Prostate CancerNCT01168323
Spaced Education to Optimize Prostate Cancer Screening
A study testing Online spaced education in people with Prostate Cancer, run by Harvard University Faculty of Medicine at 1 site in United States.
Trial summary
Two memory research findings (the spacing and testing effects) can dramatically improve retention of learning, but they have largely have been ignored by educators. The researchers have developed a novel form of online education (termed 'spaced education') based on these two effects which has been shown in randomized… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Online spaced education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Primary care providers (physicians, nurse practitioners, and physician assistants) from the 8 Veterans Affairs (VA) hospitals in the New England region (Veterans Integrated Service Network 1 [VISN-1]) were eligible to enroll.
Who cannot join
- Primary care providers (PCPs) who ordered PSA as a screen for prostate cancer less than 10 times each year were excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs Boston Healthcare System
Boston, Massachusetts, 02130
About this study
Two memory research findings (the spacing and testing effects) can dramatically improve retention of learning, but they have largely have been ignored by educators. The researchers have developed a novel form of online education (termed 'spaced education') based on these two effects which has been shown in randomized trials to improve knowledge acquisition and boost learning retention. Using prostate cancer screening as an experimental system, the researchers investigated whether spaced education could durably improve clinicians' behaviors, not just their knowledge.
- Conditions
- Prostate Cancer
- Being tested
- Online spaced education
- Keywords
- Medical Education, Educational Technology, Clinical Practice Guideline, Prostate specific antigen
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online spaced educationBehavioural
Spaced education is currently delivered via periodic emails that contain clinical case scenarios and multiple-choice questions. Upon submitting answers to each question online, clinicians receive immediate feedback and educational material. The questions are then repeated over spaced intervals of time to harness the pedagogical benefits of the spacing effect.
| Study group | Role | What they receive |
|---|---|---|
| Spaced education clinicians - cohort 1 | Experimental | Spaced education clinicians receive four isomorphic cycles of 9 spaced education emails over 36-weeks (0-2 emails per week). Each email contained one question-explanation. Receives: Behavioral: Online spaced education |
| Control clinicians - cohort 2 | No intervention | Control clinicians received no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of inappropriate prostate-specific antigen (PSA) screening performed by clinicians
The primary outcome measure was the difference in the percentage of inappropriate PSA screening performed by clinicians in the spaced education and control cohorts. Based on published clinical guidelines and reports, inappropriate PSA utilization was defined as the use of PSA for prostate cancer screening in patients >76 or <40 years old, or with an estimated life expectancy of less than 10 years.
Measured: Weeks 1-108
Secondary outcomes (4)
Change in test scores between cohorts measured in weeks 1-36
Measured: Weeks 1-36
Change in spaced education performance measured in weeks 1-36
Measured: Weeks 1-36
Clinicians' intention to participate in future spaced education programs
Assessed on end-of program survey at week 36
Measured: Week 36
Time required by clinicians to complete the spaced education questions-explanations
Assessed on end-of program survey at week 36
Measured: Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startJan 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University Faculty of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs, Agency for Healthcare Research and Quality (AHRQ), American Urological Association, Astellas Pharma US, Inc., National Institutes of Health (NIH), Wyeth is now a wholly owned subsidiary of Pfizer
- Investigators
- B. Price Kerfoot, MD EdM, Principal investigator, VA Boston Healthcare System, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168323
- Sponsor's protocol ID
- M15310
- Other IDs
- IRB# 1786, 5K08HS017147
- Status last verified
- Jul 2010
- First submitted
- 20 Jul 2010
- Last updated
- 9 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Kerfoot BP, Lawler EV, Sokolovskaya G, Gagnon D, Conlin PR. Durable improvements in prostate cancer screening from online spaced education a randomized controlled trial. Am J Prev Med. 2010 Nov;39(5):472-8. doi: 10.1016/j.amepre.2010.07.016.
PubMed 20965387
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spaced Education to Optimize Prostate Cancer Screening
- ClinicalTrials.gov ID
- NCT01168323
- Acronym / sponsor ID
- M15310
- Conditions
- Prostate Cancer
- Keywords
- Medical Education, Educational Technology, Clinical Practice Guideline, Prostate specific antigen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Harvard University Faculty of MedicineUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs, Agency for Healthcare Research and Quality (AHRQ), American Urological Association, Astellas Pharma US, Inc., National Institutes of Health (NIH), Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Jan 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 23 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two memory research findings (the spacing and testing effects) can dramatically improve retention of learning, but they have largely have been ignored by educators. The researchers have developed a novel form of online education (termed 'spaced education') based on these two effects which has been shown in randomized trials to improve knowledge acquisition and boost learning retention. Using prostate cancer screening as an experimental system, the researchers investigated whether spaced education could durably improve clinicians' behaviors, not just their knowledge.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spaced education clinicians - cohort 1 | Experimental | Behavioral: Online spaced educationSpaced education clinicians receive four isomorphic cycles of 9 spaced education emails over 36-weeks (0-2 emails per week). Each email contained one question-explanation. |
| Control clinicians - cohort 2 | No intervention | –Control clinicians received no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care providers (physicians, nurse practitioners, and physician assistants) from the 8 Veterans Affairs (VA) hospitals in the New England region (Veterans Integrated Service Network 1 [VISN-1]) were eligible to enroll.
Key exclusion criteria (1 listed)
- Primary care providers (PCPs) who ordered PSA as a screen for prostate cancer less than 10 times each year were excluded.
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 |
|---|---|---|
| Online spaced educationSpaced education is currently delivered via periodic emails that contain clinical case scenarios and multiple-choice questions. Upon submitting answers to each question online, clinicians receive immediate feedback and educational material. The questions are then repeated over spaced intervals of time to harness the pedagogical benefits of the spacing effect. | Behavioural | Spaced education clinicians - cohort 1 |
Primary outcome
Percentage of inappropriate prostate-specific antigen (PSA) screening performed by clinicians
Time frame: Weeks 1-108
The primary outcome measure was the difference in the percentage of inappropriate PSA screening performed by clinicians in the spaced education and control cohorts. Based on published clinical guidelines and reports, inappropriate PSA utilization was defined as the use of PSA for prostate cancer screening in patients >76 or <40 years old, or with an estimated life expectancy of less than 10 years.
4 secondary outcomes
Change in test scores between cohorts measured in weeks 1-36
Time frame: Weeks 1-36
Change in spaced education performance measured in weeks 1-36
Time frame: Weeks 1-36
Clinicians' intention to participate in future spaced education programs
Time frame: Week 36
Time required by clinicians to complete the spaced education questions-explanations
Time frame: Week 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2010.
- Derived from this study: PubMed 20965387Kerfoot BP, Lawler EV, Sokolovskaya G, Gagnon D, Conlin PR. Durable improvements in prostate cancer screening from online spaced education a randomized controlled trial. Am J Prev Med. 2010 Nov;39(5):472-8. doi: 10.1016/j.amepre.2010.07.016.
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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, Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online spaced education in people with Prostate Cancer, run by Harvard University Faculty of Medicine 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 9 Aug 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of inappropriate prostate-specific antigen (PSA) screening performed by clinicians (time frame: Weeks 1-108). 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 NCT01168323, 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 9 Aug 2010.