Effects of a transitional palliative care model on patients with end-stage heart failure: study protocol for a randomized controlled trial

BACKGROUND: Heart failure (HF) is characterized by high rates of readmission after hospitalization, and readmission is a major contributor to healthcare costs. The transitional care model has proven efficacy in reducing the readmission rate and economic outcomes, and increasing satisfaction with care. However, the effectiveness of the transitional care model has not been evaluated in patients with end-stage HF. This study was designed to compare the customary hospital-based care and a comprehensive transitional care model, namely the Home-based Palliative HF Program (HPHP), in terms of readmission rate, quality of life, and satisfaction with care among end-stage HF patients under palliative care. METHODS/DESIGN: This is a randomized controlled trial taking place in hospitals in Hong Kong. We have been recruiting patients with end-stage HF who are identified as appropriate for palliative care during hospitalization, on referral by their physicians. A set of questionnaires is collected from each participant upon discharge. Participants are randomized to receive usual care (customary hospital-based care) or the intervention (HPHP). The HPHP will be implemented for up to 12 months. Outcome measures will be performed at 1, 3, 6, and 12 months post-discharge. The primary outcome of this study is quality of life measured by the Chronic Heart Failure Questionnaire - Chinese version; secondary outcomes include readmission rate, symptom intensity, functional status, and satisfaction with care. DISCUSSION: This study is original and will provide important information for service development in the area of palliative care. The introduction of palliative care to end-stage organ failure patients is new and has received increasing attention worldwide in the last decade. This study adopts the randomized controlled trial, a vigorous research design, to establish scientific evidence in exploring the best model for end-stage HF patients receiving palliative care. TRIAL REGISTRATION: This trial was registered as NCT02086305 on 7 March 2014 in the United States Clinical Trials Registration, and in the Clinical Trials Registry, Hong Kong University with the trial number UW12202. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1303-7) contains supplementary material, which is available to authorized users.