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Shared Decision-Making for Elderly Depressed Primary Care Patients

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shared Decision Making
Usual Care
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression

Eligibility Criteria

65 Years - 95 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lincoln Hospital - the New York City Health and Hospitals Corporation (HHC)
  • Cornell Institute of Geriatric Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Shared Decision Making

Usual Care

Arm Description

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

Physician Usual Care of depressed patients.

Outcomes

Primary Outcome Measures

Number of Participants Who Adhered to Physician Recommended Treatment
Any mental health service use over 12 weeks.

Secondary Outcome Measures

Change in Hamilton Depression Rating Scale Scores
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.

Full Information

First Posted
December 11, 2009
Last Updated
March 31, 2017
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01031134
Brief Title
Shared Decision-Making for Elderly Depressed Primary Care Patients
Official Title
Shared Decision-Making for Elderly Depressed Primary Care Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2010 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shared Decision Making
Arm Type
Experimental
Arm Description
1 in person session followed by 2 telephone calls 1 and 2 weeks later.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Physician Usual Care of depressed patients.
Intervention Type
Behavioral
Intervention Name(s)
Shared Decision Making
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Who Adhered to Physician Recommended Treatment
Description
Any mental health service use over 12 weeks.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Hamilton Depression Rating Scale Scores
Description
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.
Time Frame
Baseline and 12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J. Raue, Ph.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lincoln Hospital - the New York City Health and Hospitals Corporation (HHC)
City
Bronx
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Facility Name
Cornell Institute of Geriatric Psychiatry
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30967321
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.
Results Reference
derived

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Shared Decision-Making for Elderly Depressed Primary Care Patients

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