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Genetics Adviser: a protocol for a mixed-methods randomised controlled trial evaluating a digital platform for genetics service delivery

INTRODUCTION: The high demand for genetic tests and limited supply of genetics professionals has created a need for alternative service delivery models. Digital tools are increasingly being used to support multiple points in the genetic testing journey; however, none are transferable across multiple...

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Autores principales: Shickh, Salma, Hirjikaka, Daena, Clausen, Marc, Kodida, Rita, Mighton, Chloe, Reble, Emma, Sam, Jordan, Panchal, Seema, Aronson, Melyssa, Graham, Tracy, Armel, Susan Randall, Glogowski, Emily, Elser, Christine, Eisen, Andrea, Carroll, June C, Shuman, Cheryl, Seto, Emily, Baxter, Nancy N, Scheer, Adena, Shastri-Estrada, Serena, Feldman, Geoff, Thorpe, Kevin E, Schrader, Kasmintan A, Lerner-Ellis, Jordan, Kim, Raymond H, Faghfoury, Hanna, Bombard, Yvonne
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9058789/
https://www.ncbi.nlm.nih.gov/pubmed/35487723
http://dx.doi.org/10.1136/bmjopen-2022-060899
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author Shickh, Salma
Hirjikaka, Daena
Clausen, Marc
Kodida, Rita
Mighton, Chloe
Reble, Emma
Sam, Jordan
Panchal, Seema
Aronson, Melyssa
Graham, Tracy
Armel, Susan Randall
Glogowski, Emily
Elser, Christine
Eisen, Andrea
Carroll, June C
Shuman, Cheryl
Seto, Emily
Baxter, Nancy N
Scheer, Adena
Shastri-Estrada, Serena
Feldman, Geoff
Thorpe, Kevin E
Schrader, Kasmintan A
Lerner-Ellis, Jordan
Kim, Raymond H
Faghfoury, Hanna
Bombard, Yvonne
author_facet Shickh, Salma
Hirjikaka, Daena
Clausen, Marc
Kodida, Rita
Mighton, Chloe
Reble, Emma
Sam, Jordan
Panchal, Seema
Aronson, Melyssa
Graham, Tracy
Armel, Susan Randall
Glogowski, Emily
Elser, Christine
Eisen, Andrea
Carroll, June C
Shuman, Cheryl
Seto, Emily
Baxter, Nancy N
Scheer, Adena
Shastri-Estrada, Serena
Feldman, Geoff
Thorpe, Kevin E
Schrader, Kasmintan A
Lerner-Ellis, Jordan
Kim, Raymond H
Faghfoury, Hanna
Bombard, Yvonne
author_sort Shickh, Salma
collection PubMed
description INTRODUCTION: The high demand for genetic tests and limited supply of genetics professionals has created a need for alternative service delivery models. Digital tools are increasingly being used to support multiple points in the genetic testing journey; however, none are transferable across multiple clinical specialties and settings nor do they encompass the entire trajectory of the journey. We aim to evaluate the effectiveness of the Genetics Adviser, an interactive, patient-facing, online digital health tool that delivers pre-test counselling, provides support during the waiting period for results, and returns results with post-test counselling, encompassing the entire patient genetic testing journey. METHODS AND ANALYSIS: We will compare the Genetics Adviser paired with a brief genetic counselling session to genetic counselling alone in a randomised controlled trial. One hundred and forty patients who previously received uninformative genetic test results for their personal and family history of cancer will be recruited from familial cancer clinics in Toronto and offered all clinically significant results from genomic sequencing. Participants randomised into the intervention arm will use the Genetics Adviser to learn about genomic sequencing, receive pre-test counselling, support during the waiting period and results, supplemented with brief counselling from a genetic counsellor. Participants in the control arm will receive standard pre-test and post-test counselling for genomic sequencing from a genetic counsellor. Our primary outcome is decisional conflict following pre-test counselling from the Genetics Adviser+genetic counsellor or counsellor alone. Secondary outcomes include: knowledge, satisfaction with decision-making, anxiety, quality of life, psychological impact of results, empowerment, acceptability and economic impact for patients and the health system. A subset of patients will be interviewed to assess user experience. ETHICS AND DISSEMINATION: This study has been approved by Clinical Trials Ontario Streamlined Research Ethics Review System (REB#20–035). Results will be shared through stakeholder workshops, national and international conferences and peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04725565.
