Breast NeoplasmNCT00295529
GenetiKiT: Evaluation of an Educational Intervention on the Delivery of Genetics Services by Family Physicians
A study testing Multifaceted educational intervention in people with Breast Neoplasm, run by University of Toronto at 1 site in Canada.
Trial summary
There is an urgent need for a knowledge translation strategy to facilitate the integration of genetics into family medicine, to improve the low knowledge base of most Canadian family physicians, ensure that the needs are met of those in the population who could benefit from genetic assessment, and facilitate… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Multifaceted educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2005to Jun 2007
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- family physicians in active practice
- practicing in one of the study communities
Who cannot join
- only one family physician per group practice
- physicians participating in one of the investigator's ongoing primary care genetics projects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GenetiKiT: Evaluation of the Impact of a Multifaceted Intervention to Enhance the Delivery of Genetics Services by Family Physicians.
There is an urgent need for a knowledge translation strategy to facilitate the integration of genetics into family medicine, to improve the low knowledge base of most Canadian family physicians, ensure that the needs are met of those in the population who could benefit from genetic assessment, and facilitate evidence-based decision-making in the face of increasing patient demand.
We have developed a multi-faceted intervention incorporating three distinct knowledge translation strategies: interactive educational sessions, a portfolio of tools for use in clinical practice and an innovative, efficient, information technology-based knowledge service designed to provide timely ("just-in-time") information which reflects both topical genetics issues and the pattern of users' queries (a so-called "push-pull" approach).
We hypothesize that a multi-faceted knowledge translation intervention will improve the delivery of genetics services by family physicians.
Read the detailed description
The intervention will be evaluated using a randomized controlled trial, in which family physicians will be allocated to receive the active or control interventions, with pre-intervention data collected 1 month prior, and post-intervention outcome data 6 months following the intervention.
A list of practicing family physicians will be obtained from the chiefs of Family Medicine at local hospitals in Toronto, Ottawa, Timmins, and Thunder Bay. We will develop a sampling frame for each site reflecting the proportion of solo and group practitioners in the community. A statistician independent of the study will generate a random number sequence to allocate practitioners to the control or intervention groups. There is a potential danger of contamination if two family physicians are recruited from the same group practice and randomized to different study arms, therefore only one physician per practice will be invited to participate in the study. Once one family physician has been recruited from a practice, all other physicians from the same practice will be deleted from the sampling frame.
Our intervention has three components: an interactive educational workshop, a portfolio of tools for family physicians to use in their day to day clinical practice, and a new IT-based knowledge service.
The workshop will deal with practical medical genetics knowledge, risks, benefits and limitations of genetic testing including psychosocial risks, confidentiality and insurance issues as well as a critical appraisal framework by which to assess genetic tests. The workshop will be 60 minutes in length and offered at several times and dates to facilitate attendance. The College of Family Physicians of Canada educational credit of 1 hour is available for participation in this project.
Several tools will be presented at the workshop:
- A family history tool B) Genetics Pearls C) Physician risk triage and management cards for familial cancer covering risk assessment and management of hereditary breast and colorectal cancer.
- A table outlining the possible consequences of genetic test results E) Patient information aids to help patients self-identify their risk of hereditary cancer F) GeneMessenger is designed primarily to address knowledge gaps about specific genetics issues in the news, about which family physicians may feel ill-equipped to form confident opinions. The research team will scan the mainstream print media for headlines or stories that relate to medical genetics discoveries or topics. Supported by a geneticist and an expert family physician, a genetic counselor will appraise the discoveries, tests or interventions for their relevance to family practice. She will prepare a definitive short review for participants within 1-2 weeks, but, where appropriate and possible, will prepare a preliminary comment for rapid communication within 1-2 days. Communication will be by email or fax as chosen by the participant. Family physicians will be able to contact the service to suggest questions or topics they would like to see addressed. This service will not provide professional advice on specific cases or patients and referrals to genetics clinics would continue in the usual fashion. Physicians would be free to seek telephone advice from geneticists or counselors regarding specific patients but these would not be addressed as part of this service.
Data will be collected one month before and six months after the intervention by postal survey to the participating physicians. Changes in intention to refer to genetics services in response to 10 clinical vignettes will be compared between the control and intervention group.
- Conditions
- Breast Neoplasm
- Being tested
- Multifaceted educational intervention
- Keywords
- Primary health care, Breast neoplasm, Education
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifaceted educational interventionBehavioural
Educational materials available at end of study
| Study group | Role | What they receive |
|---|---|---|
| Multifaceted Educational Intervention | Experimental | Intervention group received an interactive workshop, portfolio of primary care appropriate genomics tools, and Gene Messengers Receives: Behavioral: Multifaceted educational intervention |
| No education | No intervention | Educational materials at end of study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention to refer to genetic services based on clinical vignettes
Measured: 1 year
Secondary outcomes (4)
Self-efficacy
Measured: 1 year
Recall and understanding of information
Measured: 1 year
Perceived decisional conflict
Measured: 1 year
Physicians' perceptions of the value of the components of the intervention
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2006 (estimated)
- Study startApr 2005
- Primary completionJun 2007
- Study completionJun 2007
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 Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, June Carroll, University of Toronto
- Investigators
- June C Carroll, MD, Principal investigator, Mount Sinai Hospital University of TorontoJudith E Allanson, MD FRCP, Principal investigator, Children's Hospital of Eastern OntarioBrenda J Wilson, BSc MSc MB, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295529
- Sponsor's protocol ID
- 04-0109-E
- Status last verified
- Dec 2014
- First submitted
- 9 Feb 2006
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Carroll JC, Wilson BJ, Allanson J, Grimshaw J, Blaine SM, Meschino WS, Permaul JA, Graham ID. GenetiKit: a randomized controlled trial to enhance delivery of genetics services by family physicians. Fam Pract. 2011 Dec;28(6):615-23. doi: 10.1093/fampra/cmr040. Epub 2011 Jul 10.
PubMed 21746696
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GenetiKiT: Evaluation of the Impact of a Multifaceted Intervention to Enhance the Delivery of Genetics Services by Family Physicians.
- ClinicalTrials.gov ID
- NCT00295529
- Acronym / sponsor ID
- 04-0109-E
- Conditions
- Breast Neoplasm
- Keywords
- Primary health care, Breast neoplasm, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Apr 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 23 Feb 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.
There is an urgent need for a knowledge translation strategy to facilitate the integration of genetics into family medicine, to improve the low knowledge base of most Canadian family physicians, ensure that the needs are met of those in the population who could benefit from genetic assessment, and facilitate evidence-based decision-making in the face of increasing patient demand.
We have developed a multi-faceted intervention incorporating three distinct knowledge translation strategies: interactive educational sessions, a portfolio of tools for use in clinical practice and an innovative, efficient, information technology-based knowledge service designed to provide timely ("just-in-time") information which reflects both topical genetics issues and the pattern of users' queries (a so-called "push-pull" approach).
We hypothesize that a multi-faceted knowledge translation intervention will improve the delivery of genetics services by family physicians.
Detailed description
The intervention will be evaluated using a randomized controlled trial, in which family physicians will be allocated to receive the active or control interventions, with pre-intervention data collected 1 month prior, and post-intervention outcome data 6 months following the intervention.
A list of practicing family physicians will be obtained from the chiefs of Family Medicine at local hospitals in Toronto, Ottawa, Timmins, and Thunder Bay. We will develop a sampling frame for each site reflecting the proportion of solo and group practitioners in the community. A statistician independent of the study will generate a random number sequence to allocate practitioners to the control or intervention groups. There is a potential danger of contamination if two family physicians are recruited from the same group practice and randomized to different study arms, therefore only one physician per practice will be invited to participate in the study. Once one family physician has been recruited from a practice, all other physicians from the same practice will be deleted from the sampling frame.
