Clinical trial NCT01087177: Effectiveness of Pedialink CEASE Module
Official title: Evaluating Online Clinical Office-Systems Training to Address SHS Exposure of Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Keywords: Smoking
Tobacco
Pediatrics
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Flight Attendant Medical Research Institute
First posted: 2010-03-16
Enrollment: 647
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Under 18
* Cannot be reached by telephone

Primary outcomes:
measure: Rate of home and car no smoking rules.
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Jonathan P Winickoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.