GenetiKiT: Evaluation of an Educational Intervention on the Delivery of Genetics Services by Family Physicians

Breast Neoplasm Clinical Trial

Official title:

GenetiKiT: Evaluation of the Impact of a Multifaceted Intervention to Enhance the Delivery of Genetics Services by Family Physicians.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00295529
• Other study ID #: 04-0109-E
• Status: Completed
• Phase: N/A
• First received: February 9, 2006
• Last updated: December 3, 2014
• Start date: April 2005
• Est. completion date: June 2007

Study information

• Verified date: December 2014
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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 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.

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) 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.

D) 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• family physicians in active practice

• practicing in one of the study communities

Exclusion Criteria:

• only one family physician per group practice

• physicians participating in one of the investigator's ongoing primary care genetics projects

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

Behavioral:
• Multifaceted educational intervention
Educational materials available at end of study

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intention to refer to genetic services based on clinical vignettes		1 year	No
Secondary	Self-efficacy		1 year	No
Secondary	Recall and understanding of information		1 year	No
Secondary	Perceived decisional conflict		1 year	No
Secondary	Physicians' perceptions of the value of the components of the intervention		1 year	No