HypertensionNCT00904007
Interactive Spaced Education to Optimize Hypertension Management
A study testing Interactive Spaced Education (ISE) --- online education in people with Hypertension, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Interactive Spaced Education (ISE) --- online education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- VA VISN 1 primary care clinicians (MD, NP, PA) who have at least a 50% (4/8 time) clinical appointment.
Who cannot join
- VA VISN 1 primary care clinicians (MD, NP, PA) who do not have at least a 50% (4/8 time) clinical appointment.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Brockton Campus, Brockton, MA
Brockton, Massachusetts, 02301
About this study
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
Read the 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.
- Conditions
- Hypertension
- Being tested
- Interactive Spaced Education (ISE) --- online education
- Keywords
- Educational Technology, Hypertension, Education, Professional
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Spaced Education (ISE) --- online educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SE Game Cohort | Experimental | Will receive ISE intervention. Receives: Other: Interactive Spaced Education (ISE) --- online education |
| Control Cohort | No intervention | The control cohort will receive identical content online (with no ISE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-cohort Comparison of the Average Time Needed to Normalize Patients' Blood Pressure
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.
Measured: Months 1-24
Secondary outcomes (16)
Cross-cohort Comparison of Patients' Average Blood Pressure at 12 Months After Trial Launch (Last Measured Blood Pressure in Months 1-12)
Measured: Months 1-12
Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 1-12 (Last Measured Blood Pressure in Months 1-12)
Measured: Months 1-12
Cross-cohort Comparison of Patients' Average Blood Pressure at 24 Months After Trial Launch (Last Measured Blood Pressure in Months 13-24)
Measured: Months 13-24
Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 13-24 (Last Measured Blood Pressure in Months 13-24)
Measured: Months 13-24
Cross-cohort Comparison of Patients' Average Blood Pressure at 24 Months After Trial Launch (Last Measured Blood Pressure in Months 1-24)
Measured: Months 1-24
Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 1-24 (Last Measured Blood Pressure in Months 1-24)
Measured: Months 1-24
Cross-cohort Comparison of Frequency of Treatment Intensification
Measured: Months 1-24
Cross-cohort Comparison of Patients' Follow-up Intervals After Clinical Encounters With Elevated Blood Pressure
Measured: Months 1-24
Pre-test Performance Differences by Provider-related Variables (Site of Care, Age, Date of Recertification, Etc.)
Measured: Month 1
Cross-cohort Comparison of Providers' Post-test Scores (Score Improvements)
Measured: Months 1-12
Baseline Knowledge Levels of Providers Assessed Via Their Initial Responses to Spaced Education Items (Spaced Education Cohort Only)
Measured: Months 1-12
Performance Differences by Provider-related Variables (Site of Care, Age, Date of Recertification, Sex, Etc.) in the Spaced Education Program (Spaced Education Cohort Only)
Measured: Months 1-12
Provider-perceived Acceptability of Spaced Education Intervention
Measured: Months 1-12
Provider-perceived Effectiveness of Spaced Education Intervention
Measured: Months 1-12
Providers' Perceptions of the Optimal Parameters for the Spaced Education Intervention
Measured: Months 1-12
Provider-perceived Barriers and Facilitators to the Spaced Education Intervention
Measured: Months 1-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startFeb 2010
- Primary completionMar 2012
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- B. Price Kerfoot, MD EdM, Principal investigator, VA Boston Healthcare System Brockton Campus, Brockton, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904007
- Sponsor's protocol ID
- EDU 08-422
- Status last verified
- Feb 2019
- First submitted
- 15 May 2009
- Last updated
- 5 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kerfoot BP, Turchin A, Breydo E, Gagnon D, Conlin PR. An online spaced-education game among clinicians improves their patients' time to blood pressure control: a randomized controlled trial. Circ Cardiovasc Qual Outcomes. 2014 May;7(3):468-74. doi: 10.1161/CIRCOUTCOMES.113.000814.
PubMed 24847084
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Spaced Education to Optimize Hypertension Management
- ClinicalTrials.gov ID
- NCT00904007
- Acronym / sponsor ID
- EDU 08-422
- Conditions
- Hypertension
- Keywords
- Educational Technology, Hypertension, Education, Professional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Feb 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 19 May 2009 (estimated)
- Results
- Posted 26 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SE Game Cohort | Experimental | Other: Interactive Spaced Education (ISE) --- online educationWill receive ISE intervention. |
| Control Cohort | No intervention | –The control cohort will receive identical content online (with no ISE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- VA VISN 1 primary care clinicians (MD, NP, PA) who have at least a 50% (4/8 time) clinical appointment.
Key exclusion criteria (1 listed)
- VA VISN 1 primary care clinicians (MD, NP, PA) who do not have at least a 50% (4/8 time) clinical appointment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Spaced Education (ISE) --- online educationISE 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. | Other | SE Game Cohort |
Primary outcome
Cross-cohort Comparison of the Average Time Needed to Normalize Patients' Blood Pressure
Time frame: Months 1-24
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.
16 secondary outcomes
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
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
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
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
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
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
Cross-cohort Comparison of Frequency of Treatment Intensification
Time frame: Months 1-24
Cross-cohort Comparison of Patients' Follow-up Intervals After Clinical Encounters With Elevated Blood Pressure
Time frame: Months 1-24
Pre-test Performance Differences by Provider-related Variables (Site of Care, Age, Date of Recertification, Etc.)
Time frame: Month 1
Cross-cohort Comparison of Providers' Post-test Scores (Score Improvements)
Time frame: Months 1-12
Baseline Knowledge Levels of Providers Assessed Via Their Initial Responses to Spaced Education Items (Spaced Education Cohort Only)
Time frame: Months 1-12
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
Provider-perceived Acceptability of Spaced Education Intervention
Time frame: Months 1-12
Provider-perceived Effectiveness of Spaced Education Intervention
Time frame: Months 1-12
Providers' Perceptions of the Optimal Parameters for the Spaced Education Intervention
Time frame: Months 1-12
Provider-perceived Barriers and Facilitators to the Spaced Education Intervention
Time frame: Months 1-12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24847084Kerfoot BP, Turchin A, Breydo E, Gagnon D, Conlin PR. An online spaced-education game among clinicians improves their patients' time to blood pressure control: a randomized controlled trial. Circ Cardiovasc Qual Outcomes. 2014 May;7(3):468-74. doi: 10.1161/CIRCOUTCOMES.113.000814.
Related trials for Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Not yet recruitingPhase 4
A Clinical Study of MK-7962 in Chinese Participants With Pulmonary Arterial Hypertension (MK-7962-022)
Hypertension, Pulmonary
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload
Not yet recruitingObservational study
Real-World Validation for Less-Disturbing Ambulatory Blood Pressure Monitoring (ABPM) in Malaysia Using Huawei Wearables
Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
B. Price Kerfoot, MD EdM principal investigator
VA Boston Healthcare System Brockton Campus, Brockton, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Spaced Education (ISE) --- online education in people with Hypertension, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-cohort Comparison of the Average Time Needed to Normalize Patients' Blood Pressure (time frame: Months 1-24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00904007, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.