- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00904007
Interactive Spaced Education to Optimize Hypertension Management
Online interactive spaced education (ISE) is a novel educational methodology based on the "spacing effect", the psychological finding that repeated presentations of educational material over spaced intervals increase learning efficiency and improve knowledge retention. ISE is delivered using periodic emails that contain clinical case scenarios and multiple-choice question. The investigators recently completed a randomized trial involving 95 VISN 1 primary care providers (PCPs) which demonstrated that an ISE intervention can significantly improve clinician's practice patterns. Those clinicians randomized to the ISE intervention on prostate cancer screening demonstrated a 26% relative reduction in inappropriate screening. The investigators propose to conduct a randomized controlled trial involving PCPs in VISN 1 to determine whether ISE can (1) increase knowledge of the appropriate treatment of hypertensive patients, (2) reduce clinical inertia in hypertension management, and (3) improve the blood pressure control in hypertensive patients.
Anticipated Impacts on Veterans' Healthcare: This study aims to demonstrate that online interactive spaced education (ISE) can improve providers' care of patients with hypertension. ISE is the type of intervention that can be deployed across the VHA with content tailored to meet specific needs and can be implemented as a tool to improve performance measures and clinical outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Anticipated Impacts on Veterans' Healthcare: This study aims to demonstrate that online interactive spaced education (ISE) can improve providers' care of patients with hypertension. ISE is the type of intervention that can be deployed across the VHA with content tailored to meet specific needs and can be implemented as a tool to improve performance measures and clinical outcomes.
Project Background/Rationale: ISE is a novel educational methodology based on the "spacing effect", the psychological finding that repeated presentations of educational material over spaced intervals increase learning efficiency and improve knowledge retention. ISE is delivered using periodic emails that contain clinical case scenarios and multiple-choice questions. We recently completed a randomized trial involving 95 VISN 1 primary care providers (PCPs) which demonstrated that an ISE intervention can significantly improve clinician's practice patterns. Those clinicians randomized to the ISE intervention on prostate cancer screening demonstrated a 26% relative reduction in inappropriate screening.
Project Objectives: Lowering blood pressure in hypertensive patients unequivocally decreases the incidence of stroke and cardiovascular events and is highly cost-effective. The majority of patients with blood pressure above the treatment target do not have their anti-hypertensive medications appropriately intensified at clinician visits. A reduced frequency of treatment intensification is alternatively termed 'clinical inertia'. Our preliminary results show that clinicians' knowledge of hypertension management guidelines is limited, and few clinicians report following the guidelines consistently. We propose to conduct a randomized controlled trial involving PCPs in VISN 1 to determine whether ISE can (1) increase knowledge of the appropriate treatment of hypertensive patients, (2) reduce clinical inertia in hypertension management, and (3) improve the blood pressure control in hypertensive patients.
Project Methods: One hundred six VISN 1 primary care practitioners (physicians, nurse practitioners, and physician assistants) will be recruited via email to participate in the study. Participants will be randomized to one of two cohorts: (1) the intervention cohort will receive ISE over year 1, and (2) the control cohort will receive no intervention and will represent the "standard of education" on hypertension management. The ISE intervention will consist of an email every 4 days containing 1 multiple-choice questions based on a curriculum derived from clinical practice guidelines on appropriate hypertension management. Providers will submit answers to the questions online and immediately receive the correct answer and an explanation of the pertinent clinical issues. Using a new adaptive methodology, the spacing and content of the educational intervention will be individualized for each clinician based on their performance. The ISE intervention will be completed in 9-11 months. Hypertension knowledge will be assessed by a post-test at the end of year 1. Providers' clinical inertia and the blood pressures of their patients will be assessed over 2 years: initial changes attributable to ISE will be identified in year 1, while the retention of these changes will be monitored in year 2. Drawing on the interdisciplinary expertise of our investigator team, the study is positioned to enrich national debates about how best to improve the ways in which clinicians can meet their lifelong learning needs.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Brockton, Massachusetts, United States, 02301
- VA Boston Healthcare System Brockton Campus, Brockton, MA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- VA VISN 1 primary care clinicians (MD, NP, PA) who have at least a 50% (4/8 time) clinical appointment.
