The Development and Pilot Testing of a Brief Shared Decision-Making Intervention to Improve Palliative Care Outcomes for Adults With Advanced Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of qualitative interviews completed in the development phase
研究概览
简要总结
This study aims to:
- 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
- To evaluate the feasibility and acceptability of intervention procedures; and
- To explore intervention effects on ALD outcomes
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
- •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.
结局指标
主要结局
Number of qualitative interviews completed in the development phase
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- Mean Short Form 36(Baseline, 1 month, 2 months, and 3 months (post-intervention))
- Mean PROMIS Pain Intensity - Short Form V10 3a(Baseline, 1 month, 2 months, and 3 months (post-intervention))
- Mean PROMIS Fatigue - Short Form 6a(Baseline, 1 month, 2 months, and 3 months (post-intervention))
- Mean St. George's Respiratory Questionnaire(Baseline, 1 month, 2 months, and 3 months (post-intervention))
- Mean Shared Decision Making Questionnaire(Baseline (immediately post-intervention))
研究者
Maureen George
Professor of Nursing at CUIMC
Columbia University