Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555029
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Oral Health Intervention in Adult Primary Care
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multi-Level Interventions to Reduce Oral Health Disparities Among Adults in Primary Care Settings
Status:
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:
None
Brief Summary:
This study is a Stage III cRCT to test the efficacy of multi-level interventions at the practice- and provider-level to address low dental utilization attendance among Medicaid-enrolled older adults 55 years or older attending non-urgent primary care visits PCV in MetroHealth practice settings Twelve practices will be randomized into two arms A Intervention arm will receive the multi-level intervention that includes 1 Practice-level EHR changes to include ask advise assess and connect AAAC strategies 2 Provider-level Medical staff MA nurse Training in the AAAC process and complete AAAC for enrolled older adults Clinicians physiciannurse practitioner CSM-based education didactic skills training video training with standardized patients and view completed AAAC in EHR to deliver core oral health OH facts to older adults reinforce importance of dental visits and document in EHR that OH facts were delivered B Control arm will receive at the provider-level only clinicians non-theory-based information about retaining a healthy mouth using the ADA Mouth Healthy Series and deliver standard OH care for patients Older Adults will be followed at 12 months and 24 months to determine if the participant had any dental attendance
The primary objective is to test the efficacy of the practice level EHR strategy to ask OH risk assessment advise going to dentist assess willingness for referral and connect eReferral resources together with clinician theory-based education to communicate OH facts versus clinician alone standard oral health care in increasing dental attendance in primary care settings
The secondary objectives are to assess oral hygiene behavior Geriatric Oral Health Quality of life biometric measures BP serum cholesterol blood glucose hbA1c abstracted from EHR data potential mediators and moderators to investigate pathways that affect the primary and secondary outcomes and assess implementation strategies adoption reach fidelity and maintenance of providers and practices that affect older adult primary and secondary outcomes
The hypothesis is that medical staff completing the AAAC strategy and clinicians with improved OH knowledge chronicity systemic effects will deliver consistent oral health messaging to older adults at PCVs that will result in increased preventive and restorative dental utilization compared to those providers delivering standard care
The primary objective is to test the efficacy of the practice level EHR strategy to ask OH risk assessment advise going to dentist assess willingness for referral and connect eReferral resources together with clinician theory-based education to communicate OH facts versus clinician alone standard oral health care in increasing dental attendance in primary care settings
The secondary objectives are to assess oral hygiene behavior Geriatric Oral Health Quality of life biometric measures BP serum cholesterol blood glucose hbA1c abstracted from EHR data potential mediators and moderators to investigate pathways that affect the primary and secondary outcomes and assess implementation strategies adoption reach fidelity and maintenance of providers and practices that affect older adult primary and secondary outcomes
The hypothesis is that medical staff completing the AAAC strategy and clinicians with improved OH knowledge chronicity systemic effects will deliver consistent oral health messaging to older adults at PCVs that will result in increased preventive and restorative dental utilization compared to those providers delivering standard care
Detailed Description:
Study Design
This study will utilize a multi-level cluster randomized clinical trial design Phase III to assess interventions intended to address poor dental utilization among Medicaid-enrolled older adults aged 55 years or older attending non-urgent primary care visits PCV in primary care settings The focus is on addressing factors determinants at the three socio-ecological levels the practiceorganization provider medical staff MA nurse and clinicians physician nurse practitioner and the older adult A total of 12 practices will be randomized to 2 arms as follows Intervention Arm Arm A includes practice-level changes in Epic EHR for the provider-level medical staff to deliver the ask advise assess connect AAAC strategies to screen refer and provide resources for oral health clinician CSM theory-based training to deliver oral health facts to older adults and acknowledge giving facts in EHR Control Arm Arm B will receive provider-level standard non-theory based oral health training for the clinician and no changes to the EHR system or completion of AAAC by medical staff Arm B participants will receive standard of care which is to address any oral health issues if brought to the attention of the provider Each arm will consist of 6 practices n 12 47 clinicians n 95 and 400 older adults n 800 Only the 6 practices in Arm A will enroll 34 medical staff Older adults will be recruited at the first PCV and then be followed for two consecutive PCVs for approximately 24 months Providers will complete the training dependent upon arm EHR didactic skills or standard didactic prior to enrolling any patient and will participate in the study for a total of 24-36 months duration includes initial and booster training Booster training for clinicians will be completed prior to PCV 2 Immediately after randomization of practices recruitment of older adult participants will be rolled out during a two-year period ie 6 practices with 400 participants in each of the two years
