Hide and Seek with Hereditary Cancer: Improving detection of colorectal cancer patients with a high risk of Lynch syndrome

Interventions: A two-arm parallel randomised control trial (RCT) will be used to test a theory based implementation approach (Theoretical Domains Framework Implementation) against a non-theory based implementation approach to improving identification of Lynch syndrome amongst colorectal cancer patients.
At each hospital, a locally employed healthcare professional will be appointed as a paid ‘Implementation Lead’ (IL) at one day per week over a 24-month period to coordinate the implementation approach and to oversee data collection. They will have a professional understanding of the LS patient pathway, and the ability to motivate other LS stakeholders to engage with implementation processes. Each Implementation Lead will participate in a 1-day training seminar by a health psychologist from the CCNSW research team in one of two approaches (theory or non-theory). CIA Taylor developed the following training toolkit and 1-day course: http://www.improvementacademy.org/tools-and-resources/abc-for-patient-safety-toolkit.html. These training materials have been refined for this study and modified according to trial arm. Those in the theory-based trial arm will be trained in the Theoretical Domains Framework Implementation (TDFI) approach. Following training, the Implementation Lead will work through the following steps at their hospital over a 24-month period:
1. Extract baseline audit data: Clinical data from surgical, pathology and FCC databases will be extracted to determine proportion of pts appropriately referred
2. Form Implementation Team: will form a team of 8-10 multidisciplinary staff involved in the LS referral and diagnosis pathway (e.g. genetic counsellors, CRC surgeons, oncologists, pathologists, nurses, admin etc)
3. Map referral process and identify targets for change: 2 x meetings to map current processes and (using audit data) identify areas for change
4. Identify barriers to change: Staff to complete 5 min questionnaire about perceived barriers & foc
Primary outcome(s): The primary outcome will be the proportion of patients with risk-appropriate completion of the LS referral pathway. Clinical and referral data will be extracted from a number of sources (e.g. hospital, pathology and genetics databases) to assess whether patients at high-risk of Lynch syndrome (e.g. those mismatch repair deficient or high level microsatellite instability colorectal cancer tumours) were referred to a familial cancer clinic for consideration of germline Lynch syndrome testing.[Completion of the LS referral pathway within 2 months of CRC resection.]
Study Design: Purpose: Diagnosis; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy