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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier:
NCT00781703
First received: October 28, 2008
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.

Condition Intervention
Major Depression
Other: DIAMOND depression care model

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: DIAMOND Study: Evaluation of a Natural Experiment to Improve Statewide Depression Care in MN

Further study details as provided by HealthPartners Institute for Education and Research:

Primary Outcome Measures:
  • Rates of best care processes [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in depression symptoms, work productivity and total healthcare costs [ Time Frame: baseline, 3 months, 6 months, 1 year ] [ Designated as safety issue: No ]

Enrollment: 2631
Study Start Date: February 2008
Study Completion Date: February 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • comorbid psychiatric conditions
  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: NCT00781703

Sponsors and Collaborators
HealthPartners Institute for Education and Research
Investigators
Principal Investigator: Leif I Solberg, MD HealthPartners Institute for Education and Research
  More Information

No publications provided

Responsible Party: HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier: NCT00781703     History of Changes
Other Study ID Numbers: PAR-06-039, R01MH080692
Study First Received: October 28, 2008
Last Updated: July 14, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 23, 2014