Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Lung Disease
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.
Interventions
OTHERBRief 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).
Sponsors
Weill Medical College of Cornell University
National Institute of Nursing Research (NINR)
Columbia University
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of qualitative interviews completed in the development phase | Up to 6 months | Qualitative interviews will be conducted with adults with advanced lung disease and their caregivers to understand their experiences managing ALD using semi-structured in-depth individual interviews. The information collected will aid the design of BREATHE-ALD and the implementation of the pilot phase of this study. |
| Ratio of participants who completed the intervention to the number of participants consented | Up to 3 months post-intervention | To determine the level of retention, the ratio of participants who completed the intervention to the number of participants consented will be measured. |
| Mean mMRC (Modified Medical Research Council) Dyspnea Scale | Up to 3 months post-intervention | The mMRC (Modified Medical Research Council) Dyspnea Scale measures the effect of breathlessness when performing daily activities. The mMRC breathlessness scale comprises five statements that describe almost the entire range of respiratory disability from none (Grade 1) to almost complete incapacity (Grade 5). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Short Form 36 | Baseline, 1 month, 2 months, and 3 months (post-intervention) | Short Form 36 (SF-36) is a well validated instrument that measures overall health status. It consists of 36 items and has eight sections.; the scores are weighted sums of the questions in each section. Scores range from 0-100. Lower scores = more disability and higher scores = less disability |
| Mean St. George's Respiratory Questionnaire | Baseline, 1 month, 2 months, and 3 months (post-intervention) | The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. It is a 50-item questionnaire with two parts, in which part one measures frequency and severity of symptoms while part two measures activities that impact breathlessness. Scores range from 0 to 100, with higher scores indicating more limitations. |
| Mean Shared Decision Making Questionnaire | Baseline (immediately post-intervention) | The Shared Decision Making (SDM) Questionnaire-9, is a patient reported, 9-item validated instrument that consists of nine statements that measure the decisional process in medical visits from both patients' and physicians' perspectives. Each statement is rated on a six-point scale from completely disagree to completely agree. |
| Mean PROMIS Pain Intensity - Short Form V10 3a | Baseline, 1 month, 2 months, and 3 months (post-intervention) | PROMIS Pain Intensity instrument measures how much a person hurts. It is a 3-item instrument that evaluates how much pain the patient has felt in the past seven days. Each question about pain intensity is rated on a five-point scale from had no pain (1) to very severe (5). |
| Mean PROMIS Fatigue - Short Form 6a | Baseline, 1 month, 2 months, and 3 months (post-intervention) | PROMIS Fatigue instrument measures how much a person feels tired. It is a 6-10-item questionnaire that evaluates how tired or exhausted the patient has felt in the past seven days. Each question about fatigue is rated on a five-point scale from never (1) to always (5). |
Countries
United States
Outcome results
None listed