The primary outcome will be dental attendance receipt of dental care assessed through CareSource Medicaid claims data The dental attendance from Medicaid claims will be validated with a sub-set of clinical data from the dental EHR Clinical data ie encounter date tooth level caries periodontal data will be abstracted for those patients who requested an eReferral to Metro dental
Secondary outcomes from participant questionnaires will be assessed at 24 months post 1st PCV as follows oral hygiene behavior and oral health quality of life Biometric measures ie BP weight height hbA1c will be abstracted from EHR data
Participants
Study participants include medical staff intervention arm clinicians and older adult patients from primary care practices within Cuyahoga County Medical staff must be solely at the participating practice not floating between practices and not planning to leave the practice within a year Clinicians must be solely in the participating practice not floating between different practices have a minimum of 2 patient-care days per week and not planning to leave the practice within a year Older adult patient participants are those 55 years or older attending a wellness or a non-urgent PCV and enrolled in CareSource Medicaid All participants meeting the eligibility criteria will be enrolled in the study upon signing the consent form
Procedures
Pre-PCV 1 Visit
Providers Reviews the writtenelectronic consent form and signs the form Medical staff Arm A attends EHR training and clinician attends OH didactic education and skills training Arm A to communicate core OH facts dental and systemic links chronicity of dental disease dental visits to older adults or clinician Arm B attends standard ADA based didactic training Providers complete administered pre- and post-tests clinicians only socio-demographics before only and self-efficacy clinicians only to providers before and after the training session
PCV 1 Baseline
Providers Medical staff in Arm A asks oral health questions and provides an eReferralstructured referral Clinician delivers oral health facts and documents OH in EHR based on study arm
Participants before clinician encounter Research staff will review inclusionexclusion criteria the writtenelectronic consent form and patient signs the form Medical staff then proceed with the AAAC process Arm A in EHR and provide an eReferral to Metro dental or structured referral to Medicaid-accepting dentists with resources In the exam room participants will complete the following baseline questionnaires Brief Illness Perception Questionnaire-Revised for Dental Use in OlderElder Adults Brief IPQ-RDE and the Older Adult Questionnaire
Participants during clinician encounter Older adults will receive the core oral health facts from the clinician in Arm A and reinforcement for dental visits Arm B participants will receive the clinicians standard oral health care Older adults attending PCVs may have research staff directly observe the encounter to evaluate the clinicians delivery of OH communication for a sample of visits
Participants after clinician encounter Older adults will provide feedback about the OH information given to them during the medical visit with a short exit questionnaire Older adults will be given the B1 Follow-up Brief IPQ-RDE to be completed and returned
Participants after PCV 1 Older adults will receive telephone calls and text messages from research staff to remind them to complete andor return the Follow-up Brief IPQ-RDE if it has not already been returned Older adults will receive telephone calls and text messages from research staff 8 weeks after the PCV to complete the Dental Attendance Questionnaire
Before PCV 2
Providers Provide OH didactic education booster session for clinicians based on study arm
PCV 2
Providers Same assessments as PCV 1 Participants Same assessments as PCV 1
PCV 3
Providers Same assessments as PCV 1 no booster training Participants Same assessments as PCV 1 except follow-up Brief IPQ-RDE and Dental Attendance Questionnaire
Analysis Plan
Primary Statistical Analysis For the primary outcome of dental attendance preventive restorative by 12 months similarly for attendance between 12 and 24 months the investigators will use a generalized estimating equations GEE approach with practices as clusters This approach will be based on a marginal model with a logit link and include as covariates an intervention indicator variable and selected patient baseline variables considered as potential confounders A corrected standard error adjusting for the small number of clusters and a corresponding score test will be used to test for an intervention effect and 95 confidence intervals for the intervention effect on an odds ratio scale will be computed To assess possible effect modification interaction terms involving the intervention indicator and each moderator for example sociodemographic and