NCT00204282

Brief Summary

The purpose of the study is to evaluate the feasibility and efficacy of group visits led by nurse practitioners in improving diabetic preventive services and vascular risk. Diabetes is notable for its high burden on the health of urban populations, a rich literature supporting evidenced based care, and great opportunities to apply systemic primary care interventions to reduce its toll. Extensive literature demonstrates sub-optimal care in the community as well as in academic centers. Addressing the needs of patients with diabetes is challenging in the primary-care environment and nurse case management and disease-specific group visits which focus on education and self-management skills have been shown to be useful adjuncts to traditional outpatient care. The study will attempt to demonstrate that nurse practitioner run group visits, during which the NP will provide didactic education, facilitate group interaction, and arrange referrals and laboratory testing as appropriate, will improve compliance with established American Diabetes Association guidelines for screening and preventive care and in doing so lower cardiovascular risk. Satisfaction with care, quality of life, and diabetic knowledge will be assessed before and after the patients complete the program. In addition, we will attempt to characterize barriers to care for patients who were formerly established with a primary care physician in the Primary Care Group, but who have not received diabetic care there for at least one year.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Aug 2003

Typical duration for not_applicable 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

Study Start

First participant enrolled

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

September 23, 2013

Status Verified

September 1, 2013

First QC Date

September 12, 2005

Last Update Submit

September 20, 2013

Conditions

Keywords

Diabetes prevention

Outcome Measures

Primary Outcomes (1)

  • Nurse practitioner run group visits will improve compliance with established American Diabetes Association guidelines for screening and preventive care

Secondary Outcomes (1)

  • Compliance with established American Diabetes Association guidelines for screening and preventive care will lower cardiovascular risk

Interventions

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All diabetic patients age 40-79 who are followed in the Primary Care Group for Type 2 diabetes and who have seen their PCP at least 3 times in order to establish regular care

You may not qualify if:

  • Patients younger than 40 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (26)

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    PMID: 12370159BACKGROUND
  • Institute of Medicine (US) Committee on Identifying Priority Areas for Quality Improvement; Adams K, Corrigan JM, editors. Priority Areas for National Action: Transforming Health Care Quality. Washington (DC): National Academies Press (US); 2003. Available from http://www.ncbi.nlm.nih.gov/books/NBK221294/

    PMID: 25057643BACKGROUND
  • Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.

    PMID: 9742976BACKGROUND
  • Adler AI, Stratton IM, Neil HA, Yudkin JS, Matthews DR, Cull CA, Wright AD, Turner RC, Holman RR. Association of systolic blood pressure with macrovascular and microvascular complications of type 2 diabetes (UKPDS 36): prospective observational study. BMJ. 2000 Aug 12;321(7258):412-9. doi: 10.1136/bmj.321.7258.412.

    PMID: 10938049BACKGROUND
  • American Diabetes Association: clinical practice recommendations. Standards of medical for patients with diabetes mellitus. Diabetes Care 2003; 26:(suppl 1):533-50

    BACKGROUND
  • Fleming BB, Greenfield S, Engelgau MM, Pogach LM, Clauser SB, Parrott MA. The Diabetes Quality Improvement Project: moving science into health policy to gain an edge on the diabetes epidemic. Diabetes Care. 2001 Oct;24(10):1815-20. doi: 10.2337/diacare.24.10.1815. No abstract available.

    PMID: 11574448BACKGROUND
  • Centers for Disease Control and Prevention (CDC). Preventive-care practices among persons with diabetes--United States, 1995 and 2001. MMWR Morb Mortal Wkly Rep. 2002 Nov 1;51(43):965-9.

    PMID: 12433019BACKGROUND
  • Saaddine JB, Engelgau MM, Beckles GL, Gregg EW, Thompson TJ, Narayan KM. A diabetes report card for the United States: quality of care in the 1990s. Ann Intern Med. 2002 Apr 16;136(8):565-74. doi: 10.7326/0003-4819-136-8-200204160-00005.

    PMID: 11955024BACKGROUND
  • Grant RW, Cagliero E, Murphy-Sheehy P, Singer DE, Nathan DM, Meigs JB. Comparison of hyperglycemia, hypertension, and hypercholesterolemia management in patients with type 2 diabetes. Am J Med. 2002 Jun 1;112(8):603-9. doi: 10.1016/s0002-9343(02)01103-8.

    PMID: 12034408BACKGROUND
  • Sobel BE, Frye R, Detre KM; Bypass Angioplasty Revascularization Investigation 2 Diabetes Trial. Burgeoning dilemmas in the management of diabetes and cardiovascular disease: rationale for the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial. Circulation. 2003 Feb 4;107(4):636-42. doi: 10.1161/01.cir.0000048897.03553.e4.

    PMID: 12566379BACKGROUND
  • Chin MH, Zhang JX, Merrell K. Diabetes in the African-American Medicare population. Morbidity, quality of care, and resource utilization. Diabetes Care. 1998 Jul;21(7):1090-5. doi: 10.2337/diacare.21.7.1090.

