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Evaluation of a Natural Experiment to Improve Statewide Depression Care in Minnesota (MN) (DIAMOND)

Primary Purpose

Major Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DIAMOND depression care model
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Major Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • major depression
  • Patient Health Questionaire (PHQ-9) > 9
  • primary care management of depression

Exclusion Criteria:

  • comorbid psychiatric conditions

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    DIAMOND Care Model

    Arm Description

    Patients in activated clinic sites will receive the DIAMOND depression care model, including a care manager, frequent use of the Patient Health Questionnaire-9 (PHQ9), treatment adjustment as indicated, psychiatric consultation, relapse prevention.

    Outcomes

    Primary Outcome Measures

    Rates of best care processes

    Secondary Outcome Measures

    Improvement in depression symptoms, work productivity and total healthcare costs

    Full Information

    First Posted
    October 28, 2008
    Last Updated
    July 14, 2014
    Sponsor
    HealthPartners Institute
    Collaborators
    National Institute of Mental Health (NIMH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00781703
    Brief Title
    Evaluation of a Natural Experiment to Improve Statewide Depression Care in Minnesota (MN)
    Acronym
    DIAMOND
    Official Title
    DIAMOND Study: Evaluation of a Natural Experiment to Improve Statewide Depression Care in MN
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2008 (undefined)
    Primary Completion Date
    June 2012 (Actual)
    Study Completion Date
    February 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    HealthPartners Institute
    Collaborators
    National Institute of Mental Health (NIMH)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study will evaluate a unique natural experiment that aims to transform the primary care of patients with depression. The experiment's aim is to cause statewide implementation of an evidence-based care model for depression by changing the reimbursement system and by using an established regional collaborative (the Institute for Clinical Systems Improvement) to both facilitate the model's widespread use and certify that medical groups have implemented it. Study hypotheses include the following: Newly treated depressed patients in medical groups that have implemented the new reimbursement and facilitation will report receiving higher rates of best care processes than such patients in these medical groups before implementation. Rates of best care practices reported to be received by newly treated depressed patients two years after each medical group implements changes will be maintained at least at the rate reported by patients one year post implementation. Newly treated depressed patients in medical groups that have participated in the new reimbursement and facilitation will have greater improvement in depression symptoms and work productivity and lower healthcare costs than such patients in groups before participation. Medical group measures of priority for improving depression care, capability to manage change, and practice systems will be predictive of more patient-reported best care processes, both at one point in time and in change over time.
    Detailed Description
    The study will use a multiple baseline across settings with staggered implementation to test the effects of changed reimbursement and facilitated organizational change on the use and sustainability of evidenced-based care processes for patients with depression. The study will also test the effect of the care process changes on changes in depression symptoms, healthcare costs, and work productivity.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    N/A
    Enrollment
    2631 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DIAMOND Care Model
    Arm Type
    Other
    Arm Description
    Patients in activated clinic sites will receive the DIAMOND depression care model, including a care manager, frequent use of the Patient Health Questionnaire-9 (PHQ9), treatment adjustment as indicated, psychiatric consultation, relapse prevention.
    Intervention Type
    Other
    Intervention Name(s)
    DIAMOND depression care model
    Intervention Description
    Patients in activated clinic sites will receive the DIAMOND depression care model, including a care manager, frequent use of the PHQ9, treatment adjustment as indicated, psychiatric consultation, relapse prevention.
    Primary Outcome Measure Information:
    Title
    Rates of best care processes
    Time Frame
    baseline, 6 months
    Secondary Outcome Measure Information:
    Title
    Improvement in depression symptoms, work productivity and total healthcare costs
    Time Frame
    baseline, 3 months, 6 months, 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: major depression Patient Health Questionaire (PHQ-9) > 9 primary care management of depression Exclusion Criteria: comorbid psychiatric conditions
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leif I Solberg, MD
    Organizational Affiliation
    HealthPartners Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of a Natural Experiment to Improve Statewide Depression Care in Minnesota (MN)

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