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

Columbia University

Status: Completed

Conditions: Lung Diseases, Interstitial; Pulmonary Disease, Chronic Obstructive

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04930666

AAAT2217

P20NR018072 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Pre-trial

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.

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

Inclusion Criteria:

• 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.
• Patients anticipated to have less than 3-month survival.