Shared Decision-Making for Elderly Depressed Primary Care Patients

NCT01031134 | Completed Results DMC

• 1 other identifier: 1R01MH084872-01A1
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Adhered to Physician Recommended Treatment

  Any mental health service use over 12 weeks.

  12 weeks

Secondary Outcomes (1)

• Change in Hamilton Depression Rating Scale Scores

  Baseline and 12 week

Study Arms (2)

Shared Decision Making

EXPERIMENTAL

1 in person session followed by 2 telephone calls 1 and 2 weeks later.

Behavioral: Shared Decision Making

Usual Care

ACTIVE COMPARATOR

Physician Usual Care of depressed patients.

Other: Usual Care

Interventions

Shared Decision Making BEHAVIORAL

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.

Shared Decision Making

Usual Care OTHER

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.

Usual Care

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Lincoln Hospital - the New York City Health and Hospitals Corporation (HHC)

The Bronx, New York, 10451, United States

Location

Cornell Institute of Geriatric Psychiatry

White Plains, New York, 10605, United States

Location

Related Publications (1)

• 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.

  PMID: 30967321 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Patrick Raue, Ph.D.
• Organization: Weill Cornell Medical College

praue@uw.edu

206-543-3807

Study Officials

• Patrick J. Raue, Ph.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2009
• First Posted: December 14, 2009
• Study Start: April 1, 2010
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 16, 2017
• Results First Posted: June 16, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)