Effectiveness of Pedialink CEASE Module

NCT ID: NCT01087177

Last Updated: 2012-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 647 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-02-28

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.

Conditions

Tobacco Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Exposure to Pedialink CEASE Trained Site

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

Group Type: EXPERIMENTAL

Exposure to practice that has been trained in Pedialink CEASE

Intervention Type: OTHER

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

Interventions

Exposure 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Flight Attendant Medical Research Institute

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jonathan P. Winickoff, MD, MPH

Associate Professor in Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan P Winickoff, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School (HMS and HSDM)

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23594832 (View on PubMed)

Related Links

http://www.ceasetobacco.org

CEASE Website

Other Identifiers

2007p-001734

Identifier Type: -

Identifier Source: org_study_id