DiabetesPhase 3NCT00436176
Improving Diabetes Care for African Americans
A Phase 3 study testing Expanded Chronic Care Model in people with Diabetes, run by Harvard Vanguard Medical Associates at 1 site in United States.
Trial summary
The goal of this study is to investigate methods of improving diabetes care for African Americans in primary care clinics. Primary care clinicians will receive training in the delivery of cross-cultural medicine as well as regular performance feedback reports. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Expanded Chronic Care Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Nov 2008
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of diabetes mellitus (based on fasting glucose, HbA1c, and problem list)
- At least 18 years old
- At least one face-to-face visit with Harvard Vanguard primary care clinician in the last 2 years
Who cannot join
- Any patient not categorized as either White or Black based on race identifier in the electronic medical record
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard Vanguard Medical Associates
Newton, Massachusetts, 02466
About this study
Official title: The Expanded Chronic Care Model: Targeting Disparities in Diabetes Care
The goal of this study is to investigate methods of improving diabetes care for African Americans in primary care clinics. Primary care clinicians will receive training in the delivery of cross-cultural medicine as well as regular performance feedback reports.
Read the detailed description
Effective solutions are needed to address the parallel persistence of a quality chasm and racial disparities in diabetes care. Many large health care systems are adopting components of the Chronic Care Model to achieve substantial gains in diabetes care, though few health systems have successfully incorporated elements specific to minority health. We have previously identified racial disparities in key diabetes outcomes measures within an integrated health care delivery system, Harvard Vanguard Medical Associates (HVMA). This project will use a randomized, controlled study design within HVMA to evaluate whether enhancements to the Chronic Care Model can produce significant improvement in the quality of diabetes care for black patients. Intervention clinicians will receive monthly panel-level disparities report cards, health navigation training, and cultural competency training, while control clinicians will function within the context of the generic Chronic Care Model. The study will occur over a 12 month period and involve 4,000 white patients and 2,500 black patients with diabetes receiving care at 8 health centers. The primary outcomes will include rates of glucose (HbA1c <7.0), LDL cholesterol (<100 mg/dL), and blood pressure (<130/80) control. We will use patient focus groups to identify significant barriers to care and guide health navigation training. We will survey clinicians pre- and post intervention to assess the effect of the intervention on knowledge and attitudes towards disparities. Patient experiences will be assessed pre- and post-intervention using a validated instrument to determine whether the intervention can reduce existing racial disparities in patient reports of quality. We will perform a cost analysis related to the intervention using a health system perspective. In summary, this project will provide health systems with a rigorous analysis of a defined set of tools to improve diabetes care for minority populations.
- Conditions
- Diabetes
- Being tested
- Expanded Chronic Care Model
- Keywords
- Diabetes mellitus, Quality of Health Care, Cultural Competency, Performance Feedback, Health navigator, Health disparities, Racial disparities
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded Chronic Care ModelBehavioural
Intervention clinicians receive monthly performance feedback reports, cultural competency training, and health navigation training.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intervention clinicians receive monthly performance reports, cultural competency training, and health navigation training Receives: Behavioral: Expanded Chronic Care Model |
| 2 | No intervention | Control clinicians function within the context of the generic chronic care model. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of LDL cholesterol control (< 100 mg/dL)
Measured: 12 months
Rate of blood pressure control (< 130/80 mmHg)
Measured: 12 months
Rate of HbA1c control (<7%)
Measured: 12 months
Secondary outcomes (3)
Rate of HbA1c control (<8%)
Measured: 12 months
Rate of LDL cholesterol control (< 130 mg/dL)
Measured: 12 months
Rate of blood pressure control (< 140/90 mmHg)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2007 (estimated)
- Study startJun 2007
- Primary completionJun 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard Vanguard Medical Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Harvard University
- Investigators
- Thomas D Sequist, MD, MPH, Principal investigator, Harvard Vanguard Medical Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436176
- Sponsor's protocol ID
- 59751
- Status last verified
- Mar 2009
- First submitted
- 14 Feb 2007
- Last updated
- 23 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Sequist TD, Adams A, Zhang F, Ross-Degnan D, Ayanian JZ. Effect of quality improvement on racial disparities in diabetes care. Arch Intern Med. 2006 Mar 27;166(6):675-81. doi: 10.1001/archinte.166.6.675.
PubMed 16567608Sequist TD, Ayanian JZ, Marshall R, Fitzmaurice GM, Safran DG. Primary-care clinician perceptions of racial disparities in diabetes care. J Gen Intern Med. 2008 May;23(5):678-84. doi: 10.1007/s11606-008-0510-7. Epub 2008 Jan 24.
PubMed 18214625Sequist TD, Fitzmaurice GM, Marshall R, Shaykevich S, Marston A, Safran DG, Ayanian JZ. Cultural competency training and performance reports to improve diabetes care for black patients: a cluster randomized, controlled trial. Ann Intern Med. 2010 Jan 5;152(1):40-6. doi: 10.7326/0003-4819-152-1-201001050-00009.
