Effectiveness of Pedialink CEASE Module

This study has been completed.
Sponsor:
Collaborator:
Flight Attendant Medical Research Institute
Information provided by (Responsible Party):
Jonathan P. Winickoff, MD, MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01087177
First received: March 12, 2010
Last updated: March 21, 2012
Last verified: March 2012

March 12, 2010
March 21, 2012
March 2010
February 2011   (final data collection date for primary outcome measure)
Rate of home and car no smoking rules. [ Time Frame: Three months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01087177 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effectiveness of Pedialink CEASE Module
Evaluating Online Clinical Office-Systems Training to Address SHS Exposure of Children

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Tobacco Use
Other: 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.
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.
Intervention: Other: Exposure to practice that has been trained in Pedialink CEASE
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
647
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01087177
2007p-001734
No
Jonathan P. Winickoff, MD, MPH, Massachusetts General Hospital
Massachusetts General Hospital
Flight Attendant Medical Research Institute
Principal Investigator: Jonathan P Winickoff, MD, MPH Harvard Medical School
Massachusetts General Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP