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Pragmatic Collaborative Care for Cardiac Inpatients With Depression or Anxiety

Primary Purpose

Acute Coronary Syndrome, Heart Failure, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative Care
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults with a primary medical provider in the Partners Healthcare System admitted to Massachusetts General Hospital (MGH) or Brigham and Women's Hospital (BWH).
  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.

Sites / Locations

  • Massachusetts General HospitalRecruiting
  • Brigham and Women's HospitalRecruiting
  • Salem Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Collaborative Care

Enhanced Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in generic health-related quality of life
Generic HRQoL will be assessed via the Medical Outcomes Study SF-12 (SF-12).
Change in disease-specific health-related quality of life
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).
Change in mental health (depression)
Depression will be measured by the 20-item Symptom Checklist Depression Scale (SCL-20).
Change in mental health (anxiety)
Anxiety will be measured by the Hospital Anxiety and Depression Scale, Anxiety Subscale (HADS-A).
Change in optimism
Optimism will be assessed via the well-validated Life Orientation Test-Revised (LOT-R)
Change in patient satisfaction
Participant satisfaction with mental health care and cardiac care will both be measured using 10-point Likert scales.
Change in physical activity adherence
Physical activity adherence will be measured by a 7-day physical activity recall assessment for physical activity using the International Physical Activity Questionnaire (IPAQ).
Change in dietary adherence (saturated fat)
Dietary adherence will be measured by assessing saturated fat using the MEDFICTS scale calibrated to American Heart Association guidelines.
Change in dietary adherence (sodium intake)
Dietary adherence will be assessed by sodium intake measured using the Scored Sodium Questionnaire (SSQ).
Change in smoking
Change in smoking will be measured by a 7-day point prevalence smoking assessment.
Change in cardiac medication adherence
Cardiac medication adherence will be assessed using the self-report medication adherence tool from the NHLBI Heart and Soul study.
Major adverse cardiac events
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.
Healthcare costs
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).
Cost-effectiveness
Cost effectiveness will be measured using the EQ-5D health utilities scale, which allows direct assessment of cost per quality-adjusted life year (QALY).

