Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535139
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
ReMARK Addressing Disparities in Rural Communities to Increase the HPV Vaccine Recommendation Effectiveness
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ReMARK A Multi-level Strategy to Address Disparities in Rural Communities to Increase the HPV Vaccine Recommendation Effectiveness Part 3- Evaluation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
There are three main objectives of the protocol First we will evaluate the added clinical- and cost- effectiveness of parent-targeted motivational aids reminderrecall and phone-based MI alone and when combined with community-targeted healthcare access assistance beyond the effects of clinician-targeted training Second we will estimate the differential effectiveness of the implementation strategies by patient-level factors age raceethnicity sex distance from home to clinic social vulnerability Third we will measure moderation of implementation strategy effectiveness by clinic-level factors HPV vaccination priority resources clinic visit types scheduling practices and implementation success
Within 11 rural North Central Florida counties we will evaluate the layering of evidence-based implementation strategies that progressively addressing clinician parent and healthcare access barriers faced by rural communities on HPV vaccination rates among 9- to 12-year-olds To best address our main question of whether layering complementary strategies continues to increase effects on HPV vaccination we will test our hypotheses with a three-arm cluster randomized study design of nested strategies The proposed nested study design optimizes evaluation causal inference and scientific rigor by putting the maximum number of clinics towards addressing the layering of strategies Randomization will occur at the clinic level All clinics will receive implementation strategy A clinician-targeted recommendation training A random 20 of 30 of clinics will also receive facilitation of parent-targeted motivational aids B for an implementation strategy package of AB Finally a random half of the clinics who receive AB will also receive community-targeted healthcare access C for a total implementation strategy package of ABC This equates to a three-arm cluster randomized trial in which 10 clinics receive clinician- targeted recommendation training alone A 10 clinics receive clinician-targeted recommendation training and parent-targeted motivational aids AB and 10 clinics receive clinician-targeted recommendation training parent-targeted motivational aids and community-targeted healthcare access ABC
Within 11 rural North Central Florida counties we will evaluate the layering of evidence-based implementation strategies that progressively addressing clinician parent and healthcare access barriers faced by rural communities on HPV vaccination rates among 9- to 12-year-olds To best address our main question of whether layering complementary strategies continues to increase effects on HPV vaccination we will test our hypotheses with a three-arm cluster randomized study design of nested strategies The proposed nested study design optimizes evaluation causal inference and scientific rigor by putting the maximum number of clinics towards addressing the layering of strategies Randomization will occur at the clinic level All clinics will receive implementation strategy A clinician-targeted recommendation training A random 20 of 30 of clinics will also receive facilitation of parent-targeted motivational aids B for an implementation strategy package of AB Finally a random half of the clinics who receive AB will also receive community-targeted healthcare access C for a total implementation strategy package of ABC This equates to a three-arm cluster randomized trial in which 10 clinics receive clinician- targeted recommendation training alone A 10 clinics receive clinician-targeted recommendation training and parent-targeted motivational aids AB and 10 clinics receive clinician-targeted recommendation training parent-targeted motivational aids and community-targeted healthcare access ABC
Detailed Description:
There are three main objectives of the protocol First we will evaluate the added clinical- and cost-effectiveness of parent-targeted motivational aids reminderrecall and phone-based MI alone and when combined with community-targeted healthcare access assistance beyond the effects of clinician-targeted training Second we will estimate the differential effectiveness of the implementation strategies by patient-level factors age raceethnicity sex distance from home to clinic social vulnerability Third we will measure moderation of implementation strategy effectiveness by clinic-level factors HPV vaccination priority resources clinic visit types scheduling practices and implementation success
We propose a multilevel approach incorporating evidence-based strategies that address clinicians recommendations parents hesitations and access to healthcare is needed to reduce the HPV-related cancer disparities in rural areas Within 11 rural North Central Florida counties we will adapt implement and evaluate the layering of evidence-based implementation strategies by progressively addressing clinician parent and healthcare access barriers faced by rural communities on HPV vaccination rates among 9- to 12-year-olds To increase reproducibility we propose a conceptual framework specified implementation strategies randomization adaptive and sequential implementation strategies process and outcome measures appropriate statistical analysis and conservative power calculations
To best address our main question of whether layering complementary strategies continues to increase effects on HPV vaccination we will test our hypotheses with a three-arm cluster randomized study design of nested strategies The proposed nested study design optimizes evaluation causal inference and scientific rigor by putting the maximum number of clinics towards addressing the layering of strategies Randomization will occur at the clinic level All clinics will receive implementation strategy A clinician-targeted recommendation training A random 20 of 30 of clinics will also receive facilitation of parent-targeted motivational aids B for an implementation strategy package of AB Finally a random half of the clinics who receive AB will also receive community-targeted healthcare access C for a total implementation strategy package of ABC This equates to a three-arm cluster randomized trial in which 10 clinics receive clinician-targeted recommendation training alone A 10 clinics receive clinician-targeted recommendation training and parent-targeted motivational aids AB and 10 clinics receive clinician-targeted recommendation training parent-targeted motivational aids and community-targeted healthcare access ABC
