Deep Dive Randomized Control Trial - Full Text View

Sponsors and Collaborators:	Health Dialog Analytic Solutions, Inc. Health Net California Highmark Blue Cross Blue Shield
Information provided by:	Health Dialog Analytic Solutions, Inc.
ClinicalTrials.gov Identifier:	NCT00793260

Purpose

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

Condition	Intervention
Chronic Disease Arthritis Uterine Diseases Spinal Diseases Preventive Health Services	Behavioral: Enhanced Support Behavioral: Usual-Support

MedlinePlus related topics: Coping with Chronic Illness Spinal Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Subject), Parallel Assignment
Official Title:	Deep Dive Randomized Control Trial

Further study details as provided by Health Dialog Analytic Solutions, Inc.:

Primary Outcome Measures:

The primary outcome measure was total medical costs (capped at $200,000 per individual per year) and pharmacy costs. [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary measures included utilization of selected services. [ Designated as safety issue: No ]

Enrollment:	174120
Study Start Date:	July 2006
Study Completion Date:	May 2008
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Usual Support Group: Active Comparator 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.	Behavioral: 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.
Enhanced Support Group: Experimental The Enhanced-Support Group intervention used more sophisticated predictive models, more extensive outreach to engage individuals, and provided tighter feedback loops to inform the care support process.	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.

Arms

Assigned Interventions

Usual Support Group: Active Comparator

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.

Behavioral: 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.

Enhanced Support Group: Experimental

The Enhanced-Support Group intervention used more sophisticated predictive models, more extensive outreach to engage individuals, and provided tighter feedback loops to inform the care support process.

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793260

Locations

United States, Maine
Health Dialog Analytic Solutions, Inc
Portland, Maine, United States, 04101

Sponsors and Collaborators

Health Dialog Analytic Solutions, Inc.

Health Net California

Highmark Blue Cross Blue Shield

Investigators

Principal Investigator:

David E Wennberg, MD, MPH

Health Dialog Analytic Solutions, Inc.

More Information

Responsible Party:	Health Dialog Analytic Solutions, Inc ( David E. Wennberg, MD, MPH / Chief Science & Products Officer )
Study ID Numbers:	DeepDive
Study First Received:	November 17, 2008
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00793260
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Genital Diseases, Female
Spinal Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Uterine Diseases
Chronic Disease
Bone Diseases

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009