BREATHE ALD: A Shared Decision-Making Intervention for Adults With Advanced Lung Disease

NCT ID: NCT04930666

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-10
• Study Completion Date: 2025-02-06

Brief Summary

This study aims to:

1. Develop the BREATHE-ALD intervention for adults with Advanced Lung Disease, multiple chronic conditions, and palliative care needs and their caregivers using interviews with 10 advanced lung disease (ALD) adults and their caregivers

2. To evaluate the feasibility and acceptability of intervention procedures; and

3. To explore intervention effects on ALD outcomes

Detailed Description

This study addresses the important problem of adults with symptomatic advanced lung disease (ALD) who are at high risk for poor outcomes. Palliative care (PCare) improves the quality of life of individuals and their caregivers through the prevention and relief of suffering by identifying, assessing and treating the physical, psychosocial and spiritual problems associated with life-threatening illness. However, pulmonary clinicians rarely refer adults with ALD to PCare because of time demands, a lack of confidence in PCare and the perceived threat PCare poses to the relationship they have established with the ALD adult. Therefore, we are developing BREATHE-ALD (BRief intervention to Enhance Adherence to Treatment and HEalth advice in Advanced Lung Disease [ALD]), a novel shared decision-making (SDM) intervention to improve outcomes for adults with ALD.

The study includes two phases: (1) a development phase to develop BREATHE-ALD using interviews with 10 ALD adults and their caregivers with expert review to adapt BREATHE, and (2) a pilot validation phase conducting a pilot trial in which 10 adults with ALD receive BREATHE-ALD. We will follow adults with ALD for 3 months post-intervention to assess the impact of BREATHE-ALD on self-management and patient outcomes.

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

BRief intervention to Enhance Adherence to Treatment and HEalth advice in Advanced Lung Disease

BREATHE-ALD utilizes the patient's nurse practitioner (NP) to deliver a brief intervention using motivational interviewing and shared decision making, in a one-time 9-minute intervention. The NP will follow a 4-step script tailored to specific ALD self-management discussed during the most recent visit with the patient's pulmonologist. Step 1: Raise the subject (1½ minute). Step 2: Provide feedback (1½ minutes). Step 3: Enhance engagement (3 minutes). Step 4: Shared decision-making (3 minutes).

Intervention Type: OTHER

Other Intervention Names

BREATHE-ALD

Eligibility Criteria

Inclusion Criteria

• Patient participants with symptomatic advanced lung disease (ALD) followed at Weill Cornell Medicine (WCM).
• Caregiver participants who care for adults with symptomatic ALD followed at Weill Cornell Medicine.

• Patient participants with symptomatic advanced lung disease (ALD) followed at Weill Cornell Medicine (WCM).
• Nurse practitioner must manage a panel of adult ALD patients.

Exclusion Criteria

• Patients that have serious mental health conditions that preclude completion of study procedures or confound analyses.
• Caregivers that have serious mental health conditions that preclude completion of study procedures or confound analyses.

Trial

• Patients that have serious mental health conditions that preclude completion of study procedures or confound analyses.
• Patients anticipated to have less than 3-month survival.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Maureen George

Professor of Nursing at CUIMC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maureen George, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University School of Nursing

Locations

Weill Cornell Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

P20NR018072

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAT2217

Identifier Type: -

Identifier Source: org_study_id