Health TrialsbyHealthPanel

A Patient Activation Approach to Implementing Depression Treatment in Cardiac Patients

ConditionDepression and CVD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University

About this trial

This study, which is being conducted as part of a Quality Improvement (QI) Initiative at Columbia University Irving Medical Center, will test whether delivering the iHeart DepCare tool increases real world reach and adoption of depression treatment among CHD patients. As part of the QI Initiative, Clinic Navigators will administer and record (in EPIC) depression screening in advance of primary care and cardiology appointments. Eligible patients with elevated depressive symptoms will be randomized to receive usual care vs. the iHeart DepCare tool in conjunction with brief motivational, technical and navigation support per patient preference.

Aim 1: To test the effect of iHeart DepCare on depression treatment optimization (primary outcome) among coronary heart disease patients with elevated depressive symptoms.

Aim 2: To explore the effect of iHeart DepCare on implementation outcomes, including provider referrals, among coronary heart disease patients with elevated depressive symptoms.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Over 18 years of age

PHQ9 or PHQ8 score >=8

History of coronary heart disease per EHR search for ICD-9 codes of 410-414 and ICD-10 codes: I20, I21, I22, I23, I24, I25.

Appointment with a primary care provider (PCP) or cardiologist in an integrated care setting in NYP/Columbia (e.g., does not include procedure or lab-only visits)

Disqualifiers

Not English or Spanish speaking

History of severe mental illness (bipolar disorder, schizophrenia, chronic/recurrent depression, history of suicide attempt or self-inflicted injuries)

Dementia

Had an integrated mental health visit in the last 3 months as indicated in the EHR

Trial design

Design model

Parallel

Treatments tested in this trial

  • iHeart Depcare tool

    Behavioral

    The iHeart DepCare tool is an electronic patient activation and psychoeducation tool (available in English and Spanish) designed to bridge depression screening with treatment. The tool includes: 1) a description of depressive symptoms; 2) a checklist of behavioral risk factors; 3) an animation of a CVD patient going through the process of symptom recognition, help seeking, and treatment completion following a CVD event; 4) psychoeducation videos; 5) depression treatment selection support (adapted to include behavioral risk factor preferences); and 6) additional cardiac resources the patient can reference. Patients may receive brief motivational interviewing as well as technical/navigational support per patient preference to reinforce learning. Patient treatment preferences are sent via EPIC to the mental health and treating providers.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Screening aloneNo intervention 0 interventions
Group B: Screening plus iHeart DepCare tool and Motivational InterviewingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of eligible patients who initiate or intensify depression treatment

This is designed to measure depression treatment reach, which is defined as the percentage of eligible patients who initiate or intensify depression treatment within 6 months of the index visit, as indicated by ≥1 pharmacy fill data of a new or changed antidepressant and/or a new visit with a mental health provider (e.g., psychologist, psychiatrist, behavioral health provider like social workers) and/or primary care provider with a visit diagnosis of depression and/or an exercise program (e.g., cardiac rehabilitation), which will be assessed through chart extraction and tallied.

Time frame
Up to 6 months

Secondary outcomes

1

Percentage of patients in whom their clinician referred to mental health treatment

This is designed to measure treatment adoption, which is defined as the percentage of patients in whom their clinician referred to mental health treatment (e.g., collaborative care, psychotherapy, psychiatry, cardiac rehab) and/or prescribed/changed antidepressants and/or psychological/supportive counseling at the index visit, which will be assessed through chart extraction and tallied.

Time frame
Baseline
2

Mean adherence to cardiac medications

Mean adherence will be assessed as the mean proportion of days covered (PDC) for key cardiovascular disease medications (i.e., statin, antihypertensives) based on fill dates in the 3-9 months after the index visit.

Time frame
Approximately between 3 to 9 months from baseline

Other outcomes

Sponsors and contacts

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Columbia University

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov
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