Clinical trial NCT04930666: BREATHE ALD: A Shared Decision-Making Intervention for Adults With Advanced Lung Disease
Official title: The Development and Pilot Testing of a Brief Shared Decision-Making Intervention to Improve Palliative Care Outcomes for Adults With Advanced Lung Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lung Diseases, Interstitial
Keywords: Lung Disease
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
name: National Institute of Nursing Research (NINR)
First posted: 2021-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients and caregivers of patients followed for advanced lung disease at Weill Cornell Medicine. Nurse practitioner who manages ALD patients at Weill Cornell Medicine.

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.

Eligibility 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.

Primary outcomes:
measure: Number of qualitative interviews completed in the development phase
timeFrame: Up to 6 months
measure: Ratio of participants who completed the intervention to the number of participants consented
timeFrame: Up to 3 months post-intervention
measure: Mean mMRC (Modified Medical Research Council) Dyspnea Scale
timeFrame: Up to 3 months post-intervention
Secondary outcomes:
measure: Mean St. George's Respiratory Questionnaire
timeFrame: Baseline, 1 month, 2 months, and 3 months (post-intervention)
measure: Mean PROMIS Pain Intensity - Short Form V10 3a
timeFrame: Baseline, 1 month, 2 months, and 3 months (post-intervention)
measure: Mean PROMIS Fatigue - Short Form 6a
timeFrame: Baseline, 1 month, 2 months, and 3 months (post-intervention)
measure: Mean Short Form 36
timeFrame: Baseline, 1 month, 2 months, and 3 months (post-intervention)
measure: Mean Shared Decision Making Questionnaire
timeFrame: Baseline (immediately post-intervention)
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
Study officials:
affiliation: Columbia University School of Nursing
name: Maureen George, PhD
role: PRINCIPAL_INVESTIGATOR
References: