Knowledge TransferPhase 3NCT00298727
The Effect and Mediators of Two Knowledge Translation Strategies
A Phase 3 study testing SHIPS and ePBL in people with Knowledge Transfer and Clinical Decision-making, run by McMaster University at 1 site in Canada.
Trial summary
Purpose: This study will compare the effectiveness and mediators of two different knowledge transfer (KT) interventions in terms of their impact on changing knowledge and behavior (utilization and clinical reasoning) related to health outcome measures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knowledge Transfer, Clinical Decision-making
- What is being tested?
- SHIPS and ePBL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2007to Dec 2010
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A valid license to practice physical or occupational therapy.
- Ability to communicate in English will be required.
Who cannot join
- Volunteers will be required to complete a knowledge pre-test in the format of a multiple-choice questionnaire. Those who are already knowledgeable, as determined by a score of 75% or greater, will be excluded to avoid ceiling effects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Defining the Effect and Mediators of Two Knowledge Translation Strategies Designed to Alter Knowledge, Intent and Clinical Utilization of Rehabilitation Outcome Measures
Purpose: This study will compare the effectiveness and mediators of two different knowledge transfer (KT) interventions in terms of their impact on changing knowledge and behavior (utilization and clinical reasoning) related to health outcome measures.
Read the detailed description
Interventions: Two different KT interventions with the same curriculum will be evaluated: 1. Stakeholder-Hosted Interactive Problem-Based Seminar (SHIPS), and 2. Online Problem-Based course (ePBL). SHIPs will consist of face-to-face PBL (Problem-based Learning) (2½ days) with outcome measure developers as facilitators, using 6 problems generated in consultation with participants. The ePBL will consist of a 6-week web-based course with 6 generic problems developed by content experts.
Outcome Measures: Baseline predictors including demographics, knowledge, attitudes/barriers regarding outcome measures and Readiness to Change will be assessed by self-report. Immediately post-intervention and 6 months later these will be re-administered. Primary qualitative and quantitative evaluations will be conducted 6-months post-intervention to assess the relative effectiveness of KT interventions and to identify elements that contribute to changing clinical behavior. Chart audits will determine the utilization of outcome measures (counts). Incorporation of outcome measures into clinical reasoning will be assessed using an innovative technique: chart-stimulated recall.
The Study Sample: Physical and Occupational Therapists (n=144; 80% power to detect an effect size of 0.5; alpha=0.05) will be recruited in partnership with the national professional associations.
Methods: SHIPS will be conducted in three urban centers in Canada. Participants will be block allocated by a minimization procedure to either of the two interventions to minimize any prognostic differences. Trained evaluators at each site will conduct chart audits and chart-stimulated recall. Trained interviewers will conduct semi-structured interviews focused on identifying critical elements in KT and implementing practice changes. Interviews will be transcribed verbatim.
Analyses: Analysis of covariance (ANCOVA), with baseline scores as a covariate, will be used to compare chart-stimulated recall scores at 6-months post-intervention. Secondary analyses will also use ANCOVA with the remaining potential predictors. Qualitative content analysis will be conducted iteratively until saturation is achieved.
Knowledge Impact and Transfer: A strategy for optimal transfer of health outcome measures into practice will be developed and shared with multiple disciplines involved in primary and specialty management of musculoskeletal and childhood disability. In addition, we will work with national professional organizations and Ministries of Health to use the knowledge from this study to support national initiatives on implementation and to assist with best KT practices in health service education.
- Conditions
- Knowledge Transfer, Clinical Decision-making
- Being tested
- SHIPS, ePBL
- Keywords
- Knowledge transfer, Clinical decision-making, Outcome measures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHIPSBehavioural
Also called Face-to-Face workshop
Stakeholder-Hosted Interactive Problem-based Seminars
ePBLBehavioural
Online Problem-Based Course
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | SHIPS: Face-to-Face Workshop Receives: Behavioral: SHIPS |
| 2 | Active comparator | ePBL: Online Problem-Based Course Receives: Behavioral: ePBL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chart Audit Form (Utilization)
Measured: Up to 6 months post-intervention
Chart Stimulated Recall Data Collection Form
Measured: Up to 6 months post-intervention
Self-Efficacy Questionnaire
Measured: Up to 6 months post-intervention
Secondary outcomes (2)
Readiness to Change Clinical Practice Scale
Measured: Up to 6 months post-intervention
Knowledge Test
Measured: Up to 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2006 (estimated)
- Study startJan 2007
- Primary completionDec 2010
- Study completionDec 2010
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 Knowledge TransferStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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 3
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Joy C MacDermid, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298727
- Sponsor's protocol ID
- 152239
- Status last verified
- May 2011
- First submitted
- 1 Mar 2006
- Last updated
- 4 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
MacDermid JC, Solomon P, Law M, Russell D, Stratford P. Defining the effect and mediators of two knowledge translation strategies designed to alter knowledge, intent and clinical utilization of rehabilitation outcome measures: a study protocol [NCT00298727]. Implement Sci. 2006 Jul 4;1:14. doi: 10.1186/1748-5908-1-14.
