Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-25 @ 7:28 PM
Study NCT ID:
NCT02239367
Status:
COMPLETED
Last Update Posted:
2017-01-25
First Post:
2014-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Depression Decision Aid: Feasibility Pilot
Sponsor:
Weill Medical College of Cornell University
Organization:
Study Overview
Official Title:
Electronic Depression Decision Aid for Nurses in Primary Care: Development and Implementation in a Diverse Low-Income Population
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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;
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;
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30MH085943 | NIH | None | https://reporter.nih.gov/quic… | View |