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

Major Depression Clinical Trial

— DIAMOND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781703
• Other study ID #: PAR-06-039
• Secondary ID: R01MH080692
• Status: Completed
• Phase: N/A
• First received: October 28, 2008
• Last updated: July 14, 2014
• Start date: February 2008
• Est. completion date: February 2014

Study information

• Verified date: July 2014
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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:

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2631
• Est. completion date: February 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• major depression

• Patient Health Questionaire (PHQ-9) > 9

• primary care management of depression

Exclusion Criteria:

• comorbid psychiatric conditions

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
HealthPartners Institute	National Institute of Mental Health (NIMH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of best care processes		baseline, 6 months	No
Secondary	Improvement in depression symptoms, work productivity and total healthcare costs		baseline, 3 months, 6 months, 1 year	No