Clinical trial NCT01031134: Shared Decision-Making for Elderly Depressed Primary Care Patients
Official title: Shared Decision-Making for Elderly Depressed Primary Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-12-14
Enrollment: 202
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Who Adhered to Physician Recommended Treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Hamilton Depression Rating Scale Scores
timeFrame: Baseline and 12 week
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Lincoln Hospital - the New York City Health and Hospitals Corporation (HHC)
state: New York
city: White Plains
country: United States
facility: Cornell Institute of Geriatric Psychiatry
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Patrick J. Raue, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raue PJ, Schulberg HC, Bruce ML, Banerjee S, Artis A, Espejo M, Catalan I, Romero S. Effectiveness of Shared Decision-Making for Elderly Depressed Minority Primary Care Patients. Am J Geriatr Psychiatry. 2019 Aug;27(8):883-893. doi: 10.1016/j.jagp.2019.02.016. Epub 2019 Mar 1.