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Shared Decision-Making for Elderly Depressed Primary Care Patients

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01031134
First received: December 11, 2009
Last updated: March 31, 2017
Last verified: March 2017
  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: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Shared Decision-Making for Elderly Depressed Primary Care Patients

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Number of Participants Who Adhered to Physician Recommended Treatment [ Time Frame: 12 weeks ]
    Any mental health service use over 12 weeks.


Secondary Outcome Measures:
  • 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.


Enrollment: 202
Actual Study Start Date: April 2010
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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   (Adult, Senior)
Sexes Eligible for Study:   All
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>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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Patrick J. Raue, Ph.D. Weill Medical College of Cornell University
  More Information

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01031134     History of Changes
Other Study ID Numbers: 1R01MH084872-01A1 ( U.S. NIH Grant/Contract )
Study First Received: December 11, 2009
Results First Received: January 27, 2017
Last Updated: March 31, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

ClinicalTrials.gov processed this record on September 21, 2017