Peer Support & Storytelling for COPD

(ImPReSS-COPD Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Peter Lindenauer, MD, MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Baystate Medical Center

Disqualifiers: Hospice, Long-term care, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on participation in pulmonary rehabilitation and peer support.

What data supports the effectiveness of the treatment Peer Support & Storytelling for COPD?

Research shows that phone-based peer coaching can reduce depressive symptoms and sleep disturbances in COPD patients, and narrative medicine helps improve the doctor-patient relationship, which can lead to better treatment adherence. These components suggest that storytelling and peer support may positively impact COPD management. ^{1 2 3 4 5}

Is peer support and storytelling safe for use in clinical settings?

Research suggests that peer support and storytelling interventions are generally safe, as they focus on improving communication and engagement without involving medical procedures or drugs. These methods have been used to enhance safety in hospital settings and empower patients to participate in their care. ^{6 7 8 9 10}

How does the Peer Support & Storytelling treatment for COPD differ from other treatments?

This treatment is unique because it focuses on peer support and storytelling to help manage COPD, rather than relying solely on medication or traditional therapies. It emphasizes the psychosocial aspects of living with COPD, aiming to improve quality of life through shared experiences and emotional support. ^{1 2 11 12 13}

Research Team

Peter Lindenauer, MD, MSc

Principal Investigator

Baystate Health

Eligibility Criteria

This trial is for individuals over 40 with COPD who've been treated for an exacerbation and referred to pulmonary rehabilitation (PR). Participants must be willing to engage in peer coaching calls, watch storytelling videos, have a working phone, and communicate in English. Those not eligible or unwilling to attend PR, in hospice care, living in long-term facilities, or who have already completed significant PR are excluded.

Inclusion Criteria

I have been referred for lung rehab.

I have been treated for a COPD flare-up.

I am willing to engage in calls with a peer coach and watch videos.

Exclusion Criteria

I am not a candidate for pulmonary rehabilitation based on my lung function tests.

I am receiving care focused on comfort or am in hospice.

I am not willing to attend pulmonary rehabilitation.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

R61 Phase

Recruit and train peer coaches, recruit storytellers, capture narratives on video, finalize protocol, trial infrastructure, and pilot recruitment strategy

Not specified

R33 Phase

Recruit 305 adults treated for exacerbation of COPD, randomize them to Enhanced Usual Care, eUC + Storytelling, or eUC + Peer Support, and evaluate effectiveness at promoting participation in PR at 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Storytelling (Behavioral Intervention)
• Telephonic Peer Coaching (Behavioral Intervention)

Trial Overview The study tests two strategies aimed at increasing participation in PR post-exacerbation: video narratives from patients sharing their experiences with overcoming challenges related to PR and telephonic peer coaching by someone familiar with COPD. These methods will be compared against each other and enhanced usual care.

Participant Groups

Group I: Enhanced usual care + Peer support Active Control 1 Intervention

Subjects randomized to the eUC + Peer support intervention will be matched with a peer coach of the same gender, race, and approximate age. For those enrolled during a hospitalization, coaches will be instructed to attempt the initial phone contact prior to the patient's discharge; for patients enrolled after an ED visit or outpatient exacerbation, coaches will be instructed to contact the patients within 72 hours of randomization. Peer coaches will be asked to complete at least one call each week during months 1-2, biweekly calls during months 3-4, and monthly calls during months 5-6. Coaches will be asked to follow a conversation guide, provided during the initial training, to structure phone conversations with their paired patient.

Group II: Enhanced usual care Active Control 1 Intervention

Enhanced usual care describes a process in which automated surveillance is used to identify individuals experiencing a COPD exacerbation. This is followed by direct outreach - either through in-person visits while a patient is hospitalized, or by mail and telephone in the outpatient setting, to facilitate referral to PR. Subjects randomized to this arm will be given a pamphlet describing the benefits of PR.

Group III: Enhanced usual care + Storytelling Active Control 1 Intervention

Subjects randomized to the eUC + Storytelling intervention will view the video narrative(s) of one or more individuals with COPD who has overcome similar barriers and has attended a program of PR. Subjects will be shown the first chapter of the story immediately after randomization and will receive email and/or text messages to prompt viewing of subsequent chapters at 2 weeks, 1 month, 2 months, 3 months and 5 months. Emails and text messages will include a link to a REDCap document that contains a set of embedded video clips representing the next chapter in each storyteller's narrative.

Who Is Running the Clinical Trial?

Baystate Medical Center

Lead Sponsor

Trials

67

Recruited

44,500+

Peter Banko

Baystate Medical Center

Chief Executive Officer

MBA from Stanford University

Dr. Yvonne Cheung

Baystate Medical Center

Chief Medical Officer since 2024

MD from Columbia University, MPH from Harvard School of Public Health, MBA from University of Massachusetts Amherst

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Marschall S. Runge

University of Michigan

Chief Executive Officer since 2015

MD, PhD

Karen McConnell

University of Michigan

Chief Medical Officer since 2020

MD

University of Massachusetts, Worcester

Collaborator

Trials

372

Recruited

998,000+

Dr. Eric W. Dickson

University of Massachusetts, Worcester

Chief Executive Officer since 2013

MD from UMass Chan Medical School, Master's in Health Care Management from Harvard University

Dr. Andy Karson

University of Massachusetts, Worcester

Chief Medical Officer

MD

COPD Foundation

Collaborator

Trials

18

Recruited

238,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

Findings from Research

In a study of 444 COPD patients, phone-based peer coaching did not significantly improve adherence to long-term oxygen therapy (LTOT) compared to usual care, with adherence rates of 74% in usual care, 84% in reactive coaching, and 70% in proactive coaching.

However, proactive coaching was associated with significant reductions in depressive symptoms and sleep disturbances compared to usual care, suggesting potential mental health benefits despite lower adherence rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Hybrid Effectiveness/Implementation Clinical Trial of Adherence to Long-Term Oxygen Therapy for Chronic Obstructive Pulmonary Disease. Prieto-Centurion, V., Holm, KE., Casaburi, R., et al.[2023]

The use of an interactive phone telesystem significantly improved adherence to Written Action Plans in COPD patients, leading to faster recovery from exacerbations, as shown in a study involving 40 patients over one year.

A larger implementation of the telesystem with 256 patients resulted in a notable reduction in respiratory-related emergency room visits and COPD-related hospitalizations, indicating enhanced self-management and reduced healthcare utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovating the treatment of COPD exacerbations: a phone interactive telesystem to increase COPD Action Plan adherence. Farias, R., Sedeno, M., Beaucage, D., et al.[2020]

A training project in narrative medicine for 74 pulmonologists revealed that 92% of COPD patients had activity limitations at their first visit, highlighting the impact of the disease on daily life.

The study found that a positive doctor-patient relationship significantly influences therapy adherence, with only 21% of patients able to resume activities when the relationship is strained, emphasizing the importance of effective communication in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Narrative medicine educational project to improve the care of patients with chronic obstructive pulmonary disease. Cappuccio, A., Sanduzzi Zamparelli, A., Verga, M., et al.[2022]

Out-of-hospital coaching by specialized respiratory nurses for 170 severe COPD patients led to a 24% reduction in hospitalization rates and improvements in health status, anxiety, and nutritional status over a 6-month period.

The coaching program was well-accepted by patients and successfully implemented, highlighting its feasibility and effectiveness in enhancing health management and reducing healthcare costs associated with re-hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive out-of-hospital coaching for frequently hospitalized COPD patients: a before-after feasibility study. Noort, BAC., van der Vaart, T., van der Maten, J., et al.[2023]

Current COPD patient education programs have shown limited success, indicating a need for more effective designs that go beyond just providing medical information.

Future programs should focus on improving patients' self-efficacy in disease management and include a broader range of health behavior determinants to enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient education programs--can they improve outcomes in COPD? Harris, M., Smith, BJ., Veale, A.[2021]

In a study involving 1329 patients from primary care settings in Australia and England, 5.3% reported safety incidents over the past year, with the most common issues being delays in accessing care and problems with diagnosis and assessment.

The study highlighted that patient-reported incidents often differ from those reported by staff, underscoring the importance of including patient perspectives to improve safety and service quality in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nature and type of patient-reported safety incidents in primary care: cross-sectional survey of patients from Australia and England. Hernan, AL., Giles, SJ., Carson-Stevens, A., et al.[2023]

In a study involving 178 patients across nine hospital wards, face-to-face interviews at the bedside were found to be the most effective method for collecting safety concerns, yielding an average of 1.91 concerns per patient compared to 0.92 for paper forms and 0.43 for a hotline.

While the method of data collection influenced the quantity of safety concerns reported, there was no significant difference in the classification of patient safety incidents or their assessed preventability and severity across the different mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How might health services capture patient-reported safety concerns in a hospital setting? An exploratory pilot study of three mechanisms. O'Hara, JK., Armitage, G., Reynolds, C., et al.[2022]

The intervention at University College London Hospitals, which included in-situ coaching and observational audits, successfully educated theatre teams on the Five Steps to Safer Surgery, leading to improved safety practices.

