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临床试验/NCT05688982
NCT05688982招募中不适用

MOLAR: Mapping Oral Health and Local Area Resources

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 2,927 人开始时间: 2023年8月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
2,927
试验地点
1
主要终点
Linkage to oral health care

研究概览

简要总结

The goal of this clinical trial is to test the impact of a screening and linkage intervention for adverse social determinants of health (aSDoH) on oral health linkage to care for emergency department patients. Researchers will compare three groups: Patients in Arm A will receive paper handouts with general oral health and aSDoH resources. Patients in Arm B will receive paper handouts with geographically-proximate oral health and aSDoH resources. Patients in Arm C will receive geographically-proximate oral health and aSDoH resources plus active navigational assistance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
1 Year 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To be eligible to participate in this study, an individual must meet all of the following criteria:
  • No evidence of lack of capacity to provide verbal informed consent (as documented in the chart).
  • Willing to comply with all study procedures and be available by phone for the duration of the study (as reported by the patient)
  • Unmet oral health needs as ascertained by the Hope Home (adult) or Gazzaz (pediatric) questions
  • Adult (age ≥18 years old) ED patient or pediatric ED patient (>1 year of age) presenting with parent or legal guardian. Parent will be the primary study participant but if age > 7 years, the child will provide assent for medical record review.
  • Ability to communicate in English or Spanish (as reported by the patient)
  • Emergency severity index (ESI) 2-5 (as documented in the electronic medical record)
  • Residence within catchment area of 3-hospital region (defined by MGB home hospital catchment area) at initial enrollment (as reported by the patient)
  • Working phone number

排除标准

  • Patients on involuntary holds (per electronic medical record review)
  • Presenting from carceral facilities (per electronic medical record review)
  • Presenting for acute mental health care under evaluation for Section 12 (per electronic medical record review)
  • Patients presenting for assistance with intimate partner violence (IPV) or care following sexual assault

研究组 & 干预措施

C--geographic information and navigational assistance

Other

Patients in Arm C will receive geographically-proximate oral health and aSDoH resources plus active navigational assistance.

干预措施: Navigational assistance (Behavioral)

A--general information

Other

Patients in Arm A will receive paper handouts with general oral health and aSDoH resources

干预措施: General information provision (Behavioral)

B--geographic information

Other

Patients in Arm B will receive paper handouts with geographically-proximate oral health and aSDoH resources.

干预措施: Geographic information provision (Behavioral)

C--geographic information and navigational assistance

Other

Patients in Arm C will receive geographically-proximate oral health and aSDoH resources plus active navigational assistance.

干预措施: Geographic information provision (Behavioral)

结局指标

主要结局

Linkage to oral health care

时间窗: Within 12 months of randomization

binary, completion of a dental appointment or not

次要结局

  • Rate of linkage to oral health care at the neighborhood level(Within 12 months of randomization)
  • Repeat visits for oral health problems(Within 12 months of randomization)
  • Time to completion of dental appointment at the individual level(Within 12 months of randomization)
  • Oral health quality of life(Within 12 months of randomization)
  • Return visits(Within 12 months of initial visit)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Margaret Samuels-Kalow

Associate Professor

Massachusetts General Hospital

研究点 (1)

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