social support variables will be added to the above model and tested The investigators will consider alternative within-cluster association models for example by allowing for a second level of clustering of providers nested within practices and through an alternating logistic regression approach using odds ratios as measures of association among binary outcomes in a cluster or sub cluster As a supplementary analysis the investigators will analyze dental attendance in the two time periods from baseline to 12 months and from 12 to 24 months via a longitudinal model Specifically the investigators will extend the above GEE approach by accounting for clustering of the repeated measures within individual as well as within practice and possibly provider The investigators will test for an assumed common effect of the intervention on dental attendance each year as well as test for varying effects over time by adding an intervention by time interaction term to the model The initial analysis will assume that missing data are missing completely at random MCAR
To account for missing data the investigators will conduct sensitivity analyses in which responses are imputed under conservative assumptions Additionally sensitivity analysis will be conducted for those without a dental home vs those with a dental home at the start of the study For the longitudinal analysis the MCAR assumption will be assessed by modeling missingness of the dental attendance outcome and testing whether missingness in the second year is related to dental attendance in the first year If a violation of MCAR is found alternative approaches such as use of a GLIMMIX model will be considered This model will use a logit link include the same covariates as above and incorporate random effects for practices as well as second-level random effects for individuals in the longitudinal model
Secondary Statistical Analysis Secondary outcomes OH related quality of life oral hygiene behavior biometric measures collected at all three PCVs will be analyzed using a GEEmarginal model approach similarly to that described for dental utilization but using the appropriate link function depending on the variable for eg an identity link linear model may be appropriate for continuous outcomes such as the quality of life measure and biometric measures Log transformations will be considered for the sake of improving approximations to a normal distribution
Data Management
The research staff or older adult will enter answers either electronically or on paper and the research staff will review the questionnaires after completed and prior to the older adult leaving the PCV The older adult will have a copy of the questionnaire to reference during the surveys as needed Each paper form and questionnaire will be entered by one individual and verified by a different person
All study forms and questionnaires collected on paper will be double-checked and kept secure at all times Further study forms will be entered into the database and checked for inconsistencies and range and assessed for missing data Any inconsistencies outliers or missing data observed will be compared to the paper document and appropriate corrective actions carried out REDCaps native data resolution workflow will be used to document and fix any data anomalies The Data Manager will also respond to data queries generated by the PI Study Coordinator or other research staff
Following collection of all data from the project additional data processing will be required by the Data Manager eg longitudinal coding of medical illness and dental claims data creation of psychosocial scale scores Following PI concurrence the database will be locked
Data for this study will include 1 oral health screening questions 2 study questionnaires older adults provider medical staff and practice 3 abstracted medical and Dentrix dental data 4 abstracted Medicaid dental claims data 5 data from observation of providers and medical staff and 6 EHR audit data Form revisions should be minimal however should they occur changes will be submitted to the Data Manager for updating and dissemination to research staff
Quality control is primarily conducted at the study team level through internal processes of data reviewdata monitoring using periodic custom reports The Data Manger will run regular validation reports to detect data anomalies and will work with the research staff to resolve any data anomalies that arise during data entry REDCaps native data resolution workflow will be used to document and fix any data anomalies The Data Manager will also respond to data queries generated by the PI Study Coordinator or other research staff
