Depression Decision Aid: Feasibility Pilot

Electronic Depression Decision Aid for Nurses in Primary Care: Development and Implementation in a Diverse Low-Income Population

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Depression Decision Aid

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;

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10451
      • Lincoln Hospital- the New York City Health and Hospitals Corporation (HHC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Depression Decision Aid protocol; 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.

Behavioral: Depression Decision Aid; The Depression Decision Aid protocol, integrated into the Electronic Health Record (EHR), is a streamlined adaptation of an in-person Shared Decision-Making intervention.; Other Names: Shared Decision Making

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of Depression Decision Aid protocol	The number of nurse's intervention sessions based on Electronic Health Record data	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Patrick J Raue, Ph.D., Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2014
• Primary Completion (Actual): April 13, 2015
• Study Completion (Actual): April 13, 2015

Study Registration Dates

• First Submitted: September 4, 2014
• First Submitted That Met QC Criteria: September 10, 2014
• First Posted (Estimate): September 12, 2014

Study Record Updates

• Last Update Posted (Estimate): January 25, 2017
• Last Update Submitted That Met QC Criteria: January 23, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 1401014663; P30MH085943 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO