跳至主要内容
临床试验/NCT02912000
NCT02912000已完成不适用

TEACH: Technology Evaluation to Address Child Health

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 650 人开始时间: 2016年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
650
试验地点
2
主要终点
Reported screening and counseling by physicians about parental smoking, child dentist appointment, and sugar-sweetened beverages

研究概览

简要总结

The proposed study is a pre- /post-implementation study in a pediatric practice with a control practice designed to test the feasibility and effectiveness of an electronic screening and service delivery tool for three modifiable health risk factors in pediatrics: parental tobacco use, sugar-sweetened beverages consumption, and poor dental care

详细描述

Key procedures of the study include:

  1. Practices will be contacted via letters, emails and in-person discussion with practice leaders.
  2. Among practices that say yes to recruitment, a total of 2 practices will be randomly assigned to one of two groups: 1) Implementation of the electronic screening tool 2) care as usual
  3. Control and intervention practices will be trained in integrating a Research Assistant (RA) who will be hired, trained, and paid by the research study. RAs will be through networking, temporary officeservice contractors, and other local resources.
  4. A notice to parents and teenagers will be posted where all can see it when registering for their pediatric visit. The notice will announce that the practice is participating in a research study and that parents/guardians and teenagers may be approached by a study RA. Practice staff will refer parents to the RA for the Eligibility Screener.
  5. In the control practice and in the pre-implementation phase of the intervention practice, after being seen by the pediatric clinician, the parent will be approached by the RA stationed near the exit of the clinic for an exit interview consisting of the Exit Survey. Alternatively, it the practice prefers to not have RAs directly approaching patients, practice staff will refer the potential participants to the RA after checkout. Parents who agree to study participation will learn about the study, sign the consent, and complete the Exit Survey for enrolled parents/guardians. Teenagers will not be invited or involved in this part of the study.
  6. In the post-implementation phase of the intervention practice, practice staff will follow a script at the check-in desk to refer parents to the RA. Parents will be approached by the RA after checking in for their appointment. Parents who agree to study participation will complete the Intake Survey. If they are accompanied by a teenager (aged 13-18 years old, the teenager will also be presented the study. Parents will be invited to consent to their child participate in the study. If the child is 13 years old, we will seek assent from the child to answer a portion of the intake survey. If he/she is 14 years or older, consent will be sought, and if obtained, the teenager will be asked to complete a section of the survey, on the same risk factors. We are asking that written documentation of these being waived and that consent/assent be inferred from survey participation, which will be documented in the research record. Teenagers will not be compensated for this section of the study that should take less than 5 minutes to complete. After completion of the survey, the adult participants will receive, if they desire, an information sheet on the risk factors identified, as well as a summary of the screening questionnaire, to be handed to the clinician they are coming to see that day. If no risk factor is identified, no clinician handout will be given. Teenagers' response to the survey will not be shared with parents and will only be available to the principal investigator and co-investigator. Adult participants will also be asked to reach out to the RA after their appointment to complete the Exit Survey, following the procedure mentioned above.
  7. One month after the recruitment and completion of the Exit Survey, adult participants will be contacted by phone by the RA or the Principal Investigator (PI) to complete the Follow-up survey. Consent for this survey will be obtain as part of the study initial consent and preferred phone numbers will be obtained directly from the participants. After completion of the Follow-up Survey, participation in the survey will be complete.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parent of a child aged 0-18 years

排除标准

  • Parents under age 18
  • Parents who have a child with a medical emergency (any condition requiring transfer for immediate medical intervention)
  • Non-consenting individuals
  • Non-English speakers

研究组 & 干预措施

Intervention

Experimental

The intervention group will receive the TEACH intervention - an electronic tablet screening in waiting room for the modifiable risk factors

干预措施: TEACH intervention (Behavioral)

Control

No Intervention

Care as usual: No electronic tablet in waiting room

结局指标

主要结局

Reported screening and counseling by physicians about parental smoking, child dentist appointment, and sugar-sweetened beverages

时间窗: Pre-implementation (baseline) and Post-implementation

Higher rates of screening, counseling, and service delivery by clinicians in the period after implementation than at baseline (pre-implementation).

次要结局

  • Parent report of behavior change intention related to parental smoking, child sugar sweetened beverage consumption and child's dental appointment(At baseline and one month follow-up)
  • Reported behavior change related to parental smoking, child sugar sweetened beverage consumption and child's dental appointment(one month follow-up)

研究者

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

Jonathan P. Winickoff, MD, MPH

MD

Massachusetts General Hospital

研究点 (2)

Loading locations...

相似试验