Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559462
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Nudge Strategies for DPYD Testing in Patients With Gastrointestinal Cancers Treated With Fluoropyrimidines
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimizing Nudge Strategies to Increase the Adoption of DPYD Testing in Patients With Gastrointestinal GI Malignancies Treated With Fluoropyrimidines
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DPYD Nudges
Brief Summary:
5-fluorouracil and capecitabine sometimes called 5-FU fluoropyrimidines or Xeloda are a type of chemotherapy Many people have side effects from these drugs like nausea diarrhea or blood problems This research study is being conducted to learn how to help increase the number of patients offered DPYD testing before taking this type of chemotherapy drugs DPYD testing can help predict risk of side effects
Different peoples bodies break down and use drugs faster or slower Genes are the instructions that tell our bodies how to do this The DPYD gene is one of the genes that tell your body how to use chemotherapy drugs Some people have changes in their DPYD gene that can make their side effects from chemotherapy worse sometimes so bad that they die DPYD testing can tell doctors which people have these gene changes and need extra monitoring during chemotherapy
Some of the people in this study will join a focus group and read sample messages for future patients They will discuss with the other participants how well the message does its job and anything that might make the message better When there are no more messages the host may ask about other information for future patients like a website or brochure
Other people in the study will read sample messages that may be sent to future patients about DPYD testing They will select the message that they like the best and might make them ask their oncologist about testing options
Different peoples bodies break down and use drugs faster or slower Genes are the instructions that tell our bodies how to do this The DPYD gene is one of the genes that tell your body how to use chemotherapy drugs Some people have changes in their DPYD gene that can make their side effects from chemotherapy worse sometimes so bad that they die DPYD testing can tell doctors which people have these gene changes and need extra monitoring during chemotherapy
Some of the people in this study will join a focus group and read sample messages for future patients They will discuss with the other participants how well the message does its job and anything that might make the message better When there are no more messages the host may ask about other information for future patients like a website or brochure
Other people in the study will read sample messages that may be sent to future patients about DPYD testing They will select the message that they like the best and might make them ask their oncologist about testing options
Detailed Description:
INTRODUCTION AND PURPOSE
Fluoropyrimidines FPs are the cornerstone of treatment for several gastrointestinal GI malignancies Approximately 5-7 of patients carry reduced function variants in DPYD resulting in the inability to metabolize FPs predisposing them to severe life-threatening toxicities These patients can be identified through DPYD pharmacogenetic PGx testing However DPYD testing has not been widely adopted in clinical care due to implementation barriers at the system- eg access to testing integration into clinical workflows clinician- eg interpretation of results remembering to order test and patient- eg knowledge about testing worry about adverse effects of testing levels This results in substantial uncertainty and a tendency to rely on several biases eg status quo not to test loss aversion perception of loss greater than gain omission focusing on harm of action more than of non-action or confirmation validating prior beliefs that can influence health decisions Behavioral economics offers a roadmap for mitigating clinician biases using choice architecture and message framing which involves changing the EHR environment to facilitate the desired evidence-based choice and patient biases using priming which uses direct communication strategies to address potential biases prior to clinical encounters In Aim 1 we will develop patient- and clinician-directed nudges with input from key stakeholders Feedback will also be used to develop and refine educational materials to support clinical testing In Aim 2 we will pilot test the nudges using discrete choice experiments DCE to identify the optimal framing that best mitigate cognitive biases Results of the pilot will be utilized to design a randomized clinical trial testing the nudge strategies
OBJECTIVES
To obtain input from clinician and patient stakeholders to design EHR based nudges that are acceptable and will increase the likelihood of ordering DPYD testing prior to prescribing a FP for GI cancer
Aim 1 Develop and refine patient- and clinician- directed nudges that will address biases to DPYD testing Hypothesis Stakeholder feedback will result in acceptable and appropriate nudges
Aim 1a We will conduct focus groups with stakeholders and clinicians to refine the framing and content of EHR nudges that will best mitigate biases to ordering DPYD testing
Aim 1b We will conduct focus groups with patients to refine the framing of patient directed nudges that would prompt them to initiate discussion about DPYD testing with clinicians
Aim 1c Feedback from stakeholders will also be used to developrefine clinician and patient educational websites
Aim 2 Pilot test patient- and clinician- nudges using discrete choice experiments
We will test the degree to each message is associated with the greatest intention to order testing clinician or prompt discussion regarding testing patient with in a sample of 35 clinicians and 75 patients
The results of this pilot will be used as preliminary data for a NIH grant to conduct a prospective randomized implementation trial to evaluate the effectiveness of the optimized nudges to enhance the adoption of DPYD testing as an evidence-based way to reduce TRAEs and improve the quality of care for cancer patients
Fluoropyrimidines FPs are the cornerstone of treatment for several gastrointestinal GI malignancies Approximately 5-7 of patients carry reduced function variants in DPYD resulting in the inability to metabolize FPs predisposing them to severe life-threatening toxicities These patients can be identified through DPYD pharmacogenetic PGx testing However DPYD testing has not been widely adopted in clinical care due to implementation barriers at the system- eg access to testing integration into clinical workflows clinician- eg interpretation of results remembering to order test and patient- eg knowledge about testing worry about adverse effects of testing levels This results in substantial uncertainty and a tendency to rely on several biases eg status quo not to test loss aversion perception of loss greater than gain omission focusing on harm of action more than of non-action or confirmation validating prior beliefs that can influence health decisions Behavioral economics offers a roadmap for mitigating clinician biases using choice architecture and message framing which involves changing the EHR environment to facilitate the desired evidence-based choice and patient biases using priming which uses direct communication strategies to address potential biases prior to clinical encounters In Aim 1 we will develop patient- and clinician-directed nudges with input from key stakeholders Feedback will also be used to develop and refine educational materials to support clinical testing In Aim 2 we will pilot test the nudges using discrete choice experiments DCE to identify the optimal framing that best mitigate cognitive biases Results of the pilot will be utilized to design a randomized clinical trial testing the nudge strategies
OBJECTIVES
To obtain input from clinician and patient stakeholders to design EHR based nudges that are acceptable and will increase the likelihood of ordering DPYD testing prior to prescribing a FP for GI cancer
Aim 1 Develop and refine patient- and clinician- directed nudges that will address biases to DPYD testing Hypothesis Stakeholder feedback will result in acceptable and appropriate nudges
Aim 1a We will conduct focus groups with stakeholders and clinicians to refine the framing and content of EHR nudges that will best mitigate biases to ordering DPYD testing
Aim 1b We will conduct focus groups with patients to refine the framing of patient directed nudges that would prompt them to initiate discussion about DPYD testing with clinicians
Aim 1c Feedback from stakeholders will also be used to developrefine clinician and patient educational websites
Aim 2 Pilot test patient- and clinician- nudges using discrete choice experiments
We will test the degree to each message is associated with the greatest intention to order testing clinician or prompt discussion regarding testing patient with in a sample of 35 clinicians and 75 patients
The results of this pilot will be used as preliminary data for a NIH grant to conduct a prospective randomized implementation trial to evaluate the effectiveness of the optimized nudges to enhance the adoption of DPYD testing as an evidence-based way to reduce TRAEs and improve the quality of care for cancer patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None