Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06215963
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2023-12-12
Brief Title:
A4i-O A Platform for Complex Behavioral Health to Address OUD
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
App for Independence-O A4i-O - Expanding a Validated Platform for Complex Behavioral Health to Address Opioid Use Disorder
Status:
RECRUITING
Status Verified Date:
2024-01
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:
For the purposes of beta testing the first version of A4i-O 15 individuals with OUD will use the platform for one month From a design perspective this sample size is viewed as being sufficient to answer questions regarding app functionality and feasibility before moving to larger trials Additionally 15 individuals is a larger sample size than in the A4i pilot This is an open label pilot with a primary objective of troubleshooting and providing early feedback on the beta version of the technology To that end 15 participants are anticipated to be sufficient to provide robust early feedback As with the focus groups through sampling an effort will be made to secure a diverse group Any individuals who might be declined in that effort at this stage eg it is determined that no more male identifying participants are needed but they were interested would be invited to take part in the subsequent RCT
Detailed Description:
Recruitment
Recruitment will be conducted through several mechanisms First with permission to do so by their clients clinicians from within and external to CAMH are able to refer their clients to the study by emailing the study team Participants recruited from Component 1 will be presented with the opportunity to participate in Component 2 via phone call Clinicians will be made aware of the study via phone call Potential service provider participants will be approached after they have been identified by the OUD participants who have formally consented to providers being asked to participate with them Recruitment posters will be sent out to existing partnerships outlined in the component 1 portion of the protocol using the email templates provided Second component 2 will leverage the CLEARR recruitment strategy already approved and implemented in the COMPASS outpatient program at CAMH CLEARR will be used to recruit participants for this research study All new referrals will be reviewed by the CLEARR coordinator and CLEARR physician for eligibility to participate using minimal inclusionexclusion criteria outlined Once a patient is identified as potentially suitable for the research study the attending physician will be notified via outlook calendar invite or email that their patient may be eligible for the research study The attending physician will decide whether research is appropriate for the patient and if so they will ask the patient for consent to be contacted regarding the research study If the patient provides verbal consent to be contacted to receive more information about the research study the physician will connect the patient with the CLEARR coordinator or research team who will further explain the research study No personal health information PHI will be given to the research team prior to obtaining the patients consent The investigators have attached the letter of approval and the approved protocol to this submission As part of the CLEARR protocol willing participants will be pre-screened by a program RA and provided with study optionsopportunities to participate based on self-reported criteria No access to EMR prior to study consent is required for this process Below is language provided by the SUHR centralized program
The Substance Use Health Research SUHR Centralized Recruitment Database will be used to recruit participants for this study Designated Research Personnel DRP or Study Specific Research personnel will prescreen individuals to support triaging and referral of individuals to prospective studies Once a potential participant has been triaged DRP will send preferred contact information to the Study Specific Research personnel who will reach out to the individual to further explain the study Responses will be passed to the Study Specific Research Personnel only with the potential participants consent
Consent Process
Participants will be provided with a clear explanation of the objectives procedures risks and benefits of the study and all questions will be answered Questions will be asked of subjects to ensure that they understand the nature of the research the risks and potential benefits of study participation and their rights as research subjects prior to obtaining their signature on the informed consent document Participants will be informed of their responsibility to tell the research team of any medical conditions medications and changes in their health eg pregnancy while participating in this study The PI will be consulted if the research analyst has any concerns about the participants ability to understand any study procedures Participant understanding will be assessed by the RA using a post-consent discussion quiz about key procedures in the study If participant can recall and explain most of the procedures they will be asked if they would like to provide consent If participants understand only the minority of procedures the PI will be consulted The PI will discuss the situation with the RA and based on that conversation may connect with the prospective participant to follow up and assess further If it is decided that the individual is not capable of consenting they will be thanked for their interest and informed that the investigators cant proceed with their participation as they appear to be struggling to understand what is involved The investigators will not be formally assessing language comprehension or learning disability The assessment will be based upon their demonstrated ability to understand the conditions of consent and the nature of the study With participant permission their clinicians may also be consulted to better understand the participants capacity to provide consent The RA may share with the participants clinician the amount and type of information the participant seemed to have difficulty remembering or understanding from the consent form In response the study team will seek to investigate whether the participants clinician has any concerns with the participants capacity to understand or provide consent As consent is an ongoing process the investigators will continue to educate participants about the nature of the research and address any questions that may arise throughout the course of the study
Assessments