Our intervention has three components: an interactive educational workshop, a portfolio of tools for family physicians to use in their day to day clinical practice, and a new IT-based knowledge service.
The workshop will deal with practical medical genetics knowledge, risks, benefits and limitations of genetic testing including psychosocial risks, confidentiality and insurance issues as well as a critical appraisal framework by which to assess genetic tests. The workshop will be 60 minutes in length and offered at several times and dates to facilitate attendance. The College of Family Physicians of Canada educational credit of 1 hour is available for participation in this project.
Several tools will be presented at the workshop:
- A family history tool B) Genetics Pearls C) Physician risk triage and management cards for familial cancer covering risk assessment and management of hereditary breast and colorectal cancer.
- A table outlining the possible consequences of genetic test results E) Patient information aids to help patients self-identify their risk of hereditary cancer F) GeneMessenger is designed primarily to address knowledge gaps about specific genetics issues in the news, about which family physicians may feel ill-equipped to form confident opinions. The research team will scan the mainstream print media for headlines or stories that relate to medical genetics discoveries or topics. Supported by a geneticist and an expert family physician, a genetic counselor will appraise the discoveries, tests or interventions for their relevance to family practice. She will prepare a definitive short review for participants within 1-2 weeks, but, where appropriate and possible, will prepare a preliminary comment for rapid communication within 1-2 days. Communication will be by email or fax as chosen by the participant. Family physicians will be able to contact the service to suggest questions or topics they would like to see addressed. This service will not provide professional advice on specific cases or patients and referrals to genetics clinics would continue in the usual fashion. Physicians would be free to seek telephone advice from geneticists or counselors regarding specific patients but these would not be addressed as part of this service.
Data will be collected one month before and six months after the intervention by postal survey to the participating physicians. Changes in intention to refer to genetics services in response to 10 clinical vignettes will be compared between the control and intervention group.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifaceted Educational Intervention | Experimental | Behavioral: Multifaceted educational interventionIntervention group received an interactive workshop, portfolio of primary care appropriate genomics tools, and Gene Messengers |
| No education | No intervention | –Educational materials at end of study |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- family physicians in active practice
- practicing in one of the study communities
Key exclusion criteria (2 listed)
- only one family physician per group practice
- physicians participating in one of the investigator's ongoing primary care genetics projects
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 |
|---|---|---|
| Multifaceted educational interventionEducational materials available at end of study | Behavioural | Multifaceted Educational Intervention |
Primary outcome
Intention to refer to genetic services based on clinical vignettes
Time frame: 1 year
4 secondary outcomes
Self-efficacy
Time frame: 1 year
Recall and understanding of information
Time frame: 1 year
Perceived decisional conflict
Time frame: 1 year
Physicians' perceptions of the value of the components of the intervention
Time frame: 1 year
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 5 Dec 2014.
- Derived from this study: PubMed 21746696Carroll JC, Wilson BJ, Allanson J, Grimshaw J, Blaine SM, Meschino WS, Permaul JA, Graham ID. GenetiKit: a randomized controlled trial to enhance delivery of genetics services by family physicians. Fam Pract. 2011 Dec;28(6):615-23. doi: 10.1093/fampra/cmr040. Epub 2011 Jul 10.
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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.
June C Carroll, MD principal investigator
Mount Sinai Hospital University of Toronto
Judith E Allanson, MD FRCP principal investigator
Children's Hospital of Eastern Ontario
Brenda J Wilson, BSc MSc MB principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifaceted educational intervention in people with Breast Neoplasm, run by University of Toronto 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 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 5 Dec 2014. 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.
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?
Intention to refer to genetic services based on clinical vignettes (time frame: 1 year). 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 NCT00295529, 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 Dec 2014.