Shared Decision-Making for Elderly Depressed Primary Care Patients
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Health Services Research
|Official Title:||Shared Decision-Making for Elderly Depressed Primary Care Patients|
- Number of Participants Who Adhered to Physician Recommended Treatment [ Time Frame: 12 weeks ]Any mental health service use over 12 weeks.
- Change in Hamilton Depression Rating Scale Scores [ Time Frame: 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.
|Actual Study Start Date:||April 2010|
|Study Completion Date:||April 2016|
|Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Experimental: Shared Decision Making
1 in person session followed by 2 telephone calls 1 and 2 weeks later.
Behavioral: Shared Decision Making
Shared decision-making, 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 focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.
Active Comparator: Usual Care
Physician Usual Care of depressed patients.
Other: Usual Care
Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031134
|United States, New York|
|Lincoln Hospital - the New York City Health and Hospitals Corporation (HHC)|
|Bronx, New York, United States, 10451|
|Cornell Institute of Geriatric Psychiatry|
|White Plains, New York, United States, 10605|
|Principal Investigator:||Patrick J. Raue, Ph.D.||Weill Medical College of Cornell University|