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Depression Decision Aid: Feasibility Pilot

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Depression Decision Aid
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

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 21 years and older
  • Medical outpatient presenting to the Lincoln Hospital ambulatory care clinic or geriatric sub-specialty clinic
  • Screen positive for depression (Patient Health Questionnaire-9 score of 10 or greater)

Exclusion Criteria:

  • Presence of significant alcohol or substance abuse, psychotic disorder, or bipolar disorder
  • High suicide risk
  • Cognitive impairment: Mini Mental Status Exam (MMSE) score less than 24.
  • Acute or severe medical illness (ie. delirium, metastatic cancer, decompensated cardiac, liver, or kidney failure, major surgery, stroke, or myocardial infarction during the three months prior to entry.
  • Inability to speak English or Spanish
  • Aphasia interfering with communication

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Depression Decision Aid protocol

Arm Description

The Depression Decision Aid protocol, integrated into the Electronic Health Record (EHR), is a streamlined adaptation of an in-person Shared Decision-Making intervention. 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 the elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.

Outcomes

Primary Outcome Measures

Use of Depression Decision Aid protocol
The number of nurse's intervention sessions based on Electronic Health Record data

Secondary Outcome Measures

Satisfaction with the Decision Aid Measure
The Nurse Satisfaction Scale includes a measure of usefulness, clarity, ease of use, and feasibility in terms of timing when using the Decision Aid.

Full Information

First Posted
September 4, 2014
Last Updated
January 23, 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
NCT02239367
Brief Title
Depression Decision Aid: Feasibility Pilot
Official Title
Electronic Depression Decision Aid for Nurses in Primary Care: Development and Implementation in a Diverse Low-Income Population
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 30, 2014 (Actual)
Primary Completion Date
April 13, 2015 (Actual)
Study Completion Date
April 13, 2015 (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
The goal of this proposed pilot study is to test the feasibility and acceptability of a Depression Decision Aid (DDA) protocol integrated into the Electronic Health Record (EHR) and used by nurses with depressed ambulatory care patients. The Depression Decision Aid protocol is a streamlined adaptation of an in-person Shared Decision-Making (SDM) intervention, and its goal is to increase patient involvement in clinically appropriate treatment decision-making as a way of strengthening treatment engagement and outcomes. The protocol guides ambulatory care nurses in helping depressed patients (Patient Health Questionnaire-9 [PHQ-9] >10) develop informed treatment preferences through a process of education and values clarification. We will target patients in the general medical clinic, whether currently receiving depression treatment or not, because depression is highly prevalent but often poorly managed in this population.
Detailed Description
The aims of this project are to evaluate the acceptability and feasibility of an electronic Depression Decision Aid protocol with nurses and patients using questionnaire and administrative data. One to two nurses will deliver the Decision Aid protocol to 40 low-income patients (aged 21 and over) scoring >10 via routine PHQ-9 screening. Consenting nurses will be assessed regarding their satisfaction with the protocol following its use with each patient subject. Nurse fidelity to the protocol will be evaluated via their documentation of protocol use in the EHR. Consenting patient subjects will be assessed at baseline; week 1 to determine their decision about depression treatment, satisfaction with the decision-making process; and week 12 to determine treatment initiation or change, treatment adherence, and depressive status. Medical records will also be examined for documentation of medication prescription and other depression treatments. The study will test the following hypothesis concerning the Depression Decision Aid protocol: 1. Feasibility and Acceptability: a) At least 85% of each nurse's intervention sessions will meet fidelity standards via Electronic Health Record (EHR) data; b) Nurses will report high levels of satisfaction with the Decision Aid; c) Patients will report high levels of satisfaction with the decision-making process;

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Depression Decision Aid protocol
Arm Type
Experimental
Arm Description
The Depression Decision Aid protocol, integrated into the Electronic Health Record (EHR), is a streamlined adaptation of an in-person Shared Decision-Making intervention. 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 the elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.
Intervention Type
Behavioral
Intervention Name(s)
Depression Decision Aid
Other Intervention Name(s)
Shared Decision Making
Intervention Description
The Depression Decision Aid protocol, integrated into the Electronic Health Record (EHR), is a streamlined adaptation of an in-person Shared Decision-Making intervention.
Primary Outcome Measure Information:
Title
Use of Depression Decision Aid protocol
Description
The number of nurse's intervention sessions based on Electronic Health Record data
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Satisfaction with the Decision Aid Measure
Description
The Nurse Satisfaction Scale includes a measure of usefulness, clarity, ease of use, and feasibility in terms of timing when using the Decision Aid.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 21 years and older Medical outpatient presenting to the Lincoln Hospital ambulatory care clinic or geriatric sub-specialty clinic Screen positive for depression (Patient Health Questionnaire-9 score of 10 or greater) Exclusion Criteria: Presence of significant alcohol or substance abuse, psychotic disorder, or bipolar disorder High suicide risk Cognitive impairment: Mini Mental Status Exam (MMSE) score less than 24. Acute or severe medical illness (ie. delirium, metastatic cancer, decompensated cardiac, liver, or kidney failure, major surgery, stroke, or myocardial infarction during the three months prior to entry. Inability to speak English or Spanish 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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Depression Decision Aid: Feasibility Pilot

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