DiabetesPhase 2NCT00838825
Continuous Quality Improvement for Diabetes
A Phase 2 study testing introduction of the chronic care model in people with Diabetes, run by Santa Clara Valley Health & Hospital System.
Trial summary
The purpose of this study is to compare health care delivery outcomes and costs achieved by two different approaches to health care delivery. The investigators will compare health outcomes for groups of adult patents with diabetes. One group will be managed by our traditional approach to diabetes care. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- introduction of the chronic care model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Apr 2011
- Phase
- Phase 2
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary care physicians practicing in a designated site with > 200 patients assigned to their panel who have been diagnosed with diabetes
Who cannot join
- Refusal to give informed consent
About this study
Official title: Continuous Quality Improvement for Diabetes: Unique Care Delivery Design's Effect on Quality of Care and Utilization of Resources
The purpose of this study is to compare health care delivery outcomes and costs achieved by two different approaches to health care delivery. The investigators will compare health outcomes for groups of adult patents with diabetes. One group will be managed by our traditional approach to diabetes care. The second group's care delivery is structured according to a design consistent with the Chronic Care Model (CCM).
Read the detailed description
The study is comparing the effect of an intervention targeting a subset of the diabetic patients within a primary care practice on the resource utilization of resources and disease outcomes on the entire population of patients with diabetes in that practice. The effect will also be compared across the entire panel of patients assigned to the physicians in the 2 arms of the study.
- Conditions
- Diabetes
- Being tested
- introduction of the chronic care model
- Keywords
- diabetes, chronic care management, resource utilization, outcome, glycohemoglobin, hospitalization
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
introduction of the chronic care modelOther
Also called care manager, chronic care model, health care delivery, self-management
The care management team is organized according to the chronic care model for health care delivery. They are supported by an information registry for diabetes, receive instruction in self-management, have redesigned their work flow to include delegation of functions to care managers who follow specific guidelines and protocols for managing diabetes
| Study group | Role | What they receive |
|---|---|---|
| traditional | No intervention | The traditional arm is composed of primary care physicians who continue the health care delivery model existing for the 5 years prior to the study. The traditional includes the physician, a pool of resources including random assignment of diabetic educators and includes the entire panel of patients assigned to the PCP. |
| care management | Experimental | The care management group is composed of primary care physicians who have been assigned a specific physician extender, the care manager, and an additional medical assistant and form a care manager team working together with registry support, team meetings and instruction in self-management and includes the entire panel of patients assigned to the PCP. Receives: Other: introduction of the chronic care model |
What is being measured
The primary outcome is the main question the study is designed to answer.
resource utilization
Measured: baseline compared to 2 years intervention
Secondary outcomes (2)
compliance with process measures
Measured: 3 years
metabolic outcome
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startApr 2005
- Primary completionMar 2008
- Study completionApr 2011
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 DiabetesStudies 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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santa Clara Valley Health & Hospital System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Kearns, Santa Clara Valley Health & Hospital System
- Investigators
- Patrick J Kearns, MD, Principal investigator, Santa Clara Valley Health & Hospital System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838825
- Sponsor's protocol ID
- SCVMC 2/8/08-10
- Status last verified
- May 2016
- First submitted
- 5 Feb 2009
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data will be shared in a peer review journal
Publications
Kearns P. Diabetes Care Management Teams Did Not Reduce Utilization When Compared With Traditional Care: A Randomized Cluster Trial. Manag Care. 2017 Oct;26(10):33-40.
PubMed 29068297
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Quality Improvement for Diabetes: Unique Care Delivery Design's Effect on Quality of Care and Utilization of Resources
- ClinicalTrials.gov ID
- NCT00838825
- Acronym / sponsor ID
- SCVMC 2/8/08-10
- Conditions
- Diabetes
- Keywords
- diabetes, chronic care management, resource utilization, outcome, glycohemoglobin, hospitalization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Santa Clara Valley Health & Hospital SystemUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 6 Feb 2009 (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.
The purpose of this study is to compare health care delivery outcomes and costs achieved by two different approaches to health care delivery. The investigators will compare health outcomes for groups of adult patents with diabetes. One group will be managed by our traditional approach to diabetes care. The second group's care delivery is structured according to a design consistent with the Chronic Care Model (CCM).
Detailed description
The study is comparing the effect of an intervention targeting a subset of the diabetic patients within a primary care practice on the resource utilization of resources and disease outcomes on the entire population of patients with diabetes in that practice. The effect will also be compared across the entire panel of patients assigned to the physicians in the 2 arms of the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional | No intervention | –The traditional arm is composed of primary care physicians who continue the health care delivery model existing for the 5 years prior to the study. The traditional includes the physician, a pool of resources including random assignment of diabetic educators and includes the entire panel of patients assigned to the PCP. |
| care management | Experimental | Other: introduction of the chronic care modelThe care management group is composed of primary care physicians who have been assigned a specific physician extender, the care manager, and an additional medical assistant and form a care manager team working together with registry support, team meetings and instruction in self-management and includes the entire panel of patients assigned to the PCP. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care physicians practicing in a designated site with > 200 patients assigned to their panel who have been diagnosed with diabetes
Key exclusion criteria (1 listed)
- Refusal to give informed consent
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 |
|---|---|---|
| introduction of the chronic care modelAlso: care manager, chronic care model, health care delivery, self-managementThe care management team is organized according to the chronic care model for health care delivery. They are supported by an information registry for diabetes, receive instruction in self-management, have redesigned their work flow to include delegation of functions to care managers who follow specific guidelines and protocols for managing diabetes | Other | care management |
Primary outcome
resource utilization
Time frame: baseline compared to 2 years intervention
2 secondary outcomes
compliance with process measures
Time frame: 3 years
metabolic outcome
Time frame: 3 years
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 10 May 2016.
- Derived from this study: PubMed 29068297Kearns P. Diabetes Care Management Teams Did Not Reduce Utilization When Compared With Traditional Care: A Randomized Cluster Trial. Manag Care. 2017 Oct;26(10):33-40.
- Individual participant dataSharing planned: No. Data will be shared in a peer review journal
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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.
Patrick J Kearns, MD principal investigator
Santa Clara Valley Health & Hospital System
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing introduction of the chronic care model in people with Diabetes, run by Santa Clara Valley Health & Hospital System.
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 1 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 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
resource utilization (time frame: baseline compared to 2 years intervention). 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 NCT00838825, 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 10 May 2016.