Deep Dive Randomized Control Trial

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

Study Overview

• Status: Completed
• Conditions: Uterine Diseases; Arthritis; Spinal Diseases; Chronic Disease; Preventive Health Services
• Intervention / Treatment: Behavioral: Usual-Support; Behavioral: Enhanced Support

• Study Type: Interventional
• Enrollment (Actual): 174120
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Support Group; 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.
Experimental: Enhanced Support Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary outcome measure was total medical costs (capped at $200,000 per individual per year) and pharmacy costs.

Secondary Outcome Measures

Outcome Measure
Secondary measures included utilization of selected services.

Collaborators and Investigators

• Sponsor: Health Dialog
• Collaborators: Highmark Blue Cross Blue Shield; Health Net California
• Investigators: Principal Investigator: David E Wennberg, MD, MPH, Health Dialog

Publications and helpful links

General Publications

• Wennberg DE, Marr A, Lang L, O'Malley S, Bennett G. A randomized trial of a telephone care-management strategy. N Engl J Med. 2010 Sep 23;363(13):1245-55. doi: 10.1056/NEJMsa0902321.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: November 17, 2008
• First Submitted That Met QC Criteria: November 18, 2008
• First Posted (Estimate): November 19, 2008

Study Record Updates

• Last Update Posted (Estimate): November 19, 2008
• Last Update Submitted That Met QC Criteria: November 18, 2008
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Musculoskeletal Diseases; Bone Diseases; Chronic Disease; Spinal Diseases; Uterine Diseases
• Other Study ID Numbers: DeepDive