Depression Decision Aid: Feasibility Pilot

NCT02239367 | Completed DMC

• 2 other identifiers: 1401014663P30MH085943
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Use of Depression Decision Aid protocol

  The number of nurse's intervention sessions based on Electronic Health Record data

  12 weeks

Secondary Outcomes (1)

• Satisfaction with the Decision Aid Measure

  12 weeks

Study Arms (1)

Depression Decision Aid protocol

EXPERIMENTAL

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

Interventions

Depression Decision Aid BEHAVIORAL

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

Also known as: Shared Decision Making

Depression Decision Aid protocol

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

The Bronx, New York, 10451, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Patrick J Raue, Ph.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 12, 2014
• Study Start: May 30, 2014
• Primary Completion: April 13, 2015
• Study Completion: April 13, 2015
• Last Updated: January 25, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)