Early Detection of GEnetic Risk (EDGE)

Study Overview
=================
Brief Summary
-----------------
The study intervention involves having patients complete a familial cancer risk assessment survey. Those who are found to be at high risk will be offered genetic testing for a panel of hereditary cancers. A previvor plan will be created to assist patients and their providers in completing the appropriate follow-up for those with a mutation identified.

Detailed Description
-----------------
Current practice guidelines from ACMG (American College of Medical Genetics and Genomics) provide referral indications for cancer predisposition assessment. Identifying patients with high genetic risk for breast, ovary, colon, or other cancers has important clinical ramifications for an individual's healthcare, but genetic risk if often not identified because of testing barriers at several levels. Barriers at the provider level include inadequacies in risk recognition, patient referrals and availability of genetic professionals to provide counseling in a traditional testing paradigm. Barriers at the level of the patient include poor understanding of the availability and benefits of testing and inadequate access to testing services. How to best implement appropriate genomic testing and follow-up care into an operating healthcare system is not known. Issues of communication, clinical flow, reportable actions, and transmission of information and support are of critical importance, and must change and grow to accommodate the new information contained within genomic testing. Studies to date of the implementation process have been conducted in high resourced facilities, under optimal conditions, often not at the system level. Aims include: Compare the efficacy and implementation of two strategies for identifying members of a primary care clinic's population who have a family or personal history of cancer and offering high-risk individuals to obtain genetic testing for cancer susceptibility mutations in a randomized trial. The two methods are: 1) Point of Care (POC) approach: A tablet-based screening for family/personal history of cancer will be offered to all patients aged 25 and up coming in for a routine appointment at the clinic. 2) Direct Patient Engagement (DPE): Letters will be sent to all individuals aged 25 and older in a clinic's population, inviting them to visit a web site for screening for family /personal history of cancer. In both strategies, those determined to be high-risk will receive online education about genetic testing and an invitation to obtain such testing through a web-based platform. Outcomes will be the fraction of the active clinic patient population that completes screening and the fraction of the active clinic patient population that undergoes testing. Hypothesis 1: DPE screening will result in a higher proportion of active patients who screen for familial cancer risk compared with POC screening. Hypothesis 2: Of screened patients, POC patients will produce a higher proportion of tested patients compared with DPE. Identify changes, problems, and inefficiencies in clinical flow and interactions during and after the implementation of genomic testing for cancer risk across primary care clinics. Evaluate the effects of two methods of implementation of genomic screening for cancer risk on patient, provider, and health system leader reports of benefits and harms, satisfaction, perceived quality of care, including across gender, racial/ethnic, socioeconomic, and genetic literacy divides. Evaluate the value (cost-effectiveness) and affordability (budget impact) of each screening strategy.

Official Title
-----------------
Implementing the Moon: Getting Genomic Testing to the Public

Conditions
-----------------
Genetic Predisposition

Intervention / Treatment
-----------------
* Behavioral: Population-level screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for Patients: Age 25 or older An active patient at a participating clinic (had at least one visit in the past 12 months) Comfortable reading and writing in English Exclusion Criteria: Those who do not meet inclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Point of Care<br>In the point of care (POC) arm, patients will be approached at the time they come in to the clinic for a routine visit with their primary care provider. We will screen patients for familial cancer risk using electronic tablets in the waiting room or, in the case of a telehealth visit, through telephone contact before the visit. Patients identified as high risk will be offered genetic testing for a panel of hereditary cancers. | Behavioral: Population-level screening<br>* The study intervention involves having patients complete a familial cancer risk assessment survey. Those who are found to be at high risk will be offered genetic testing for a panel of hereditary cancers. A previvor plan will be created to assist patients and their providers in completing the appropriate follow-up for those with a mutation identified.<br>|
| Experimental: Direct Patient Engagement<br>In the direct patient engagement (DPE) arm, patients will be identified by reviewing clinic records to create an active patient list (i.e., those who have had a visit in the past year). We will contact patients by postal mail and email to provide a link to the online risk screening tool. The patient outreach is not tied to a specific visit and the online screening can be completed at any time. Patients identified as high risk will be offered genetic testing for a panel of hereditary cancers. | Behavioral: Population-level screening<br>* The study intervention involves having patients complete a familial cancer risk assessment survey. Those who are found to be at high risk will be offered genetic testing for a panel of hereditary cancers. A previvor plan will be created to assist patients and their providers in completing the appropriate follow-up for those with a mutation identified.<br>|
| No Intervention: Stakeholder Interviews and Surveys<br>Samples of patients, providers, and clinic leaders will be assessed at several points throughout the study - baseline and multiple follow-ups. We will use a mixed methods approach, with both quantitative assessments (surveys) and qualitative assessments (interviews). Baseline assessments will provide initial data on the patient population and current clinic functioning and help in implementation planning. The midpoint and final assessments will provide estimates of change in patients, providers, and clinic leaders as a result of the implementation. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of screening | Fraction of the active clinic patient population that completes screening | 1.5 years | 
| Rate of testing | Fraction of the active clinic patient population that undergoes testing. | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation barriers on the clinic-level | To identify changes, problems, and inefficiencies in clinical flow and interactions during and after the implementation of genomic testing for cancer risk across primary care clinics. | 1.5 years | 
| Genetic Literacy and Comprehension (GLAC) | GLAC scale for genetic literacy. | up to 2 years | 
| Implementation Leadership Scale (ILS) | ILS scale. | up to 2 years | 
| Implementation Climate Scale (ICS) | ICS scale. | up to 2 years | 
| Organizational Readiness to Change Assessment (ORCA) | ORCA scale. | up to 2 years | 
| Intervention characteristics (ex: evidence strength and quality) | Self-developed measure. | up to 2 years | 
| Trust in Physician Scale (TIPS) | TIPS scale for Physician trust. | up to 2 years | 
| Patient Satisfaction Questionnaire Short-Form (PSQ-18) | PSQ-18 | up to 2 years | 
| Communication with family members | Self-developed measure. | up to 2 years | 
| Reasons for completing (or not completing) genetic testing | Self-developed measure. | up to 2 years | 
| Reasons for completing (or not completing) screening. | Self-developed measure. | up to 1.5 years | 
| Quality of life scale | Self-developed measure to measure patient quality of life. | up to 1.5 years | 
| Health literacy | Self-developed measure patient's health literacy. | up to 1.5 years | 
| Cost-benefit analysis - cost-effectiveness | Sel-developed measure to evaluate the value (cost-effectiveness) at each site | up to 5 years | 
| Cost-benefit analysis - budget impact | Self-developed measure to measure the affordability of each screening strategy at each site | up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Care, Genetic Testing, Risk Assessment, Hereditary Cancer, Implementation