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CompletedNCT01087177Updated Mar 22, 2012

Effectiveness of Pedialink CEASE Module

An interventional study of Exposure to practice that has been trained in Pedialink CEASE in Tobacco Use, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-22.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
647
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study involves the testing of a Pedialink module through parent exit interviews in one intervention practice and one control practice. Pedialink is the American Academy of Pediatrics' online home for continuous professional development. The intervention site will complete the Pedialink module and the control site will be given routine tobacco control materials.

We will measure changes in practice patterns in the two pediatric practices following the implementation of the online training. At each of these practices, the parents or guardians of children seen by the practice will be surveyed for a one week period before, and a one week period six weeks after either using the online training module (intervention) or being given routine tobacco materials (control).

A follow-up telephone survey will be given to some parents at 3-months. Those given the telephone survey are parents or guardians who smoke or parents or guardians who live with a smoker and are surveyed at the second time-point.

We hypothesize that intervention practices will have higher rates of screening for home and car no-smoking rules and higher rates of advising for home and car no-smoking rules.

Read the detailed description

This study will involve developing an online training and dissemination system to train pediatricians to address the secondhand smoke exposure of children. We will gather pediatric staff responses to the specific components of the online training and refine this training for a range of outpatient pediatric office settings. We will test the feasibility and efficacy of implementing the online training and dissemination system within the pediatric office setting. We will also gather parental responses to specific components of the pediatric visit, which will be impacted by the online training for pediatric offices.

The following hypotheses will be tested:

Primary Hypothesis

H1. The following measures of physician behavior, as assessed by exit interviews, 3 month follow up telephone interviews of parents or guardians who smoke or parents or guardians who live with a smoker and chart review of 20 charts, will increase more in the intervention practice than in the control practice:

  • Screening for home no-smoking rule
  • Screening for car no-smoking rule
  • Advising parents about the need for a strictly enforced no-smoking in the home rule
  • Advising parents about the need for a strictly enforced no-smoking in the car rule.

Secondary Hypothesis H2. Compared to the control practice, the intervention practice will have a greater increase in the summary scores that measure the key processes of practice implementation shown to predict successful practice change. This implementation process will be measured by administering previously validated surveys to physicians and key practice staff before and following the implementation of the office system.

02

Conditions studied

  • Tobacco Use

Keywords

  • Smoking
  • Tobacco
  • Pediatrics
03

In context

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Parent or guardian of child seen by the practice.
  • Smoke or live with a smoker.
  • Speak English or Spanish.

Exclusion criteria

Exclusion Criteria:

  • Under 18
  • Cannot be reached by telephone
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
647 participants (actual)

Study arms

  • Experimental
    Exposure to Pedialink CEASE Trained Site

    Parents at a practice where the clinicians were trained to address tobacco use through the Pedialink CEASE module.

    Other: Exposure to practice that has been trained in Pedialink CEASE

Interventions

  • OtherExposure to practice that has been trained in Pedialink CEASE

    Child has had an appointment at a practice that was trained in Pedialink CEASE at the time of the interview.

06

What researchers measure

Primary outcomes

  1. Rate of home and car no smoking rules.

    Time frame: Three months

07

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
08

References and documents

Publications

  • Hipple B, Nabi-Burza E, Hall N, Regan S, Winickoff JP. Distance-based training in two community health centers to address tobacco smoke exposure of children. BMC Pediatr. 2013 Apr 17;13:56. doi: 10.1186/1471-2431-13-56. PubMed 23594832 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01087177
Lead sponsor
Massachusetts General Hospital
Collaborators
Flight Attendant Medical Research Institute
Responsible party
Jonathan P. Winickoff, MD, MPH (Associate Professor in Pediatrics, Massachusetts General Hospital) — Principal investigator
First posted
Mar 16, 2010
Start date
Mar 2010
Primary completion
Feb 2011
Completion
Feb 2011
Last update
Mar 22, 2012

Study contacts

Jonathan P Winickoff, MD, MPH
principal investigator · Harvard Medical School (HMS and HSDM)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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