Outreach to Reduce Depression Disparities
Primary Purpose
Depression
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Outreach messaging
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria:
- New diagnosis of major depressive disorder or dysthymic disorder at a primary care visit ("new" defined as no depression diagnosis, psychotherapy visit or filled antidepressant prescription in the prior year)
- Continuously enrolled in the participating health system for 365 days prior to the eligible diagnosis (to assure capture of prior diagnoses or treatments)
- PHQ-9 depression score of 10 or more within 14 days before to 7 days after the eligible diagnosis
- No filled prescription for any antidepressant medication OR psychotherapy visit attended within 30 days of the eligible diagnosis*
- No recorded PHQ-9 depression score less than 5 since the eligible diagnosis
- At least 18 years of age or older
Exclusion Criteria:
- Diagnosis of schizophrenia or bipolar disorder in the prior 2 years
- Not registered to use EHR patient portal
- Previously requested to not be contacted for research
Sites / Locations
- Kaiser Permanente, Hawaii Market
- Henry Ford Health
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Care
Outreach Messaging
Arm Description
Participants assigned to usual care will not receive outreach messages (online or via telephone) by study staff.
Participants in the outreach messaging arm will receive messages via online secure message system (embedded within the health care record) and/or telephone.
Outcomes
Primary Outcome Measures
Initiation of formal depression treatment
Defined as either at least one filled prescription for any antidepressant medication or attending at least one individual psychotherapy visit.
Secondary Outcome Measures
Full Information
NCT ID
NCT05580406
First Posted
October 11, 2022
Last Updated
August 22, 2023
Sponsor
Kaiser Permanente
Collaborators
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT05580406
Brief Title
Outreach to Reduce Depression Disparities
Official Title
Outreach to Reduce Depression Disparities
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 13, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Henry Ford Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Previous research by Mental Health Research Network (MHRN) investigators and others demonstrates that online messaging and other telehealth technologies can effectively and efficiently address premature discontinuation of depression treatment. These interventions, however, have focused on adherence after treatment initiation and have been tested primarily in non-Hispanic white populations. Less is known about the acceptability and effectiveness of different communication modalities (online messaging, mailed letters, telephone) among racial and ethnic minority populations. Implementation of electronic-Health (eHealth) technologies must take care not to exacerbate health disparities.
This clinical trial involves a pilot trial to evaluate a population-based outreach program to improve rates of depression treatment initiation among traditionally underserved racial and ethnic groups. This pilot work intends to inform a subsequent full-scale pragmatic trial to examine impact on health disparities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants assigned to usual care will not receive outreach messages (online or via telephone) by study staff.
Arm Title
Outreach Messaging
Arm Type
Experimental
Arm Description
Participants in the outreach messaging arm will receive messages via online secure message system (embedded within the health care record) and/or telephone.
Intervention Type
Behavioral
Intervention Name(s)
Outreach messaging
Intervention Description
Participants will receive outreach messages via health care system secure messaging and/or phone following a new diagnosis of depression made in primary care if the participant has failed to initiate treatment (pharmacotherapy or psychotherapy) within 30 days of new diagnosis.
Primary Outcome Measure Information:
Title
Initiation of formal depression treatment
Description
Defined as either at least one filled prescription for any antidepressant medication or attending at least one individual psychotherapy visit.
Time Frame
within 60 days of randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
New diagnosis of major depressive disorder or dysthymic disorder at a primary care visit ("new" defined as no depression diagnosis, psychotherapy visit or filled antidepressant prescription in the prior year)
Continuously enrolled in the participating health system for 365 days prior to the eligible diagnosis (to assure capture of prior diagnoses or treatments)
Patients Health Questionnaire-9 (PHQ-9) depression score of 10 or more within 14 days before to 7 days after the eligible diagnosis
No filled prescription for any antidepressant medication OR psychotherapy visit attended within 30 days of the eligible diagnosis*
No recorded PHQ-9 depression score less than 5 since the eligible diagnosis
At least 18 years of age or older
Exclusion Criteria:
Diagnosis of schizophrenia or bipolar disorder in the prior 2 years
Not registered to use Electronic Health Record (EHR) patient portal
Previously requested to not be contacted for research
Facility Information:
Facility Name
Kaiser Permanente, Hawaii Market
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Henry Ford Health
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Outreach to Reduce Depression Disparities
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