This study will utilize a multi-level cluster randomized clinical trial design Phase III to assess interventions intended to address poor dental utilization among Medicaid-enrolled older adults aged 55 years or older attending non-urgent primary care visits PCV in primary care settings The focus is on addressing factors determinants at the three socio-ecological levels the practiceorganization provider medical staff MA nurse and clinicians physician nurse practitioner and the older adult A total of 12 practices will be randomized to 2 arms as follows Intervention Arm Arm A includes practice-level changes in Epic EHR for the provider-level medical staff to deliver the ask advise assess connect AAAC strategies to screen refer and provide resources for oral health clinician CSM theory-based training to deliver oral health facts to older adults and acknowledge giving facts in EHR Control Arm Arm B will receive provider-level standard non-theory based oral health training for the clinician and no changes to the EHR system or completion of AAAC by medical staff Arm B participants will receive standard of care which is to address any oral health issues if brought to the attention of the provider Each arm will consist of 6 practices n 12 47 clinicians n 95 and 400 older adults n 800 Only the 6 practices in Arm A will enroll 34 medical staff Older adults will be recruited at the first PCV and then be followed for two consecutive PCVs for approximately 24 months Providers will complete the training dependent upon arm EHR didactic skills or standard didactic prior to enrolling any patient and will participate in the study for a total of 24-36 months duration includes initial and booster training Booster training for clinicians will be completed prior to PCV 2 Immediately after randomization of practices recruitment of older adult participants will be rolled out during a two-year period ie 6 practices with 400 participants in each of the two years
The primary outcome will be dental attendance receipt of dental care assessed through CareSource Medicaid claims data The dental attendance from Medicaid claims will be validated with a sub-set of clinical data from the dental EHR Clinical data ie encounter date tooth level caries periodontal data will be abstracted for those patients who requested an eReferral to Metro dental
Secondary outcomes from participant questionnaires will be assessed at 24 months post 1st PCV as follows oral hygiene behavior and oral health quality of life Biometric measures ie BP weight height hbA1c will be abstracted from EHR data
Participants
Study participants include medical staff intervention arm clinicians and older adult patients from primary care practices within Cuyahoga County Medical staff must be solely at the participating practice not floating between practices and not planning to leave the practice within a year Clinicians must be solely in the participating practice not floating between different practices have a minimum of 2 patient-care days per week and not planning to leave the practice within a year Older adult patient participants are those 55 years or older attending a wellness or a non-urgent PCV and enrolled in CareSource Medicaid All participants meeting the eligibility criteria will be enrolled in the study upon signing the consent form
Procedures
Pre-PCV 1 Visit
Providers Reviews the writtenelectronic consent form and signs the form Medical staff Arm A attends EHR training and clinician attends OH didactic education and skills training Arm A to communicate core OH facts dental and systemic links chronicity of dental disease dental visits to older adults or clinician Arm B attends standard ADA based didactic training Providers complete administered pre- and post-tests clinicians only socio-demographics before only and self-efficacy clinicians only to providers before and after the training session
PCV 1 Baseline
Providers Medical staff in Arm A asks oral health questions and provides an eReferralstructured referral Clinician delivers oral health facts and documents OH in EHR based on study arm
Participants before clinician encounter Research staff will review inclusionexclusion criteria the writtenelectronic consent form and patient signs the form Medical staff then proceed with the AAAC process Arm A in EHR and provide an eReferral to Metro dental or structured referral to Medicaid-accepting dentists with resources In the exam room participants will complete the following baseline questionnaires Brief Illness Perception Questionnaire-Revised for Dental Use in OlderElder Adults Brief IPQ-RDE and the Older Adult Questionnaire
Participants during clinician encounter Older adults will receive the core oral health facts from the clinician in Arm A and reinforcement for dental visits Arm B participants will receive the clinicians standard oral health care Older adults attending PCVs may have research staff directly observe the encounter to evaluate the clinicians delivery of OH communication for a sample of visits
Participants after clinician encounter Older adults will provide feedback about the OH information given to them during the medical visit with a short exit questionnaire Older adults will be given the B1 Follow-up Brief IPQ-RDE to be completed and returned
Participants after PCV 1 Older adults will receive telephone calls and text messages from research staff to remind them to complete andor return the Follow-up Brief IPQ-RDE if it has not already been returned Older adults will receive telephone calls and text messages from research staff 8 weeks after the PCV to complete the Dental Attendance Questionnaire
Before PCV 2
Providers Provide OH didactic education booster session for clinicians based on study arm
PCV 2
Providers Same assessments as PCV 1 Participants Same assessments as PCV 1
PCV 3
Providers Same assessments as PCV 1 no booster training Participants Same assessments as PCV 1 except follow-up Brief IPQ-RDE and Dental Attendance Questionnaire
Analysis Plan
