Shared Decision-Making for Elderly Depressed Primary Care Patients

Weill Cornell Medicine (WCM) logo

Weill Cornell Medicine (WCM)

Status

Completed

Conditions

Depression

Treatments

Other: Usual Care
Behavioral: Shared Decision Making

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01031134
1R01MH084872-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Shared decision-making (SDM), in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The proposed study will evaluate the impact of a brief SDM nursing intervention among elderly, depressed primary care patient subjects in comparison to physician recommended Usual Care. The focus of the SDM intervention is to empower depressed patients and help them arrive at a treatment decision that can be successfully carried out.

Full description

Shared Decision Making (SDM) may be particularly relevant for depressed individuals, as it seeks to enhance their autonomy and empowerment in a manner that directly addresses the helplessness and hopelessness associated with depression. Shared decision-making interventions are being developed for depression in primary care, but have yet to be adequately tested. It is also unknown whether the same premises regarding shared decision-making's ability to enhance autonomy and empowerment pertain to elderly populations. This randomized study will recruit elderly depressed primary care patient subjects and evaluate the impact of a three-session SDM nursing intervention on their (1) adherence to antidepressant medication or psychotherapy and on (2) their reduction in depressive symptoms. The comparison group will be physician-recommended Usual Care (UC). The focus of the SDM intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented. The study randomizes physicians to provide their depressed patients with SDM or UC. A total of 210 elderly depressed patient subjects whose physicians recommend starting depression treatment, will receive either Shared Decision-Making (SDM) or the physician recommended Usual Care (UC) comparison condition. Participants will be assessed at baseline and at weeks 4, 8, 12, and 24 to determine treatment adherence and depressive status. Nurses currently employed by the participating physicians will administer the SDM intervention.

Enrollment

202 patients

Sex

All

Ages

65 to 95 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age: 65 years and older;
  • Medical outpatient presenting to Lincoln Hospital, Bronx NY, the New York City Health and Hospitals Corporation (HHC);
  • Screen positive (PHQ-9 score>9 for depression, in addition to primary care physician recommendation for depression treatment.

Exclusion criteria

  • Presence of significant alcohol or substance abuse, psychotic disorder, or bipolar disorder;
  • High suicide risk, i.e. intent or plan to attempt suicide in near future;
  • Current treatment with antidepressant medication or psychotherapy prior to index physician visit (with the exception of low doses of antidepressant medication for pain disorders);
  • Cognitive impairment: MMSE score <20 or clinical diagnosis of dementia;
  • Acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver, or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or drugs often causing depression, e.g., steroids, reserpine, alpha-methyl-dopa, tamoxifen, vincristine;
  • Aphasia interfering with communication.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

202 participants in 2 patient groups

Shared Decision Making
Experimental group
Description:
1 in person session followed by 2 telephone calls 1 and 2 weeks later.
Treatment:
Behavioral: Shared Decision Making
Usual Care
Active Comparator group
Description:
Physician Usual Care of depressed patients.
Treatment:
Other: Usual Care

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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