Molen and colleagues demonstrated that a pretreatment SPL rehabilitation program is feasible and offers reasonable patient compliance despite of the burden caused by ongoing chemo-radiation therapy for HNC patients.¹⁶Similarly, early nutrition counseling for HNC patients undergoing RT has reported to decrease unintended weight loss and malnutrition compared with late nutrition intervention.¹⁹

Although there are clear gaps in care for HNC patients from the clinicians’ perspective, the patients surveyed indicated a clear satisfaction with their care at the cancer center. Almost all patients were satisfied with their relationships with clinicians in the team. Some patients mentioned complaints of insufficient pre-operative education and waiting time, but there were not significant complaints about coordination, which clinicians had identified as a major issue. This is likely explained by the small sample size and the patients’ inability to see the background interclinician communication.

A crucial suggestion to address all of these gaps in care was the implementation of a nurse navigator. With the support of hospital and cancer center administration, a nurse navigator was hired to address the needs of HNC patients throughout their disease trajectory. The team agreed that the nurse navigator should make contact with HNC patients during their initial appointment at the surgical ENT office. This initial contact allows the nurse navigator to provide support and connection to resources. Thereafter, early contact with this patient population allows the nurse navigator to follow the patient through the continuum of care from biopsy and diagnosis to survivorship. The nurse navigator facilitates communication between clinicians, patients and their families; and provides emotional support to patients while helping to manage their financial and transportation needs.²⁹

Limitations

This is a quality improvement project with a small sample size of HNC cases. Data from this gap analysis are not statistically significant; yet, are clinically relevant in the management of the HNC population at the cancer center. Likewise, the patient sample size was small, making definitive generalizations about patient experience difficult; however, the data are helpful in highlighting possible problems for patients.