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CompletedNCT02239367Updated Jan 25, 2017

Depression Decision Aid: Feasibility Pilot

An interventional study of Depression Decision Aid in Depression, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2017-01-25.

Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled May 2014, registered Sep 2014).
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
21 Years and older
Sex
All
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Study 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.

Read the 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;
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Conditions studied

03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 18 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.

Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralDepression 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.

    Also known as: Shared Decision Making

06

What researchers measure

Primary outcomes

  1. Use of Depression Decision Aid protocol

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

    Time frame: 12 weeks

Secondary outcomes

  1. 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.

    Time frame: 12 weeks

07

Study locations

1 site
  • Lincoln Hospital- the New York City Health and Hospitals Corporation (HHC)
    Bronx, New York 10451, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02239367
Lead sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Sep 12, 2014
Start date
May 30, 2014
Primary completion
Apr 13, 2015
Completion
Apr 13, 2015
Last update
Jan 25, 2017

Study contacts

Patrick J Raue, Ph.D.
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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