Chronic heart failure (CHF), interstitial lung disease (pulmonary fibrosis or ILD) and chronic obstructive pulmonary disease (COPD) have commonalities that make them ideal for early palliative care provided alongside disease-specific treatments. Quality of life is reduced in these illnesses because, despite disease-specific treatments, the same symptoms (e.g., shortness of breath, fatigue) often persist in CHF, ILD and COPD. Quality of life is also reduced because between 50-60% of patients with these illnesses have clinically significant depressive symptoms. Finally, few Veterans with these illnesses engage in advance care planning.
We will conduct a hybrid effectiveness and implementation study to determine whether the benefits of early palliative care extend to CHF, ILD, and COPD.
Aim 1: Determine the effect of the Advancing Symptom Alleviation with Palliative Treatment (ADAPT) intervention on (a) quality of life as a primary outcome, and (b) depression, symptom burden, advance care planning communication and documentation, disease-specific health status, emergency department visits, hospitalizations, and mortality as secondary outcomes.
Aim 2: Examine the implementation of the ADAPT intervention.
Aim 2a: Assess the degree, barriers, and facilitators of implementation of various intervention components. Identify which intervention components and processes are most critical from the perspectives of patients, intervention team members, and primary care providers whose patients received the intervention.
Aim 2b. Evaluate the resources (e.g., personnel time and other costs) associated with the intervention, and estimate the resources needed for implementation and maintenance of the ADAPT program in other VA settings.
The study will be conducted at the VA Eastern Colorado and Puget Sound Health Care systems. We will enroll 300 Veterans with CHF, ILD or COPD who have poor quality of life and are at risk for hospitalization or death. Randomization will occur at the patient level with 1:1 randomization of patients to intervention or control groups.
The ADAPT intervention consists of the following components: (1) algorithm-guided management of breathlessness, fatigue, pain, and sleep disturbance provided by a nurse; the algorithms supplement disease-focused treatments with palliative and behavioral treatments; (2) a structured psychosocial care program targeting adjustment to illness and depression, provided by a social worker; and (3) engagement of patients and providers in advance care planning. The nurse and social worker are teamed with a palliative care specialist and primary care provider in brief weekly meetings. The team is integrated into primary care through ADAPT nurse interaction with primary care providers and through electronic medical record (CPRS) communication.
The primary outcome is the difference in patient-reported Function Assessment of Chronic Illness Therapy-General (FACT-G) score at 6 months. For Aim 2, we will conduct a mixed method evaluation to assess intervention implementation. Data will be collected from the intervention database, patient interviews, email surveys of primary care providers, and interviews and notes from the intervention team.
Accrual for this clinical trial is ongoing. There are no findings yet.
This project is significant for Veterans because it addresses CHF, ILD and COPD, serious illnesses which together affect 15-25% of Veterans and are the top two reasons for VA medical hospitalizations. The proposed study will impact clinical care for Veterans with CHF or COPD by testing an innovative, theory-driven palliative symptom management, psychosocial care, and advance care planning intervention to improve quality of life and provision of care according to Veterans goals and preferences. By improving symptoms and depression, and providing care aligned with Veterans goals and preferences, the intervention could achieve the "triple aim" by improving quality of life while reducing health care utilization (emergency department visits, hospitalizations) and the costs they incur.
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