About this trial
Germline testing for hereditary cancer syndromes is underutilized across most health care settings. Using a learning health care approach, the Genomics-enabled Learning Health Systems (gLHS) network aims to evaluate the impact of a suite of implementation strategies to increase germline test ordering by oncology care teams (i.e., mainstreaming) for eligible patients with breast, pancreatic or colorectal cancer. Secondarily, the study will investigate completion of testing by eligible patients, as well as impact on overall rates of germline test ordering in patients with cancer. The network will bundle and deploy different implementation strategies across the clinical sites in three 6-month phases. A maintenance phase after the implementation periods will measure genetic testing rates without any additional implementation strategies to determine persistence of effects. The implementation strategies address clinician-level factors, and thus oncologists and their team members (e.g. advanced practice providers, nurse navigators, case managers) will be the focus of evaluating the impact of implementation strategies. Strategies that will be considered include provider education, audit and feedback reports, facilitation, peer support, and electronic health record (EHR) system optimization to support germline testing. Using the RE-AIM QuEST framework, outcomes will be assessed using mixed methods separately for each eligible cancer type. Data collection from the EHR, other relevant data sources, and qualitative provider feedback will be used to assess ordering and completion of tests and the effect of the implementation strategies on germline testing rates in oncology clinics.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Oncology care team members (including, but not limited to, oncologists, advanced practice providers, nurse navigators, caring for patients with adult patients with breast cancer, pancreatic cancer or colorectal cancer.
Disqualifiers
Providers not on the oncology care team
Trial design
Single group
Treatments tested in this trial
Implementation strategies
BehavioralWe will deploy different strategy bundles across the clinical sites in three approximate 6-month phases. Phase I - Facilitation of provider training, educational materials, and information resources; Patient-facing educational material and information resources Phase II - Audit and feedback report on existing patients; Practice champion support; Optimizing EHR strategies Phase III - EHR tools to facilitate prospective identification of patients, testing, and result reporting
Treatment groups
Trial outcomes
Primary outcomes
Germline Genetic Testing Ordered for Breast Cancer Patients
Number of eligible breast cancer patients with germline genetic testing ordered by an oncology care team provider, or associated with an oncology visit, within 7 days of an oncology encounter divided by the number of eligible breast cancer patients seen by the oncology team
Germline Genetic Testing Ordered for Pancreatic Cancer Patients
Number of eligible pancreatic cancer patients with germline genetic testing ordered by an oncology care team provider, or associated with an oncology visit, within 7 days of an oncology encounter divided by the number of eligible pancreatic cancer patients seen by the oncology care team.
Germline Genetic Testing Ordered for Colorectal Cancer Patients
Number of eligible colorectal cancer patients with germline genetic testing ordered by an oncology care team provider, or associated with an oncology visit, within 7 days of an oncology encounter divided by the number of eligible colorectal cancer patients seen by the oncology care team.
Secondary outcomes
Germline Genetic Testing Completed by Breast Cancer Patients
Number of eligible breast cancer patients completing germline testing order that was placed by their oncology care team divided by the number of eligible breast cancer patients with an order placed by the oncology care team determined by EHR data extraction.
Germline Genetic Testing Completed by Pancreatic Cancer Patients
Number of eligible pancreatic cancer patients completing germline testing order that was placed by their oncology care team divided by the number of eligible pancreatic cancer patients with an order placed by the oncology care team determined by EHR data extraction.
Germline Genetic Testing Completed by Colorectal Cancer Patients
Number of eligible colorectal cancer patients completing germline testing order that was placed by their oncology care team divided by the number of eligible colorectal cancer patients with an order placed by the oncology care team determined by EHR data extraction.
Sponsors and contacts
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Josh Peterson
Lead sponsor
Vanderbilt University Medical Center
Sponsor institution
National Human Genome Research Institute (NHGRI)
Collaborator
National Cancer Institute (NCI)
Collaborator