Rationale and study design of a patient-centered intervention to improve health status in chronic heart failure: The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) randomized trial

Abstract

While contemporary heart failure management has led to some improvements in morbidity and mortality, patients continue to report poor health status (i.e., burdensome symptoms, impaired function, and poor quality of life). The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) trial is a NIH-funded, three-site, randomized clinical trial that examines the effect of the CASA intervention compared to usual care on the primary outcome of patient-reported health status at 6months in patients with heart failure and poor health status. The CASA intervention involves a nurse who works with patients to treat symptoms (e.g., shortness of breath, fatigue, pain) using disease-specific and palliative approaches, and a social worker who provides psychosocial care targeting depression and adjustment to illness. The intervention uses a collaborative care team model of health care delivery and is structured and primarily phone-based to enhance reproducibility and scalability. This article describes the rationale and design of the CASA trial, including several decision points: (1) how to design a patient-centered intervention to improve health status; (2) how to structure the intervention so that it is reproducible and scalable; and (3) how to systematically identify outpatients with heart failure most likely to need and benefit from the intervention. The results should provide valuable information to providers and health systems about the use of team care to manage symptoms and provide psychosocial care in chronic illness.

Trial registration: ClinicalTrials.gov NCT01739686.

Keywords: Heart failure; Palliative care; Patient-reported outcome; Psychosocial care; Quality of life; Randomized clinical trial.

Figure 1.. Conceptual Model & Proposed Intervention Effects.

By addressing depression and symptom experience, the Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) intervention is hypothesized to improve patient health status.