Pilot Evaluation of a Management Toolkit for Airway Clearance Therapy in Bronchiectasis (IMPACT BE)

Abstract

Background

Airway clearance therapies (ACTs) are recommended as an integral part of the management of non–cystic fibrosis bronchiectasis (BE) to prevent inflammation, mucus accumulation, and infection that occur because of ineffective secretion clearance. Adherence to ACTs is low, in part because of perceived burden and a lack of standardization of education and training programs for patients. Poor adherence is associated with more frequent exacerbations, worse health outcomes, and worse quality of life. Structured educational programs increase adherence to ACT among people with cystic fibrosis and may show similar results for people with BE.

Objective

This pilot study evaluated the feasibility, clinical utility, sustainability, and expert opinions of this educational program addressing gaps in ACT knowledge and skills in people with BE.

Methods

The Individual Management of Patient Airway Clearance Therapy– Bronchiectasis (IMPACT BE) was implemented in nine BE centers with 100 patients. Qualitative and quantitative data were collected from patients and providers.

Results

The IMPACT BE program demonstrated good uptake in a clinic setting by multidisciplinary team members, with improvements in medical teams’ evaluation of their ability to provide education to patients. All healthcare teams indicated that this program could become a sustainable part of their clinic. Qualitative responses from patients indicated the program was comprehensive and easy to use.

Conclusion

In this pilot study, IMPACT BE was found to be useful in teaching airway clearance to people with BE. The open-access toolkit was well received by both patients and a diverse array of providers in a clinic setting.

Non–cystic fibrosis bronchiectasis (BE) is associated with significant healthcare and economic burden, with an estimated prevalence of 350,000 to 500,000 cases in the United States (1–4). There is broad recognition that in many people BE is not adequately diagnosed and treated, and thus the prevalence is likely to be an underestimate (5).

One of the primary causes of morbidity and mortality in individuals with BE is the inability to effectively clear secretions, leading to a cycle of recurrent infection and inflammation, impaired cilia functioning, and a decreased ability to clear infection (6). To combat ineffective secretion clearance, airway clearance therapies (ACTs) are used to help clear secretions that play a key role in this cycle of inflammation, mucus accumulation, and infection (6, 7). ACTs have been associated with lower mortality after hospitalization for severe exacerbations, as well as reduced frequency and severity of subsequent exacerbations (8, 9).

ACT includes positive expiratory pressure devices, postural drainage, chest percussion, exercise programs, directed coughing techniques, and high-frequency chest wall oscillation, among others. These therapies are prescribed as daily treatments for those with chronic productive cough and excess mucus and are important during both stable periods and acute exacerbations (7). A Cochrane Review found ACTs were safe and may account for improvements in lung function, sputum expectoration, and health-related quality of life (10). Recommendations from experts suggest that the choice of ACT be individualized for patients based on disease state, severity, and preference (11–13). However, patients are not often aware of the variety of ACTs that are available, and thus individualization of prescribed therapies is limited.

Although treatment guidelines recommending ACTs for people with BE have been published, adherence to treatment is low, with rates of adherence documented at 30–41% (14, 15). Data from the U.S. Bronchiectasis Research Registry found significant cessation of ACT use 1 year after initiation (16). This lack of adherence has been tied to worse health outcomes, including more frequent exacerbations (14). Note that a recent “roadmap” of patient-centered priorities reported that prevention of exacerbations was at the top of the list (16). Poor adherence has been associated, in part, with the challenges of tailoring ACT to individual patients and a lack of effective patient education and skills training (14, 15, 17). It has also been associated with a lack of clear instructions and training for patients and beliefs that therapy is difficult and may not be effective (17, 18). Lack of time and resources have been identified by providers as key factors affecting their implementation of ACT (19). In a study of people with cystic fibrosis, less than half the participating centers regularly used an effective behavioral intervention to increase adherence (20).