Full Information

First Posted
April 6, 2017
Last Updated
September 11, 2023
Sponsor
Massachusetts General Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03118752
Brief Title
Pragmatic Collaborative Care for Cardiac Inpatients With Depression or Anxiety
Official Title
Pragmatic Collaborative Care for Cardiac Inpatients With Depression or Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
March 28, 2024 (Anticipated)
Study Completion Date
March 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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. Procedures for Participants in Enhanced Usual Care. For participants randomized to eUC, baseline psychiatric and medical assessments will be transmitted to the patient's electronic health record. During the enrollment admission, the care manager will also inform the participant and treatment team about the specific symptoms on the study instruments and their clinical relevance (and will alert teams to the data transmitted to the electronic health record). eUC participants also will be free to receive any treatment for mental health or cardiac conditions throughout the study. At follow-up study assessments for eUC (and CC) participants at 26 and 52 weeks, psychiatric symptom data will be transmitted to the electronic health record, and providers will be alerted if psychiatric symptoms persist. If acute safety concerns are identified at follow-ups or other contacts, the study team will also arrange as-needed urgent care). Finally, the investigators will provide eUC participants with blood pressure cuffs and/or scales if needed, to ensure that outcome improvements in CC are not simply due to their provision. Study Endpoints. Functional, HRQoL, psychological, and care process outcomes (Specific Aim 1) The investigators will assess the intervention's impact on multiple functional and psychological outcomes, including physical function (using the Duke Activity Status Index (primary study outcome), generic HRQoL (Medical Outcomes Study SF-12), disease-specific HRQoL (Kansas City Cardiomyopathy Questionnaire, Seattle Angina Questionnaire), depression (SCL-20), anxiety (Hospital Anxiety and Depression Scale - anxiety subscale), optimism (Life Orientation Test - Revised), and participant satisfaction. Behavioral and medical outcomes (Specific Aim 2) The investigators will assess the intervention's impact on adherence to medications (using the self-report medication adherence tool from the NHLBI Heart and Soul study), diet (using the MEDFICTS (meats, eggs, dairy, fried foods, fat in baked goods, convenience foods, fats added at the table, and snacks) scale for saturated fat intake and the Scored Sodium Questionnaire for sodium intake), physical activity (using the International Physical Activity Questionnaire), and smoking (7-day point prevalence smoking assessment). The investigators also will monitor for major adverse cardiac events (defined as admission for an ACS, percutaneous intervention, or acute HF, or mortality). Cost and related outcomes (Specific Aim 3) Finally, the investigators will monitor medical utilization using Partners Healthcare records ahd the Massachusetts All Payer Claims Database. For cost effectiveness, the investigators will use the EuroQol five dimensions questionnaire (EQ-5D) health utilities scale, which allows direct assessment of cost per quality-adjusted life year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Heart Failure, Depression, Generalized Anxiety Disorder, Panic Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will be a randomized, controlled, 2-arm, single blinded trial.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Collaborative Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Collaborative Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in physical function
Description
Physical function will be assessed with the Duke Activity Status Index (DASI).
Time Frame
Baseline, 26 weeks, 52 weeks
Secondary Outcome Measure Information:
Title
Change in generic health-related quality of life
Description
Generic HRQoL will be assessed via the Medical Outcomes Study SF-12 (SF-12).
Time Frame
Baseline, 26 weeks, 52 weeks
Title
Change in disease-specific health-related quality of life
Description
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).
Time Frame
Baseline, 26 weeks, 52 weeks
Title
Change in mental health (depression)
Description
Depression will be measured by the 20-item Symptom Checklist Depression Scale (SCL-20).
Time Frame
Baseline, 26 weeks, 52 weeks
Title
Change in mental health (anxiety)
Description
Anxiety will be measured by the Hospital Anxiety and Depression Scale, Anxiety Subscale (HADS-A).
Time Frame
Baseline, 26 weeks, 52 weeks
Title
Change in optimism
Description
Optimism will be assessed via the well-validated Life Orientation Test-Revised (LOT-R)
Time Frame
Baseline, 26 weeks, 52 weeks
Title
Change in patient satisfaction
Description
Participant satisfaction with mental health care and cardiac care will both be measured using 10-point Likert scales.
Time Frame
Baseline, 26 weeks, 52 weeks
Title
Change in physical activity adherence
Description
Physical activity adherence will be measured by a 7-day physical activity recall assessment for physical activity using the International Physical Activity Questionnaire (IPAQ).
Time Frame
Baseline, 26 weeks, 52 weeks
Title
Change in dietary adherence (saturated fat)
Description
Dietary adherence will be measured by assessing saturated fat using the MEDFICTS scale calibrated to American Heart Association guidelines.
Time Frame
Baseline, 26 weeks, 52 weeks
Title
Change in dietary adherence (sodium intake)
Description
Dietary adherence will be assessed by sodium intake measured using the Scored Sodium Questionnaire (SSQ).
Time Frame
Baseline, 26 weeks, 52 weeks
Title
Change in smoking
Description
Change in smoking will be measured by a 7-day point prevalence smoking assessment.
Time Frame
Baseline, 26 weeks, 52 weeks
Title
Change in cardiac medication adherence
Description
Cardiac medication adherence will be assessed using the self-report medication adherence tool from the NHLBI Heart and Soul study.
Time Frame
Baseline, 26 weeks, 52 weeks
Title
Major adverse cardiac events
Description
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.
Time Frame
52 weeks
Title
Healthcare costs
Description
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).
Time Frame
52 weeks
Title
Cost-effectiveness
Description
Cost effectiveness will be measured using the EQ-5D health utilities scale, which allows direct assessment of cost per quality-adjusted life year (QALY).
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeff Huffman, MD
Phone
617-724-9141
Email
jhuffman@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff C Huffman, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff Huffman, MD
Phone
617-724-2910
Email
jhuffman@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Jeff Huffman, MD
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hermioni Amonoo, MD, MPP
Phone
617-732-6727
Email
Hermioni_Amonoo@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Hermioni Amonoo, MD, MPP
Facility Name
Salem Hospital
City
Salem
State/Province
Massachusetts
ZIP/Postal Code
01970
Country
United States
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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Pragmatic Collaborative Care for Cardiac Inpatients With Depression or Anxiety

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