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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
  Purpose

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.


Condition Intervention
Tobacco Use
Other: Exposure to practice that has been trained in Pedialink CEASE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Evaluating Online Clinical Office-Systems Training to Address SHS Exposure of Children

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Rate of home and car no smoking rules. [ Time Frame: Three months ] [ Designated as safety issue: No ]

Enrollment: 647
Study Start Date: March 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Child has had an appointment at a practice that was trained in Pedialink CEASE at the time of the interview.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087177

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Flight Attendant Medical Research Institute
Investigators
Principal Investigator: Jonathan P Winickoff, MD, MPH Harvard Medical School
  More Information

Additional Information:
No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jonathan P. Winickoff, MD, MPH, Associate Professor in Pediatrics, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01087177     History of Changes
Other Study ID Numbers: 2007p-001734
Study First Received: March 12, 2010
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Smoking
Tobacco
Pediatrics

ClinicalTrials.gov processed this record on November 20, 2014