Exclusion Criteria:
- VA VISN 1 primary care clinicians (MD, NP, PA) who do not have at least a 50% (4/8 time) clinical appointment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SE Game Cohort
Will receive ISE intervention.
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ISE is a novel educational methodology based on the "spacing effect", the psychological finding that repeated presentations of educational material over spaced intervals increase learning efficiency and improve knowledge retention.
ISE is delivered using periodic emails that contain clinical case scenarios and multiple-choice questions.
|
No Intervention: Control Cohort
The control cohort will receive identical content online (with no ISE)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cross-cohort Comparison of the Average Time Needed to Normalize Patients' Blood Pressure
Time Frame: Months 1-24
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A unique hypertensive period served as the unit of analysis.
A hypertensive period started on the first day during the study when a patient's BP was elevated.
It ended on the first subsequent day when it was <140/90 mm Hg or on the last day BP was recorded during the study.
Duration of the hypertensive period (days) was the outcome measure.
BP measurements obtained in the course of routine care were used to ascertain study outcomes, whether obtained by the PCP or at other clinic visits.
These measurements were obtained from structured data (ie, BP recordings in the electronic medical record) and natural language processing of provider notes as previously described.
If several measurements were recorded on the same day, the lowest mean arterial BP was used.
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Months 1-24
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cross-cohort Comparison of Patients' Average Blood Pressure at 12 Months After Trial Launch (Last Measured Blood Pressure in Months 1-12)
Time Frame: Months 1-12
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Months 1-12
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Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 1-12 (Last Measured Blood Pressure in Months 1-12)
Time Frame: Months 1-12
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Months 1-12
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Cross-cohort Comparison of Patients' Average Blood Pressure at 24 Months After Trial Launch (Last Measured Blood Pressure in Months 13-24)
Time Frame: Months 13-24
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Months 13-24
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Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 13-24 (Last Measured Blood Pressure in Months 13-24)
Time Frame: Months 13-24
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Months 13-24
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Cross-cohort Comparison of Patients' Average Blood Pressure at 24 Months After Trial Launch (Last Measured Blood Pressure in Months 1-24)
Time Frame: Months 1-24
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Months 1-24
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Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 1-24 (Last Measured Blood Pressure in Months 1-24)
Time Frame: Months 1-24
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Months 1-24
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Cross-cohort Comparison of Frequency of Treatment Intensification
Time Frame: Months 1-24
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Months 1-24
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Cross-cohort Comparison of Patients' Follow-up Intervals After Clinical Encounters With Elevated Blood Pressure
Time Frame: Months 1-24
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Months 1-24
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Pre-test Performance Differences by Provider-related Variables (Site of Care, Age, Date of Recertification, Etc.)
Time Frame: Month 1
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Month 1
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Cross-cohort Comparison of Providers' Post-test Scores (Score Improvements)
Time Frame: Months 1-12
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Months 1-12
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Baseline Knowledge Levels of Providers Assessed Via Their Initial Responses to Spaced Education Items (Spaced Education Cohort Only)
Time Frame: Months 1-12
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Months 1-12
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Performance Differences by Provider-related Variables (Site of Care, Age, Date of Recertification, Sex, Etc.) in the Spaced Education Program (Spaced Education Cohort Only)
Time Frame: Months 1-12
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Months 1-12
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Provider-perceived Acceptability of Spaced Education Intervention
Time Frame: Months 1-12
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Months 1-12
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Provider-perceived Effectiveness of Spaced Education Intervention
Time Frame: Months 1-12
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Months 1-12
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Providers' Perceptions of the Optimal Parameters for the Spaced Education Intervention
Time Frame: Months 1-12
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Months 1-12
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Provider-perceived Barriers and Facilitators to the Spaced Education Intervention
Time Frame: Months 1-12
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Months 1-12
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Collaborators and Investigators
Investigators
- Principal Investigator: B. Price Kerfoot, MD EdM, VA Boston Healthcare System Brockton Campus, Brockton, MA
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EDU 08-422
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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