Shared Decision-Making for Elderly Depressed Primary Care Patients - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT01031134

Purpose

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.

Condition	Intervention
Depression	Behavioral: Shared Decision Making Other: Usual Care

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Shared Decision-Making for Elderly Depressed Primary Care Patients

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Adherence to physician recommended treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Depression symptom reduction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	210
Study Start Date:	January 2010
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Shared Decision Making	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	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.

Arms

Assigned Interventions

Experimental: Shared Decision Making

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

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.

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

Ages Eligible for Study:	65 Years to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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>15) 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 <24 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01031134

Contacts

Contact: Timothy E Clark, MTS

914-997-4390

tec2004@med.cornell.edu

Locations

United States, New York
Lincoln Hospital - the New York City Health and Hospitals Corporation (HHC)	Recruiting
Bronx, New York, United States, 10451
Principal Investigator: Patrick J. Raue, Ph.D.
Cornell Institute of Geriatric Psychiatry	Recruiting
White Plains, New York, United States, 10605
Principal Investigator: Patrick J. Raue, Ph.D.

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Patrick J. Raue, Ph.D.

Weill Medical College of Cornell University

More Information

No publications provided

Responsible Party:	Patrick J. Raue, Ph.D. - Associate Professor of Psychology in Psychiatry, Weill Cornell Medical College
ClinicalTrials.gov Identifier:	NCT01031134 History of Changes
Other Study ID Numbers:	1 R01 MH084872-01A1
Study First Received:	December 11, 2009
Last Updated:	March 29, 2011
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Additional relevant MeSH terms:

Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012