Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224848
Status:
COMPLETED
Last Update Posted:
2016-11-06
First Post:
2005-09-21
Brief Title:
Guideline Adherence for Heart Health
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-08
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:
GLAD Heart
Brief Summary:
This study addresses the challenges associated with implementation of clinical practice guidelines CPGs and is motivated by our interest in gaining insight regarding the following general research questions about CPG implementation
A Can physician adherence to complex CPGs be promoted by use of a hand-held computerized decision support tool providing patient-specific recommendations documentation and drug dosing assistance B Will increased adherence to CPGs reduce variation in management by age gender and raceethnicity such that disparities in healthcare are reduced or eliminated C What are the cost implications of using PDA-based technology to promote CPG adherence
This randomized controlled unblinded practice-based trial will address these research questions by testing the following hypotheses in a 2 year behavioral intervention period
1 The absolute proportion of patients that is treated appropriately with respect to lipid-lowering drug therapy within 4 months after testing will be increased by a net of at least 9 by the intervention as measured in baseline and follow-up independent cross-sectional samples of eligible patients primary endpoint
2 The absolute proportion of patients that is treated to the appropriate low density lipoprotein cholesterol LDL-C goal during follow-up of the baseline cohort of eligible patients is increased by a net of at least 12 by the intervention secondary endpoint
3 The proportions of eligible patients that are appropriately screened risk-stratified and counseled regarding therapeutic lifestyle changes are increased by the intervention tertiary endpoints
4 The intervention effect in subgroups defined by disease status CVD diabetes or neither age gender and raceethnicity reduces any disparities observed at baseline exploratory analyses
5 In addition we will estimate the marginal cost effectiveness of the intervention for the primary endpoint
The aims were modified in Year 1 to include an attention control group to enable evaluating and testing the impact of strategies to improve adherence to the recently released JNC 7 guideline by testing the following hypotheses
1 The absolute proportion of patients that is treated appropriately with respect to blood pressure lowering drug therapy will be 10 greater in intervention practices than in comparison practices as measured in follow-up independent cross-sectional samples of eligible patients primary endpoint
2 The absolute proportion of patients that is treated to the appropriate blood pressure goal during follow-up will be 10 greater in the intervention practices secondary endpoint
3 The intervention effect in subgroups defined by disease status CVD diabetes or neither age gender and raceethnicity reduces any disparities observed at baseline exploratory analyses
4 In addition we will estimate the marginal cost effectiveness of the intervention for the primary endpoint
A Can physician adherence to complex CPGs be promoted by use of a hand-held computerized decision support tool providing patient-specific recommendations documentation and drug dosing assistance B Will increased adherence to CPGs reduce variation in management by age gender and raceethnicity such that disparities in healthcare are reduced or eliminated C What are the cost implications of using PDA-based technology to promote CPG adherence
This randomized controlled unblinded practice-based trial will address these research questions by testing the following hypotheses in a 2 year behavioral intervention period
1 The absolute proportion of patients that is treated appropriately with respect to lipid-lowering drug therapy within 4 months after testing will be increased by a net of at least 9 by the intervention as measured in baseline and follow-up independent cross-sectional samples of eligible patients primary endpoint
2 The absolute proportion of patients that is treated to the appropriate low density lipoprotein cholesterol LDL-C goal during follow-up of the baseline cohort of eligible patients is increased by a net of at least 12 by the intervention secondary endpoint
3 The proportions of eligible patients that are appropriately screened risk-stratified and counseled regarding therapeutic lifestyle changes are increased by the intervention tertiary endpoints
4 The intervention effect in subgroups defined by disease status CVD diabetes or neither age gender and raceethnicity reduces any disparities observed at baseline exploratory analyses
5 In addition we will estimate the marginal cost effectiveness of the intervention for the primary endpoint
The aims were modified in Year 1 to include an attention control group to enable evaluating and testing the impact of strategies to improve adherence to the recently released JNC 7 guideline by testing the following hypotheses
1 The absolute proportion of patients that is treated appropriately with respect to blood pressure lowering drug therapy will be 10 greater in intervention practices than in comparison practices as measured in follow-up independent cross-sectional samples of eligible patients primary endpoint
2 The absolute proportion of patients that is treated to the appropriate blood pressure goal during follow-up will be 10 greater in the intervention practices secondary endpoint
3 The intervention effect in subgroups defined by disease status CVD diabetes or neither age gender and raceethnicity reduces any disparities observed at baseline exploratory analyses
