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
About this trial
This is an interventional health services research trial for Major Depression
Eligibility Criteria
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
NCT ID
NCT00781703
First Posted
October 28, 2008
Last Updated
July 14, 2014
Sponsor
HealthPartners Institute
Collaborators
National Institute of Mental Health (NIMH)
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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