Health Knowledge, Attitudes, PracticeOTEBPNCT01512823
Randomised Trial of Two Educational Intervention for Improving Evidence-based Practice Knowledge, Atttitudes and Practice
A study testing Education in people with Health Knowledge, Attitudes, Practice, run by University of Cape Town at 1 site in South Africa.
Trial summary
This pragmatic randomised controlled trial (RCT) used a two-group parallel design with matched-pair stratification by type (clinician/manager) and knowledge score. The trial aimed to: 1) determine whether an IE was more effective than a DE for improving EBP knowledge, skills and use at 12 weeks, and 2) to investigate… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitudes, Practice
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Africa
- Study dates
- Nov 2007to Mar 2011
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Occupational therapists employed by the Western Cape Department of Health (DOH)
- Working at least 20 hours per week
Who cannot join
- Working at a distance of more than 1½ hours from Cape Town
- Therapists who would be leaving the DOH before December 2008 or taking leave during the time of the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Trial of the Effectiveness of Two Educational Interventions to Improve Evidence-based Practice Knowledge, Attitudes and Behaviour in Occupational Therapists
This pragmatic randomised controlled trial (RCT) used a two-group parallel design with matched-pair stratification by type (clinician/manager) and knowledge score. The trial aimed to: 1) determine whether an IE was more effective than a DE for improving EBP knowledge, skills and use at 12 weeks, and 2) to investigate the feasibility of conducting a RCT with occupational therapists in a public health setting. Occupational therapists employed by the Western Cape Department of Health (DOH) form,ed the study population(N=98). Fifty-eight consented to participate and were randomly allocated to either an interactive (IE) or a didactic (DE) educational intervention using coin tossing. Data was collected at baseline and 12 weeks The primary outcome was increased EBP knowledge at 12 weeks shown by an improved total knowledge score. Secondary outcomes were improved attitudes and behaviour. Data were collected at the health facilities where participants were employed. Raters for the audit were blinded but participants and the provider could not be blinded.
Thirty participants were allocated to receive the IE and 28 the DE. Twenty-five participants in the IE and 21 in the DE completed the trial and were included in the 12 week analysis. Results revealed no significant difference between the groups in the primary knowledge outcome at 12 weeks. Examination of within-group changes revealed significant improvements in knowledge in both groups (IE: T=4.0, p<0.001; DE: T=12.0, p=0.002), but the IE also showed a significant increase in behaviour (T=64.5, p=0.044) and attitudes on one sub-scale (T=33.0, p=0.039). As the study was powered at 43%, it may have failed to detect significant differences at 12 weeks. Conducting a high-quality RCT was feasible and the risk of bias was assessed as low. The OTEBP trial adds strength to the existing evidence that both didactic and interactive educational interventions can improve knowledge, but it seems that interactive interventions may be more effective for changing behaviour. High-quality pragmatic trials can feasibly be conducted within the public health service
- Conditions
- Health Knowledge, Attitudes, Practice
- Being tested
- Education
- Keywords
- randomised controlled trial, educational intervention, occupational therapy
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Interactive educational intervention:
- 4 hour education session (with notes and 'evidence packs'); presentations, small group discussion tasks and practice of particular skills - 2 hour session (1 week later)
- Emailed notes from second session
- Telephonic/email follow-up (reminders)
Didactic educational intervention:
- 4 hour education session (with notes and 'evidence packs'; questions answered but no discussion or application of skills
| Study group | Role | What they receive |
|---|---|---|
| Interactive educational intervention | Experimental | Two education sessions (four-hours and two-hours respectively), emailed notes and reminders Receives: Behavioral: Education |
| Didactic educational intervention | Experimental | Education alone Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shortened Fresno Test of Competence in Evidence-based Practice (SAFT)
Modified from the Adapted Fresno Test of Competence in EBP (AFT) (McCluskey and Bishop, 2009), the SAFT consists of three items testing knowledge of writing a PICO question based on a clinical scenario, ability to identify the most suitable study design to answer the question, and knowledge of possible sources of information. The total possible score is 30 points. The test is scored using a grading rubric. Two versions are availbale for measuring outcomes of educational interventions.
Measured: 12 weeks
Secondary outcomes (1)
Audit checklist
9-item checklist for auditing patient records to determine the extent to which occupational therapists monitor the effectiveness of their interventions.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startNov 2007
- Primary completionJan 2009
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health Knowledge, Attitudes, PracticeStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of South Africa
- Responsible party
- Principal investigator, Helen Buchanan, University of Cape Town
- Investigators
- Helen Buchanan, PhD, Principal investigator, University of Cape TownNandi Siegfried, PhD, Study director, South African Cochrane Centre & University of Cape TownJennifer Jelsma, PhD, Study director, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512823
- Sponsor's protocol ID
- REC REF: 259/2006
- Acronym
- OTEBP
- Status last verified
- Feb 2012
- First submitted
- 13 Jan 2012
- Last updated
- 6 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Buchanan H, Jelsma J, Siegfried N. Measuring evidence-based practice knowledge and skills in occupational therapy--a brief instrument. BMC Med Educ. 2015 Oct 30;15:191. doi: 10.1186/s12909-015-0475-2.
