Multi-Level Interventions to Reduce Oral Health Disparities Among Adults in Primary Care Settings
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 929
- 试验地点
- 2
- 主要终点
- Dental Attendance
研究概览
简要总结
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 (physician/nurse 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.
详细描述
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 practice/organization, 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 = 95 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, i.e. 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 (i.e. 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 (i.e. BP, weight, height, hbA1c) will be abstracted from EHR data.
Participants:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Use Epic EHR
- •Have older adults covered by Medicaid
- •Located within 60 miles of the CWRU research offices
- •Provider (medical staff or clinician):
- •Medical staff (MA, nurse):
- •Do not float between practices
- •Plan not to leave practice within a year
- •Provide a signed and dated consent form
- •Clinicians (Physician, NP):
- •Have a minimum of 2 patient-care days per week
- •Do not float between practices
- •Plan not to leave practice within a year
- •Provide signed and dated consent form
- •Older Adult/Patient Participant:
- •Enrolled in CareSource Medicaid Plan
- •Female or male aged 55 years or older
- •Attending non-urgent primary care visits (PCV) at enrolled site
- •Provide signed and dated informed consent form
- •Planning to stay in the immediate area for the next year
- •Enrolled in the Adult Wellness Registry
排除标准
- •The presence of any serious medical health condition (such as dementia or other cognitive disorder not allowing them to participate) where the clinician indicates they should not participate.
- •The presence of any serious mental health disorders such as schizophrenia where the clinician indicates they should not participate.
结局指标
主要结局
Dental Attendance
时间窗: Data will be abstracted from Medicaid Claims data from baseline PCV #1 to 24 month exit visit (PCV #3)
Receipt of dental care as number of visits through Medicaid Claims data (Current Dental Terminology (CDT) codes for preventive or restorative procedures in the past 12 months).
Dental visits
时间窗: Data will be abstracted from dental EHR from baseline PCV#1 to 24 month exit visit (PCV #3)
Receipt of preventive and restorative dental care as number of visits through dental EHR data
次要结局
- Change in oral hygiene(Assessed as change between baseline primary care visit (PCV #1) and 24 month follow-up exit visit (PCV#3))
- Change in Oral Health Quality of Life(Assessed as change between baseline primary care visit (PCV #1) and 24 month follow-up exit visit (PCV#3))
- Change in Biometric Measures -blood glucose(Data will be abstracted from Epic EHR to assess changes from baseline primary care visit (PCV #1) and 24 month follow-up exit visit (PCV #3))
- Change in Biometric Measures-BMI(Data will be abstracted from Epic EHR to assess BMI changes from baseline primary care visit (PCV #1) and 24 month follow-up exit visit (PCV #3))
- Change in Biometric Measures-Blood Pressure(Data will be abstracted from Epic EHR to assess changes from baseline primary care visit (PCV #1) and 24 month follow-up exit visit (PCV #3))
- Change in Biometric Measures -serum cholesterol(Data will be abstracted from Epic EHR to assess changes from baseline primary care visit (PCV #1) and 24 month follow-up exit visit (PCV #3))
- Change in Biometric Measures -Hemoglobin A1C(Data will be abstracted from Epic EHR to assess changes from baseline primary care visit (PCV #1) and 24 month follow-up exit visit (PCV #3))
研究者
Suchitra Nelson
Associate Dean and Professor
Case Western Reserve University