NCT04930666

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

The Development and Pilot Testing of a Brief Shared Decision-Making Intervention to Improve Palliative Care Outcomes for Adults With Advanced Lung Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	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).

Timeline

• Start date: 2021-11-10
• Primary completion: 2025-02-06
• Completion: 2025-02-06
• First posted: 2021-06-18
• Last updated: 2025-04-15

Locations

1 site across 1 country: United States