PubMed 26519165Buchanan H, Siegfried N, Jelsma J, Lombard C. Comparison of an interactive with a didactic educational intervention for improving the evidence-based practice knowledge of occupational therapists in the public health sector in South Africa: a randomised controlled trial. Trials. 2014 Jun 10;15:216. doi: 10.1186/1745-6215-15-216.
PubMed 24916176
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial of the Effectiveness of Two Educational Interventions to Improve Evidence-based Practice Knowledge, Attitudes and Behaviour in Occupational Therapists
- ClinicalTrials.gov ID
- NCT01512823
- Acronym / sponsor ID
- OTEBP / REC REF: 259/2006
- Conditions
- Health Knowledge, Attitudes, Practice
- Keywords
- randomised controlled trial, educational intervention, occupational therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- National Research Foundation of South Africa
- Study start
- Nov 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 19 Jan 2012 (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.
This pragmatic randomised controlled trial (RCT) used a two-group parallel design with matched-pair stratification by type (clinician/manager) and knowledge score. The trial aimed to: 1) determine whether an IE was more effective than a DE for improving EBP knowledge, skills and use at 12 weeks, and 2) to investigate the feasibility of conducting a RCT with occupational therapists in a public health setting. Occupational therapists employed by the Western Cape Department of Health (DOH) form,ed the study population(N=98). Fifty-eight consented to participate and were randomly allocated to either an interactive (IE) or a didactic (DE) educational intervention using coin tossing. Data was collected at baseline and 12 weeks The primary outcome was increased EBP knowledge at 12 weeks shown by an improved total knowledge score. Secondary outcomes were improved attitudes and behaviour. Data were collected at the health facilities where participants were employed. Raters for the audit were blinded but participants and the provider could not be blinded.
Thirty participants were allocated to receive the IE and 28 the DE. Twenty-five participants in the IE and 21 in the DE completed the trial and were included in the 12 week analysis. Results revealed no significant difference between the groups in the primary knowledge outcome at 12 weeks. Examination of within-group changes revealed significant improvements in knowledge in both groups (IE: T=4.0, p<0.001; DE: T=12.0, p=0.002), but the IE also showed a significant increase in behaviour (T=64.5, p=0.044) and attitudes on one sub-scale (T=33.0, p=0.039). As the study was powered at 43%, it may have failed to detect significant differences at 12 weeks. Conducting a high-quality RCT was feasible and the risk of bias was assessed as low. The OTEBP trial adds strength to the existing evidence that both didactic and interactive educational interventions can improve knowledge, but it seems that interactive interventions may be more effective for changing behaviour. High-quality pragmatic trials can feasibly be conducted within the public health service
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive educational intervention | Experimental | Behavioral: EducationTwo education sessions (four-hours and two-hours respectively), emailed notes and reminders |
| Didactic educational intervention | Experimental | Behavioral: EducationEducation alone |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Occupational therapists employed by the Western Cape Department of Health (DOH)
- Working at least 20 hours per week
Key exclusion criteria (2 listed)
- Working at a distance of more than 1½ hours from Cape Town
- Therapists who would be leaving the DOH before December 2008 or taking leave during the time of the intervention
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 |
|---|---|---|
| EducationInteractive educational intervention: * 4 hour education session (with notes and 'evidence packs'); presentations, small group discussion tasks and practice of particular skills - 2 hour session (1 week later) * Emailed notes from second session * Telephonic/email follow-up (reminders) Didactic educational intervention: - 4 hour education session (with notes and 'evidence packs'; questions answered but no discussion or application of skills | Behavioural | Didactic educational intervention, Interactive educational intervention |
Primary outcome
Shortened Fresno Test of Competence in Evidence-based Practice (SAFT)
Time frame: 12 weeks
Modified from the Adapted Fresno Test of Competence in EBP (AFT) (McCluskey and Bishop, 2009), the SAFT consists of three items testing knowledge of writing a PICO question based on a clinical scenario, ability to identify the most suitable study design to answer the question, and knowledge of possible sources of information. The total possible score is 30 points. The test is scored using a grading rubric. Two versions are availbale for measuring outcomes of educational interventions.
1 secondary outcome
Audit checklist
Time frame: 12 weeks
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 6 Feb 2012.
- Derived from this study: PubMed 26519165Buchanan H, Jelsma J, Siegfried N. Measuring evidence-based practice knowledge and skills in occupational therapy--a brief instrument. BMC Med Educ. 2015 Oct 30;15:191. doi: 10.1186/s12909-015-0475-2.
- Derived from this study: PubMed 24916176Buchanan H, Siegfried N, Jelsma J, Lombard C. Comparison of an interactive with a didactic educational intervention for improving the evidence-based practice knowledge of occupational therapists in the public health sector in South Africa: a randomised controlled trial. Trials. 2014 Jun 10;15:216. doi: 10.1186/1745-6215-15-216.
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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.
Helen Buchanan, PhD principal investigator
University of Cape Town
Nandi Siegfried, PhD study director
South African Cochrane Centre & University of Cape Town
Jennifer Jelsma, PhD study director
University of Cape Town
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Health Knowledge, Attitudes, Practice, run by University of Cape Town at 1 site in South Africa.
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 2 inclusion and 2 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 6 Feb 2012. 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 South Africa. 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?
Shortened Fresno Test of Competence in Evidence-based Practice (SAFT) (time frame: 12 weeks). 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 NCT01512823, which also lists 2 linked publications.
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 6 Feb 2012.