Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382636
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-01-08
Brief Title:
Engaging Patients in Prenatal Genetic Testing Decisions as a Pathway to Improve Obstetric Outcomes
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Engaging Patients in Prenatal Genetic Testing Decisions as a Pathway to Improve Obstetric Outcomes
Status:
RECRUITING
Status Verified Date:
2024-08
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:
OPUS
Brief Summary:
The goal of this study is to ensure that pregnant patients have the resources and support needed to access Prenatal Screening Diagnostic Testing PSD in an informed and evidence-based fashion by developing an innovative digital tool to support patients decision-making and contributing fundamental knowledge to advance science in a way that promotes patients access to new prenatal applications of genomic science and technology Our central hypothesis is that by focusing on patient engagement as a key driver to improve patient outcomes the use of an evidence-based artificial-intelligence AI powered patient engagement tool will increase patients ability to seek information and structure a decision-making process that in turn increases informed decisions about PSD and decreases decisional conflict associated with those decisions
Using data from NEST Ensuring Patients Informed Access to NIPT non-invasive prenatal testing the investigators designed the next iteration of NEST a point-of care shared decision-making tool powered by artificial intelligence AI to provide a personalized and dynamic decision support tool Obstetric Prenatal Genetic Testing Engagement Solution OPUS OPUS is an AI-enabled healthcare chatbot a computer program capable of processing and simulating human conversation that provides patients with personalized information and decision-making support at different stages of the PSD pathway It functions using a series of questions contained in the NEST with a branching logic sequence of questions and answers based on the responses to and from the patient using a conversational and adaptable interaction It also contains nested tiers of information ranging from introductory to detailed information about patient engagement health literacy the different PSD options and resources to learn about insurance coverage for PSD OPUS was designed to be accessed by patients with different technological resources and preferences using a cell phone a mobile device or a computer
Using data from NEST Ensuring Patients Informed Access to NIPT non-invasive prenatal testing the investigators designed the next iteration of NEST a point-of care shared decision-making tool powered by artificial intelligence AI to provide a personalized and dynamic decision support tool Obstetric Prenatal Genetic Testing Engagement Solution OPUS OPUS is an AI-enabled healthcare chatbot a computer program capable of processing and simulating human conversation that provides patients with personalized information and decision-making support at different stages of the PSD pathway It functions using a series of questions contained in the NEST with a branching logic sequence of questions and answers based on the responses to and from the patient using a conversational and adaptable interaction It also contains nested tiers of information ranging from introductory to detailed information about patient engagement health literacy the different PSD options and resources to learn about insurance coverage for PSD OPUS was designed to be accessed by patients with different technological resources and preferences using a cell phone a mobile device or a computer
Detailed Description:
Study overview
The investigators will conduct a randomized cluster trial to examine the impact of the Obstetric Prenatal Genetic Testing Engagement Solution OPUS on the decision-making process about Prenatal Screening Diagnostic Testing PSD from the perspectives of patients partners and providers In doing so the investigators will examine important changes that have taken place in genetic technology and healthcare In-depth semi-structured interviews will be conducted to gain greater insight into the decision-making process and strategies throughout pregnancy to gain a longitudinal understanding of how decision-making unfolds with the utilization of tests and gestational age The investigators will employ a method that allows for the study of decision-making across diverse patient and provider populations including urban and rural communities and academic and community practices to understand how these factors in addition to social determinants of health influence patients informed access to PSD The team will collaborate the Advisory Group and in consultation with the Data Safety monitoring Board DSMB assembled for this study to ensure scientific rigor in the experimental design and conduct of the study analysis and interpretation of the data and dissemination of the final results and version of the tool
Methods
Study population and recruitment Participants will include three groups 1 Obstetric OB providers 2 patients and 3 patient partners Subject recruitment will take place at the three study sites 1 the Cleveland Clinic Health System 2 the MetroHealth Medical System and 3 the Neighborhood Family Practice Community Health Centers
Randomization
