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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Canada1 site
  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

Other trials in Canada

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:

  1. 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.
  2. 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 groups in NCT00295529
Study groupRoleWhat they receive
Multifaceted Educational InterventionExperimentalIntervention group received an interactive workshop, portfolio of primary care appropriate genomics tools, and Gene Messengers
Receives: Behavioral: Multifaceted educational intervention
No educationNo interventionEducational materials at end of study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intention to refer to genetic services based on clinical vignettes

    Measured: 1 year

Secondary outcomes (4)
  1. Self-efficacy

    Measured: 1 year

  2. Recall and understanding of information

    Measured: 1 year

  3. Perceived decisional conflict

    Measured: 1 year

  4. 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.

  1. First posted23 Feb 2006 (estimated)
  2. Study startApr 2005
  3. Primary completionJun 2007
  4. Study completionJun 2007

Resources

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)
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

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.

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