Random Assignment
Clinics will be randomized into three equal arms Ten clinics will receive clinician-targeted recommendation training alone A Ten clinics will receive clinician-targeted recommendation training and parent-targeted motivational aids AB Ten clinics will receive clinician-targeted recommendation training parent-targeted motivational aids and community-targeted healthcare access ABC
Delivery of interventions
As delivery of interventions is conducted at the clinic level and all interventions are evidence-based these interventions will be conducted as quality improvement
Clinician-targeted Recommendation Training All participating clinicians and nurses at all 30 participating clinics will be offered trainings via a one-hour Zoom video conference Structured after and intending to enhance and expand the NCI Evidence-based Program by focusing on empathy as central to the conversation and including 9- to 10-year-olds who are not eligible for Tetanus Diphtheria and Pertussis or Meningitis ACWY Drs Staras PI Thompson and Bylund developed and have conducted preliminary testing of the C-LEAR Counsel Listen Empathize Answer Recommend training as part of our R37 Staras PI Section C22 C-LEAR incorporates concepts from Motivational Interviewing facework theories and patient-centered communication
Parent-targeted Motivational Aids Twenty of the 30 clinics will be offered the parent-targeted motivational aids implementation strategy which includes reminderrecall and parent-targeted phone- based MI
ReminderRecall We will facilitate clinic staff sending these customized reminderrecall messages via one of three methods postcards text messages or phone calls to increase clinic adaptability to existing services and workflow We will assist clinics in identifying 9- to 12-year-olds who have not received the HPV vaccine though the Florida state immunization registry and their EHR systems Reminderrecall for initiation and follow-up doses will be sent at three meaningful milestones
1 two weeks before an adolescents birthday 2 two weeks prior to fall school start and 3 within the first weeks of January
Parent-targeted Phone-based MI Following our previously feasible and acceptable process for phone-based MI parents who have been sent at least two reminderrecall messages for initiation or follow-up without response contact or clinic visit after one month will be eligible for phone-based MI Based on our pilot study we anticipate MI sessions will last approximately ten minutes
Community-targeted Healthcare Access We will address social determinants faced by families living in rural areas in three ways 1 linking patients to transportation assistance 2 providing a mobile vaccination clinic and 3 linking patients to health insurance navigators The activities will be managed by the UF Health Cancer Centers Community Outreach and Engagement Community Navigation office as these services are consistent with their current offerings UF Pediatrics and UF CTSI will offer mobile vaccine clinics as part of standard of care 40 times during the intervention period 4 times for each of the 10 assigned clinics The mobile vaccination clinics will offer all adolescent vaccines HPV Tetanus Diphtheria and Pertussis Meningitis ACWY Influenza - in season and COVID-19 Adolescents will receive the vaccines free of charge billed to insurance or the Federal Vaccines for Children Program which covers vaccines for all children 18 years and under who are eligible for Medicaid or are uninsured underinsured or Native American or Alaskan Native All administered vaccines will be reported to the Florida immunization registry and thus discoverable by clinics statewide including participating clinics
Statistical Analysis and Design
We will randomize 30 participating clinics to three arms 10 clinics per study arm We will use constrained randomization to reduce imbalance among a priori determined confounders ie baseline vaccination rate The statistical team will be blinded to study arm assignments
Clinical Effectiveness Analysis The proposed group randomized trial consists of clustered data with patients nested within clinics Any statistical analysis that ignores lack of independence due to nesting will be subject to inflated type-1 errors To account for the clinic level clustering effect intervention effects on HPV vaccine initiation will be estimated with generalized linear mixed models We describe briefly our general strategy for specifying both the covariance and mean models for proposed analyses in Aims 1 through 3
In this trial cluster sampling generates exchangeable observations and therefore compound symmetric covariance for patients nested within clinics is appropriate Implementing the covariance model can be done for our binary outcome HPV vaccine initiation in PROC GLIMMIX in SAS by specifying a random intercept for clinic In addition to efficiently accounting for non-independence a generalized linear mixed model approach provides the flexibility to specify different link and variance functions based Our primary specification will be a log link and binomial variance to directly estimate the risk ratio Should model convergence issues arise we will estimate a logit model on the odds scale
We propose a multilevel approach incorporating evidence-based strategies that address clinicians recommendations parents hesitations and access to healthcare is needed to reduce the HPV-related cancer disparities in rural areas Within 11 rural North Central Florida counties we will adapt implement and evaluate the layering of evidence-based implementation strategies by progressively addressing clinician parent and healthcare access barriers faced by rural communities on HPV vaccination rates among 9- to 12-year-olds To increase reproducibility we propose a conceptual framework specified implementation strategies randomization adaptive and sequential implementation strategies process and outcome measures appropriate statistical analysis and conservative power calculations