PubMed 16820055
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Effect and Mediators of Two Knowledge Translation Strategies Designed to Alter Knowledge, Intent and Clinical Utilization of Rehabilitation Outcome Measures
- ClinicalTrials.gov ID
- NCT00298727
- Acronym / sponsor ID
- 152239
- Conditions
- Knowledge Transfer, Clinical Decision-making
- Keywords
- Knowledge transfer, Clinical decision-making, Outcome measures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Mar 2006 (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.
Purpose: This study will compare the effectiveness and mediators of two different knowledge transfer (KT) interventions in terms of their impact on changing knowledge and behavior (utilization and clinical reasoning) related to health outcome measures.
Detailed description
Interventions: Two different KT interventions with the same curriculum will be evaluated: 1. Stakeholder-Hosted Interactive Problem-Based Seminar (SHIPS), and 2. Online Problem-Based course (ePBL). SHIPs will consist of face-to-face PBL (Problem-based Learning) (2½ days) with outcome measure developers as facilitators, using 6 problems generated in consultation with participants. The ePBL will consist of a 6-week web-based course with 6 generic problems developed by content experts.
Outcome Measures: Baseline predictors including demographics, knowledge, attitudes/barriers regarding outcome measures and Readiness to Change will be assessed by self-report. Immediately post-intervention and 6 months later these will be re-administered. Primary qualitative and quantitative evaluations will be conducted 6-months post-intervention to assess the relative effectiveness of KT interventions and to identify elements that contribute to changing clinical behavior. Chart audits will determine the utilization of outcome measures (counts). Incorporation of outcome measures into clinical reasoning will be assessed using an innovative technique: chart-stimulated recall.
The Study Sample: Physical and Occupational Therapists (n=144; 80% power to detect an effect size of 0.5; alpha=0.05) will be recruited in partnership with the national professional associations.
Methods: SHIPS will be conducted in three urban centers in Canada. Participants will be block allocated by a minimization procedure to either of the two interventions to minimize any prognostic differences. Trained evaluators at each site will conduct chart audits and chart-stimulated recall. Trained interviewers will conduct semi-structured interviews focused on identifying critical elements in KT and implementing practice changes. Interviews will be transcribed verbatim.
Analyses: Analysis of covariance (ANCOVA), with baseline scores as a covariate, will be used to compare chart-stimulated recall scores at 6-months post-intervention. Secondary analyses will also use ANCOVA with the remaining potential predictors. Qualitative content analysis will be conducted iteratively until saturation is achieved.
Knowledge Impact and Transfer: A strategy for optimal transfer of health outcome measures into practice will be developed and shared with multiple disciplines involved in primary and specialty management of musculoskeletal and childhood disability. In addition, we will work with national professional organizations and Ministries of Health to use the knowledge from this study to support national initiatives on implementation and to assist with best KT practices in health service education.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: SHIPSSHIPS: Face-to-Face Workshop |
| 2 | Active comparator | Behavioral: ePBLePBL: Online Problem-Based Course |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A valid license to practice physical or occupational therapy.
- Ability to communicate in English will be required.
Key exclusion criteria (1 listed)
- Volunteers will be required to complete a knowledge pre-test in the format of a multiple-choice questionnaire. Those who are already knowledgeable, as determined by a score of 75% or greater, will be excluded to avoid ceiling effects.
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 |
|---|---|---|
| SHIPSAlso: Face-to-Face workshopStakeholder-Hosted Interactive Problem-based Seminars | Behavioural | 1 |
| ePBLOnline Problem-Based Course | Behavioural | 2 |
Primary outcome
Chart Audit Form (Utilization)
Time frame: Up to 6 months post-intervention
Chart Stimulated Recall Data Collection Form
Time frame: Up to 6 months post-intervention
Self-Efficacy Questionnaire
Time frame: Up to 6 months post-intervention
2 secondary outcomes
Readiness to Change Clinical Practice Scale
Time frame: Up to 6 months post-intervention
Knowledge Test
Time frame: Up to 6 months post-intervention
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 4 May 2011.
- Background: PubMed 16820055MacDermid JC, Solomon P, Law M, Russell D, Stratford P. Defining the effect and mediators of two knowledge translation strategies designed to alter knowledge, intent and clinical utilization of rehabilitation outcome measures: a study protocol [NCT00298727]. Implement Sci. 2006 Jul 4;1:14. doi: 10.1186/1748-5908-1-14.
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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.
Joy C MacDermid, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHIPS and ePBL in people with Knowledge Transfer and Clinical Decision-making, run by McMaster University at 1 site in Canada.
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 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 4 May 2011. 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 Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Chart Audit Form (Utilization) (time frame: Up to 6 months post-intervention). The study lists 3 primary outcomes in all. 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 NCT00298727, 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 4 May 2011.