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Remote Supervision for Implementing Collaborative Care for Perinatal Depression (MInD-I)

Primary Purpose

Perinatal Depression

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Longitudinal Remote Consultation
Collaborative Care
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Perinatal Depression

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Patient Participants:

Inclusion Criteria:

  • Patient participants must be perinatal women,
  • Age 18-45,
  • Receiving care at one of the 20 OCHIN or non-OCHIN health centers participating in the study and must have major depression as determined by a score of ≥10 on the PHQ-9 depression screener.

Exclusion Criteria:

  • Age <18 or >45,
  • Male.

Health Center Participating Sites:

Inclusion Criteria:

  • Use of the shared OCHIN Epic electronic record for perinatal care or use of the secure AIMS CMTS/Caseload Tracker/spreadsheet patient registry for perinatal care and
  • A minimum of 50 prenatal patients annually.

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Longitudinal Remote Consultation

Collaborative Care

Arm Description

This is the active treatment arm consisting of 10 cluster randomized health centers receiving both training in collaborative care and longitudinal remote consultation (LRC) support.

This comparator arm will consist of 10 cluster randomized health centers who receive training in collaborative care.

Outcomes

Primary Outcome Measures

Clinical depression outcomes
Patient Health Questionnaire-9 (PHQ-9); level of depression symptomatology and functional impairment.

Secondary Outcome Measures

Implementation outcomes
To assess the degree to which sites in the two conditions complete implementation, the investigators will use the Stages of Implementation Completion tool tailored for collaborative care, SIC-CC.

Full Information

First Posted
November 23, 2016
Last Updated
April 27, 2021
Sponsor
University of Washington
Collaborators
OCHIN, Inc., Oregon Social Learning Center, University of Pennsylvania, Washington University School of Medicine, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02976025
Brief Title
Remote Supervision for Implementing Collaborative Care for Perinatal Depression
Acronym
MInD-I
Official Title
Remote Supervision for Implementing Collaborative Care for Perinatal Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
OCHIN, Inc., Oregon Social Learning Center, University of Pennsylvania, Washington University School of Medicine, National Institute of Mental Health (NIMH)

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
This study evaluates the impact of a longitudinal remote consultation (LRC) implementation strategy for collaborative care depression treatment among perinatal women. All participating health centers will receive training in collaborative care. Cluster randomization will be used to assign the addition of LRC to select health centers. Differences in implementation success, clinical outcomes, and costs will be compared after a 12 month implementation period and 13-21 month sustainment period.
Detailed Description
Depression is a common and serious disorder among pregnant women but few from low income groups receive effective treatment. The highly evidence based collaborative care (CC) model for depression has been shown to work for women in pregnancy but has not been widely implemented in this population. The proposed study targets improving dissemination of the evidence based CC treatment model for pregnant and postpartum women with depression, a common disorder of the perinatal period (pregnancy and the first year following birth). Longitudinal remote consultation (LRC) is an implementation strategy that has been have shown to improve fidelity to evidence-based practices and patient outcomes for mental health innovations. The investigators believe LRC can be used with equal benefit for complex interventions such as CC. The purpose of this study is to compare two implementation strategies for Collaborative Care depression treatment: 1) standard implementation and 2) standard implementation + Longitudinal Remote Consultation (LRC). This research is being done in order to assess implementation and patient outcomes in sites receiving a standard implementation approach with and without LRC. The results of the proposed study will provide information on the benefits and relative value of ongoing consultation, such as LRC, for implementation of complex interventions like collaborative care. The proposed study will involve twenty health centers providing prenatal care which are part of the national OCHIN Network or other health center network. All sites will receive a standard implementation approach. After pre-implementation training ten of the sites will be randomly selected to receive LRC. Implementation and clinical outcomes as well as costs will be compared between the study conditions after a 12 month implementation period and a 13-21 month sustainment period. The results of the proposed study will provide critical generalizable knowledge regarding the benefits of ongoing consultation for implementation of complex interventions like collaborative care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Depression

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Longitudinal Remote Consultation
Arm Type
Experimental
Arm Description
This is the active treatment arm consisting of 10 cluster randomized health centers receiving both training in collaborative care and longitudinal remote consultation (LRC) support.
Arm Title
Collaborative Care
Arm Type
Active Comparator
Arm Description
This comparator arm will consist of 10 cluster randomized health centers who receive training in collaborative care.
Intervention Type
Other
Intervention Name(s)
Longitudinal Remote Consultation
Other Intervention Name(s)
LRC
Intervention Description
Longitudinal Remote Consultation utilizes video conferencing to efficiently link providers to consultants who provide timely feedback and training in collaborative care. LRC will be provided in addition to standard collaborative care training and support.
Intervention Type
Other
Intervention Name(s)
Collaborative Care
Other Intervention Name(s)
CC
Intervention Description
Standard collaborative care implementation training and support.
Primary Outcome Measure Information:
Title
Clinical depression outcomes
Description
Patient Health Questionnaire-9 (PHQ-9); level of depression symptomatology and functional impairment.
Time Frame
12 months post-initiation of collaborative care
Secondary Outcome Measure Information:
Title
Implementation outcomes
Description
To assess the degree to which sites in the two conditions complete implementation, the investigators will use the Stages of Implementation Completion tool tailored for collaborative care, SIC-CC.
Time Frame
12 month post-implementation of collaborative care
Other Pre-specified Outcome Measures:
Title
Cost and cost-effectiveness
Description
For a cost-benefit analysis, the investigators will use of the Cost of Implementing New Strategies (COINS) method to assess costs in the two conditions. This methodology takes advantage of the SIC-CC instrument as a costing template to map the use of resources and associated costs to these to study conditions. Costs associated with implementation in each of these conditions will be carried out for all 20 health centers included in the study.
Time Frame
12-month post-implementation of collaborative care

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patient Participants: Inclusion Criteria: Patient participants must be perinatal women, Age 18-45, Receiving care at one of the 20 OCHIN or non-OCHIN health centers participating in the study and must have major depression as determined by a score of ≥10 on the PHQ-9 depression screener. Exclusion Criteria: Age <18 or >45, Male. Health Center Participating Sites: Inclusion Criteria: Use of the shared OCHIN Epic electronic record for perinatal care or use of the secure AIMS CMTS/Caseload Tracker/spreadsheet patient registry for perinatal care and A minimum of 50 prenatal patients annually.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Bennett
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We intend to share de-identified data once study is complete.

Learn more about this trial

Remote Supervision for Implementing Collaborative Care for Perinatal Depression

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