Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129493
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-08-09
Brief Title:
Group Visits to Improve Hypertension Management
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Group Visits to Improve Hypertension Management
Status:
COMPLETED
Status Verified Date:
2009-05
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:
This study investigates group medical visits as a quality improvement strategy for hypertension It studies group visits in which patients see their own primary care provider together with other patients who have hypertension The group visits are intended to enhance the patients self-efficacy for self-management of their chronic disease hypertension
Detailed Description:
BACKGROUND Many veterans with hypertension have poorly controlled blood pressure BP new strategies for quality improvement are needed A new model of care delivery Group Medical Visits holds promise as a means to improve blood pressure control by enhancing patients self-efficacy for self-management of their chronic disease
Objectives The overriding goal of this implementation project is to translate research findings about management of hypertension into practice and thereby to improve patient outcome ie adequacy of control of BP in patients with hypertension Specific objectives are to develop and implement a model of group medical visits in iterative steps to evaluate whether group medical visits improve patient adherence to prescribed antihypertensive medications and improve BP control and to assess patient physician and health care system factors involved in successfully making organizational changes to encompass group medical visits
Methods Study site primary care clinics at VA Palo Alto Study Design staircase design with 2 steps of designimplementationformative-evaluationredesign with increasing numbers of participants followed by a 3rd step evaluating the final model Participants primary care providers MDs and RNPs and their patients with hypertension Participating primary care providers PCPs are randomly allocated 21 Group Visits GVinterventioncontrol patients of intervention PCPs are also randomly allocated 21 yielding 3 study arms patients of GV-PCPs enrolled in GVs patients of GV-PCPs not in GVs and patients of non-GV-PCPs This design allows for comparison between control patients of primary care providers conducting group visits with primary care providers who do not participate in the group medical appointment intervention Intervention group medical visits of patients with their own PCP Group visits include both education and medical care components Organizational component tracking of organizational issues in establishing the program of group visits interviews with key stakeholders to identify barriers and facilitators to implementing the new model of care Outcome measures patients blood pressures BPs medication adherence satisfaction and health-related quality of life PCP satisfaction qualitative analysis of themes from interviews for patient physician and medical center factors involved in making organizational changes to encompass group visits
Findings We exceeded the target enrollment for primary care providers PCPs with a total of 16 11 intervention 5 control We enrolled 296 patients 7 had incomplete baseline data leaving 289 patients 145 allocated to GVs 73 control patients of GV-PCPs and 71 control patients of control PCPs We have also enrolled an additional 12 staff members for interviews including the one PCP who did not elect to participate Study arm comparisons will not be made until the final data collection is complete In formative evaluations we found that patient medical needs were met in the group setting and that both patients and PCPs were satisfied with the GV format PCPs and patients have requested that the GVs continue after the study ends Space for the GVs has been a major barrier particularly in light of ongoing construction in the clinic building
Status We are now in Step 3 with plans to end the intervention phase at the end of March 2006 and complete final data collection soon thereafter
Impact Group Medical visits are a new model of health care delivery that hold promise for improving patient access patient and provider satisfaction and clinical outcomes
Objectives The overriding goal of this implementation project is to translate research findings about management of hypertension into practice and thereby to improve patient outcome ie adequacy of control of BP in patients with hypertension Specific objectives are to develop and implement a model of group medical visits in iterative steps to evaluate whether group medical visits improve patient adherence to prescribed antihypertensive medications and improve BP control and to assess patient physician and health care system factors involved in successfully making organizational changes to encompass group medical visits
Methods Study site primary care clinics at VA Palo Alto Study Design staircase design with 2 steps of designimplementationformative-evaluationredesign with increasing numbers of participants followed by a 3rd step evaluating the final model Participants primary care providers MDs and RNPs and their patients with hypertension Participating primary care providers PCPs are randomly allocated 21 Group Visits GVinterventioncontrol patients of intervention PCPs are also randomly allocated 21 yielding 3 study arms patients of GV-PCPs enrolled in GVs patients of GV-PCPs not in GVs and patients of non-GV-PCPs This design allows for comparison between control patients of primary care providers conducting group visits with primary care providers who do not participate in the group medical appointment intervention Intervention group medical visits of patients with their own PCP Group visits include both education and medical care components Organizational component tracking of organizational issues in establishing the program of group visits interviews with key stakeholders to identify barriers and facilitators to implementing the new model of care Outcome measures patients blood pressures BPs medication adherence satisfaction and health-related quality of life PCP satisfaction qualitative analysis of themes from interviews for patient physician and medical center factors involved in making organizational changes to encompass group visits
Findings We exceeded the target enrollment for primary care providers PCPs with a total of 16 11 intervention 5 control We enrolled 296 patients 7 had incomplete baseline data leaving 289 patients 145 allocated to GVs 73 control patients of GV-PCPs and 71 control patients of control PCPs We have also enrolled an additional 12 staff members for interviews including the one PCP who did not elect to participate Study arm comparisons will not be made until the final data collection is complete In formative evaluations we found that patient medical needs were met in the group setting and that both patients and PCPs were satisfied with the GV format PCPs and patients have requested that the GVs continue after the study ends Space for the GVs has been a major barrier particularly in light of ongoing construction in the clinic building
Status We are now in Step 3 with plans to end the intervention phase at the end of March 2006 and complete final data collection soon thereafter
Impact Group Medical visits are a new model of health care delivery that hold promise for improving patient access patient and provider satisfaction and clinical outcomes
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