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spelling pubmed-90587892022-05-12 Genetics Adviser: a protocol for a mixed-methods randomised controlled trial evaluating a digital platform for genetics service delivery Shickh, Salma Hirjikaka, Daena Clausen, Marc Kodida, Rita Mighton, Chloe Reble, Emma Sam, Jordan Panchal, Seema Aronson, Melyssa Graham, Tracy Armel, Susan Randall Glogowski, Emily Elser, Christine Eisen, Andrea Carroll, June C Shuman, Cheryl Seto, Emily Baxter, Nancy N Scheer, Adena Shastri-Estrada, Serena Feldman, Geoff Thorpe, Kevin E Schrader, Kasmintan A Lerner-Ellis, Jordan Kim, Raymond H Faghfoury, Hanna Bombard, Yvonne BMJ Open Genetics and Genomics INTRODUCTION: The high demand for genetic tests and limited supply of genetics professionals has created a need for alternative service delivery models. Digital tools are increasingly being used to support multiple points in the genetic testing journey; however, none are transferable across multiple clinical specialties and settings nor do they encompass the entire trajectory of the journey. We aim to evaluate the effectiveness of the Genetics Adviser, an interactive, patient-facing, online digital health tool that delivers pre-test counselling, provides support during the waiting period for results, and returns results with post-test counselling, encompassing the entire patient genetic testing journey. METHODS AND ANALYSIS: We will compare the Genetics Adviser paired with a brief genetic counselling session to genetic counselling alone in a randomised controlled trial. One hundred and forty patients who previously received uninformative genetic test results for their personal and family history of cancer will be recruited from familial cancer clinics in Toronto and offered all clinically significant results from genomic sequencing. Participants randomised into the intervention arm will use the Genetics Adviser to learn about genomic sequencing, receive pre-test counselling, support during the waiting period and results, supplemented with brief counselling from a genetic counsellor. Participants in the control arm will receive standard pre-test and post-test counselling for genomic sequencing from a genetic counsellor. Our primary outcome is decisional conflict following pre-test counselling from the Genetics Adviser+genetic counsellor or counsellor alone. Secondary outcomes include: knowledge, satisfaction with decision-making, anxiety, quality of life, psychological impact of results, empowerment, acceptability and economic impact for patients and the health system. A subset of patients will be interviewed to assess user experience. ETHICS AND DISSEMINATION: This study has been approved by Clinical Trials Ontario Streamlined Research Ethics Review System (REB#20–035). Results will be shared through stakeholder workshops, national and international conferences and peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04725565. BMJ Publishing Group 2022-04-29 /pmc/articles/PMC9058789/ /pubmed/35487723 http://dx.doi.org/10.1136/bmjopen-2022-060899 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Genetics and Genomics
Shickh, Salma
Hirjikaka, Daena
Clausen, Marc
Kodida, Rita
Mighton, Chloe
Reble, Emma
Sam, Jordan
Panchal, Seema
Aronson, Melyssa
Graham, Tracy
Armel, Susan Randall
Glogowski, Emily
Elser, Christine
Eisen, Andrea
Carroll, June C
Shuman, Cheryl
Seto, Emily
Baxter, Nancy N
Scheer, Adena
Shastri-Estrada, Serena
Feldman, Geoff
Thorpe, Kevin E
Schrader, Kasmintan A
Lerner-Ellis, Jordan
Kim, Raymond H
Faghfoury, Hanna
Bombard, Yvonne
Genetics Adviser: a protocol for a mixed-methods randomised controlled trial evaluating a digital platform for genetics service delivery
title Genetics Adviser: a protocol for a mixed-methods randomised controlled trial evaluating a digital platform for genetics service delivery
title_full Genetics Adviser: a protocol for a mixed-methods randomised controlled trial evaluating a digital platform for genetics service delivery
title_fullStr Genetics Adviser: a protocol for a mixed-methods randomised controlled trial evaluating a digital platform for genetics service delivery
title_full_unstemmed Genetics Adviser: a protocol for a mixed-methods randomised controlled trial evaluating a digital platform for genetics service delivery
title_short Genetics Adviser: a protocol for a mixed-methods randomised controlled trial evaluating a digital platform for genetics service delivery
title_sort genetics adviser: a protocol for a mixed-methods randomised controlled trial evaluating a digital platform for genetics service delivery
topic Genetics and Genomics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9058789/
https://www.ncbi.nlm.nih.gov/pubmed/35487723
http://dx.doi.org/10.1136/bmjopen-2022-060899
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