There was a 68% increase in near miss reporting and a reduction in surgical harm incidents, indicating that the intervention effectively enhanced behavioral reliability and overall surgical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing an integrated in-situ coaching, observational audit, and story-telling intervention to support safe surgery. Carthey, J., McCormack, K., Coombes, J., et al.[2018]

The PROSPER Consortium aims to enhance safety reporting in healthcare by integrating patient-reported outcomes (PROs) into the assessment of adverse events, recognizing the importance of the patient's perspective in understanding treatment effects.

Despite advancements in technology and increased focus on patient involvement, current safety reporting still heavily relies on healthcare professionals, which can lead to under-reporting and discrepancies between patient experiences and clinician perceptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance. Banerjee, AK., Okun, S., Edwards, IR., et al.[2022]

Incorporating patient-peer support into hospital care can empower patients to take a more proactive role in their safety, addressing gaps in access to innovative safety technologies.

Interviews with 30 patients and caregivers revealed that patient-peer support can enhance the quality and safety of hospital care by providing valuable resources and engagement opportunities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Value of Patient-Peer Support in Improving Hospital Safety. Haldar, S., Mishra, SR., Khelifi, M., et al.[2021]

In a case series involving 19 COPD patients, those with more advanced disease (group 1) showed significant improvements in patient activation, mastery, and anxiety after using an Internet-based health program with nurse-coach support, while the less advanced group (group 2) did not show similar benefits.

Both groups reported feeling more informed about COPD and experienced improvements in physical functioning, but group 1 particularly valued the nurse-coach support, which was deemed more important than the online program for building confidence in self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case series of an off-the-shelf online health resource with integrated nurse coaching to support self-management in COPD. Early, F., Young, JS., Robinshaw, E., et al.[2018]

A peer-led self-management program (SMP) for COPD patients in regional Tasmania was found to be acceptable, providing a platform for sharing experiences and support among individuals living with the disease.

The study highlighted that communication between health experts and patients can be unclear, which may create tension; however, peer-led SMPs can empower patients and enhance their quality of life by fostering social connections and shared understanding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of a peer-led self-management program for people living with chronic obstructive pulmonary disease in regional Southern Tasmania in Australia: A qualitative study. Mudzingwa, IT., Ayton, JE.[2023]

A study involving 100 nonsmoking patients with COPD showed that peer-support nursing interventions significantly improved social support, self-management efficacy, and healthy lifestyle scores compared to routine care alone.

Patients receiving peer support also demonstrated a greater improvement in their six-minute walking distance, indicating enhanced pulmonary function and overall quality of life after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits Conferred by Peer-Support Nursing Intervention to Pulmonary Function and Quality of Life in Nonsmoking Patients with COPD. Yao, X., Wang, X., Yuan, J., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Hybrid Effectiveness/Implementation Clinical Trial of Adherence to Long-Term Oxygen Therapy for Chronic Obstructive Pulmonary Disease. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Innovating the treatment of COPD exacerbations: a phone interactive telesystem to increase COPD Action Plan adherence. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Narrative medicine educational project to improve the care of patients with chronic obstructive pulmonary disease. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Intensive out-of-hospital coaching for frequently hospitalized COPD patients: a before-after feasibility study. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Patient education programs--can they improve outcomes in COPD? [2021]

6. England pubmed.ncbi.nlm.nih.gov

Nature and type of patient-reported safety incidents in primary care: cross-sectional survey of patients from Australia and England. [2023]

7. England pubmed.ncbi.nlm.nih.gov

How might health services capture patient-reported safety concerns in a hospital setting? An exploratory pilot study of three mechanisms. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Implementing an integrated in-situ coaching, observational audit, and story-telling intervention to support safe surgery. [2018]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

The Value of Patient-Peer Support in Improving Hospital Safety. [2021]

11. New Zealand pubmed.ncbi.nlm.nih.gov

A case series of an off-the-shelf online health resource with integrated nurse coaching to support self-management in COPD. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Acceptability of a peer-led self-management program for people living with chronic obstructive pulmonary disease in regional Southern Tasmania in Australia: A qualitative study. [2023]

13. Egypt pubmed.ncbi.nlm.nih.gov

Benefits Conferred by Peer-Support Nursing Intervention to Pulmonary Function and Quality of Life in Nonsmoking Patients with COPD. [2022]