Deep Dive Randomized Control Trial

Chronic Disease Clinical Trial

Official title:

Deep Dive Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00793260
• Other study ID #: DeepDive
• Status: Completed
• Phase: N/A
• First received: November 17, 2008
• Last updated: November 18, 2008
• Start date: July 2006
• Est. completion date: May 2008

Study information

• Verified date: November 2008
• Source: Health Dialog
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Compare two care management support program models on medical costs and utilization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174120
• Est. completion date: May 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All employees, dependents and retirees in one of seven large employer groups, including a state university system, a state employee group, two manufacturing companies, a natural resource extraction company, a public educational service agency, and a nonprofit multiple employer association for independent colleges were eligible for inclusion.

Exclusion Criteria:

• no financial information was available from their facility and professional claims;

• they were in an employer sub-group ineligible for care support services;

• they asked not be to contacted or were deceased;

• gender information was missing from their eligibility files;

• their claims data from the year prior to the start of the study indicated diagnoses of HIV, AIDS, end-stage renal disease (ESRD), organ transplants, or necrotizing fasciitis (intended to improve the likelihood of a balanced distribution of costs and conditions); OR

• they were in an employer sub-group with less than four months of enrollment prior to the study start date (resulting in too little information for stratification).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Arthritis
• Chronic Disease
• Preventive Health Services
• Spinal Diseases
• Uterine Diseases

Intervention

Behavioral:
• Enhanced Support
The Enhanced-Support Group program used lower risk thresholds for targeted outreach of individuals with chronic illness and for those likely to face discrete surgical interventions. Individuals at high financial risk but without one of the five chronic conditions were included in the Enhanced-Support Group. The Enhanced-Support Group received up to five initial reach attempts while the Usual-Support Group received up to three attempts. The Enhanced-Support Group used a 'tight loop' management structure including detailed, timely coach level feedback reports on efficiency and effectiveness.
• Usual-Support
Predictive models in the Usual-Support Group were aimed at identifying individuals through medical claims and administrative data (such as hospitalization notification). The output of the predictive models is a rank-ordered, or stratified, list of individuals who have support needs. These lists were then used to generate outbound mail, interactive voice response (IVR) calls or calls by health coaches.

Locations

Country	Name	City	State
United States	Health Dialog Analytic Solutions, Inc	Portland	Maine

Sponsors (3)

Lead Sponsor	Collaborator
Health Dialog	Health Net California, Highmark Blue Cross Blue Shield

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure was total medical costs (capped at $200,000 per individual per year) and pharmacy costs.			No
Secondary	Secondary measures included utilization of selected services.			No