Although suboptimal adherence is multifactorial (21, 22), one proven method of increasing adherence to prescribed therapy is through the use of a structured educational training program (23–26). Although no universally adopted program for ACT in BE exists, this type of education has been shown to improve adherence to ACT in people with cystic fibrosis and may show comparable results for those with BE (27, 28).

Objective

The purpose of this project was to evaluate the benefits of and barriers to implementation of the Individual Management of Patient Airway Clearance Therapy–Bronchiectasis (IMPACT BE) program, which includes a structured assessment, action plan, and series of patient-friendly educational videos and resources.

Methods

This initiative was implemented at nine pulmonary clinics across the United States and the United Kingdom during a 14-week period from September through December of 2019. The coronavirus disease (COVID-19) pandemic and the subsequent effect on the healthcare system in general and pulmonary clinics specifically led to a delay between the conclusion of the program and the submission of this manuscript.

Participating clinics comprised those associated with advisory team members as well as those recommended by members of the panel, with the goal of having a diverse group of clinics with respect to geography and size and both community- and university-based centers. A mix of new and established adult patients with non–cystic fibrosis BE were identified by and recruited into the study by care teams who believed that they could benefit from the IMPACT BE program. Patients who visited the clinic at least once during this 3-month period were eligible for inclusion. The protocol for the pilot study was reviewed by the Oregon Health and Sciences University Institutional Review Board, which deemed it exempt from review. The collection of the patient-requested demographic data is only to validate the representative nature of this sample compared with a typical BE population.

The IMPACT BE Program (https://impact-be.com) was created to address the long-standing gap in education about the various airway clearance options for people with BE. The IMPACT BE toolset (see Figure E1 and Table E1 in the data supplement) was developed by a professional medical education company, SPARK Healthcare, in collaboration with a multidisciplinary group of clinician advisors recruited from BE programs in the United States and United Kingdom, including pulmonary medicine and infectious disease physicians, respiratory therapists, pulmonary nurses, and physiatrists. The types of airway clearance therapies in the toolset were selected by the advisors to represent a comprehensive set of options that could be offered to anyone diagnosed with BE. Although the toolset development was supported by International Biophysics, they were not involved in the creation of the toolset content or in data analysis/interpretation.

IMPACT BE toolsets were available at every site, and clinicians were instructed to implement them during routine clinic visits, per a guided implementation training (Figure E2). Each pilot center team identified a program lead or “champion” who attended a 90-minute training webinar before the implementation of IMPACT BE at their center. The champions were the main point of contact for the pilot, completed the surveys on their center’s behalf, and helped to train team members in the use of this program. No specific instructions were provided on the amount of time providers should spend with the toolset components. Each clinic had the discretion to use the program in the way that best fit their processes/patients. Thus, this was a real-world implementation study.

The uptake of the intervention was assessed through utilization data on each component of the toolset. A tracker was used by care teams to capture the details of each encounter where a patient used at least one component of the toolset. The tracker also captured patient age and sex, as well as the role of the provider who conducted the session. Ethnicity and forced expiratory volume in 1 second were not captured during the pilot program but were added to the data post hoc and included in the analyses for a subset of patients to provide a more complete picture of the patient population included in this study. Quantitative and qualitative program feedback was solicited from both providers and patients at the completion of the study. A care team member on behalf of each center completed pre- and postimplementation surveys on behalf of the team to ascertain the overall impression of the program, perceived barriers to implementation, and recommendations to improve the toolset (Tables E2 and E3). Semistructured one-on-one patient interviews were conducted by one of the authors with seven patients at the end of the pilot program, and a thematic analysis was performed (29).

Results

Demographics of Pilot Patient Participants

The IMPACT BE pilot program was piloted at eight sites in the United States and one in the United Kingdom. A total of 100 individuals were enrolled, with demographic characteristics typical of adult BE clinic populations as described in Table 1. One patient was reportedly invited to participate in the study but declined.

Table 1.

Study sites and patient characteristics

Location of participating BE centers
Total number of centers	9
U.S. based centers	8
UK based centers	1
Number of patients per BE center
Total number of participating patients	100
University of Alabama at Birmingham	5
Mount Sinai Downtown	11
Mount Sinai Uptown	30
Royal Papworth	7
University of North Carolina	11
Santa Barbara Cottage Hospital	9
Cleveland Clinic	9
Cleveland Clinic–Independence Family Health Center	10
National Jewish Health	8
Distribution of IMPACT BE utilization by care team member per encounter
Total number of encounters	124
M.D.	46
R.N.	21
R.T.	18
P.T.	16
N.P./P.A.	15
M.A./C.N.A.	8
Participating patients
Age, yr, median (range)	67 (22–90)
Sex, % (n)
Female	69 (69)
Male	31 (31)
Ethnicity,* % (n)
White non-Hispanic	70 (70)
Black non-Hispanic	4 (4)
Hispanic	1 (1)
Asian	1 (1)
FEV1,† L, mean (range)	1.78 (0.71–5.00)

Definition of abbreviations: BE = bronchiectasis; FEV₁ = forced expiratory volume in 1 second; IMPACT BE = Individual Management of Patient Airway Clearance Therapy–Bronchiectasis; M.A./C.A.N. = medical assistant/certified nursing assistant; M.D. = medical doctor; N.P./P.A. = nurse practitioner/physician’s assistant; P.T. = physical therapist; R.N. = registered nurse; R.T. = respiratory therapist.

^*Race and ethnicity data were captured for a subset of patients (n = 76).

^† FEV₁ was captured for a subset of patients (n = 73).

Multidisciplinary Uptake of IMPACT BE Program

During the study period, there were 124 individual encounters in which patients used at least one component of the IMPACT BE toolkit. Multiple encounters with the toolkit took place during one patient visit, but with different care team members involved with the patient visit, and were captured on the tracker. The distribution of IMPACT BE use by care team member per encounter is presented in Table 1.

Utilization of IMPACT BE Toolkit Components

Utilization rates for IMPACT BE toolset components are presented in Figure 1 and indicate that the Airway Clearance Assessment and the Action Plan were the most widely used components, with the Assessment being used in 97% of encounters and the Action Plan in 91% of encounters.

Figure 1.

IMPACT BE toolkit use. IMPACT BE = Individual Management of Patient Airway Clearance Therapy–Bronchiectasis.

Satisfaction and Utilization Data from Providers

Post intervention survey results demonstrated that teams rated the Airway Clearance Assessment, IMPACT BE website, and Action Plan as the three most useful components of the toolkit, as noted in Figure 1. The Poster was both the least used and reported as the least useful of the toolkit components.

Post intervention survey results from the nine pilot sites demonstrated that the IMPACT BE program had positive effects on providers’ interactions with patients. All nine teams reported that their patients found the program to be somewhat or extremely valuable, and this was also reflected in the qualitative patient responses. All of the participating clinicians believed the program could become a sustainable part of their clinic. When asked to identify the challenges they encountered when implementing the IMPACT BE program, “Finding time in clinic to administer the program” was identified as the biggest challenge, with 89% of respondents ranking this as their clinic’s biggest challenge. Sixty-six percent of teams reported that they spent 16 minutes or more engaging with patients on a typical encounter that used IMPACT BE.

The IMPACT BE program positively impacted the care teams’ approach to patient education about ACTs. Pre and post intervention surveys demonstrated an increase in ratings of agreement with statements related to teams having a clear process for educating patients regarding ACT, providing comprehensive patient education for new ACTs, and providing ongoing targeted education and materials about ACTs to their patients with BE (Figure 2).

Figure 2.

Comparison of pre and post intervention survey results from participating teams (n = 9) about attitudes on ACT education and practices. Responses to 3 questions in pre and post survey by each team are summarized in panels A–C. ACT = airway clearance technique; pre = pre intervention survey; post = post intervention survey.

Qualitative Input from Patient Participants

A subset of patients (n = 7), ranging in age from 40 to 82 years, four of whom were female, provided qualitative responses to a series of questions in a semistructured interview conducted by one of the authors. Participants were asked to evaluate the program, their perceptions of each toolkit component, and recommendations to improve the program (Table E4). A majority of patients responded positively to these questions. In general, they found the educational materials and tools comprehensive and easy to use and said they provided valuable information to begin a discussion with their provider (“…pretty comprehensive and informative package. It will be useful to me as I meet with the doctor.”). The Action Plan included a signature line for setting goals for ACT. Most found the signature helpful for improving motivation and accountability (“Signing that and doing that I’ve honestly tried a lot harder.” “By signing, I’m committed to doing it. I kind of like that.”); however, a few thought it was “goofy” or “childish.” Suggestions for improving the IMPACT BE program focused on using time in the waiting room to complete the assessment forms, helping patients identify symptom patterns that signal a potential exacerbation, and adding videos on cleaning and disinfecting devices and other equipment.

Discussion

Given the importance of ACT as a component of disease management in BE, improving adherence is a critical goal for enhancing clinical outcomes (7, 8, 15). A structured education program that uses a patient-centered approach may increase adherence to ACT among those with BE (10, 27). This pilot study evaluated a patient educational training program developed to address the long-standing gap in education about ACT options for people with BE. The IMPACT BE program had rapid onset of use that was viewed as feasible and sustainable by program teams in a clinical setting. A strength of this program was the multidisciplinary use of the program, including physicians, advanced care practitioners, respiratory therapists, physical therapists, and registered nurses. It was well received by a wide array of providers and made a positive impact on providers’ interactions while teaching patients about ACT. Providers reported that the program was valuable, with qualitative feedback from patients confirming this result. The IMPACT BE program is free, which facilitates sustainability and equity in its use. Widespread adoption of this program may have a positive impact on the use of ACT among those with BE.

The program materials were developed by a professional health education company; however, the materials and training were provided at no charge and are freely accessible at https://impact-be.com. A future version of this program might include integration into electronic medical records to facilitate tracking. In addition, future research should evaluate the IMPACT BE program in a randomized controlled trial or waitlist control design to assess its full impact on utilization, adherence, and health outcomes.

Finding the time during the clinic to administer the program was identified as the biggest challenge to implementation. This barrier can be proactively addressed by giving patients the assessment tool in the waiting room and streamlining the tools to make them more user friendly. This study used a convenience sample, testing the program with those who had a scheduled clinic appointment during the 3-month study period, which may have biased the results. To minimize these biases, a multinational group of BE clinics, both large and small, were used for recruitment, including private/community practices as well as large, university-based centers. This was a small pilot study, but the IMPACT BE program has the potential to be used for larger studies.

Based on provider and patient feedback collected during the pilot study, minor edits were made to the tools and the website to improve user experience, including clearer formatting and minor content changes. At the request of care teams, the final program materials were also translated into Spanish, Chinese, and Vietnamese to reach a wider range of patients. Since the time of this pilot program, the IMPACT BE toolset was modified for use in patients with cystic fibrosis, and a similar pilot study was conducted. Future directions for this program include adapting this program for use in additional disease states that require airway clearance therapy, such as chronic obstructive pulmonary disease.

Conclusions

IMPACT BE, a structured education program designed to address gaps in ACT knowledge and skills in people with BE, was used by a variety of members of multidisciplinary care teams in their patient encounters. The program improved their ability to provide education to their patients, and all providers indicated that this program could become a sustainable part of their clinic. Qualitative responses from patients indicated the program was comprehensive and easy to use. Broad implementation of IMPACT BE may improve adherence to ACT among people with BE and have a positive impact on outcomes.