Chronic DiseaseNCT00793260
Deep Dive Randomized Control Trial
A study testing Enhanced Support and Usual-Support in people with Chronic Disease and Arthritis, run by Health Dialog at 1 site in United States.
Trial summary
Compare two care management support program models on medical costs and utilization. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, Arthritis, Uterine Diseases
- What is being tested?
- Enhanced Support and Usual-Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174,120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Health Dialog Analytic Solutions, Inc
Portland, Maine, 04101
About this study
Compare two care management support program models on medical costs and utilization.
- Being tested
- Enhanced Support, Usual-Support
- Medical subject headings
- Chronic Disease, Arthritis, Uterine Diseases, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced SupportBehavioural
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-SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Enhanced Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startJul 2006
- Primary completionJun 2007
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 174,120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Dialog
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Health Net California, Highmark Blue Cross Blue Shield
- Investigators
- David E Wennberg, MD, MPH, Principal investigator, Health Dialog
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793260
- Sponsor's protocol ID
- DeepDive
- Status last verified
- Nov 2008
- First submitted
- 17 Nov 2008
- Last updated
- 19 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 20860506
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Dive Randomized Control Trial
- ClinicalTrials.gov ID
- NCT00793260
- Acronym / sponsor ID
- DeepDive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174,120 participants (actual)
- Lead sponsor
- Health DialogIndustry (pharma, biotech, devices)
- Collaborators
- Health Net California, Highmark Blue Cross Blue Shield
- Study start
- Jul 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 19 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare two care management support program models on medical costs and utilization.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Support Group | Active comparator | Behavioral: Usual-SupportPredictive 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 | Behavioral: Enhanced SupportThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced SupportThe 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. | Behavioural | Enhanced Support Group |
| Usual-SupportPredictive 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. | Behavioural | Usual Support Group |
Primary outcome
The primary outcome measure was total medical costs (capped at $200,000 per individual per year) and pharmacy costs.
1 secondary outcome
Secondary measures included utilization of selected services.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2008.
- Derived from this study: PubMed 20860506Wennberg 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.
Related trials for Chronic Disease
RecruitingPhase 1
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
B-cell Mediated Autoimmune Disorders
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
Chronic Inflammatory Demyelinating Polyneuropathy, CIDP
Enrolling by invitationPhase 3
Long-term Safety and Efficacy Study of Riliprubart in Participants With CIDP
Polyneuropathy, Inflammatory Demyelinating, Chronic
RecruitingPhase 2/3
Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide
Chronic Hepatitis D
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Multiple Sclerosis (MS) Primary Progressive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David E Wennberg, MD, MPH principal investigator
Health Dialog
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Support and Usual-Support in people with Chronic Disease and Arthritis, run by Health Dialog at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure was total medical costs (capped at $200,000 per individual per year) and pharmacy costs.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00793260, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2008.