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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. [ABSTRACT FROM AUTHOR]

Background: Tobacco consumption is a preventable risk factor for chronic disease and complicates the treatment of medical conditions. Therefore, the German health insurance company AOK NORDWEST has developed a collaborative smoking cessation intervention for individuals with cardiovascular disease, chronic obstructive pulmonary disease and heavy smokers, with the aim of reducing tobacco consumption. The objective of the study ENTER is to evaluate the effectiveness of the collaborative smoking cessation intervention and determine its cost-effectiveness.Methods/design: This study is a cluster-randomized controlled trial conducted with 40 medical practices that are being selected from different geographic regions in Germany. Participating medical practices will be randomly allocated to either the intervention or control group. Within the medical practices, a total of 800 patients will be recruited for participation in the study and blinded to group assignment. Patients are included in the study if they are 18 years or older, insured by AOK, heavy smokers (smoke at least 20 cigarettes per day) and/or suffer from chronic obstructive pulmonary disease or cardiovascular disease. Exclusion criteria are patients who are nonsmokers, who have cognitive impairments or who are illiterate. Physicians from medical practices in the intervention group will motivate patients to participate in a smoking cessation program offered by the health insurance, refer them to the program and ask about their program participation. Physicians from medical practices in the control group will provide usual care. Data collection will take place on the date of study inclusion and after 6 and 12 months. The primary outcome is the amount of cigarettes consumed during the past 30 days, 12 months after the initial medical consultation. Secondary outcomes are abstinence from smoking, health-related quality of life and respiratory complaints. Moreover, a process evaluation and health economic analysis will be performed.Discussion: The results of this study will help to determine whether the collaborative smoking cessation intervention is an effective and feasible way to promote smoking cessation in the primary care setting and provide evidence regarding its cost-effectiveness.Trial Registration: German Clinical Trials Register DRKS00006079 . Registered 4 June 2014. [ABSTRACT FROM AUTHOR]