Providers will be randomized by practice into 1 the intervention arm utilizing OPUS or 2 the control arm utilizing standard practice patterns with respect to education and counseling usual care The rationale for randomization by practice is to prevent contamination between study arms as a patient may see more than one provider within a practice over the course of her prenatal care
Comparators
Intervention OPUS is a chatbot that will provide an artificial intelligence AI powered conversational and personalized interaction to assist patients in seeking information about their PSD options It was designed by Cleveland Clinic Information Technology IT and Power ObjectsMicrosoft with the goal of meeting patients where they are in their decision-making regarding the nature and detail of information and decision-support needed to navigate PSD decisions OPUS can be accessed from a cell phone mobile device or computer using a web-based or text-based approach It was also developed based on existing studies demonstrating the benefits of healthcare chatbots The investigators will implement mechanisms that minimize barriers to access OPUS making tablets available on-site for patients with limited technology and providing broadband Intent as needed to access OPUS intervention or other educational resources intervention and control groups OPUS will utilize the Microsoft Azure Health Bot and Dynamics 365 technology and build on the existing Cleveland Clinic health IT solutions to support patient engagement in other clinical contexts that meet requirements of Health Information Portability and Accountability Act HIPAA and encryption for protected health information PHI management
Participants will be exposed to OPUS at three key time points as determined by our NEST R01 Time Point 1 T1 - Prior to the initial prenatal visit This represents the time period before patients initiate discussions with their providers about genetic risk and PSD It may include patients at 7-21 weeks estimated gestational age EGA Time Point 2 T2 - Prior to the initial PSD decision This time point represents the patients initial step in the PSD decision-making pathway It may include patients at 9-23 weeks EGA Time Point 3 T3 - Prior to the 2nd trimester anatomical ultrasound US This is a time point with different significance for patients based on initial PSD choices This includes patients who present for a an initial assessment after declining all PSD prior to the 2nd trimester ultrasound b follow-up assessment after receiving an abnormal result on a prior screening or c subsequent routine assessment after receiving a normal result on a prior screen or diagnostic test It may include patients at 18-23 weeks EGA Participants may opt-out of engaging with OPUS at any time point in the study
Control The control group will receive standard counseling per usual care They will proceed with the appointment with the scheduled provider who will discuss genetic risk and assessment per his or her usual counseling and practice patterns
Aim 1 Determine the ability of OPUS to structure a decision-making process about PSD that aligns with patient needs and preferences compared to usual care
The investigators hypothesize that patients exposed to OPUS will have higher levels of engagement that will enable them to structure a shared or informed decision-making process that aligns with their needs and preferences
Patient Measures
Information about participants demographics reproductive and medical history will be collected from the electronic medical records EMR The investigators will then collect data using administration of a series of surveys and semi-structured interviews to assess the impact of OPUS at the key time points in the decision-making pathway All instruments will be distributed and completed via Research Electronic Data Capture REDCap Survey with a paper version available at participant request The investigators will also make tablets available at the clinical visit for participants to complete the survey
Patient Activation
The investigators will utilize a modified version of the Patient Activation Measure PAM-13 to measure patient activation regarding PSD decisions The PAM-13 is a widely used standardized measure of patient activation in healthcare decisions It is an interval-level scale developed to assess respondents understanding of their role in the care process and having the knowledge skill and confidence to manage healthcare decisions
Decision preferences statuspreferences
The investigators will measure participants preferences regarding decision-making experiences with shared decision making SDM The investigators will measure decision-making decisionspreferences at the following timepoints T1 Pre-visit and T1 Post-visit This will include questions about printed or online materials accessed for self-education
Decision-making
The research assistant will place a small audio-recording device in the exam room to record the content interaction and duration of dialogue about genetic risk and risk assessment and remove it immediately after the visit This approach will allow for evaluation of patient and patientpartner dyads in healthcare discussions with the provider The investigators have elected to audio record instead of video record to minimize the Hawthorne effect and because of the sensitive nature of the physical exam during this visit Our prior work has demonstrated that this approach can be successfully used
