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

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified November 2016 by Ian Bennett, University of Washington
Sponsor:
Collaborators:
Ochin, Inc.
Oregon Social Learning Center
University of Pennsylvania
Washington University School of Medicine
Information provided by (Responsible Party):
Ian Bennett, University of Washington
ClinicalTrials.gov Identifier:
NCT02976025
First received: November 23, 2016
Last updated: NA
Last verified: November 2016
History: No changes posted
  Purpose
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 Intervention
Perinatal Depression Other: Longitudinal Remote Consultation Other: Collaborative Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Remote Supervision for Implementing Collaborative Care for Perinatal Depression

Resource links provided by NLM:


Further study details as provided by Ian Bennett, University of Washington:

Primary Outcome Measures:
  • 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:
  • 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:
  • 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.


Estimated Enrollment: 20
Study Start Date: January 2017
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02976025

Contacts
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
Investigators
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 ( US NIH Grant/Contract Award Number )
Study First Received: November 23, 2016
Last Updated: November 23, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: We intend to share de-identified data once study is complete.

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

ClinicalTrials.gov processed this record on June 23, 2017