    PMID: 9653601BACKGROUND
  • Renders CM, Valk GD, Griffin SJ, Wagner EH, Eijk Van JT, Assendelft WJ. Interventions to improve the management of diabetes in primary care, outpatient, and community settings: a systematic review. Diabetes Care. 2001 Oct;24(10):1821-33. doi: 10.2337/diacare.24.10.1821.

    PMID: 11574449BACKGROUND
  • Sadur CN, Moline N, Costa M, Michalik D, Mendlowitz D, Roller S, Watson R, Swain BE, Selby JV, Javorski WC. Diabetes management in a health maintenance organization. Efficacy of care management using cluster visits. Diabetes Care. 1999 Dec;22(12):2011-7. doi: 10.2337/diacare.22.12.2011.

    PMID: 10587835BACKGROUND
  • Norris SL, Nichols PJ, Caspersen CJ, Glasgow RE, Engelgau MM, Jack L, Isham G, Snyder SR, Carande-Kulis VG, Garfield S, Briss P, McCulloch D. The effectiveness of disease and case management for people with diabetes. A systematic review. Am J Prev Med. 2002 May;22(4 Suppl):15-38. doi: 10.1016/s0749-3797(02)00423-3.

    PMID: 11985933BACKGROUND
  • Montori VM, Dinneen SF, Gorman CA, Zimmerman BR, Rizza RA, Bjornsen SS, Green EM, Bryant SC, Smith SA; Translation Project Investigator Group. The impact of planned care and a diabetes electronic management system on community-based diabetes care: the Mayo Health System Diabetes Translation Project. Diabetes Care. 2002 Nov;25(11):1952-7. doi: 10.2337/diacare.25.11.1952.

    PMID: 12401738BACKGROUND
  • Olivarius NF, Beck-Nielsen H, Andreasen AH, Horder M, Pedersen PA. Randomised controlled trial of structured personal care of type 2 diabetes mellitus. BMJ. 2001 Oct 27;323(7319):970-5. doi: 10.1136/bmj.323.7319.970.

    PMID: 11679387BACKGROUND
  • Gaede P, Vedel P, Larsen N, Jensen GV, Parving HH, Pedersen O. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med. 2003 Jan 30;348(5):383-93. doi: 10.1056/NEJMoa021778.

    PMID: 12556541BACKGROUND
  • Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness. JAMA. 2002 Oct 9;288(14):1775-9. doi: 10.1001/jama.288.14.1775.

    PMID: 12365965BACKGROUND
  • Vrijhoef HJ, Diederiks JP, Spreeuwenberg C, Wolffenbuttel BH, van Wilderen LJ. The nurse specialist as main care-provider for patients with type 2 diabetes in a primary care setting: effects on patient outcomes. Int J Nurs Stud. 2002 May;39(4):441-51. doi: 10.1016/s0020-7489(01)00046-3.

    PMID: 11909620BACKGROUND
  • Lenz ER, Mundinger MO, Hopkins SC, Lin SX, Smolowitz JL. Diabetes care processes and outcomes in patients treated by nurse practitioners or physicians. Diabetes Educ. 2002 Jul-Aug;28(4):590-8. doi: 10.1177/014572170202800413.

    PMID: 12224199BACKGROUND
  • Rickheim PL, Weaver TW, Flader JL, Kendall DM. Assessment of group versus individual diabetes education: a randomized study. Diabetes Care. 2002 Feb;25(2):269-74. doi: 10.2337/diacare.25.2.269.

    PMID: 11815494BACKGROUND
  • Chapin RB, Williams DC, Adair RF. Diabetes control improved when inner-city patients received graphic feedback about glycosylated hemoglobin levels. J Gen Intern Med. 2003 Feb;18(2):120-4. doi: 10.1046/j.1525-1497.2003.20367.x.

    PMID: 12542586BACKGROUND
  • Rachmani R, Levi Z, Slavachevski I, Avin M, Ravid M. Teaching patients to monitor their risk factors retards the progression of vascular complications in high-risk patients with Type 2 diabetes mellitus--a randomized prospective study. Diabet Med. 2002 May;19(5):385-92. doi: 10.1046/j.1464-5491.2002.00701.x.

    PMID: 12027926BACKGROUND
  • Ciechanowski PS, Katon WJ, Russo JE. Depression and diabetes: impact of depressive symptoms on adherence, function, and costs. Arch Intern Med. 2000 Nov 27;160(21):3278-85. doi: 10.1001/archinte.160.21.3278.

    PMID: 11088090BACKGROUND
  • Terry K. Better quality care, bigger paycheck. Med Econ. 2002 Sep 9;79(17):99-100, 103-6, 109-10. No abstract available.

    PMID: 12298136BACKGROUND
  • Hawryluk M: CMS project to measure physician quality of care. Am Med News. American Medical Association. February 2003

    BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Andrew Davis, M.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

August 1, 2003

Study Completion

December 1, 2005

Last Updated

September 23, 2013

Record last verified: 2013-09

Locations