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临床试验/NCT03118752
NCT03118752已完成不适用

Pragmatic Collaborative Care for Cardiac Inpatients With Depression or Anxiety

Massachusetts General Hospital6 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2017年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
290
试验地点
6
主要终点
Change in physical function

研究概览

简要总结

The investigators will complete a pragmatic randomized trial (N=260 randomized participants) of the 26-week blended collaborative care (CC) intervention compared to enhanced usual care (eUC) in patients admitted for acute coronary syndrome (ACS) or heart failure (HF) found to have current depression, generalized anxiety disorder (GAD), or panic disorder (PD). The CC intervention will use a novel three-pronged approach to these high-risk patients. Care managers will provide centralized care coordination and specific interventions targeting: (1) the psychiatric disorders, (2) cardiac health behaviors, and (3) the cardiac illness. The primary study outcome will be physical function at 26 weeks, measured by the Duke Activity Status Index (DASI), given links between function and new cardiac events. The investigators will also examine effects on numerous other outcomes important to patients and healthcare systems.

Specific Aim 1 [patient-centered outcomes-primary aim]: To compare between-group differences in the CC and eUC conditions on improvements in physical function, health-related quality of life, mental health, patient satisfaction, and other key patient-reported outcomes at 26 and 52 weeks.

Specific Aim 2 [adherence and medical outcomes]: To compare between-group differences on health behaviors (physical activity, diet, smoking, medication adherence) and major adverse cardiac events.

Specific Aim 3 [cost]: To compare healthcare costs between groups and assess the cost-effectiveness of CC.

Hypotheses: The investigators expect this bolstered CC program to be associated with superior improvements in physical function, health-related quality of life, patient satisfaction, and adherence at 26 weeks, with promising effects on major adverse cardiac events. The investigators likewise expect the intervention to be cost-effective (<$10,000/quality-adjusted life year) over the study period.

详细描述

Study Visits/Contacts/Interventions

Procedures for Participants in the Collaborative Care Intervention

In the hospital, participants randomized to CC will work with the care manager to: (a) define specific goals related to their psychiatric condition, health behaviors, and self-care, (b) initiate care for their psychiatric condition, and (c) make a plan for a health goal, using a structured tool based on prior work, with a specific and systematic focus on social, functional, financial, and other barriers to behavior change.

Following discharge, all contact will be via phone, with the same care manager completing phone sessions to enhance alliance and care continuity. Contacts will last typically 30-45 minutes using a structured but highly flexible approach designed to manage acute issues and cover some aspect of all three care targets based on patient needs/preferences, without requiring care managers to complete all possible interventions at each call. Care managers will prioritize topics to be addressed at each contact, responding first to urgent concerns (e.g., chest pain, suicidal ideation). Next, the care manager will touch on all three aspects of the intervention, with the depth of focus for each component based on prior sessions and current issues. He/she will review psychiatric symptoms and treatment. The care manager will gauge progress on health behavior goals, review motivation/barriers to goal completion, and make an action plan for the next week. Finally, he/she will compare cardiac medication lists to guidelines and review weight/blood pressure self-monitoring. Calls will occur weekly for the first 6 weeks, then may be spaced out in subsequent weeks based on the patient's psychiatric symptoms, progress toward health behavior goals, and cardiovascular status. Both the participant and care manager will agree upon the amount of time between calls after the first 6 weeks, though participants will be encouraged to contact the care manager sooner if needed.

  • 1 Targeting multiple psychiatric conditions. First, the care manager will assist in the assessment and management of depression, GAD, and/or PD using standardized scales. At weekly team meetings, care managers and supervising clinicians will review participants' scores to allow iterative recommendations for treatment, and supervision will be provided to care managers about psychotherapeutic content. A treat-to-target approach will be used for psychiatric disorders, with a goal of remission. Treatments for mood/anxiety disorders may include medications (with selective serotonin reuptake inhibitors [SSRIs] typically recommended), psychotherapy (telephone-delivered cognitive behavioral therapy [CBT] sessions, supplemented by CBT workbooks), or relaxation response (RR) training.
  • 2 Targeting cardiac health behaviors. The investigators will systematically target health behaviors, primarily via motivational interviewing given its efficacy for a wide variety of behaviors in medical patients. The investigators will focus on four specific health behaviors (diet, exercise, smoking, and medication adherence). During admission, care managers and participants will identify one behavior to target and set a specific goal aligned with ACS/HF guidelines and the medical team's recommendations. Care managers will utilize motivational interviewing techniques to assist participants in considering, making, and maintaining change toward that goal. A focus on health behaviors will then continue throughout the 26 weeks.
  • 3 Targeting the cardiac condition. First, care managers will review the participant's medication regimen and compare it to published guidelines for ACS and HF. The care manager will discuss this with the study cardiologist and, if the regimen appears suboptimal, they will suggest to the patient's physician(s) possible adjustments. Second, care managers will encourage participants to check blood pressure and weight daily and will review data at study calls; if the readings deviate from targets (e.g., HF patient gaining weight), the care manager will review with the cardiologist and contact patients' medical providers as indicated. The investigators will provide (commercially-available) digital scales or automated blood pressure cuffs to participants (in either group) who need them.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • Adults with a primary medical provider in the Partners Healthcare System admitted to Massachusetts General Hospital (MGH) or Brigham and Women's Hospital (BWH).
  • Admission for acute coronary syndrome (myocardial infarction or unstable angina) or acute heart failure.
  • Clinical depression, GAD, or PD, identified using the Patient Health Questionnaire-9 (PHQ-9) for depression and the Primary Care Evaluation of Mental Disorders (PRIME-MD) anxiety modules.

排除标准

  • Medical conditions precluding interviews or likely to lead to death within 6 months (per clinical team).
  • Inability to participate in study procedures: cognitive deficits (via 6-item cognitive screen designed for research) or non-fluency in English.
  • Complex psychiatric conditions. The investigators will exclude patients with bipolar disorder, psychosis, or an active substance use disorder, as well as those with active suicidal ideation.

结局指标

主要结局

Change in physical function

时间窗: Baseline, 26 weeks, 52 weeks

Physical function will be assessed with the Duke Activity Status Index (DASI).

次要结局

  • Change in patient satisfaction(Baseline, 26 weeks, 52 weeks)
  • Change in generic health-related quality of life(Baseline, 26 weeks, 52 weeks)
  • Change in disease-specific health-related quality of life(Baseline, 26 weeks, 52 weeks)
  • Cost-effectiveness(52 weeks)
  • Change in mental health (depression)(Baseline, 26 weeks, 52 weeks)
  • Change in optimism(Baseline, 26 weeks, 52 weeks)
  • Change in dietary adherence (sodium intake)(Baseline, 26 weeks, 52 weeks)
  • Healthcare costs(52 weeks)
  • Change in physical activity adherence(Baseline, 26 weeks, 52 weeks)
  • Change in mental health (anxiety)(Baseline, 26 weeks, 52 weeks)
  • Change in dietary adherence (saturated fat)(Baseline, 26 weeks, 52 weeks)
  • Change in smoking(Baseline, 26 weeks, 52 weeks)
  • Major adverse cardiac events(52 weeks)
  • Change in cardiac medication adherence(Baseline, 26 weeks, 52 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeff C. Huffman, MD

Associate Chief of Psychiatry

Massachusetts General Hospital

研究点 (6)

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