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Completed

NCT Number: NCT02239367

Depression Decision Aid: Feasibility Pilot

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

The Bronx, New York, 10451, United States

About this study

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:

  • 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;

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Shared Decision Making

Primary outcomes

  1. Use of Depression Decision Aid protocol

    Time frame: 12 weeks

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

Secondary outcomes

  1. Satisfaction with the Decision Aid Measure

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 12, 2014
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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