Interviews
The investigators will conduct semi-structured interviews with a subset of patients at T1 Post-visit T2 Post-test n 40 to gain additional information about OPUSs usability feasibility and acceptability of the intervention The interviews will be guided by an interview guide developed in conjunction with the Advisory Group and audio recorded for data analysis purposes
Provider measures
Providers will complete a baseline questionnaire OB1 at the time of enrollment to collect information about demographics medical education and training including any training specific to healthcare communication and clinical practice It will also contain a self-assessment of the providers ability to facilitate a SDM process
Aim 2 Determine the ability of OPUS to improve a patients ability to make an informed choice about PSD compared to usual care
The investigators hypothesize that patients exposed to OPUS will have higher rates of informed choice regarding the utilization or decline of prenatal genetic testing
Data collection
Patients will complete the Informed Choice for Screens and Diagnostic Tests survey ICSD an instrument developed and validated as part of NEST at the following intervals T1-Pre-visit T1 Post-visit T2 Post-test and T3 Pre-ultrasound US The investigators will also assess health literacy using the validated self-administered medical term recognition test METER an instrument successfully used during NEST
Data analysis
Analysis will be conducted to determine the impact of OPUS on the variables of knowledge attitudes and deliberation the variables will be analyzed together as components of the informed choice and then separately to understand the effect of exposure to OPUS on each variable The investigators will also examine the change of these variables together and separately from T1 to T2 and T3 Based on the methods described by the author Marteau and adapted for the ICSD the variables of knowledge and attitudes and choice will be categorized These data will be summed to determine whether responses at different time points represented an informed choice good knowledge positive attitude and intention or decision to utilize consistent with behavior or an uninformed choice poor knowledge negative attitude and attitude was inconsistent with behavior for the utilized screen or diagnostic test Logistic regression methods will be used to assess differences in exposure to OPUS and reproductive demographic eg raceethnicity technology access social economic status SES and clinical practice variables
Aim 3 Determine the extent to which OPUS reduces patients uncertainty and decisional conflict associated with PSD decisions
The investigators hypothesize that patients exposed to OPUS will have lower levels of decisional uncertainty and conflict throughout the PSD pathway compared to patients exposed to usual care
Data collection
The investigators will use the validated Decisional Conflict Scale DCS to examine the presence of decisional conflict understand its impact on patient experience and identify modifiable factors to reduce it at T2 T3 and T4 This validated instrument was used successfully as part of NEST that uses Likert scale items to measure personal perceptions of uncertainty in the decision-making process and modifiable factors contributing to uncertainty Our goal in selecting this measure is to assess the process of obtaining information and making a choice not the outcome of the decision to utilize or not utilize PSD
Data analysis
Analysis will be conducted to determine the impact of OPUS on decisional conflict independently and as a function of informed choice including variables of knowledge attitudes and deliberation separately and together patient activation and SDMIDM Analysis will be conducted in a fashion described by the author OConnor to determine the level of decisional conflict Logistic regression will be used to assess correlations between informed choice measures patient demographic measures and measures of decisional conflict The data for each time point will be combined and the analysis re-run using repeated measures logistic regression methods and including test time as an additional independent variable Analyses will be conducted to examine differences in reduction of decisional conflict in addition to baseline uncertainty and anxiety across subgroups including by raceethnicity knowledgehealth literacy insurance status reproductive history
The investigators will conduct a randomized cluster trial to examine the impact of the Obstetric Prenatal Genetic Testing Engagement Solution OPUS on the decision-making process about Prenatal Screening Diagnostic Testing PSD from the perspectives of patients partners and providers In doing so the investigators will examine important changes that have taken place in genetic technology and healthcare In-depth semi-structured interviews will be conducted to gain greater insight into the decision-making process and strategies throughout pregnancy to gain a longitudinal understanding of how decision-making unfolds with the utilization of tests and gestational age The investigators will employ a method that allows for the study of decision-making across diverse patient and provider populations including urban and rural communities and academic and community practices to understand how these factors in addition to social determinants of health influence patients informed access to PSD The team will collaborate the Advisory Group and in consultation with the Data Safety monitoring Board DSMB assembled for this study to ensure scientific rigor in the experimental design and conduct of the study analysis and interpretation of the data and dissemination of the final results and version of the tool
