Clinical trial NCT05399056: Improving Participation in Pulmonary Rehabilitation Through Peer Support and Storytelling
Official title: Improving Participation in Pulmonary Rehabilitation Through Peer Support and Storytelling
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Pulmonary rehabilitation
Storytelling
Peer coaching
motivational interviewing
Behavioral interventions
chronic obstructive pulmonary disease
Lead sponsor: Baystate Medical Center
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: University of Massachusetts, Worcester
name: COPD Foundation
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-06-01
Enrollment: 305
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Chronic Obstructive Pulmonary Disease (COPD) affects approximately 16 million Americans and is characterized by recurrent exacerbations that lead to 1.5 million Emergency Department visits and 700,000 hospitalizations annually. Pulmonary rehabilitation (PR) is a structured program of exercise and self-management support that has been proven to relieve shortness of breath and increase quality of life when initiated after an exacerbation, but unfortunately, few eligible patients participate. This project will compare the effectiveness of two novel strategies - one involving video narratives of other patients telling their story of how they overcame challenges and completed PR, the other involving telephonic peer coaching with an individual with lived experience - to enhanced usual care, and to each other, at increasing patient participation in PR after an exacerbation.

Detailed description: Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) lead to roughly 1.5 million ED visits and 700,000 hospitalizations annually. Recovery is slow and accompanied by high levels of acute care utilization and mortality. Pulmonary Rehabilitation (PR) is a structured program of exercise and self-management support that has been shown to relieve dyspnea and improve quality of life. Clinical guidelines recommend PR for patients with stable COPD and after an exacerbation. Unfortunately, even when referred by physicians, research has shown that few patients who might benefit from PR ever begin treatment.

The primary goal of this project is to identify effective strategies for promoting and sustaining participation in PR. Peer Support involves pairing a patient with a trained peer from a similar background, and facing similar health challenges, who has completed PR. There is a growing body of evidence demonstrating the feasibility, acceptability, and effectiveness of telephonic peer support for chronic disease management. Narrative interventions, or 'Storytelling', are novel approaches for changing attitudes and behaviors of patients that involve creating and disseminating videos narrated by individuals with lived experience with the same condition or facing the same treatment. Storytelling interventions have been shown to help individuals achieve better blood pressure control, and storytelling is being studied in a variety of other clinical contexts.

In the R61 Phase, the investigators will recruit and train a cohort of peer coaches in behavior change techniques, and will recruit a diverse group of storytellers, capture their narratives on video, and create a library of 6-8 powerful stories. The investigators will finalize the protocol, trial infrastructure, and pilot the recruitment strategy. During the R33 Phase, the investigators will recruit 305 adults treated for exacerbation of COPD, and randomize them to 1) Enhanced "Usual Care" (eUC); 2) eUC + Storytelling; or 3) eUC + Peer Support. The investigators will evaluate the effectiveness of each strategy compared to eUC, and to each other, at promoting participation in PR at 6 months.

Using a mixed-methods approach, the investigators will evaluate intervention acceptability, sustainability, and cost, from the perspectives of the patients and peer coaches as well as PR program staff and hospital leadership. This information will be uses to refine the strategies and to disseminate an implementation package that will enable other PR programs to adopt these approaches.

Eligibility criteria: Inclusion Criteria:

* 40 years or older
* Received treatment for COPD exacerbation in either inpatient or outpatient setting
* Referred for pulmonary rehabilitation
* Ability to understand and communicate in English
* Willingness to participate in calls with peer coach and to view storytelling videos
* Working phone

Exclusion Criteria:

* Unwilling to attend PR
* Not eligible for PR based on spirometry or other clinical contraindications as determined by PR staff
* Currently enrolled in, or completion of 12 or more sessions of PR in the past
* Comfort measures only or Hospice care
* Resident of long-term care facility
* Unable or unwilling to give informed consent

Primary outcomes:
measure: Number of Pulmonary Rehabilitation (PR) sessions: Completion of ≥6 PR sessions within 6 months of randomization
timeFrame: 6 months
Secondary outcomes:
measure: Any attendance (yes/no) at PR within 6 months of randomization.
timeFrame: 6 months
measure: Total number of PR sessions completed within 6 months of randomization.
timeFrame: 6 months
measure: Time to first PR session attended
timeFrame: 6 months
Other outcomes:
measure: Change in Modified Medical Research Council (mMRC) dyspnea scale from randomization to 6 months
timeFrame: 6 months
measure: Change in Clinical COPD Questionnaire (CCQ) from randomization to 6 months
timeFrame: 6 months
measure: Change in Hospital Anxiety and Depression Scale (HADS) from randomization to 6 months
timeFrame: 6 months
measure: Activation (Self Efficacy for Managing Chronic Diseases 6)
timeFrame: 6 months
measure: Change in Medical Outcomes Survey (MOS) Social Support Survey from randomization to 6 months
timeFrame: 6 months
measure: Change in UCLA Loneliness Scale from randomization to 6 months
timeFrame: 6 months
measure: Total # of COPD Exacerbations
timeFrame: 6 months
measure: Total # of ED visits
timeFrame: 6 months
measure: Total # of Hospitalizations
timeFrame: 6 months
measure: Change in Modified Medical Research Council (mMRC) dyspnea scale from enrollment to 12 months - For Peer Coach subjects
timeFrame: 12 months
measure: Change in Clinical COPD Questionnaire (CCQ) from enrollment to 12 months- For Peer Coach subjects
timeFrame: 12 months
measure: Change in Activation (Self Efficacy for Managing Chronic Diseases 6) from enrollment to 12 months - For Peer Coach subjects
timeFrame: 12 months
measure: Change in Hospital Anxiety and Depression Scale (HADS) from enrollment to 12 months - For Peer Coach subjects
timeFrame: 12 months
measure: Change in UCLA Loneliness Scale from enrollment to 12 months - For Peer Coach subjects
timeFrame: 12 months
measure: Change in Satisfaction with life scale (SWLS) from enrollment to 12 months - For Peer Coach subjects
timeFrame: 12 months
Locations:
city: Springfield
country: United States
facility: Baystate Health
state: Massachusetts
Study officials:
affiliation: Baystate Health
name: Peter Lindenauer, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: