Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00204282
Status:
COMPLETED
Last Update Posted:
2013-09-23
First Post:
2005-09-12
Brief Title:
The Effectiveness of Improving Compliance With Diabetic Preventative Services and Modifying Vascular Risk
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
The Effectiveness of Nurse Practitioner Led Group Visits in Improving Compliance With Diabetic Preventative Services and Modifying Vascular Risk
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 CDCs 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 Fishers exact test alpha beta 01 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None