4 In addition we will estimate the marginal cost effectiveness of the intervention for the primary endpoint
Detailed Description:
BACKGROUND
Many investigators have identified gaps in the quality of care delivered in routine practice in the US According to the Institute of Medicine IOM report Crossing the Quality Chasm A New Health System for the 21st Century the gap between evidence and practice might be better termed a chasm High blood cholesterol was identified as one of 15 high priority conditions for Department of Health and Human Services DHHS initial focus In addition the report stresses the importance of increased use of information technology to support clinical and administrative processes Six major aims are spelled out in the IOM report health care should be safe effective patient-centered timely efficient and equitable We have developed an intervention that is grounded in this philosophy Specifically we are focusing on a guideline that promotes the timely use of safe and effective interventions in a patient-tailored manner A hand-held computerized decision support tool will be a core component of the intervention to support consistent and efficient medical decision-making Although our goal is to improve overall adherence with the chosen guideline we expect that the quality improvement process will result in increased equity reflected in reduced disparities with respect to appropriate treatment between patient subgroups defined by gender raceethnicity and age
DESIGN NARRATIVE
GLAD Heart is a randomized trial The study intervention academic detailing on ATPIII and a hand-held computerized decision support tool that provides patient-specific ATPIII-based risk stratification and treatment recommendations for cholesterol management and an attention control intervention academic detailing on JNC7 and automated blood pressure devices will be delivered at the level of randomization which is the practice All practices N64 will receive usual care consisting of guideline dissemination baseline performance feedback continuing education and patient education materials Outcomes will be assessed based on patient level data from chart reviews N 20000 of adult patients eligible for cholesterol measurement To assess ATPIII-related outcomes we will compare changes in baseline and follow-up chart abstraction between the two arms To assess JNC7-related outcomes we will compare differences in follow-up chart abstraction only between the two arms Appropriate analytic methods will be used to analyze these correlated data Impact evaluation for both arms will be conducted via baseline and follow-up surveys of participating providers Process evaluation will be conducted by tracking use of the PDA-based tool and monitoring appropriate use of the automated blood pressure devices Other tracking information will be collected to ensure intervention and data collection success
Many investigators have identified gaps in the quality of care delivered in routine practice in the US According to the Institute of Medicine IOM report Crossing the Quality Chasm A New Health System for the 21st Century the gap between evidence and practice might be better termed a chasm High blood cholesterol was identified as one of 15 high priority conditions for Department of Health and Human Services DHHS initial focus In addition the report stresses the importance of increased use of information technology to support clinical and administrative processes Six major aims are spelled out in the IOM report health care should be safe effective patient-centered timely efficient and equitable We have developed an intervention that is grounded in this philosophy Specifically we are focusing on a guideline that promotes the timely use of safe and effective interventions in a patient-tailored manner A hand-held computerized decision support tool will be a core component of the intervention to support consistent and efficient medical decision-making Although our goal is to improve overall adherence with the chosen guideline we expect that the quality improvement process will result in increased equity reflected in reduced disparities with respect to appropriate treatment between patient subgroups defined by gender raceethnicity and age
DESIGN NARRATIVE
GLAD Heart is a randomized trial The study intervention academic detailing on ATPIII and a hand-held computerized decision support tool that provides patient-specific ATPIII-based risk stratification and treatment recommendations for cholesterol management and an attention control intervention academic detailing on JNC7 and automated blood pressure devices will be delivered at the level of randomization which is the practice All practices N64 will receive usual care consisting of guideline dissemination baseline performance feedback continuing education and patient education materials Outcomes will be assessed based on patient level data from chart reviews N 20000 of adult patients eligible for cholesterol measurement To assess ATPIII-related outcomes we will compare changes in baseline and follow-up chart abstraction between the two arms To assess JNC7-related outcomes we will compare differences in follow-up chart abstraction only between the two arms Appropriate analytic methods will be used to analyze these correlated data Impact evaluation for both arms will be conducted via baseline and follow-up surveys of participating providers Process evaluation will be conducted by tracking use of the PDA-based tool and monitoring appropriate use of the automated blood pressure devices Other tracking information will be collected to ensure intervention and data collection success
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL070742 | NIH | None | httpsreporternihgovquickSearchR01HL070742 |