NCT01882348

Brief Summary

The proposed study is a Cluster Randomized Controlled Trial designed to test the sustainability of a previously developed, tested, effectively implemented tobacco control strategy-the CEASE intervention, employing state of the art tobacco dependence treatment for parents who smoke.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,888

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
1.8 years until next milestone

Study Start

First participant enrolled

April 14, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2017

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

2.5 years

First QC Date

June 18, 2013

Last Update Submit

April 8, 2019

Conditions

Tobacco Dependence

Keywords

tobacco control, tobacco treatment, pediatrics, parents

Outcome Measures

Primary Outcomes (1)

  • Delivery of Assistance

    • Delivery of cessation assistance, defined as prescribing medication, or enrolling in the quitline or other program

    over 2 years

Secondary Outcomes (4)

  • Change in practice prevalence of parents who smoke

    over 2 years

  • Parental quit rate

    over 2 years

  • Smokefree homes and cars

    over 2 years

  • Parental use of pharmacotherapy or services

    over 2 years

Study Arms (2)

Usual Care Control

NO INTERVENTION

Control groups will receive equal number of contacts for training in preparation for enrollment and data collection for the study. Clinicians will be given the option to receive a standard American Academy of Pediatrics tobacco control pamphlet to distribute. Control groups have the option to receive access to the CEASE online module intervention at the conclusion of the research study which allows practitioners in this group to receive 26 continuing education credit hours.

Intervention

EXPERIMENTAL

The Intervention Group will receive the CEASE Intervention

Behavioral: CEASE Intervention

Interventions

CEASE InterventionBEHAVIORAL

The CEASE intervention works within existing systems of care to address parental smoking. Elements include (1) Identification of smokers and self-assessment of quitting preferences; (2) Counseling (brief motivational messaging elements include collaborative goal setting, set quit date, personal barriers to quitting, problem-solving strategies, implementing smoke-free homes and cars, and social support, strategies shown to increase satisfaction with the pediatric visit. (3) Medication (NRT prescription and free 1 week supply (while supplies last)-including for those cutting down to quit as recommended in latest guidelines); (4) Quitline enrollment; and (5) Review of CEASE action sheets at each visit until the family is smoke-free.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents or guardians who smoke or who are former smokers (quit in the last 2 years), are present at the visit, and whose child (any age) is seen by a pediatrician in a participating practice.
  • "Smoker" will be defined as answering "yes" to the screening question: "Have you smoked a single cigarette, even a puff, in the past 7 days?"
  • "Former smoker" will be defined as answering "no" to the screening question: "Have you smoked a single cigarette, even a puff, in the past 7 days?" and "yes" to the screening question: "Have you quit smoking in the last 2 years?"

You may not qualify if:

  • Parents under age 18
  • Parents who have a child with a medical emergency (any condition requiring transfer for immediate medical intervention)
  • Non-consenting individuals
  • Non-English speakers
  • Prior enrollment in the study during a previous healthcare visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (8)

  • Nabi-Burza E, Winickoff JP, Drehmer JE, Zeegers MP, Walters BH. A Qualitative Study of Factors Influencing Implementation of Tobacco Control in Pediatric Practices. J Smok Cessat. 2022 May 5;2022:4156982. doi: 10.1155/2022/4156982. eCollection 2022.

    PMID: 35603037DERIVED

  • Nabi-Burza E, Drehmer JE, Walters BH, Willemsen MC, Zeegers MPA, Winickoff JP. Smoking Cessation Treatment for Parents Who Dual Use E-Cigarettes and Traditional Cigarettes. J Smok Cessat. 2021 Mar 17;2021:6639731. doi: 10.1155/2021/6639731. eCollection 2021.

    PMID: 34306227DERIVED

  • Nabi-Burza E, Wasserman R, Drehmer JE, Walters BH, Luo M, Ossip D, Winickoff JP. Spontaneous Smoking Cessation in Parents. J Smok Cessat. 2021 May 17;2021:5526715. doi: 10.1155/2021/5526715. eCollection 2021.

    PMID: 34306222DERIVED

  • Nabi-Burza E, Drehmer JE, Hipple Walters B, Rigotti NA, Ossip DJ, Levy DE, Klein JD, Regan S, Gorzkowski JA, Winickoff JP. Treating Parents for Tobacco Use in the Pediatric Setting: The Clinical Effort Against Secondhand Smoke Exposure Cluster Randomized Clinical Trial. JAMA Pediatr. 2019 Oct 1;173(10):931-939. doi: 10.1001/jamapediatrics.2019.2639.

    PMID: 31403675DERIVED

  • Nabi-Burza E, Winickoff JP, Drehmer JE, Gorzkowski JA, Klein JD, Levy DE, Ossip DJ, Regan S, Rigotti NA, Hipple Walters B. Innovations in parental smoking cessation assistance delivered in the child healthcare setting. Transl Behav Med. 2020 Oct 8;10(4):1039-1052. doi: 10.1093/tbm/ibz070.

    PMID: 31157864DERIVED

  • Nabi-Burza E, Regan S, Walters BH, Drehmer JE, Rigotti NA, Ossip DJ, Gorzkowski JA, Levy DE, Winickoff JP. Parental Dual Use of e-Cigarettes and Traditional Cigarettes. Acad Pediatr. 2019 Sep-Oct;19(7):842-848. doi: 10.1016/j.acap.2019.04.001. Epub 2019 Apr 11.

    PMID: 30981026DERIVED

  • Drehmer JE, Nabi-Burza E, Hipple Walters B, Ossip DJ, Levy DE, Rigotti NA, Klein JD, Winickoff JP. Parental Smoking and E-cigarette Use in Homes and Cars. Pediatrics. 2019 Apr;143(4):e20183249. doi: 10.1542/peds.2018-3249. Epub 2019 Mar 11.

    PMID: 30858346DERIVED

  • Drehmer JE, Ossip DJ, Nabi-Burza E, Hipple Walters B, Gorzkowski JA, Winickoff JP. Pediatric Office Delivery of Smoking Cessation Assistance for Breast-Feeding Mothers. Nicotine Tob Res. 2020 Mar 16;22(3):346-353. doi: 10.1093/ntr/nty247.

    PMID: 30521040DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Jonathan P Winickoff, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jonathan P. Winickoff, MD

Study Record Dates

First Submitted

June 18, 2013

First Posted

June 20, 2013

Study Start

April 14, 2015

Primary Completion

October 26, 2017

Study Completion

October 26, 2017

Last Updated

April 9, 2019

Record last verified: 2019-04

Locations

US(1)