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TEACH: Technology Evaluation to Address Child Health (TEACH)

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ClinicalTrials.gov Identifier: NCT02912000
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : March 22, 2018
Sponsor:
Collaborators:
Academic Pediatric Association
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Jonathan P. Winickoff, MD, MPH, Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Smoking Obesity Dental Caries Behavioral: TEACH intervention Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 650 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: TEACH: Technology Evaluation to Address Child Health
Study Start Date : September 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
The intervention group will receive the TEACH intervention - an electronic tablet screening in waiting room for the modifiable risk factors
Behavioral: TEACH intervention
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.

No Intervention: Control
Care as usual: No electronic tablet in waiting room



Primary Outcome Measures :
  1. Reported screening and counseling by physicians about parental smoking, child dentist appointment, and sugar-sweetened beverages [ Time Frame: 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).


Secondary Outcome Measures :
  1. Parent report of behavior change intention related to parental smoking, child sugar sweetened beverage consumption and child's dental appointment [ Time Frame: At baseline and one month follow-up ]
    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.

  2. Reported behavior change related to parental smoking, child sugar sweetened beverage consumption and child's dental appointment [ Time Frame: one month follow-up ]
    At one month follow-up, the intervention group will have a greater increase in reported healthy behavior than the control group.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912000


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Academic Pediatric Association
Fonds de la Recherche en Santé du Québec
Investigators
Principal Investigator: Jonathan P Winickoff, MD MPH Massachusetts General Hospital

Responsible Party: Jonathan P. Winickoff, MD, MPH, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02912000     History of Changes
Other Study ID Numbers: 2016P000711/MGH
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jonathan P. Winickoff, MD, MPH, Massachusetts General Hospital:
Dental Health Services
Sugar-Sweetened Beverages
Tobacco control
Pediatrics
Parents

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases