Background: Pulmonary rehabilitation (PR) decreases rehospitalization for people with COPD. However, less than 2% receive PR, partly due to lack of referral and sparsity of PR facilities. This disparity is particularly pronounced in African American and Hispanic persons with COPD. Telehealth-provided PR could increase access and improve health outcomes. Methods: We applied the RE-AIM framework in a post-hoc analysis of our mixed methods RCT comparing referral to Telehealth-delivered PR (TelePR) versus standard PR (SPR) for African American and Hispanic COPD patients hospitalized for COPD exacerbation. Both arms received a referral to PR for 8 weeks, social worker follow-up, and surveys administered at baseline, 8 weeks, 6, and 12 months. PR sessions were conducted twice a week for 90 min each (16 sessions total). Quantitative data were analyzed using 2-sample t tests or nonparametric Wilcoxon tests for continuous data and χ²/Fisher exact tests for categorical data. Logistic regression–estimated odds ratios (ORs) were used for the intention-to-treat primary outcome. Qualitative interviews were conducted at the end of the study to assess adherence and satisfaction and were analyzed using inductive and deductive methods. The goal was to understand Reach (whether the target population was able to be enrolled), Effectiveness (primary outcome was a composite of 6-month COPD rehospitalization and death), Adoption (proportion of people willing to initiate the program), Implementation (whether the program was able to be executed as intended, and Maintenance (whether the program was continued). Results: Two hundred nine people enrolled out of a 276-recruitment goal. Only 85 completed at least one PR session 57/111 (51%) TelePR; 28/98 (28%) SPR. Referral to TelePR compared to SPR did not decrease the composite outcome of 6-month COPD-readmission rate/death (OR1.35;95%CI 0.69,2.66). There was significant reduction in fatigue (PROMIS® scale) from baseline to 8-weeks in TelePR compared to SPR (MD-1.34; ± SD4.22; p = 0.02). Participants who received TelePR experienced improvements from baseline in several outcomes (ie, before and after 8 weeks of PR) in the following: COPD symptoms, knowledge about COPD management, fatigue, and functional capacity. Among the patients who had 1 initial visit, adherence rates were similar (TelePR arm, 59% of sessions; SPR arm, 63%). No intervention-related adverse events occurred. Barriers to PR adoption included difficulty or reluctance to complete medical clearances and beliefs about PR efficacy. Notably, only 9 participants sustained exercise after program completion. Maintenance of the program was not possible due to low insurance reimbursement and sparsity of Respiratory Therapists. Conclusions: TelePR can reach COPD patients with health disparities and can be successfully implemented. The small sample size and large confidence intervals prevent conclusion about the relative effectiveness of participating in TelePR compared to SPR. However, improved outcomes were seen for those in TelePR as well as in SPR. Increasing adoption of PR and TelePR requires consideration of comorbidity burden, and perception of PR utility, and must facilitate medical clearances. Given the sparsity of SPR locations, TelePR can overcome at least the barrier of access. However, given the challenges to the uptake and completion of PR - many of the additional barriers in PR (both in TelePR and SPR) need to be addressed. Awareness of these real-world challenges will not only inform implementation of TelePR for clinicians seeking to adopt this platform but will also inform study designers and reviewers regarding the feasibility of approaches to patient recruitment and retention.

Background: Cystic fibrosis (CF) is a life-limiting genetic disease that causes chronic lung infections. We developed an internet-based decision aid (DA) to help patients with CF make better informed decisions regarding treatments and advance care planning. We built the DA around two major treatment decisions: whether to have a lung transplant and whether to agree to invasive mechanical ventilation (intubation). Objective: This study aims to conduct usability testing of the InformedChoices CF DA among key stakeholder groups. Methods: We performed a patient needs assessment using think-aloud usability testing with patients with CF, their surrogates, and CF clinicians. Think-aloud participants provided feedback while navigating the DA, and after viewing, they answered surveys. Transcripts from the think-aloud sessions and survey results were categorized into common, generalizable themes and optimizations for improving content, comprehension, and navigation. We assessed the ease of use of the DA (System Usability Scale) and also assessed the participants’ perceptions regarding the overall tone, with an emphasis on emotional reactions to the DA content, level of detail, and usefulness of the information for making decisions about either intubation or lung transplantation, including how well they understood the information and were able to apply it to their own decision-making process. We also assessed the DA’s ease of navigation, esthetics, and whether participants were able to complete a series of usability tasks (eg, locating specific information in the DA or using the interactive survival estimates calculator) to ensure that the website was easy to navigate during the clinic-based advance care planning discussions. Results: A total of 12 participants from 3 sites were enrolled from March 9 to August 30, 2018, for the usability testing: 5 CF clinicians (mean age 48.2, SD 12.0 years), 5 adults with CF, and 2 family and surrogate caregivers of people with CF (mean age of CF adults and family and surrogate caregivers 38.8, SD 10.8 years). Among the 12 participants, the average System Usability Scale score for the DA was 88.33 (excellent). Think-aloud analysis identified 3 themes: functionality, visibility and navigation, and content and usefulness. Areas for improvement included reducing repetition, enhancing comprehension, and changing the flow. Several changes to improve the content and usefulness of the DA were recommended, including adding information about alternatives to childbearing, such as adoption and surrogacy. On the basis of survey responses, we found that the navigation of the site was easy for clinicians, patients, and surrogates who participated in usability testing. Conclusions: Usability testing revealed areas of potential improvement. Testing also yielded positive feedback, suggesting the DA’s future success. Integrating changes before implementation should improve the DA’s comprehension, navigation, and usefulness and lead to greater adoption.

Background: Elexacaftor/tezacaftor/ivacaftor (ETI) has reduced many symptoms of cystic fibrosis (CF). Objectives: We sought to identify the impact of ETI on both symptoms and treatment decisions among adults with CF. Design: Participants were enrolled in a cross-sectional study. Surveys were sent via a RedCap link. Semistructured interviews were administered remotely via Microsoft Teams. Interviews were audio recorded and professionally transcribed. Methods: We assessed Cystic Fibrosis Questionnaire-Revised (CFQ-R) subscales for physical, respiratory, emotion, and treatment, and analyzed semistructured interviews covering CF treatment regimens and daily living. Quantitative and qualitative results were analyzed separately and via a mixed-methods convergence coding matrix. Results: Twenty-four adults with CF taking ETI were included. CFQ-R subscale scores (mean scores/standard deviation) were physical (82.1/22.8), respiratory (83.7/11.2), emotion (65.3/14.2), and treatment (57.5/20.1). Three themes about decision-making for non-ETI-treatments emerged: (1) How I’m feeling, (2) Not noticing a difference, and (3) Uncertainty about long-term impact of modifying treatment regimens, and we found participants weighed each of these factors in their treatment decisions. Key findings from mixed-methods analysis show that among individuals experiencing higher CFQ-R scores for physical and respiratory compared to emotion and treatment, there were statements indicating that while those participants were experiencing better physical health, many continued their burdensome treatment regimens. Conclusion: With little long-term data on the impact of reducing non-ETI treatments, participants weighed how they were feeling, treatment efficacy beliefs, and risk tolerance when making treatment decisions.

Severe Chronic Obstructive Pulmonary Disease patients are often unprepared to make decisions about accepting intubation for respiratory failure. We developed a Web-based decision aid, InformedTogether, to facilitate severe Chronic Obstructive Pulmonary Disease patients’ preparation for decision making about whether to accept invasive mechanical ventilation for respiratory failure. We describe feasibility testing of the InformedTogether decision aid. Mixed methods, pre- and postintervention feasibility study in outpatient pulmonary and geriatric clinics. Clinicians used InformedTogether with severe Chronic Obstructive Pulmonary Disease patients. Patient-participants completed pre- and postassessments about InformedTogether use. The outcomes measured were the following: feasibility/acceptability, communication (Combined Outcome Measure for Risk Communication [COMRADE], Medical Communication Competency Scale [MCCS], Observing Patient Involvement [OPTION] scales), and effectiveness of InformedTogether on changing patients' knowledge, Decisional Conflict Scale, and motivation. We enrolled 11 clinicians and 38 Chronic Obstructive Pulmonary Disease patients at six sites. Feasibility/acceptability: Clinicians and patients gave positive responses to acceptability questions (mean 74.1/89 max [SD 7.24] and mean 59.63/61 [SD 4.49], respectively). Communication: 96% of clinicians stated InformedTogether improved communication (modified MCCS mean 44.54/49 [SD 2.97]; mean OPTION score 32.03/48 [SD 9.27]; mean COMRADE Satisfaction 4.31/5.0 [SD 0.58]; and COMRADE Confidence 4.18/5.0 [SD 0.56]). Preference: Eighty percent of patients discussed preferences with their surrogates by 1-month. Effectiveness: Knowledge scores increased significantly after using InformedTogether (mean difference 3.61 [SD 3. 44], P=.001) and Decisional Conflict decreased (mean difference Decisional Conflict Scale pre/post -13.76 [SD 20.39], P=.006). Motivation increased after viewing the decision aid. InformedTogether supports high-quality communication and shared decision making among Chronic Obstructive Pulmonary Disease patients, clinicians, and surrogates. The increased knowledge and opportunity to deliberate and discuss treatment choices after using InformedTogether should lead to improved decision making at the time of critical illness.