Deep Dive Randomized Control Trial

NCT ID: NCT00793260

Last Updated: 2008-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Disease Arthritis Uterine Diseases Spinal Diseases Preventive Health Services

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Usual-Support

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Enhanced Support

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Health Net California

UNKNOWN

Sponsor Role collaborator

Highmark Blue Cross Blue Shield

UNKNOWN

Sponsor Role collaborator

Health Dialog

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Health Dialog Analytic Solutions, Inc

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David E Wennberg, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Health Dialog

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Health Dialog Analytic Solutions, Inc

Portland, Maine, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 20860506 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DeepDive

Identifier Type: -

Identifier Source: org_study_id