PubMed 20048271
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Expanded Chronic Care Model: Targeting Disparities in Diabetes Care
- ClinicalTrials.gov ID
- NCT00436176
- Acronym / sponsor ID
- 59751
- Conditions
- Diabetes
- Keywords
- Diabetes mellitus, Quality of Health Care, Cultural Competency, Performance Feedback, Health navigator, Health disparities, Racial disparities
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Harvard Vanguard Medical AssociatesUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Harvard University
- Study start
- Jun 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 16 Feb 2007 (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 goal of this study is to investigate methods of improving diabetes care for African Americans in primary care clinics. Primary care clinicians will receive training in the delivery of cross-cultural medicine as well as regular performance feedback reports.
Detailed description
Effective solutions are needed to address the parallel persistence of a quality chasm and racial disparities in diabetes care. Many large health care systems are adopting components of the Chronic Care Model to achieve substantial gains in diabetes care, though few health systems have successfully incorporated elements specific to minority health. We have previously identified racial disparities in key diabetes outcomes measures within an integrated health care delivery system, Harvard Vanguard Medical Associates (HVMA). This project will use a randomized, controlled study design within HVMA to evaluate whether enhancements to the Chronic Care Model can produce significant improvement in the quality of diabetes care for black patients. Intervention clinicians will receive monthly panel-level disparities report cards, health navigation training, and cultural competency training, while control clinicians will function within the context of the generic Chronic Care Model. The study will occur over a 12 month period and involve 4,000 white patients and 2,500 black patients with diabetes receiving care at 8 health centers. The primary outcomes will include rates of glucose (HbA1c <7.0), LDL cholesterol (<100 mg/dL), and blood pressure (<130/80) control. We will use patient focus groups to identify significant barriers to care and guide health navigation training. We will survey clinicians pre- and post intervention to assess the effect of the intervention on knowledge and attitudes towards disparities. Patient experiences will be assessed pre- and post-intervention using a validated instrument to determine whether the intervention can reduce existing racial disparities in patient reports of quality. We will perform a cost analysis related to the intervention using a health system perspective. In summary, this project will provide health systems with a rigorous analysis of a defined set of tools to improve diabetes care for minority populations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Expanded Chronic Care ModelIntervention clinicians receive monthly performance reports, cultural competency training, and health navigation training |
| 2 | No intervention | –Control clinicians function within the context of the generic chronic care model. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of diabetes mellitus (based on fasting glucose, HbA1c, and problem list)
- At least 18 years old
- At least one face-to-face visit with Harvard Vanguard primary care clinician in the last 2 years
Key exclusion criteria (1 listed)
- Any patient not categorized as either White or Black based on race identifier in the electronic medical record
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 |
|---|---|---|
| Expanded Chronic Care ModelIntervention clinicians receive monthly performance feedback reports, cultural competency training, and health navigation training. | Behavioural | 1 |
Primary outcome
Rate of LDL cholesterol control (< 100 mg/dL)
Time frame: 12 months
Rate of blood pressure control (< 130/80 mmHg)
Time frame: 12 months
Rate of HbA1c control (<7%)
Time frame: 12 months
3 secondary outcomes
Rate of HbA1c control (<8%)
Time frame: 12 months
Rate of LDL cholesterol control (< 130 mg/dL)
Time frame: 12 months
Rate of blood pressure control (< 140/90 mmHg)
Time frame: 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 23 Mar 2009.
- Background: PubMed 16567608Sequist TD, Adams A, Zhang F, Ross-Degnan D, Ayanian JZ. Effect of quality improvement on racial disparities in diabetes care. Arch Intern Med. 2006 Mar 27;166(6):675-81. doi: 10.1001/archinte.166.6.675.
- Background: PubMed 18214625Sequist TD, Ayanian JZ, Marshall R, Fitzmaurice GM, Safran DG. Primary-care clinician perceptions of racial disparities in diabetes care. J Gen Intern Med. 2008 May;23(5):678-84. doi: 10.1007/s11606-008-0510-7. Epub 2008 Jan 24.
- Derived from this study: PubMed 20048271Sequist TD, Fitzmaurice GM, Marshall R, Shaykevich S, Marston A, Safran DG, Ayanian JZ. Cultural competency training and performance reports to improve diabetes care for black patients: a cluster randomized, controlled trial. Ann Intern Med. 2010 Jan 5;152(1):40-6. doi: 10.7326/0003-4819-152-1-201001050-00009.
- HVMA websiteLink provided by the sponsor.
- Robert Wood Johnson Foundation national program officeLink provided by the sponsor.
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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.
Thomas D Sequist, MD, MPH principal investigator
Harvard Vanguard Medical Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Expanded Chronic Care Model in people with Diabetes, run by Harvard Vanguard Medical Associates 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 3 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 23 Mar 2009. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Rate of LDL cholesterol control (< 100 mg/dL) (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT00436176, which also lists 3 linked publications.
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 23 Mar 2009.