Depression Decision Aid: Feasibility Pilot

NCT ID: NCT02239367

Last Updated: 2017-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-30
• Study Completion Date: 2015-04-13

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;

Conditions

Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Depression Decision Aid

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Shared Decision Making

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick J Raue, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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

The Bronx, New York, United States

Countries

United States

Other Identifiers

P30MH085943

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1401014663

Identifier Type: -

Identifier Source: org_study_id