Efficacy of team-based collaborative care for distressed patients in secondary prevention of chronic coronary heart disease (TEACH): study protocol of a multicenter randomized controlled trial

BMC Cardiovascular Disorders - 2020
Christoph Herrmann‐Lingen1, Christian Albus2, Martina de Zwaan3, Franziska Geiser4, Katrin Heinemann1, Martin Hellmich5, Matthias Michal6, Monika Sadlonova7, Ralf Tostmann8, Rolf Wachter9, Bea Herbeck Belnap10
1Department of Psychosomatic Medicine and Psychotherapy, University of Göttingen Medical Center, Von-Siebold-Str. 5, 37075, Göttingen, Germany
2Department of Psychosomatics and Psychotherapy, University of Cologne, Cologne, Germany
3Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover, Germany
4Department of Psychosomatic Medicine and Psychotherapy, University of Bonn Medical Center, Bonn, Germany
5Institute of Medical Statistics and Computational Biology, Faculty of Medicine, University Hospital Cologne, University of Cologne, Cologne, Germany
6Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Mainz, Mainz, Germany
7German Center for Cardiovascular Research (DZHK), Partner Site Göttingen, Göttingen, Germany
8Clinical Trials Unit, University of Göttingen Medical Center, Göttingen, Germany
9Clinic and Policlinic for Cardiology, University Hospital of Leipzig, Leipzig, Germany
10Center for Behavioral Health, Media, and Technology, University of Pittsburgh School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA

Tóm tắt

Abstract Background Coronary heart disease (CHD) is the leading cause of death and years of life lost worldwide. While effective treatments are available for both acute and chronic disease stages there are unmet needs for effective interventions to support patients in health behaviors required for secondary prevention. Psychosocial distress is a common comorbidity in patients with CHD and associated with substantially reduced health-related quality of life (HRQoL), poor health behavior, and low treatment adherence. Methods In a confirmatory, randomized, controlled, two-arm parallel group, multicenter behavioral intervention trial we will randomize 440 distressed CHD patients with at least one insufficiently controlled cardiac risk factor to either their physicians' usual care (UC) or UC plus 12-months of blended collaborative care (TeamCare = TC). Trained nurse care managers (NCM) will proactively support patients to identify individual sources of distress and risk behaviors, establish a stepwise treatment plan to improve self-help and healthy behavior, and actively monitor adherence and progress. Additional e-health resources are available to patients and their families. Intervention fidelity is ensured by a treatment manual, an electronic patient registry, and a specialist team regularly supervising NCM via videoconferences and recommending protocol and guideline-compliant treatment adjustments as indicated. Recommendations will be shared with patients and their physicians who remain in charge of patients’ care. Since HRQoL is a recommended outcome by both, several guidelines and patient preference we chose a ≥ 50% improvement over baseline on the HeartQoL questionnaire at 12 months as primary outcome. Our primary hypothesis is that significantly more patients receiving TC will meet the primary outcome criterion compared to the UC group. Secondary hypotheses will evaluate improvements in risk factors, psychosocial variables, health care utilization, and durability of intervention effects over 18–30 months of follow-up. Discussion TEACH is the first study of a blended collaborative care intervention simultaneously addressing distress and medical CHD risk factors conducted in cardiac patients in a European health care setting. If proven effective, its results can improve long-term chronic care of this vulnerable patient group and may be adapted for patients with other chronic conditions. Trial registration: German Clinical Trials Register, DRKS00020824, registered on 4 June, 2020; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00020824

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