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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01013220
Other study ID # R01MH076227
Secondary ID
Status Completed
Phase N/A
First received November 12, 2009
Last updated December 15, 2014
Start date January 2009
Est. completion date September 2014

Study information

Verified date December 2014
Source Florida State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Randomized trials demonstrate that depression management products can improve clinical and organizational outcomes sufficiently for selected employers to realize a return on investment. Rather than usual care marketing which uses voltage-enhanced promises to sell voltage-diminished products, the investigators designed an evidence-based (EB) intervention to encourage employers to purchase a depression management product that offers the type, intensity and duration of care shown to provide clinical and organizational value. In an RCT designed to examine employer benefit purchasing behavior of depression products in 360 employer members of over 20 regional business coalitions, the research team proposes: (a) to compare the impact of evidence-based (EB) to usual care (UC) presentations on employer benefit purchasing behavior, and (b) to identify mediators and organizational moderators of intervention impact on employer benefit purchasing behavior.

This study addresses what policy analysts argue is one of the most pivotal problems in the translation of evidence-based care to 'real world' settings: whether purchasers can be influenced to buy health care products on the basis of value rather than cost. In the likely event that EB > UC, the study will provide encouragement to use an evidence-based approach to market new health care products to private payers on the basis of the product's clinical and organizational value. UC may achieve comparable outcomes to EB if the limiting factors in benefit purchasing are organizational, purchasing group and vendor constraints that no intervention can meaningfully modify. Support for this scenario would encourage the targeted marketing of new products to coalition members with empirically identified organizational, purchasing group and vendor characteristics, using usual care strategies.


Recruitment information / eligibility

Status Completed
Enrollment 293
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Coalitions who belong to the National Business Coalition on Health are eligible if:

- they have 30+ employer purchasers/affiliates as members

- they act as more than purchasing agents

- (3)they did not participate in the research team's preliminary studies on this topic.

- Employers of participating coalitions are eligible if:

- they are a public or private organization providing health care benefits to 100+ domestic employees

- they have not purchased a depression management product in the past two years.

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Other:
Depression Product Detailing
two hour academic detailing of depression management products to employees with responsibility for purchasing health care benefits technical assistance in purchasing high quality depression management products
Depression HEDIS detailing
academic detailing to employees responsible for purchasing health care benefits on how to use HEDIS indicators for depression to assure their depressed employees receive high quality care for the condition technical assistance

Locations

Country Name City State
United States Colorado Business Group on Health Denver Colorado

Sponsors (3)

Lead Sponsor Collaborator
Florida State University Colorado Business Group on Health, University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary employer purchase of depression management product two years after intervention No
Secondary fidelity of depression management model purchased to evidence-based models two years after intervention No
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