Primary Statistical Analysis For the primary outcome of dental attendance preventive restorative by 12 months similarly for attendance between 12 and 24 months the investigators will use a generalized estimating equations GEE approach with practices as clusters This approach will be based on a marginal model with a logit link and include as covariates an intervention indicator variable and selected patient baseline variables considered as potential confounders A corrected standard error adjusting for the small number of clusters and a corresponding score test will be used to test for an intervention effect and 95 confidence intervals for the intervention effect on an odds ratio scale will be computed To assess possible effect modification interaction terms involving the intervention indicator and each moderator for example sociodemographic and social support variables will be added to the above model and tested The investigators will consider alternative within-cluster association models for example by allowing for a second level of clustering of providers nested within practices and through an alternating logistic regression approach using odds ratios as measures of association among binary outcomes in a cluster or sub cluster As a supplementary analysis the investigators will analyze dental attendance in the two time periods from baseline to 12 months and from 12 to 24 months via a longitudinal model Specifically the investigators will extend the above GEE approach by accounting for clustering of the repeated measures within individual as well as within practice and possibly provider The investigators will test for an assumed common effect of the intervention on dental attendance each year as well as test for varying effects over time by adding an intervention by time interaction term to the model The initial analysis will assume that missing data are missing completely at random MCAR
To account for missing data the investigators will conduct sensitivity analyses in which responses are imputed under conservative assumptions Additionally sensitivity analysis will be conducted for those without a dental home vs those with a dental home at the start of the study For the longitudinal analysis the MCAR assumption will be assessed by modeling missingness of the dental attendance outcome and testing whether missingness in the second year is related to dental attendance in the first year If a violation of MCAR is found alternative approaches such as use of a GLIMMIX model will be considered This model will use a logit link include the same covariates as above and incorporate random effects for practices as well as second-level random effects for individuals in the longitudinal model
Secondary Statistical Analysis Secondary outcomes OH related quality of life oral hygiene behavior biometric measures collected at all three PCVs will be analyzed using a GEEmarginal model approach similarly to that described for dental utilization but using the appropriate link function depending on the variable for eg an identity link linear model may be appropriate for continuous outcomes such as the quality of life measure and biometric measures Log transformations will be considered for the sake of improving approximations to a normal distribution
Data Management
The research staff or older adult will enter answers either electronically or on paper and the research staff will review the questionnaires after completed and prior to the older adult leaving the PCV The older adult will have a copy of the questionnaire to reference during the surveys as needed Each paper form and questionnaire will be entered by one individual and verified by a different person
All study forms and questionnaires collected on paper will be double-checked and kept secure at all times Further study forms will be entered into the database and checked for inconsistencies and range and assessed for missing data Any inconsistencies outliers or missing data observed will be compared to the paper document and appropriate corrective actions carried out REDCaps native data resolution workflow will be used to document and fix any data anomalies The Data Manager will also respond to data queries generated by the PI Study Coordinator or other research staff
Following collection of all data from the project additional data processing will be required by the Data Manager eg longitudinal coding of medical illness and dental claims data creation of psychosocial scale scores Following PI concurrence the database will be locked
Data for this study will include 1 oral health screening questions 2 study questionnaires older adults provider medical staff and practice 3 abstracted medical and Dentrix dental data 4 abstracted Medicaid dental claims data 5 data from observation of providers and medical staff and 6 EHR audit data Form revisions should be minimal however should they occur changes will be submitted to the Data Manager for updating and dissemination to research staff
Quality control is primarily conducted at the study team level through internal processes of data reviewdata monitoring using periodic custom reports The Data Manger will run regular validation reports to detect data anomalies and will work with the research staff to resolve any data anomalies that arise during data entry REDCaps native data resolution workflow will be used to document and fix any data anomalies The Data Manager will also respond to data queries generated by the PI Study Coordinator or other research staff
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