Assessments will be scheduled via email andor telephone by the study RP All assessments will be conducted either virtually via WebEx using either the teleconferencing or videoconferencing features depending on the participants preference or in person onsite at the CAMH Queen Site If they choose the virtual option participants will be provided with the meeting link and phone number to join the WebEx call The study RP will also use screen sharing to show the participant the questionnaires to assist with completing the assessment If they choose in person the person will be provided instructions to the CAMH Queen Site where the RP will meet them by the screening station to bring to the room that the research personnel has booked The RP will then provide a CAMH approved tablet Participants will have the option to complete some brief non-clinical surveys over email in the event of technical difficulties or time constraints These surveys include the participant satisfaction survey Survey responses will be secured using REDCap software REDCap is a software located on Secure CAMH networks the survey is not accessible or editable by external link once the survey is completed So if anyone intercepted the email with a link after the participant filled out the survey the information captured in the survey would not be accessible
Interviews
Semi-structured interviews will be recorded using WebEx and transcribed verbatim Transcripts are automatically provided by WebEx when the recording function is used Within 30 days the recording will be deleted from WebEx and will be stored on the T-Drive The study staff conducting the focus groups will review the recording and correct any mistakes in the transcript that may have occurred during automated transcription Following transcription the video will be deleted and no identifiable information will be included in the transcripts
A4i-O Installation
Installations will be conducted after the screeningbaseline assessment either virtually via WebEx using either the teleconferencing or videoconferencing features depending on the participants preference or in person across from each other on-site following proper COVID safety protocols Although there is no app user manual participants will receive thorough instructions on how to use the app when on-boarded and can use the navigational tools within the app shown in Appendix 7 As well a staff member will check-in with the participant within their first week of using the app to troubleshoot for any technical difficulties the participant may be experiencing The RP conducting the installation will walk the participant through the installation and how to use the app by showing the participant either a screen share or on their own device what they app looks like and how to use each feature
First Week Check-Ins
At the end of the first week participants will be contacted for a brief check in about their experience with the app to see if they are having any challenges using the technology Problems will be addressed by study staff as soon as possible
Provider Dashboard Summaries
Anonymized summaries of the dashboard data will be sent to providers monthly via password protected files Providers will also be able to log in to view the dashboard through the A4i-O portal In the current version of A4i the dashboard summaries include user-entered information on mood ratings reported sleep quality medication adherence and goal progression The exact information available through the dashboard in Component 2 may be subject to change based on the results of Component 1 The intended use of the portal is to help clinicians have a better understanding of these variables in their clients lives outside appointments Clinicians are instructed to use this information to inform their care if and how they see clinically fit Clinicians can access these summaries through the clinical portals at any time Participants are advised that the app is not to be used as a means of contacting their clinicians with the expectation of a response
Data Analysis
Interview recordings will be transcribed verbatim The content of the interviews will be thematically analysed with a consensus process used to validate the analysis 1 Quantitative analyses will be primarily descriptive with outcomes probed with sample size caveats using paired samples t-tests and Cohens d effect size analyses
Conflict of Interest
In the interest of ensuring full disclosure the A4i-O app is being developed together with a private company A4i Inc Both CAMH and Sean Kidd the lead researcher own and have shares in A4i Sean Kidd holds a position as an officer of A4i as the co-founder and co-owner Steps being taken to address this conflict of interest include things like disclosing this information whenever people are approached about research with A4i having the data analyzed by experts not involved in A4i and making anonymized data available for other researchers to examine and confirm
Recruitment will be conducted through several mechanisms First with permission to do so by their clients clinicians from within and external to CAMH are able to refer their clients to the study by emailing the study team Participants recruited from Component 1 will be presented with the opportunity to participate in Component 2 via phone call Clinicians will be made aware of the study via phone call Potential service provider participants will be approached after they have been identified by the OUD participants who have formally consented to providers being asked to participate with them Recruitment posters will be sent out to existing partnerships outlined in the component 1 portion of the protocol using the email templates provided Second component 2 will leverage the CLEARR recruitment strategy already approved and implemented in the COMPASS outpatient program at CAMH CLEARR will be used to recruit participants for this research study All new referrals will be reviewed by the CLEARR coordinator and CLEARR physician for eligibility to participate using minimal inclusionexclusion criteria outlined Once a patient is identified as potentially suitable for the research study the attending physician will be notified via outlook calendar invite or email that their patient may be eligible for the research study The attending physician will decide whether research is appropriate for the patient and if so they will ask the patient for consent to be contacted regarding the research study If the patient provides verbal consent to be contacted to receive more information about the research study the physician will connect the patient with the CLEARR coordinator or research team who will further explain the research study No personal health information PHI will be given to the research team prior to obtaining the patients consent The investigators have attached the letter of approval and the approved protocol to this submission As part of the CLEARR protocol willing participants will be pre-screened by a program RA and provided with study optionsopportunities to participate based on self-reported criteria No access to EMR prior to study consent is required for this process Below is language provided by the SUHR centralized program
The Substance Use Health Research SUHR Centralized Recruitment Database will be used to recruit participants for this study Designated Research Personnel DRP or Study Specific Research personnel will prescreen individuals to support triaging and referral of individuals to prospective studies Once a potential participant has been triaged DRP will send preferred contact information to the Study Specific Research personnel who will reach out to the individual to further explain the study Responses will be passed to the Study Specific Research Personnel only with the potential participants consent
Consent Process
