A Theory-Informed, Brief Patient Activation and Motivational Interviewing Approach to Implementing Depression Treatment in Cardiac Patients: A Quality Improvement Initiative
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Percentage of eligible patients who initiate or intensify depression treatment
研究概览
简要总结
This study, which is being conducted as part of a Quality Improvement (QI) Initiative at Columbia University Irving Medical Center, will test whether delivering the iHeart DepCare tool increases real world reach and adoption of depression treatment among CHD patients. As part of the QI Initiative, Clinic Navigators will administer and record (in EPIC) depression screening in advance of primary care and cardiology appointments. Eligible patients with elevated depressive symptoms will be randomized to receive usual care vs. the iHeart DepCare tool in conjunction with brief motivational, technical and navigation support per patient preference.
Aim 1: To test the effect of iHeart DepCare on depression treatment optimization (primary outcome) among coronary heart disease patients with elevated depressive symptoms.
Aim 2: To explore the effect of iHeart DepCare on implementation outcomes, including provider referrals, among coronary heart disease patients with elevated depressive symptoms.
详细描述
Depression is common in patients with coronary heart disease (CHD) and associated with increased cardiac morbidity and mortality. Evidence-based mental health treatment improves depressive symptoms and quality of life, yet few CHD patients engage in treatment. The investigator previously tested the efficacy of an implementation strategy centered around a patient activation and psychoeducation tool (iHeart DepCare) for improving depressive symptoms and uptake of depression treatment in CHD patients. The research now expands to test the real-world effectiveness of the iHeart DepCare tool in cardiology and primary care settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age
- •PHQ9 or PHQ8 score >=8
- •History of coronary heart disease per EHR search for ICD-9 codes of 410-414 and ICD-10 codes: I20, I21, I22, I23, I24, I
- •Appointment with a primary care provider (PCP) or cardiologist in an integrated care setting in NYP/Columbia (e.g., does not include procedure or lab-only visits)
- •Has a PCP at NYP/Columbia active on the NYP/Columbia EHR
排除标准
- •Not English or Spanish speaking
- •History of severe mental illness (bipolar disorder, schizophrenia, chronic/recurrent depression, history of suicide attempt or self-inflicted injuries)
- •Had an integrated mental health visit in the last 3 months as indicated in the EHR
- •Enrollment in the post-implementation period of IRB# AAAR9175
研究组 & 干预措施
Screening alone
As part of a Quality Improvement Initiative, navigators and clinical staff call patients to screen patients for depression using the Patient Health Questionnaire (PHQ)-2 followed by the PHQ-9 in advance of scheduled office visits with cardiologists or primary care clinicians and enter results into Epic for providers to view during their visits and refer and manage depression at their discretion. Patients will receive the clinic's mental health informational resource.
Screening plus iHeart DepCare tool and Motivational Interviewing
As part of a Quality Improvement Initiative, navigators and clinical staff call patients to screen patients for depression using the Patient Health Questionnaire (PHQ)-2 followed by the PHQ-9 in advance of scheduled office visits with cardiologists or primary care clinicians and enter results into Epic for providers to view during their visits and refer and manage depression at their discretion.
Eligible patients who screen positive for depression (PHQ-9 ≥8) are administered the Heart DepCare tool along with motivational, technical and navigational support per patient preference. Clinical and mental health providers are sent the patient's treatment preferences via EPIC.
干预措施: iHeart Depcare tool (Behavioral)
结局指标
主要结局
Percentage of eligible patients who initiate or intensify depression treatment
时间窗: Up to 6 months
This is designed to measure depression treatment reach, which is defined as the percentage of eligible patients who initiate or intensify depression treatment within 6 months of the index visit, as indicated by ≥1 pharmacy fill data of a new or changed antidepressant and/or a new visit with a mental health provider (e.g., psychologist, psychiatrist, behavioral health provider like social workers) and/or primary care provider with a visit diagnosis of depression and/or an exercise program (e.g., cardiac rehabilitation), which will be assessed through chart extraction and tallied.
次要结局
- Percentage of patients in whom their clinician referred to mental health treatment(Baseline)
- Mean adherence to cardiac medications(Approximately between 3 to 9 months from baseline)
研究者
Nathalie Moise
Assistant Professor of Medicine
Columbia University