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TEACH: Technology Evaluation to Address Child Health (TEACH)

Primary Purpose

Smoking, Obesity, Dental Caries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TEACH intervention
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Smoking focused on measuring Dental Health Services, Sugar-Sweetened Beverages, Tobacco control, Pediatrics, Parents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Parent of a child aged 0-18 years

Exclusion Criteria:

  • 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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

Care as usual: No electronic tablet in waiting room

Outcomes

Primary Outcome Measures

Reported screening and counseling by physicians about parental smoking, child dentist appointment, and sugar-sweetened beverages
Higher rates of screening, counseling, and service delivery by clinicians in the period after implementation than at baseline (pre-implementation).

Secondary Outcome Measures

Parent report of behavior change intention related to parental smoking, child sugar sweetened beverage consumption and child's dental appointment
Compared to the pre-implementation period, parents in the post-implementation period will have greater behavior change intention for each modifiable risk factor. This difference will be greater in the intervention practice than in the control practice.
Reported behavior change related to parental smoking, child sugar sweetened beverage consumption and child's dental appointment
At one month follow-up, the intervention group will have a greater increase in reported healthy behavior than the control group.

Full Information

First Posted
September 21, 2016
Last Updated
March 20, 2018
Sponsor
Massachusetts General Hospital
Collaborators
Academic Pediatric Association, Fonds de la Recherche en Santé du Québec
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1. Study Identification

Unique Protocol Identification Number
NCT02912000
Brief Title
TEACH: Technology Evaluation to Address Child Health
Acronym
TEACH
Official Title
TEACH: Technology Evaluation to Address Child Health
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Academic Pediatric Association, Fonds de la Recherche en Santé du Québec

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
Key procedures of the study include: Practices will be contacted via letters, emails and in-person discussion with practice leaders. 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 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. 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. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Obesity, Dental Caries
Keywords
Dental Health Services, Sugar-Sweetened Beverages, Tobacco control, Pediatrics, Parents

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
650 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention group will receive the TEACH intervention - an electronic tablet screening in waiting room for the modifiable risk factors
Arm Title
Control
Arm Type
No Intervention
Arm Description
Care as usual: No electronic tablet in waiting room
Intervention Type
Behavioral
Intervention Name(s)
TEACH intervention
Intervention Description
The TEACH intervention screens family for three modifiable behaviors ahead of the clinical encounter: parental tobacco use, children consumption of sugar-sweetened beverages and child dental health. The information from the screening is then shared with clinicians.
Primary Outcome Measure Information:
Title
Reported screening and counseling by physicians about parental smoking, child dentist appointment, and sugar-sweetened beverages
Description
Higher rates of screening, counseling, and service delivery by clinicians in the period after implementation than at baseline (pre-implementation).
Time Frame
Pre-implementation (baseline) and Post-implementation
Secondary Outcome Measure Information:
Title
Parent report of behavior change intention related to parental smoking, child sugar sweetened beverage consumption and child's dental appointment
Description
Compared to the pre-implementation period, parents in the post-implementation period will have greater behavior change intention for each modifiable risk factor. This difference will be greater in the intervention practice than in the control practice.
Time Frame
At baseline and one month follow-up
Title
Reported behavior change related to parental smoking, child sugar sweetened beverage consumption and child's dental appointment
Description
At one month follow-up, the intervention group will have a greater increase in reported healthy behavior than the control group.
Time Frame
one month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Parent of a child aged 0-18 years Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan P Winickoff, MD MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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TEACH: Technology Evaluation to Address Child Health

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