NCT00436176

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,000

participants targeted

Target at P75+ for phase_3 diabetes

Timeline
Completed

Started Jun 2007

Typical duration for phase_3 diabetes

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

First Submitted

Initial submission to the registry

February 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

March 23, 2009

Status Verified

March 1, 2009

Enrollment Period

1 year

First QC Date

February 14, 2007

Last Update Submit

March 20, 2009

Conditions

Diabetes

Keywords

Diabetes mellitusQuality of Health CareCultural CompetencyPerformance FeedbackHealth navigatorHealth disparitiesRacial disparities

Outcome Measures

Primary Outcomes (3)

  • Rate of LDL cholesterol control (< 100 mg/dL)

    12 months

  • Rate of blood pressure control (< 130/80 mmHg)

    12 months

  • Rate of HbA1c control (<7%)

    12 months

Secondary Outcomes (3)

  • Rate of HbA1c control (<8%)

    12 months

  • Rate of LDL cholesterol control (< 130 mg/dL)

    12 months

  • Rate of blood pressure control (< 140/90 mmHg)

    12 months

Study Arms (2)

1

EXPERIMENTAL

Intervention clinicians receive monthly performance reports, cultural competency training, and health navigation training

Behavioral: Expanded Chronic Care Model

2

NO INTERVENTION

Control clinicians function within the context of the generic chronic care model.

Interventions

Expanded Chronic Care ModelBEHAVIORAL

Intervention clinicians receive monthly performance feedback reports, cultural competency training, and health navigation training.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any patient not categorized as either White or Black based on race identifier in the electronic medical record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard Vanguard Medical Associates

Newton, Massachusetts, 02466, United States

Location

Related Publications (3)

  • 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.

    PMID: 16567608BACKGROUND

  • Sequist 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.

    PMID: 18214625BACKGROUND

  • Sequist 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.

    PMID: 20048271DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Thomas D Sequist, MD, MPH

    Harvard Vanguard Medical Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2007

First Posted

February 16, 2007

Study Start

June 1, 2007

Primary Completion

June 1, 2008

Study Completion

November 1, 2008

Last Updated

March 23, 2009

Record last verified: 2009-03

Locations

US(1)