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Pragmatic Collaborative Care for Cardiac Inpatients With Depression or Anxiety

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ClinicalTrials.gov Identifier: NCT03118752
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : April 4, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jeff C. Huffman, MD, Massachusetts General Hospital

Brief Summary:

The investigators will complete a pragmatic randomized trial (N=260) 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.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Heart Failure Depression Generalized Anxiety Disorder Panic Disorder Behavioral: Collaborative Care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will be a randomized, controlled, 2-arm, single blinded trial.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pragmatic Collaborative Care for Cardiac Inpatients With Depression or Anxiety
Actual Study Start Date : October 16, 2017
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Collaborative Care
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
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.

No Intervention: Enhanced Usual Care
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.



Primary Outcome Measures :
  1. Change in physical function [ Time Frame: Baseline, 26 weeks, 52 weeks ]
    Physical function will be assessed with the Duke Activity Status Index (DASI).


Secondary Outcome Measures :
  1. Change in generic health-related quality of life [ Time Frame: Baseline, 26 weeks, 52 weeks ]
    Generic HRQoL will be assessed via the Medical Outcomes Study SF-12 (SF-12).

  2. Change in disease-specific health-related quality of life [ Time Frame: Baseline, 26 weeks, 52 weeks ]
    Disease-specific HRQoL, measured via the Kansas City Cardiomyopathy Questionnaire (KCCQ; for participants with heart failure) or the Seattle Angina Questionnaire (SAQ; for participants who experienced an acute coronary syndrome).

  3. Change in mental health (depression) [ Time Frame: Baseline, 26 weeks, 52 weeks ]
    Depression will be measured by the 20-item Symptom Checklist Depression Scale (SCL-20).

  4. Change in mental health (anxiety) [ Time Frame: Baseline, 26 weeks, 52 weeks ]
    Anxiety will be measured by the Hospital Anxiety and Depression Scale, Anxiety Subscale (HADS-A).

  5. Change in optimism [ Time Frame: Baseline, 26 weeks, 52 weeks ]
    Optimism will be assessed via the well-validated Life Orientation Test-Revised (LOT-R)

  6. Change in patient satisfaction [ Time Frame: Baseline, 26 weeks, 52 weeks ]
    Participant satisfaction with mental health care and cardiac care will both be measured using 10-point Likert scales.

  7. Change in physical activity adherence [ Time Frame: Baseline, 26 weeks, 52 weeks ]
    Physical activity adherence will be measured by a 7-day physical activity recall assessment for physical activity using the International Physical Activity Questionnaire (IPAQ).

  8. Change in dietary adherence (saturated fat) [ Time Frame: Baseline, 26 weeks, 52 weeks ]
    Dietary adherence will be measured by assessing saturated fat using the MEDFICTS scale calibrated to American Heart Association guidelines.

  9. Change in dietary adherence (sodium intake) [ Time Frame: Baseline, 26 weeks, 52 weeks ]
    Dietary adherence will be assessed by sodium intake measured using the Scored Sodium Questionnaire (SSQ).

  10. Change in smoking [ Time Frame: Baseline, 26 weeks, 52 weeks ]
    Change in smoking will be measured by a 7-day point prevalence smoking assessment.

  11. Change in cardiac medication adherence [ Time Frame: Baseline, 26 weeks, 52 weeks ]
    Cardiac medication adherence will be assessed using the self-report medication adherence tool from the NHLBI Heart and Soul study.

  12. Major adverse cardiac events [ Time Frame: 52 weeks ]
    Major adverse cardiac events (MACE) will be defined as admission for an acute coronary event (ACS or new percutaneous intervention) or acute HF, or mortality.

  13. Healthcare costs [ Time Frame: 52 weeks ]
    Direct program costs will be measured by a compiled value from the following parts: (1) patient assessment (including Electronic Health Record [EHR] alerts/PROM); (2) care manager and other team member time (including training); (3) medications for psychiatric and cardiac conditions; (4) care registry development/maintenance; and (5) mental health specialty referrals. Patient costs include both direct costs (e.g., copayments) and indirect costs (patient time, valued via Bureau of Labor Statistics).

  14. Cost-effectiveness [ Time Frame: 52 weeks ]
    Cost effectiveness will be measured using the EQ-5D health utilities scale, which allows direct assessment of cost per quality-adjusted life year (QALY).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults with a primary medical provider in the Partners Healthcare System admitted to Massachusetts General Hospital (MGH) or Salem Hospital.
  2. Admission for acute coronary syndrome (myocardial infarction or unstable angina) or acute heart failure.
  3. 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.

Exclusion Criteria:

  1. Medical conditions precluding interviews or likely to lead to death within 6 months (per clinical team).
  2. Inability to participate in study procedures: cognitive deficits (via 6-item cognitive screen designed for research) or non-fluency in English.
  3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118752


Contacts
Contact: Jeff Huffman, MD 617-724-9141 jhuffman@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jeff Huffman, MD    617-724-2910    jhuffman@mgh.harvard.edu   
Principal Investigator: Jeff Huffman, MD         
Salem Hospital Recruiting
Salem, Massachusetts, United States, 01970
Contact: Mark Schechter, MD    978-354-4010    mschechter@partners.org   
Principal Investigator: Mark Schechter, MD         
Sponsors and Collaborators
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jeff C Huffman, MD Massachusetts General Hospital

Responsible Party: Jeff C. Huffman, MD, Associate Chief of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03118752     History of Changes
Other Study ID Numbers: 2016P002870
1R01HL133149-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators will download final research data, from which the investigators will generate deidentified datasets that are free of patient names, medical record numbers, addresses, or other personal identifiers. The investigators will also review the data to ensure that there is not additional information by which patients could be deductively identified. Data will be provided in a Microsoft Excel spreadsheet or in a file compatible with specific commonly used statistical packages (Stata, SPSS, and SAS). It will be deposited in the publicly available Dataverse repository used within the Harvard system.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Depression
Depressive Disorder
Anxiety Disorders
Panic Disorder
Mood Disorders
Mental Disorders
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Heart Failure
Acute Coronary Syndrome
Pathologic Processes
Behavioral Symptoms
Myocardial Ischemia