Participants will be provided with a clear explanation of the objectives procedures risks and benefits of the study and all questions will be answered Questions will be asked of subjects to ensure that they understand the nature of the research the risks and potential benefits of study participation and their rights as research subjects prior to obtaining their signature on the informed consent document Participants will be informed of their responsibility to tell the research team of any medical conditions medications and changes in their health eg pregnancy while participating in this study The PI will be consulted if the research analyst has any concerns about the participants ability to understand any study procedures Participant understanding will be assessed by the RA using a post-consent discussion quiz about key procedures in the study If participant can recall and explain most of the procedures they will be asked if they would like to provide consent If participants understand only the minority of procedures the PI will be consulted The PI will discuss the situation with the RA and based on that conversation may connect with the prospective participant to follow up and assess further If it is decided that the individual is not capable of consenting they will be thanked for their interest and informed that the investigators cant proceed with their participation as they appear to be struggling to understand what is involved The investigators will not be formally assessing language comprehension or learning disability The assessment will be based upon their demonstrated ability to understand the conditions of consent and the nature of the study With participant permission their clinicians may also be consulted to better understand the participants capacity to provide consent The RA may share with the participants clinician the amount and type of information the participant seemed to have difficulty remembering or understanding from the consent form In response the study team will seek to investigate whether the participants clinician has any concerns with the participants capacity to understand or provide consent As consent is an ongoing process the investigators will continue to educate participants about the nature of the research and address any questions that may arise throughout the course of the study
Assessments
Assessments will be scheduled via email andor telephone by the study RP All assessments will be conducted either virtually via WebEx using either the teleconferencing or videoconferencing features depending on the participants preference or in person onsite at the CAMH Queen Site If they choose the virtual option participants will be provided with the meeting link and phone number to join the WebEx call The study RP will also use screen sharing to show the participant the questionnaires to assist with completing the assessment If they choose in person the person will be provided instructions to the CAMH Queen Site where the RP will meet them by the screening station to bring to the room that the research personnel has booked The RP will then provide a CAMH approved tablet Participants will have the option to complete some brief non-clinical surveys over email in the event of technical difficulties or time constraints These surveys include the participant satisfaction survey Survey responses will be secured using REDCap software REDCap is a software located on Secure CAMH networks the survey is not accessible or editable by external link once the survey is completed So if anyone intercepted the email with a link after the participant filled out the survey the information captured in the survey would not be accessible
Interviews
Semi-structured interviews will be recorded using WebEx and transcribed verbatim Transcripts are automatically provided by WebEx when the recording function is used Within 30 days the recording will be deleted from WebEx and will be stored on the T-Drive The study staff conducting the focus groups will review the recording and correct any mistakes in the transcript that may have occurred during automated transcription Following transcription the video will be deleted and no identifiable information will be included in the transcripts
A4i-O Installation
Installations will be conducted after the screeningbaseline assessment either virtually via WebEx using either the teleconferencing or videoconferencing features depending on the participants preference or in person across from each other on-site following proper COVID safety protocols Although there is no app user manual participants will receive thorough instructions on how to use the app when on-boarded and can use the navigational tools within the app shown in Appendix 7 As well a staff member will check-in with the participant within their first week of using the app to troubleshoot for any technical difficulties the participant may be experiencing The RP conducting the installation will walk the participant through the installation and how to use the app by showing the participant either a screen share or on their own device what they app looks like and how to use each feature
First Week Check-Ins
At the end of the first week participants will be contacted for a brief check in about their experience with the app to see if they are having any challenges using the technology Problems will be addressed by study staff as soon as possible
Provider Dashboard Summaries
Anonymized summaries of the dashboard data will be sent to providers monthly via password protected files Providers will also be able to log in to view the dashboard through the A4i-O portal In the current version of A4i the dashboard summaries include user-entered information on mood ratings reported sleep quality medication adherence and goal progression The exact information available through the dashboard in Component 2 may be subject to change based on the results of Component 1 The intended use of the portal is to help clinicians have a better understanding of these variables in their clients lives outside appointments Clinicians are instructed to use this information to inform their care if and how they see clinically fit Clinicians can access these summaries through the clinical portals at any time Participants are advised that the app is not to be used as a means of contacting their clinicians with the expectation of a response
Data Analysis
Interview recordings will be transcribed verbatim The content of the interviews will be thematically analysed with a consensus process used to validate the analysis 1 Quantitative analyses will be primarily descriptive with outcomes probed with sample size caveats using paired samples t-tests and Cohens d effect size analyses
Conflict of Interest
In the interest of ensuring full disclosure the A4i-O app is being developed together with a private company A4i Inc Both CAMH and Sean Kidd the lead researcher own and have shares in A4i Sean Kidd holds a position as an officer of A4i as the co-founder and co-owner Steps being taken to address this conflict of interest include things like disclosing this information whenever people are approached about research with A4i having the data analyzed by experts not involved in A4i and making anonymized data available for other researchers to examine and confirm
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?:
False
Is an FDA AA801 Violation?:
None