Pragmatic Collaborative Care for Cardiac Inpatients With Depression or Anxiety

NCT03118752 | Completed DMC

• 2 other identifiers: 2016P0028701R01HL133149-01A1
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Acute Coronary Syndrome; Heart Failure; Depression; Generalized Anxiety Disorder; Panic Disorder

Outcome Measures

Primary Outcomes (1)

• Change in physical function

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

  Baseline, 26 weeks, 52 weeks

Secondary Outcomes (14)

• 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

• Change in mental health (depression)

  Baseline, 26 weeks, 52 weeks

• Change in mental health (anxiety)

  Baseline, 26 weeks, 52 weeks

• Change in optimism

  Baseline, 26 weeks, 52 weeks

Study Arms (2)

Collaborative Care

EXPERIMENTAL

Participants randomized to collaborative care (CC) will receive a 26-week, telephone based CC intervention. Care managers will monitor participants' psychiatric symptoms, review current treatments for their psychiatric and cardiac illnesses, deliver psychotherapeutic interventions, provide education about self-monitoring for cardiac symptoms, perform motivational interviewing to encourage health behavior adherence, and coordinate care between psychiatric/cardiac specialists and participants' primary care physicians. CC will utilize a treat-to-target approach, with a goal of remission of psychiatric and cardiac symptoms.

Behavioral: Collaborative Care

Enhanced Usual Care

NO INTERVENTION

Participants in the enhanced usual care (eUC) arm will not receive any specific intervention, though they will be free to receive any treatment for psychiatric or cardiac illness. Participants' outpatient providers will be informed of their psychiatric diagnosis, which may lead to higher-than-usual treatment for psychiatric illness.

Interventions

Collaborative Care BEHAVIORAL

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.

Collaborative Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Salem Hospital

Salem, Massachusetts, 01970, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Heart Failure; Depression; Generalized Anxiety Disorder; Panic Disorder

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavioral Symptoms; Behavior; Anxiety Disorders; Mental Disorders

Study Officials

• Jeff C Huffman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief of Psychiatry

Model Details: This study will be a randomized, controlled, 2-arm, single blinded trial.

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 18, 2017
• Study Start: October 16, 2017
• Primary Completion: March 8, 2024
• Study Completion: March 8, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

US (3)