CClinicalTrials.gg
CompletedNCT00904007Updated Feb 5, 2019Results posted

Interactive Spaced Education to Optimize Hypertension Management

An interventional study of Interactive Spaced Education (ISE) --- online education in Hypertension, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-05.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
111
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hypertension

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Keywords

  • Educational Technology
  • Hypertension
  • Education, Professional
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 111 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • VA VISN 1 primary care clinicians (MD, NP, PA) who have at least a 50% (4/8 time) clinical appointment.

Exclusion criteria

Exclusion Criteria:

  • VA VISN 1 primary care clinicians (MD, NP, PA) who do not have at least a 50% (4/8 time) clinical appointment.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
111 participants (actual)

Study arms

  • Experimental
    SE Game Cohort

    Will receive ISE intervention.

    Other: Interactive Spaced Education (ISE) --- online education

  • No intervention
    Control Cohort

    The control cohort will receive identical content online (with no ISE)

Interventions

  • OtherInteractive Spaced Education (ISE) --- online 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 questions.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Months 1-24

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Cross-cohort Comparison of Frequency of Treatment Intensification

    Time frame: Months 1-24

  8. Cross-cohort Comparison of Patients' Follow-up Intervals After Clinical Encounters With Elevated Blood Pressure

    Time frame: Months 1-24

  9. Pre-test Performance Differences by Provider-related Variables (Site of Care, Age, Date of Recertification, Etc.)

    Time frame: Month 1

  10. Cross-cohort Comparison of Providers' Post-test Scores (Score Improvements)

    Time frame: Months 1-12

  11. Baseline Knowledge Levels of Providers Assessed Via Their Initial Responses to Spaced Education Items (Spaced Education Cohort Only)

    Time frame: Months 1-12

  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

  13. Provider-perceived Acceptability of Spaced Education Intervention

    Time frame: Months 1-12

  14. Provider-perceived Effectiveness of Spaced Education Intervention

    Time frame: Months 1-12

  15. Providers' Perceptions of the Optimal Parameters for the Spaced Education Intervention

    Time frame: Months 1-12

  16. Provider-perceived Barriers and Facilitators to the Spaced Education Intervention

    Time frame: Months 1-12

07

Results

Posted Aug 26, 2014

Participant flow

Participant flow — Overall Study
MilestoneSE Game CohortControl Cohort
Started5556
Completed5556
Not completed00

Outcome measures

PrimaryCross-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.

Time frame:
Months 1-24
Reported as:
Median · days
Cross-cohort Comparison of the Average Time Needed to Normalize Patients' Blood Pressure
daysSE Game CohortControl Cohort
Cross-cohort Comparison of the Average Time Needed to Normalize Patients' Blood Pressure137 (0 to 365)145 (0 to 365)
SecondaryCross-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

No measurements were reported for this outcome.

SecondaryCross-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

No measurements were reported for this outcome.

SecondaryCross-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

No measurements were reported for this outcome.

SecondaryCross-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

No measurements were reported for this outcome.

SecondaryCross-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

No measurements were reported for this outcome.

SecondaryCross-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

No measurements were reported for this outcome.

SecondaryCross-cohort Comparison of Frequency of Treatment Intensification
Time frame:
Months 1-24

No measurements were reported for this outcome.

SecondaryCross-cohort Comparison of Patients' Follow-up Intervals After Clinical Encounters With Elevated Blood Pressure
Time frame:
Months 1-24

No measurements were reported for this outcome.

SecondaryPre-test Performance Differences by Provider-related Variables (Site of Care, Age, Date of Recertification, Etc.)
Time frame:
Month 1

No measurements were reported for this outcome.

SecondaryCross-cohort Comparison of Providers' Post-test Scores (Score Improvements)
Time frame:
Months 1-12

No measurements were reported for this outcome.

SecondaryBaseline Knowledge Levels of Providers Assessed Via Their Initial Responses to Spaced Education Items (Spaced Education Cohort Only)
Time frame:
Months 1-12

No measurements were reported for this outcome.

SecondaryPerformance 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

No measurements were reported for this outcome.

SecondaryProvider-perceived Acceptability of Spaced Education Intervention
Time frame:
Months 1-12

No measurements were reported for this outcome.

SecondaryProvider-perceived Effectiveness of Spaced Education Intervention
Time frame:
Months 1-12

No measurements were reported for this outcome.

SecondaryProviders' Perceptions of the Optimal Parameters for the Spaced Education Intervention
Time frame:
Months 1-12

No measurements were reported for this outcome.

SecondaryProvider-perceived Barriers and Facilitators to the Spaced Education Intervention
Time frame:
Months 1-12

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm 1—0/55 (0%)0/55 (0%)
Arm 2—0/56 (0%)0/56 (0%)

Baseline characteristics

Participants' baseline demographic characteristics were similar between randomized cohorts.

Age, Continuous
Age, Continuous(years)SE Game CohortControl CohortTotal
Mean50.5 ± 9.753.1 ± 8.551.8 ± 9.2
Sex: Female, Male
Sex: Female, Male(Participants)SE Game CohortControl CohortTotal
Female353873
Male201838
08

Study locations

1 site
  • VA Boston Healthcare System Brockton Campus, Brockton, MA
    Brockton, Massachusetts 02301, United States
09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00904007
Lead sponsor
VA Office of Research and Development
Responsible party
Sponsor
First posted
May 19, 2009
Start date
Feb 2010
Primary completion
Mar 2012
Completion
Sep 2014
Results posted
Aug 26, 2014
Last update
Feb 5, 2019

Study contacts

B. Price Kerfoot, MD EdM
principal investigator · VA Boston Healthcare System Brockton Campus, Brockton, MA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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