We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02976025
Recruitment Status : Not yet recruiting
First Posted : November 29, 2016
Last Update Posted : November 29, 2016
Information provided by (Responsible Party):

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 receiving care from federally qualified health centers (FQHCs). All participating FQHCs will receive training in collaborative care. Cluster randomization will be used to assign the addition of LRC to select FQHCs. Differences in implementation success, clinical outcomes, and costs will be compared after a 12 month implementation period and 13-21 month sustainment period.

Condition or disease Intervention/treatment
Perinatal Depression Other: Longitudinal Remote Consultation Other: Collaborative Care

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. We 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 federally qualified health centers (FQHCs) providing prenatal care and which are part of the national OCHIN 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Remote Supervision for Implementing Collaborative Care for Perinatal Depression
Study Start Date : January 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Longitudinal Remote Consultation
This is the active treatment arm consisting of 10 cluster randomized federally qualified health centers receiving both training in collaborative care and longitudinal remote consultation (LRC) support.
Other: Longitudinal Remote Consultation
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
Other Name: LRC
Active Comparator: Collaborative Care
This comparator arm will consist of 10 cluster randomized federally qualified health centers who receive training in collaborative care.
Other: Collaborative Care
Standard collaborative care implementation training and support
Other Name: CC

Outcome Measures

Primary Outcome Measures :
  1. Clinical depression outcomes [ Time Frame: 12 months post-initiation of collaborative care ]
    Patient Health Questionnaire-9 (PHQ-9); level of depression symptomatology and functional impairment

Secondary Outcome Measures :
  1. Implementation Outcomes [ Time Frame: 12 month post implementation of collaborative care ]
    To assess the degree to which sites in the two conditions complete implementation we will use the Stages of Implementation Completion tool tailored for collaborative care, SIC-CC

Other Outcome Measures:
  1. Cost and cost-effectiveness [ Time Frame: 12-month post-implementation of collaborative care ]
    For a cost-benefit analysis, we 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.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Patient Participants:

Inclusion: Patient participants must be perinatal women, age 18-45, receiving care at one of the 20 OCHIN health centers participating in the study and have major depression defined by ≥10 on the PHQ-9.

Exclusion: age <18 or >45, male

FQHC Participating Sites:

Inclusion: Must be part of the OCHIN network with perinatal patient population

Exclusion: Outside OCHIN network

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02976025

Contact: Perry Foley foleyp@ochin.org

Sponsors and Collaborators
University of Washington
Ochin, Inc.
Oregon Social Learning Center
University of Pennsylvania
Washington University School of Medicine
Principal Investigator: Ian Bennett University of Washington
More Information

Responsible Party: Ian Bennett, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT02976025     History of Changes
Other Study ID Numbers: 1R01MH108548-01 ( U.S. NIH Grant/Contract )
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We intend to share de-identified data once study is complete.

Additional relevant MeSH terms:
Depressive Disorder
Asphyxia Neonatorum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Infant, Newborn, Diseases