Inventi Impact: Cardiovascular Nursing

Inventi:hcvn/20765/16

Assessing the Effectiveness of Enhanced Psychological Care for Patients with Depressive Symptoms\nAttending Cardiac Rehabilitation Compared with Treatment as Usual (CADENCE): Study Protocol for\na Pilot Cluster Randomised Controlled Trial

Background: Around 17 % of people eligible for UK cardiac rehabilitation programmes following an acute coronary\nsyndrome report moderate or severe depressive symptoms. While maximising psychological health is a core goal of\ncardiac rehabilitation, psychological care can be fragmented and patchy. This study tests the feasibility and\nacceptability of embedding enhanced psychological care, composed of two management strategies of proven\neffectiveness in other settings (nurse-led mental health care coordination and behavioural activation), within\nthe cardiac rehabilitation care pathway.\nMethods/Design: This study tests the uncertainties associated with a large-scale evaluation by conducting an\nexternal pilot trial with a nested qualitative study. We aim to recruit and randomise eight comprehensive cardiac\nrehabilitation teams (clusters) to intervention (embedding enhanced psychological care into routine cardiac\nrehabilitation programmes) or control (routine cardiac rehabilitation programmes alone) arms. Up to 64 patients\n(eight per team) identified with depressive symptoms upon initial assessment by the cardiac rehabilitation team\nwill be recruited, and study measures will be administered at baseline (before starting rehabilitation) and at 5 months\nand 8 months post baseline. Outcomes include depressive symptoms, cardiac mortality and morbidity, anxiety,\nhealth-related quality of life and service resource use. Trial data on cardiac team and patient recruitment, and the\nretention and flow of patients through treatment will be used to assess intervention feasibility and acceptability.\nQualitative interviews will be undertaken to explore trial participants� and cardiac rehabilitation nurses� views and\nexperiences of the trial methods and intervention, and to identify reasons why patients declined to take part in\nthe trial. Outcome data will inform a sample size calculation for a definitive trial.\nDiscussion: The pilot trial and qualitative study will inform the design of a fully powered cluster randomised\ncontrolled trial to evaluate the effectiveness and cost-effectiveness of the provision of enhanced psychological\ncare within cardiac rehabilitation programmes