Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012753
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Brief Title:
Automated Calls With Nurse Follow-Up to Improve Diabetes Ambulatory Care
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Automated Calls With Nurse Follow-Up to Improve Diabetes Ambulatory Care
Status:
COMPLETED
Status Verified Date:
2007-02
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:
Regular outpatient follow-up is important for all diabetes patients with some needing frequent attention because their health is unstable their treatment regimen is complex or their social supports are inadequate However many patients live with access barriers that limit their use of outpatient services fail to attend outpatient appointments and experience worse outcomes than trials of aggressive management suggest is possible Although labor-intensive telephone care programs are one potential strategy for bringing diabetes management services into patients homes and improving their glycemic control Automated telephone disease management ATDM systems can augment telephone care by providing frequent monitoring and health education to large patient panels while focusing clinicians attention on individuals who need it most Although this technology has shown some promise it has not been rigorously evaluated particularly in VA
Detailed Description:
Background
Regular outpatient follow-up is important for all diabetes patients with some needing frequent attention because their health is unstable their treatment regimen is complex or their social supports are inadequate However many patients live with access barriers that limit their use of outpatient services fail to attend outpatient appointments and experience worse outcomes than trials of aggressive management suggest is possible Although labor-intensive telephone care programs are one potential strategy for bringing diabetes management services into patients homes and improving their glycemic control Automated telephone disease management ATDM systems can augment telephone care by providing frequent monitoring and health education to large patient panels while focusing clinicians attention on individuals who need it most Although this technology has shown some promise it has not been rigorously evaluated particularly in VA
Objectives
This study evaluated Automated Telephone Disease Management ATDM calls with telephone nurse follow-up as a means of improving the quality of VA diabetes care Specifically we will determine whether this service improves patients glucose control improves other important outcomes such as their quality of life satisfaction with care and health service use improves health behaviors such as self-monitoring of blood glucose fat intake and medication adherence and has effects that vary across patient subgroups
Methods
Patients with diabetes mellitus using hypoglycemic medication were enrolled during outpatient visits to a university-affiliated VA health care system and randomized to usual care or bi-weekly ATDM assessment and self-care education calls with follow-up by a nurse educator The intervention process was evaluated by examining patients patterns of ATDM use and the reliability and validity of information they provided Telephone surveys were used to measure intervention effects at 12-months on patients self-care symptoms satisfaction with care and perceived access barriers The impact on VA utilization was evaluated using electronic utilization databases and glycemic control was measured using laboratory tests A total of 292 patients were randomized and 272 93 provided data at 12-months Intervention patients completed ATDM assessments consistently throughout the observation period and the assessments identified groups of intervention patients with varying degrees of health risk at baseline Compared to control patients intervention patients at 12-months reported more frequent glucose self-monitoring fewer access problems and greater satisfaction with care all p 005 Intervention patients were more likely than controls to have been seen in podiatry clinics 53 versus 31 p 0003 and diabetes specialty clinics 31 versus 17 p 003 during the study The intervention did not influence mean endpoint HgA1c levels overall However among patients with baseline HgA1c 8 mean endpoint values among intervention and control patients were 87 and 92 respectively p 005 intervention effects were even greater among patients with baseline HgA1c 9 Moreover intervention patients at follow-up reported fewer symptoms of poor glycemic control than patients receiving usual care 36 versus 44 p 003
Status
Completed
Regular outpatient follow-up is important for all diabetes patients with some needing frequent attention because their health is unstable their treatment regimen is complex or their social supports are inadequate However many patients live with access barriers that limit their use of outpatient services fail to attend outpatient appointments and experience worse outcomes than trials of aggressive management suggest is possible Although labor-intensive telephone care programs are one potential strategy for bringing diabetes management services into patients homes and improving their glycemic control Automated telephone disease management ATDM systems can augment telephone care by providing frequent monitoring and health education to large patient panels while focusing clinicians attention on individuals who need it most Although this technology has shown some promise it has not been rigorously evaluated particularly in VA
Objectives
This study evaluated Automated Telephone Disease Management ATDM calls with telephone nurse follow-up as a means of improving the quality of VA diabetes care Specifically we will determine whether this service improves patients glucose control improves other important outcomes such as their quality of life satisfaction with care and health service use improves health behaviors such as self-monitoring of blood glucose fat intake and medication adherence and has effects that vary across patient subgroups
Methods
Patients with diabetes mellitus using hypoglycemic medication were enrolled during outpatient visits to a university-affiliated VA health care system and randomized to usual care or bi-weekly ATDM assessment and self-care education calls with follow-up by a nurse educator The intervention process was evaluated by examining patients patterns of ATDM use and the reliability and validity of information they provided Telephone surveys were used to measure intervention effects at 12-months on patients self-care symptoms satisfaction with care and perceived access barriers The impact on VA utilization was evaluated using electronic utilization databases and glycemic control was measured using laboratory tests A total of 292 patients were randomized and 272 93 provided data at 12-months Intervention patients completed ATDM assessments consistently throughout the observation period and the assessments identified groups of intervention patients with varying degrees of health risk at baseline Compared to control patients intervention patients at 12-months reported more frequent glucose self-monitoring fewer access problems and greater satisfaction with care all p 005 Intervention patients were more likely than controls to have been seen in podiatry clinics 53 versus 31 p 0003 and diabetes specialty clinics 31 versus 17 p 003 during the study The intervention did not influence mean endpoint HgA1c levels overall However among patients with baseline HgA1c 8 mean endpoint values among intervention and control patients were 87 and 92 respectively p 005 intervention effects were even greater among patients with baseline HgA1c 9 Moreover intervention patients at follow-up reported fewer symptoms of poor glycemic control than patients receiving usual care 36 versus 44 p 003
Status
Completed
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