Ignite Creation Date:
2024-05-05 @ 11:40 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01384045
Status:
COMPLETED
Last Update Posted:
2012-12-18
First Post:
2011-06-27
Brief Title:
Outreach for Diabetes Cure
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Randomized Trial of Health Promotion Outreach for Diabetes Cure
Status:
COMPLETED
Status Verified Date:
2011-06
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:
Using a socioeconomic raceethnic and gender-diverse sample of patients who receive diabetes care from a University of Colorado Hospital UCH primary care provider PCP carry out a randomized-controlled trial of usual care versus an outreach intervention designed to increase guideline concordance with American Diabetes Association ADA recommendations for blood pressure Low-density lipoprotein LDL and glycosylated hemoglobin A1c goals referrals for retinal exams and aspirin therapyPrimary hypotheses The proportion of patients meeting goal will be 10 higher in the intervention compared with control group in the following domains 1 LDL100 mgdL 2 A1c70 and 3 Systolic blood pressure130 mm Hg or diastolic blood pressure80 mm Hg
Detailed Description:
Ten percent of all people over the age of 20 and 21 of all people over the age of 60 have diabetes Diabetes is the sixth leading cause of death and is one of the most prominent causes of heart disease stroke blindness nephropathy and neuropathy Total health care expenditures for diabetes and its complications are enormous amounting to more than 132 billion in direct and indirect costs in 2002 Nationally substantial percentages of diabetic patients are not meeting ADA Health Plan Employer Data and Information Set HEDIS and Physician Quality Reporting Initiative PQRI guidelines for care that are intended to reduce morbidity and mortality associated with this disease In order to improve these statistics novel ways of delivering primary and secondary preventive diabetes care are needed The growing use of electronic medical record systems and the ability to extract clinically-relevant information from administrative data sets offer powerful opportunities to identify patients who are falling through the cracks reach out to them proactively where they live and render medical services and education in ways that maximize convenience and minimize barriers associated with sporadic and time-limited clinic visits
The delivery of preventive and chronic disease services is sub-optimal in outpatient settings Rates of guideline concordance for diabetes care within University of Colorado Hospital UCH are in most instances modestly better than national averages yet there remains tremendous room for improvement Clinic visits are often too brief for medical providers to review and arrange for all recommended care Providers are frequently hampered by poorly-organized clinical data and a lack of automated reminders Finally many patients do not know about recommendations for care and prefer to focus on acute concerns during clinic visits
Although decision support in the medical providers office can improve guideline-based care for chronic illness it does not improve outcomes among patients who fail to make clinic appointments or who make appointments for reasons unrelated to the illness The investigators developed a health promotion outreach system HPOS to overcome many of these barriers The purpose of HPOS is to increase access to and enhance the delivery of guideline-based care by communicating with patients outside of clinical settings
Our diabetes-specific HPOS intervention incorporates the following key elements 1 electronic queries of administrative claims to identify patients who are not up-to-date with recommended diabetes services 2 mail and telephone outreach to alert patients about recommendations for care and facilitate the direct scheduling of primary care provider PCP visits laboratory testing several days before PCP visits and ophthalmology appointments and 3 advance PCP notification regarding the intended diabetes focus of appointments arranged through the outreach process The purpose of this study is to assess whether this intervention improves guideline concordance for LDL cholesterol hemoglobin A1c blood pressure retinal examinations and aspirin therapy as well as clinical attention to diabetes during primary care visits
The investigators believe our intervention will reduce several barriers associated with usual care First the investigators reach out proactively to inform patients about recommendations for care instead of waiting for them to make appointments haphazardly and often for reasons unrelated to diabetes The investigators make daytime and evening telephone calls to patients many of whom are undoubtedly busy and forgetful when they do not themselves call in response to letters that summarize personalized recommendations The investigators schedule all laboratories and PCP visits at a single point in time over the phone and then send reminder postcards that summarize this information Rather than completing laboratory testing during PCP visits and then requiring PCPs to convey recommendations for care several days later the investigators schedule laboratories ahead of time whenever possible so that timely information will be available help guide clinical decision-making at the point of care Finally the investigators notify patients and PCPs in advance about the diabetes-specific purpose of scheduled appointments and specific areas needing clinical attention
The delivery of preventive and chronic disease services is sub-optimal in outpatient settings Rates of guideline concordance for diabetes care within University of Colorado Hospital UCH are in most instances modestly better than national averages yet there remains tremendous room for improvement Clinic visits are often too brief for medical providers to review and arrange for all recommended care Providers are frequently hampered by poorly-organized clinical data and a lack of automated reminders Finally many patients do not know about recommendations for care and prefer to focus on acute concerns during clinic visits
Although decision support in the medical providers office can improve guideline-based care for chronic illness it does not improve outcomes among patients who fail to make clinic appointments or who make appointments for reasons unrelated to the illness The investigators developed a health promotion outreach system HPOS to overcome many of these barriers The purpose of HPOS is to increase access to and enhance the delivery of guideline-based care by communicating with patients outside of clinical settings
Our diabetes-specific HPOS intervention incorporates the following key elements 1 electronic queries of administrative claims to identify patients who are not up-to-date with recommended diabetes services 2 mail and telephone outreach to alert patients about recommendations for care and facilitate the direct scheduling of primary care provider PCP visits laboratory testing several days before PCP visits and ophthalmology appointments and 3 advance PCP notification regarding the intended diabetes focus of appointments arranged through the outreach process The purpose of this study is to assess whether this intervention improves guideline concordance for LDL cholesterol hemoglobin A1c blood pressure retinal examinations and aspirin therapy as well as clinical attention to diabetes during primary care visits
The investigators believe our intervention will reduce several barriers associated with usual care First the investigators reach out proactively to inform patients about recommendations for care instead of waiting for them to make appointments haphazardly and often for reasons unrelated to diabetes The investigators make daytime and evening telephone calls to patients many of whom are undoubtedly busy and forgetful when they do not themselves call in response to letters that summarize personalized recommendations The investigators schedule all laboratories and PCP visits at a single point in time over the phone and then send reminder postcards that summarize this information Rather than completing laboratory testing during PCP visits and then requiring PCPs to convey recommendations for care several days later the investigators schedule laboratories ahead of time whenever possible so that timely information will be available help guide clinical decision-making at the point of care Finally the investigators notify patients and PCPs in advance about the diabetes-specific purpose of scheduled appointments and specific areas needing clinical attention
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