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

July 14, 2014 updated by: HealthPartners Institute

DIAMOND Study: Evaluation of a Natural Experiment to Improve Statewide Depression Care in MN

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2631

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • comorbid psychiatric conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: DIAMOND Care Model
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.
Other: DIAMOND depression care model
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rates of best care processes
Time Frame: baseline, 6 months
baseline, 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in depression symptoms, work productivity and total healthcare costs
Time Frame: baseline, 3 months, 6 months, 1 year
baseline, 3 months, 6 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Leif I Solberg, MD, HealthPartners Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

October 28, 2008

First Submitted That Met QC Criteria

October 28, 2008

First Posted (Estimate)

October 29, 2008

Study Record Updates

Last Update Posted (Estimate)

July 15, 2014

Last Update Submitted That Met QC Criteria

July 14, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAR-06-039
  • R01MH080692 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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