Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455384
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2023-09-05
Brief Title:
The Genetics Navigator Evaluating a Digital Platform for Genomics Health Services
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
The Genetics Navigator Evaluating a Digital Platform for Genomics Health Services
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Genetic testing GT including targeted panels exome and genome sequencing is increasingly being used for patient care as it improves diagnosis and health outcomes In spite of these benefits genetic testing is a complex and costly health service This results in unequal access increased wait times and inconsistencies in care The use of e-health tools to support genetic testing delivery can result in a better patient experience and reduced distress associated with waiting for results and empower patients to receive and act on medical results We have previously developed and tested an interactive adaptable and patient-centred digital decision support tool Genetics ADvISER to be used for genetic testing decision making and have now developed the Genetics Navigator GN a patient-centred e-health navigation platform for end-to-end genetic service delivery The objective of this study is to evaluate the effectiveness of the GN in an RCT in reducing distress with patients and parents of patients being offered genetic testing Results of this trial will be used to establish whether the GN is effective to use in practice If effective GN could fill a critical clinical care gap and improve health outcomes and service use by reducing counselling burden as well as overuse underuse and misuse of services These are concerns policy makers seek to address through the triple aims of health care1 This study represents a significant advance in personalized health by assessing the effectiveness of this novel comprehensive e-health platform to ultimately improve genetic service delivery accessibility patient experiences and patient outcomes
Detailed Description:
BACKGROUND Genetic testing is a catalyst for personalized health Technologies such as targeted panels and genomic sequencing GS are exerting a profound influence on clinical care by ushering personalized medicine into mainstream practice With substantial improvements in diagnostic performance has come unprecedented demand for genetic testing for a broad range of clinical indicationsThe volume of testing and complexity of genetic testing analysis places unsustainable pressure on the standard model of care for delivering genetics services which is heavily dependent on multiple interconnected clinical specialists including medical geneticists genetic counsellors clinical laboratory directors bioinformaticians and genome analysts based in tertiary care centres With this increased demand innovative strategies for increasing capacity and efficiency of genetic service delivery are needed Our research team has built on our previous preliminary work to develop the Genetics Navigator GN to fill this gap The GN is meant to provide end-to-end support to genomic services and patients who are offered genetic testing The GN is meant to provide patients with information about genetic testing help patients make decisions about genetic testing collect patient history and family history collection before their appointment and provide genetic test results The study is interested in comparing the effectiveness of the Genetics Navigator with traditional medical appointments with genetic counsellors and medical geneticists
RATIONALE There are limited e-health tools for the delivery of GS Few e-health tools exist to support the comprehensive delivery of GS and very few have been rigorously evaluated61 Existing tools target cancer settings42 education36 or return of results46 but are not integrated to enable a seamless end-to-end patient journey Consequently existing tools are limited in scope and scale Finally due to the lack of comprehensive e-health tools for GS little is known about end users needs for an e-health platform Understanding end users needs and requirements are critical to the development of an effective e-health solution for GS health service delivery Finally the development of our Genetics Navigator tool represents an innovative strategy to address significant health service delivery barriers and advance the implementation of personalized health by increasing efficiency of genetic service delivery and improving patient experience
OBJECTIVES AND HYPOTHESIS Evaluate the effectiveness cost-effectiveness and user experience of the Genetics Navigator compared to usual care standard genetic counselling with patients and parents of patients receiving genetic testing Hypothesis Use of the Genetics Navigator will improve emotional functioning decrease distress primary outcome anxiety and decisional conflict knowledge quality of life patient empowerment personal utility and intention to and actual follow through with management recommendations compared to usual care
METHOD This is a non-blinded prospective repeated measures randomized controlled superiority trial where we will evaluate the effectiveness and cost-effectiveness of the Genetics Navigator in reducing patient distress compared to usual care As a part of this trial patients will receive genetic test results related to a range of clinical indications A qualitative sub-study will examine user experience
STUDY POPULATION
Trial Adult genetics patients aged 18 years at Sinai Health System Sinai and parentslegal guardians of pediatric patients at the Hospital for Sick Children SickKids who are currently eligible to receive clinical genetic testing as determined by a medical geneticist
Qualitative Interviews We will interview a purposive sample of up to 20 adult patients and 20 parents legal guardians in each arm within 6 months of completing their participation
INTERVENTION Participants in the intervention arm will use the Genetics Navigator to support the delivery of genetic services including intake education pre- and post-test counselling and physician-generated management recommendations The Navigator will be supported by consults with genetics professionals via in-personphonevideo-conferencing
CONTROLParticipants in the control arm will receive their genetic counselling and test results through usual care which consists of in-personphonevideo-conference consults with genetic counsellors and medical geneticists
RATIONALE There are limited e-health tools for the delivery of GS Few e-health tools exist to support the comprehensive delivery of GS and very few have been rigorously evaluated61 Existing tools target cancer settings42 education36 or return of results46 but are not integrated to enable a seamless end-to-end patient journey Consequently existing tools are limited in scope and scale Finally due to the lack of comprehensive e-health tools for GS little is known about end users needs for an e-health platform Understanding end users needs and requirements are critical to the development of an effective e-health solution for GS health service delivery Finally the development of our Genetics Navigator tool represents an innovative strategy to address significant health service delivery barriers and advance the implementation of personalized health by increasing efficiency of genetic service delivery and improving patient experience
OBJECTIVES AND HYPOTHESIS Evaluate the effectiveness cost-effectiveness and user experience of the Genetics Navigator compared to usual care standard genetic counselling with patients and parents of patients receiving genetic testing Hypothesis Use of the Genetics Navigator will improve emotional functioning decrease distress primary outcome anxiety and decisional conflict knowledge quality of life patient empowerment personal utility and intention to and actual follow through with management recommendations compared to usual care
METHOD This is a non-blinded prospective repeated measures randomized controlled superiority trial where we will evaluate the effectiveness and cost-effectiveness of the Genetics Navigator in reducing patient distress compared to usual care As a part of this trial patients will receive genetic test results related to a range of clinical indications A qualitative sub-study will examine user experience
STUDY POPULATION
Trial Adult genetics patients aged 18 years at Sinai Health System Sinai and parentslegal guardians of pediatric patients at the Hospital for Sick Children SickKids who are currently eligible to receive clinical genetic testing as determined by a medical geneticist
Qualitative Interviews We will interview a purposive sample of up to 20 adult patients and 20 parents legal guardians in each arm within 6 months of completing their participation
INTERVENTION Participants in the intervention arm will use the Genetics Navigator to support the delivery of genetic services including intake education pre- and post-test counselling and physician-generated management recommendations The Navigator will be supported by consults with genetics professionals via in-personphonevideo-conferencing
CONTROLParticipants in the control arm will receive their genetic counselling and test results through usual care which consists of in-personphonevideo-conference consults with genetic counsellors and medical geneticists
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None