Methods
Study population and recruitment Participants will include three groups 1 Obstetric OB providers 2 patients and 3 patient partners Subject recruitment will take place at the three study sites 1 the Cleveland Clinic Health System 2 the MetroHealth Medical System and 3 the Neighborhood Family Practice Community Health Centers
Randomization
Providers will be randomized by practice into 1 the intervention arm utilizing OPUS or 2 the control arm utilizing standard practice patterns with respect to education and counseling usual care The rationale for randomization by practice is to prevent contamination between study arms as a patient may see more than one provider within a practice over the course of her prenatal care
Comparators
Intervention OPUS is a chatbot that will provide an artificial intelligence AI powered conversational and personalized interaction to assist patients in seeking information about their PSD options It was designed by Cleveland Clinic Information Technology IT and Power ObjectsMicrosoft with the goal of meeting patients where they are in their decision-making regarding the nature and detail of information and decision-support needed to navigate PSD decisions OPUS can be accessed from a cell phone mobile device or computer using a web-based or text-based approach It was also developed based on existing studies demonstrating the benefits of healthcare chatbots The investigators will implement mechanisms that minimize barriers to access OPUS making tablets available on-site for patients with limited technology and providing broadband Intent as needed to access OPUS intervention or other educational resources intervention and control groups OPUS will utilize the Microsoft Azure Health Bot and Dynamics 365 technology and build on the existing Cleveland Clinic health IT solutions to support patient engagement in other clinical contexts that meet requirements of Health Information Portability and Accountability Act HIPAA and encryption for protected health information PHI management
Participants will be exposed to OPUS at three key time points as determined by our NEST R01 Time Point 1 T1 - Prior to the initial prenatal visit This represents the time period before patients initiate discussions with their providers about genetic risk and PSD It may include patients at 7-21 weeks estimated gestational age EGA Time Point 2 T2 - Prior to the initial PSD decision This time point represents the patients initial step in the PSD decision-making pathway It may include patients at 9-23 weeks EGA Time Point 3 T3 - Prior to the 2nd trimester anatomical ultrasound US This is a time point with different significance for patients based on initial PSD choices This includes patients who present for a an initial assessment after declining all PSD prior to the 2nd trimester ultrasound b follow-up assessment after receiving an abnormal result on a prior screening or c subsequent routine assessment after receiving a normal result on a prior screen or diagnostic test It may include patients at 18-23 weeks EGA Participants may opt-out of engaging with OPUS at any time point in the study
Control The control group will receive standard counseling per usual care They will proceed with the appointment with the scheduled provider who will discuss genetic risk and assessment per his or her usual counseling and practice patterns
Aim 1 Determine the ability of OPUS to structure a decision-making process about PSD that aligns with patient needs and preferences compared to usual care
The investigators hypothesize that patients exposed to OPUS will have higher levels of engagement that will enable them to structure a shared or informed decision-making process that aligns with their needs and preferences
Patient Measures
Information about participants demographics reproductive and medical history will be collected from the electronic medical records EMR The investigators will then collect data using administration of a series of surveys and semi-structured interviews to assess the impact of OPUS at the key time points in the decision-making pathway All instruments will be distributed and completed via Research Electronic Data Capture REDCap Survey with a paper version available at participant request The investigators will also make tablets available at the clinical visit for participants to complete the survey
Patient Activation
The investigators will utilize a modified version of the Patient Activation Measure PAM-13 to measure patient activation regarding PSD decisions The PAM-13 is a widely used standardized measure of patient activation in healthcare decisions It is an interval-level scale developed to assess respondents understanding of their role in the care process and having the knowledge skill and confidence to manage healthcare decisions
Decision preferences statuspreferences
