NCT00793260

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174,120

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2008

Completed
Last Updated

November 19, 2008

Status Verified

November 1, 2008

Enrollment Period

11 months

First QC Date

November 17, 2008

Last Update Submit

November 18, 2008

Conditions

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Secondary measures included utilization of selected services.

Study Arms (2)

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

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

Interventions

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.

Enhanced Support Group
Usual-SupportBEHAVIORAL

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.

Usual Support Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Dialog Analytic Solutions, Inc

Portland, Maine, 04101, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Chronic DiseaseArthritisUterine DiseasesSpinal Diseases

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsJoint DiseasesMusculoskeletal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesBone Diseases

Study Officials

  • David E Wennberg, MD, MPH

    Health Dialog

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 17, 2008

First Posted

November 19, 2008

Study Start

July 1, 2006

Primary Completion

June 1, 2007

Study Completion

May 1, 2008

Last Updated

November 19, 2008

Record last verified: 2008-11

Locations