Pragmatic Collaborative Care for Cardiac Inpatients With Depression or Anxiety

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.

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.