The investigators will measure participants preferences regarding decision-making experiences with shared decision making SDM The investigators will measure decision-making decisionspreferences at the following timepoints T1 Pre-visit and T1 Post-visit This will include questions about printed or online materials accessed for self-education
Decision-making
The research assistant will place a small audio-recording device in the exam room to record the content interaction and duration of dialogue about genetic risk and risk assessment and remove it immediately after the visit This approach will allow for evaluation of patient and patientpartner dyads in healthcare discussions with the provider The investigators have elected to audio record instead of video record to minimize the Hawthorne effect and because of the sensitive nature of the physical exam during this visit Our prior work has demonstrated that this approach can be successfully used
Interviews
The investigators will conduct semi-structured interviews with a subset of patients at T1 Post-visit T2 Post-test n 40 to gain additional information about OPUSs usability feasibility and acceptability of the intervention The interviews will be guided by an interview guide developed in conjunction with the Advisory Group and audio recorded for data analysis purposes
Provider measures
Providers will complete a baseline questionnaire OB1 at the time of enrollment to collect information about demographics medical education and training including any training specific to healthcare communication and clinical practice It will also contain a self-assessment of the providers ability to facilitate a SDM process
Aim 2 Determine the ability of OPUS to improve a patients ability to make an informed choice about PSD compared to usual care
The investigators hypothesize that patients exposed to OPUS will have higher rates of informed choice regarding the utilization or decline of prenatal genetic testing
Data collection
Patients will complete the Informed Choice for Screens and Diagnostic Tests survey ICSD an instrument developed and validated as part of NEST at the following intervals T1-Pre-visit T1 Post-visit T2 Post-test and T3 Pre-ultrasound US The investigators will also assess health literacy using the validated self-administered medical term recognition test METER an instrument successfully used during NEST
Data analysis
Analysis will be conducted to determine the impact of OPUS on the variables of knowledge attitudes and deliberation the variables will be analyzed together as components of the informed choice and then separately to understand the effect of exposure to OPUS on each variable The investigators will also examine the change of these variables together and separately from T1 to T2 and T3 Based on the methods described by the author Marteau and adapted for the ICSD the variables of knowledge and attitudes and choice will be categorized These data will be summed to determine whether responses at different time points represented an informed choice good knowledge positive attitude and intention or decision to utilize consistent with behavior or an uninformed choice poor knowledge negative attitude and attitude was inconsistent with behavior for the utilized screen or diagnostic test Logistic regression methods will be used to assess differences in exposure to OPUS and reproductive demographic eg raceethnicity technology access social economic status SES and clinical practice variables
Aim 3 Determine the extent to which OPUS reduces patients uncertainty and decisional conflict associated with PSD decisions
The investigators hypothesize that patients exposed to OPUS will have lower levels of decisional uncertainty and conflict throughout the PSD pathway compared to patients exposed to usual care
Data collection
The investigators will use the validated Decisional Conflict Scale DCS to examine the presence of decisional conflict understand its impact on patient experience and identify modifiable factors to reduce it at T2 T3 and T4 This validated instrument was used successfully as part of NEST that uses Likert scale items to measure personal perceptions of uncertainty in the decision-making process and modifiable factors contributing to uncertainty Our goal in selecting this measure is to assess the process of obtaining information and making a choice not the outcome of the decision to utilize or not utilize PSD
Data analysis
Analysis will be conducted to determine the impact of OPUS on decisional conflict independently and as a function of informed choice including variables of knowledge attitudes and deliberation separately and together patient activation and SDMIDM Analysis will be conducted in a fashion described by the author OConnor to determine the level of decisional conflict Logistic regression will be used to assess correlations between informed choice measures patient demographic measures and measures of decisional conflict The data for each time point will be combined and the analysis re-run using repeated measures logistic regression methods and including test time as an additional independent variable Analyses will be conducted to examine differences in reduction of decisional conflict in addition to baseline uncertainty and anxiety across subgroups including by raceethnicity knowledgehealth literacy insurance status reproductive history
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