Chronic IllnessNCT01912430
Retrospective Data Analysis of VitalCare Targeted Population Management on Scott and White Chronically Ill Beneficiaries
A study testing ICC (Integrated Care Coaching) Intervention Group in people with Chronic Illness, run by Scott & White Health Plan at 1 site in United States.
Trial summary
New payment methods such as Accountable Care Organization (ACO's) and medical homes facilitate are new models for providers to deliver cost effective, quality patient outcomes. Integrated Care Coaching (ICC) is a healthcare delivery model combining telephonic interventions with an intelligent information technology… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Illness
- What is being tested?
- ICC (Integrated Care Coaching) Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17,559 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Dec 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Having one or more of 21 chronic conditions, including those with depression and multiple chronic comorbidities.
Who cannot join
- Presence of Major Cancer, HIV, or ESRD in either the baseline or measurement periods
- Claims in excess of $100,000 in either baseline or intervention period.
- Claims for long term care or hospice in either baseline or intervention period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Data Analysis of the Impact of Vital Care Targeted Population Management Upon a Matched Cohort of Scott and White Health Plan Beneficiaries
New payment methods such as Accountable Care Organization (ACO's) and medical homes facilitate are new models for providers to deliver cost effective, quality patient outcomes. Integrated Care Coaching (ICC) is a healthcare delivery model combining telephonic interventions with an intelligent information technology platform that offered validated protocols and patient outcomes tracking. Health Integrated, Inc. has developed a validated program of Integrated Care Coaching (ICC), which was branded as "VitalCare", and implemented with over 7,000 members of the Scott and White Health Plan in Texas, would reduce healthcare costs/achieve a return on investment (ROI), improve clinical outcomes, and be satisfying for participants.
Read the detailed description
A prospective, pre-post historical control design trial with a concurrent control group cost/satisfaction analysis with a retrospective clinical study was undertaken with adult, Scott and White Health Plan (SWHP) patients with chronic illnesses. From 2007 to 2010, a total of 7,411 ICC and 10,148 control patients participated. Variables were costs, return on investment (ROI), iterative Patient Health Questionnaire (PHQ)9 scores, and satisfaction.
- Conditions
- Chronic Illness
- Being tested
- ICC (Integrated Care Coaching) Intervention Group
- Keywords
- Integrated Care Coaching, Chronic Care Coaching, Care Coaching
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICC (Integrated Care Coaching) Intervention GroupBehavioural
Also called Health Integrated Inc. Integrated Care Coaching (ICC)
| Study group | Role | What they receive |
|---|---|---|
| ICC (Integrated Care Coaching) | Experimental | Received evidence-based, protocol-driven integrated care coaching intervention to improve chronic illness health outcomes (clinical, financial). Receives: Behavioral: ICC (Integrated Care Coaching) Intervention Group |
| Control Group | Experimental | Matched cohort by age and chronic illness diagnoses - no intervention Receives: Behavioral: ICC (Integrated Care Coaching) Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return of Investment and Cost of Medical Care
Primary outcomes were ROI and cost of medical care (including inpatient, outpatient, emergency room, office and other (ie, physical therapy). ICC participants and control group members had a minimum of 6 months to a maximum of 12 months measurement period.
Measured: 6 to 12 months
Secondary outcomes (1)
Level of Depressive Symptoms per Interactive Patient Health Questionnaire (PHQ-9) scores
Secondary outcome was level of depressive symptoms per Interactive Patient Health Questionnaire (PHQ-9) scores. ICC participants and control group members had a minimum of 6 months to a maximum of 12 months measurement period.
Measured: 6 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic IllnessStudies 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17,559 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scott & White Health Plan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marylou Buyse, M.D., M.S., Principal investigator, Scott and White Health Plan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912430
- Sponsor's protocol ID
- 120246
- Status last verified
- Jul 2013
- First submitted
- 18 Jul 2013
- Last updated
- 1 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Data Analysis of the Impact of Vital Care Targeted Population Management Upon a Matched Cohort of Scott and White Health Plan Beneficiaries
- ClinicalTrials.gov ID
- NCT01912430
- Acronym / sponsor ID
- 120246
- Conditions
- Chronic Illness
- Keywords
- Integrated Care Coaching, Chronic Care Coaching, Care Coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17,559 participants (actual)
- Lead sponsor
- Scott & White Health PlanIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 31 Jul 2013 (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.
New payment methods such as Accountable Care Organization (ACO's) and medical homes facilitate are new models for providers to deliver cost effective, quality patient outcomes. Integrated Care Coaching (ICC) is a healthcare delivery model combining telephonic interventions with an intelligent information technology platform that offered validated protocols and patient outcomes tracking. Health Integrated, Inc. has developed a validated program of Integrated Care Coaching (ICC), which was branded as "VitalCare", and implemented with over 7,000 members of the Scott and White Health Plan in Texas, would reduce healthcare costs/achieve a return on investment (ROI), improve clinical outcomes, and be satisfying for participants.
Detailed description
A prospective, pre-post historical control design trial with a concurrent control group cost/satisfaction analysis with a retrospective clinical study was undertaken with adult, Scott and White Health Plan (SWHP) patients with chronic illnesses. From 2007 to 2010, a total of 7,411 ICC and 10,148 control patients participated. Variables were costs, return on investment (ROI), iterative Patient Health Questionnaire (PHQ)9 scores, and satisfaction.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICC (Integrated Care Coaching) | Experimental | Behavioral: ICC (Integrated Care Coaching) Intervention GroupReceived evidence-based, protocol-driven integrated care coaching intervention to improve chronic illness health outcomes (clinical, financial). |
| Control Group | Experimental | Behavioral: ICC (Integrated Care Coaching) Intervention GroupMatched cohort by age and chronic illness diagnoses - no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Having one or more of 21 chronic conditions, including those with depression and multiple chronic comorbidities.
Key exclusion criteria (3 listed)
- Presence of Major Cancer, HIV, or ESRD in either the baseline or measurement periods
- Claims in excess of $100,000 in either baseline or intervention period.
- Claims for long term care or hospice in either baseline or intervention period.
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 |
|---|---|---|
| ICC (Integrated Care Coaching) Intervention GroupAlso: Health Integrated Inc. Integrated Care Coaching (ICC) | Behavioural | Control Group, ICC (Integrated Care Coaching) |
Primary outcome
Return of Investment and Cost of Medical Care
Time frame: 6 to 12 months
Primary outcomes were ROI and cost of medical care (including inpatient, outpatient, emergency room, office and other (ie, physical therapy). ICC participants and control group members had a minimum of 6 months to a maximum of 12 months measurement period.
1 secondary outcome
Level of Depressive Symptoms per Interactive Patient Health Questionnaire (PHQ-9) scores
Time frame: 6 to 12 months
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 1 Aug 2013.
Related trials for Chronic Illness
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
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.
Marylou Buyse, M.D., M.S. principal investigator
Scott and White Health Plan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICC (Integrated Care Coaching) Intervention Group in people with Chronic Illness, run by Scott & White Health Plan 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 2 inclusion and 3 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 1 Aug 2013. 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?
Return of Investment and Cost of Medical Care (time frame: 6 to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2013.