Shared Decision-Making for Elderly Depressed Primary Care Patients

Not Applicable

Completed

• Conditions: Depression
• Interventions: Other: Usual Care; Behavioral: Shared Decision Making

• Registration Number: NCT01031134
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2009-12-11
• Study First Submitted QC: 2009-12-11
• Study First Posted: 2009-12-14
• Study Start: 2010-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Results First Submitted: 2017-01-27
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-31
• Last Update Submitted: 2017-03-31
• Results First Posted: 2017-06-16
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Physician Usual Care of depressed patients.
Shared Decision Making	Shared Decision Making	1 in person session followed by 2 telephone calls 1 and 2 weeks later.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Adhered to Physician Recommended Treatment	12 weeks	Any mental health service use over 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Change in Hamilton Depression Rating Scale Scores	Baseline and 12 week	Hamilton Depression Rating Scale change score from baseline to 12 weeks. This scale measures severity of depressive symptoms (range 0-76), with higher scores indicating more severe symptomatology.

Trial Locations

Locations (2)

Lincoln Hospital - the New York City Health and Hospitals Corporation (HHC); 🇺🇸 Bronx, New York, United States

Cornell Institute of Geriatric Psychiatry; 🇺🇸 White Plains, New York, United States