DiabetesNCT00204282
The Effectiveness of Improving Compliance With Diabetic Preventative Services and Modifying Vascular Risk
A study testing Educational presentation, group discussion, questionnaires in people with Diabetes, run by University of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Educational presentation, group discussion, questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Dec 2005
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients younger than 40 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Nurse Practitioner Led Group Visits in Improving Compliance With Diabetic Preventative Services and Modifying Vascular Risk
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.
Read the detailed description
Patients who are 40 to 79 years old, and who have had at least three visits with a primary care physician will be the focus of the study. Patients will be recruited by letter, co-signed by the PCP and the study P1 A second letter will be sent 2 weeks after the first. After an intake visit, random allocation will divide 150 patients into 2 arms, one a series of 3 NP-led group classes and the other, usual care. Baseline data, including blood pressure control, foot and retinal examination rates, serum lipids, Alc, microalbumin, pneumococcal vaccination, smoking status and counseling, and ASA and lipid medication use will be assessed at enrollment and again at completion of the study. In addition patients will complete a diabetic knowledge scale, quality of life assessment (SF- 12) and ADA patient satisfaction survey. Several measures will be gathered both by chart review and oral administration of the CDC's BRFSS 2002 diabetes module survey, permitting cross validation. Statistical analysis of the differences between proportions (2x2 for independent samples) will be performed using chi-square. Preliminary power analysis (Power Precision; Biostat, Englewood, NJ) suggests adequate power (using Fisher's exact test, alpha beta 0.1, assuming reasonably achievable effect sizes) for at least several intermediate outcomes.
Patients in the 'group visit' arm are expected to attend three 90-minute educational group visits over six months, with group visits directed by a nurse practitioner. Patients will be asked to attend three sessions (8-10 patients in each) within six months. All patients will continue to see their primary care physicians as scheduled. The focus of the visits will be on diabetic and vascular risk goals, dietary education, and self-management skills. A graphical 'Diabetic Health Tracker' modified from Chapin et al will be provided to group class attendees; such an intervention may improve vascular risk endpoints. The group visit provider team will have the ability to make referrals, administer recommended vaccines, and adjust medications in consultation with the primary care physician; NPs will also make phone contact with the class group members between visits to report results and help assure follow-up; such case management functions may also improve outcomes. Additional telephone outreach will be made to patients who both: 1) do respond to the 2 recruiting letters, and 2) who have not been seen in the past 12 months in order review barriers to care. A brief phone screen for depression will be considered given data linking depression to non-adherence.
As the burden of chronic illness rises along with healthcare costs, innovative approaches are required. Diabetes care has been repeatedly identified by government and private payers as area of focus and perhaps even a future subject for "pay for performance". We hope our study can contribute to better diabetic care and, in the longer term, to improved patient health.
- Conditions
- Diabetes
- Being tested
- Educational presentation, group discussion, questionnaires
- Keywords
- Diabetes prevention
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational presentation, group discussion, questionnairesBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 2003
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Davis, M.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204282
- Sponsor's protocol ID
- 12567A
- Status last verified
- Sep 2013
- First submitted
- 12 Sep 2005
- Last updated
- 23 Sep 2013
- Results posted
- No
Publications
Saydah SH, Eberhardt MS, Loria CM, Brancati FL. Age and the burden of death attributable to diabetes in the United States. Am J Epidemiol. 2002 Oct 15;156(8):714-9. doi: 10.1093/aje/kwf111.
PubMed 12370159Institute 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/
PubMed 25057643Intensive 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.
PubMed 9742976Adler 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.
PubMed 10938049American Diabetes Association: clinical practice recommendations. Standards of medical for patients with diabetes mellitus. Diabetes Care 2003; 26:(suppl 1):533-50
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.
PubMed 11574448Centers 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.
PubMed 12433019Saaddine 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.
PubMed 11955024Grant 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.
PubMed 12034408Sobel 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.
PubMed 12566379Chin 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.
PubMed 9653601Renders 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.
PubMed 11574449Sadur 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.
PubMed 10587835Norris 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.
PubMed 11985933Montori 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.
PubMed 12401738
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Nurse Practitioner Led Group Visits in Improving Compliance With Diabetic Preventative Services and Modifying Vascular Risk
- ClinicalTrials.gov ID
- NCT00204282
- Acronym / sponsor ID
- 12567A
- Conditions
- Diabetes
- Keywords
- Diabetes prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Aug 2003
- Study completion
- Dec 2005
- First posted
- 20 Sep 2005 (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 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.
Detailed description
Patients who are 40 to 79 years old, and who have had at least three visits with a primary care physician will be the focus of the study. Patients will be recruited by letter, co-signed by the PCP and the study P1 A second letter will be sent 2 weeks after the first. After an intake visit, random allocation will divide 150 patients into 2 arms, one a series of 3 NP-led group classes and the other, usual care. Baseline data, including blood pressure control, foot and retinal examination rates, serum lipids, Alc, microalbumin, pneumococcal vaccination, smoking status and counseling, and ASA and lipid medication use will be assessed at enrollment and again at completion of the study. In addition patients will complete a diabetic knowledge scale, quality of life assessment (SF- 12) and ADA patient satisfaction survey. Several measures will be gathered both by chart review and oral administration of the CDC's BRFSS 2002 diabetes module survey, permitting cross validation. Statistical analysis of the differences between proportions (2x2 for independent samples) will be performed using chi-square. Preliminary power analysis (Power Precision; Biostat, Englewood, NJ) suggests adequate power (using Fisher's exact test, alpha beta 0.1, assuming reasonably achievable effect sizes) for at least several intermediate outcomes.
Patients in the 'group visit' arm are expected to attend three 90-minute educational group visits over six months, with group visits directed by a nurse practitioner. Patients will be asked to attend three sessions (8-10 patients in each) within six months. All patients will continue to see their primary care physicians as scheduled. The focus of the visits will be on diabetic and vascular risk goals, dietary education, and self-management skills. A graphical 'Diabetic Health Tracker' modified from Chapin et al will be provided to group class attendees; such an intervention may improve vascular risk endpoints. The group visit provider team will have the ability to make referrals, administer recommended vaccines, and adjust medications in consultation with the primary care physician; NPs will also make phone contact with the class group members between visits to report results and help assure follow-up; such case management functions may also improve outcomes. Additional telephone outreach will be made to patients who both: 1) do respond to the 2 recruiting letters, and 2) who have not been seen in the past 12 months in order review barriers to care. A brief phone screen for depression will be considered given data linking depression to non-adherence.
As the burden of chronic illness rises along with healthcare costs, innovative approaches are required. Diabetes care has been repeatedly identified by government and private payers as area of focus and perhaps even a future subject for "pay for performance". We hope our study can contribute to better diabetic care and, in the longer term, to improved patient health.
Study design
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients younger than 40 years of age
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 |
|---|---|---|
| Educational presentation, group discussion, questionnaires | Behavioural | – |
Primary outcome
Nurse practitioner run group visits will improve compliance with established American Diabetes Association guidelines for screening and preventive care
1 secondary outcome
Compliance with established American Diabetes Association guidelines for screening and preventive care will lower cardiovascular risk
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 Sep 2013.
- Background: PubMed 12370159Saydah SH, Eberhardt MS, Loria CM, Brancati FL. Age and the burden of death attributable to diabetes in the United States. Am J Epidemiol. 2002 Oct 15;156(8):714-9. doi: 10.1093/aje/kwf111.
- Background: PubMed 25057643Institute 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/
- Background: PubMed 9742976Intensive 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.
- Background: PubMed 10938049Adler 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.
- BackgroundAmerican Diabetes Association: clinical practice recommendations. Standards of medical for patients with diabetes mellitus. Diabetes Care 2003; 26:(suppl 1):533-50
- Background: PubMed 11574448Fleming 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.
- Background: PubMed 12433019Centers 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.
- Background: PubMed 11955024Saaddine 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.
- Background: PubMed 12034408Grant 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.
- Background: PubMed 12566379Sobel 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.
- Background: PubMed 9653601Chin 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.
- Background: PubMed 11574449Renders 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.
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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.
Andrew Davis, M.D. principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational presentation, group discussion, questionnaires in people with Diabetes, run by University of Chicago 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 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 23 Sep 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?
Nurse practitioner run group visits will improve compliance with established American Diabetes Association guidelines for screening and preventive care. 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 NCT00204282, which also lists 26 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 Sep 2013.