To best address our main question of whether layering complementary strategies continues to increase effects on HPV vaccination we will test our hypotheses with a three-arm cluster randomized study design of nested strategies The proposed nested study design optimizes evaluation causal inference and scientific rigor by putting the maximum number of clinics towards addressing the layering of strategies Randomization will occur at the clinic level All clinics will receive implementation strategy A clinician-targeted recommendation training A random 20 of 30 of clinics will also receive facilitation of parent-targeted motivational aids B for an implementation strategy package of AB Finally a random half of the clinics who receive AB will also receive community-targeted healthcare access C for a total implementation strategy package of ABC This equates to a three-arm cluster randomized trial in which 10 clinics receive clinician-targeted recommendation training alone A 10 clinics receive clinician-targeted recommendation training and parent-targeted motivational aids AB and 10 clinics receive clinician-targeted recommendation training parent-targeted motivational aids and community-targeted healthcare access ABC
Random Assignment
Clinics will be randomized into three equal arms Ten clinics will receive clinician-targeted recommendation training alone A Ten clinics will receive clinician-targeted recommendation training and parent-targeted motivational aids AB Ten clinics will receive clinician-targeted recommendation training parent-targeted motivational aids and community-targeted healthcare access ABC
Delivery of interventions
As delivery of interventions is conducted at the clinic level and all interventions are evidence-based these interventions will be conducted as quality improvement
Clinician-targeted Recommendation Training All participating clinicians and nurses at all 30 participating clinics will be offered trainings via a one-hour Zoom video conference Structured after and intending to enhance and expand the NCI Evidence-based Program by focusing on empathy as central to the conversation and including 9- to 10-year-olds who are not eligible for Tetanus Diphtheria and Pertussis or Meningitis ACWY Drs Staras PI Thompson and Bylund developed and have conducted preliminary testing of the C-LEAR Counsel Listen Empathize Answer Recommend training as part of our R37 Staras PI Section C22 C-LEAR incorporates concepts from Motivational Interviewing facework theories and patient-centered communication
Parent-targeted Motivational Aids Twenty of the 30 clinics will be offered the parent-targeted motivational aids implementation strategy which includes reminderrecall and parent-targeted phone- based MI
ReminderRecall We will facilitate clinic staff sending these customized reminderrecall messages via one of three methods postcards text messages or phone calls to increase clinic adaptability to existing services and workflow We will assist clinics in identifying 9- to 12-year-olds who have not received the HPV vaccine though the Florida state immunization registry and their EHR systems Reminderrecall for initiation and follow-up doses will be sent at three meaningful milestones
1 two weeks before an adolescents birthday 2 two weeks prior to fall school start and 3 within the first weeks of January
Parent-targeted Phone-based MI Following our previously feasible and acceptable process for phone-based MI parents who have been sent at least two reminderrecall messages for initiation or follow-up without response contact or clinic visit after one month will be eligible for phone-based MI Based on our pilot study we anticipate MI sessions will last approximately ten minutes
Community-targeted Healthcare Access We will address social determinants faced by families living in rural areas in three ways 1 linking patients to transportation assistance 2 providing a mobile vaccination clinic and 3 linking patients to health insurance navigators The activities will be managed by the UF Health Cancer Centers Community Outreach and Engagement Community Navigation office as these services are consistent with their current offerings UF Pediatrics and UF CTSI will offer mobile vaccine clinics as part of standard of care 40 times during the intervention period 4 times for each of the 10 assigned clinics The mobile vaccination clinics will offer all adolescent vaccines HPV Tetanus Diphtheria and Pertussis Meningitis ACWY Influenza - in season and COVID-19 Adolescents will receive the vaccines free of charge billed to insurance or the Federal Vaccines for Children Program which covers vaccines for all children 18 years and under who are eligible for Medicaid or are uninsured underinsured or Native American or Alaskan Native All administered vaccines will be reported to the Florida immunization registry and thus discoverable by clinics statewide including participating clinics
Statistical Analysis and Design
We will randomize 30 participating clinics to three arms 10 clinics per study arm We will use constrained randomization to reduce imbalance among a priori determined confounders ie baseline vaccination rate The statistical team will be blinded to study arm assignments
Clinical Effectiveness Analysis The proposed group randomized trial consists of clustered data with patients nested within clinics Any statistical analysis that ignores lack of independence due to nesting will be subject to inflated type-1 errors To account for the clinic level clustering effect intervention effects on HPV vaccine initiation will be estimated with generalized linear mixed models We describe briefly our general strategy for specifying both the covariance and mean models for proposed analyses in Aims 1 through 3
In this trial cluster sampling generates exchangeable observations and therefore compound symmetric covariance for patients nested within clinics is appropriate Implementing the covariance model can be done for our binary outcome HPV vaccine initiation in PROC GLIMMIX in SAS by specifying a random intercept for clinic In addition to efficiently accounting for non-independence a generalized linear mixed model approach provides the flexibility to specify different link and variance functions based Our primary specification will be a log link and binomial variance to directly estimate the risk ratio Should model convergence issues arise we will estimate a logit model on the odds scale
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