Depression Decision Aid: Feasibility Pilot

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02239367
• Other study ID #: 1401014663
• Secondary ID: P30MH085943
• Status: Completed
• Phase: N/A
• First received: September 4, 2014
• Last updated: January 23, 2017
• Start date: May 30, 2014
• Est. completion date: April 13, 2015

Study information

• Verified date: January 2017
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 13, 2015
• Est. primary completion date: April 13, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Lincoln Hospital- the New York City Health and Hospitals Corporation (HHC)	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of Depression Decision Aid protocol	The number of nurse's intervention sessions based on Electronic Health Record data	12 weeks
Secondary	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