Phone-Based Postpartum Continuing Care for Smoking Cessation (PPCC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Maryland
Information provided by (Responsible Party):
Chestnut Health Systems
ClinicalTrials.gov Identifier:
NCT01684592
First received: September 11, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

Smoking is a leading cause of death and other negative health outcomes. While a high percentage of women quit smoking during pregnancy, the majority relapse in the first 6 months postpartum. We propose developing and pilot testing a phone-based postpartum continuing care (PPCC) protocol based on existing evidence-based approaches to increase smoking cessation, reduce relapse, increase early re-intervention, and reduce infant exposure to environmental tobacco smoke in the postpartum period.


Condition Intervention Phase
Smoking Cessation
Pregnancy
Behavioral: Phone-based postpartum continuing care
Behavioral: Standard care
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phone-Based Postpartum Continuing Care: Smoking Cessation Beginning in Pregnancy

Resource links provided by NLM:


Further study details as provided by Chestnut Health Systems:

Primary Outcome Measures:
  • Change in self-reported cigarettes per day smoked at 6 months postpartum [ Time Frame: Baby's birth and 6 months postpartum ] [ Designated as safety issue: No ]
    Days of self-reported smoking multiplied by the average number of self-reported times they smoke per day.


Secondary Outcome Measures:
  • Change in self-reported cigarettes per day smoked at 3 months postpartum [ Time Frame: Baby's birth and 3 months postpartum ] [ Designated as safety issue: No ]
    Days of self-reported smoking multiplied by the average number of self-reported times they smoke per day

  • Change in number of days smoked cigarettes at 3 months postpartum [ Time Frame: Baby's birth and 3 months postpartum ] [ Designated as safety issue: No ]
    Days in past 90 days minus days of any tobacco use (regardless of frequency of use). Urine cotinine levels will asses the validity of self reported abstinence at measurement points.

  • Change in number of days smoked cigarettes at 6 months postpartum [ Time Frame: Baby's birth and 6 months postpartum ] [ Designated as safety issue: No ]
    Days in past 90 days minus days of any tobacco use (regardless of frequency of use). Urine cotinine levels will asses the validity of self reported abstinence at measurement points.

  • Days before relapse [ Time Frame: Baseline to 6 months postpartum ] [ Designated as safety issue: No ]
    Days from quit date to first use of any tobacco (including 0 for same day). Quit date is checked against prior self reports, positive cotinine, and records.

  • Time between Relapse and talking to a health professional about smoking [ Time Frame: Baseline to 6 months postpartum ] [ Designated as safety issue: No ]
    The days between the first day smoking after at least 7 days of abstinence to the first time they talk to a health professional (either physician, quitline, or PPCC counselor)

  • Time between Relapse and the Resumption of Abstinence [ Time Frame: Baseline to 6 months postpartum ] [ Designated as safety issue: No ]
    Days between first use of tobacco after quit date to the first period of 7 days without use.

  • Times mother smoked while breastfeeding [ Time Frame: Baby's birth to 6 months postpartum ] [ Designated as safety issue: No ]
    Based on the days of smoking while breastfeeding (or within 30 minutes of breastfeeding) times the frequency of use on day.

  • Times mother smoked in the room with infant [ Time Frame: Baby's birth to 6 months postpartum ] [ Designated as safety issue: No ]
    Based on the days of smoking in the room times the frequency of number of times smoked in the room on a day.

  • Cotinine level of the infant [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]
    Based on NicCheck I urine cotinine test conducted with infant at 6 months postpartum using the "cotton roll" method of urine collection.


Estimated Enrollment: 130
Study Start Date: October 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard care
Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)
Behavioral: Standard care
All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A's brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up.
Experimental: Standard care plus PPCC
Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum
Behavioral: Phone-based postpartum continuing care
PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby's birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week.
Other Name: PPCC
Behavioral: Standard care
All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A's brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up.

Detailed Description:

The large majority of women who quit smoking during pregnancy relapse in the first six months postpartum, highlighting a need for effective postpartum continuing care that supports women through the challenging postpartum period when stress is high and motivation to stay quit may decline. Existing relapse prevention interventions (typically delivered during pregnancy) have been found to be of little benefit during the postpartum period, suggesting the need for a more formal continuing care approach. Phone-based protocols for smoking cessation have been widely disseminated and effective because they address the need for flexible access, but are passive and not typically utilized by women in the postpartum period.

The proposed pilot study will develop and test a Phone-based Postpartum Continuing Care (PPCC) model that draws from existing evidence-based protocols--the 5 A's and Recovery Management Checkups (RMC)-- shown to be effective with other populations. The experimental PPCC will reinforce the importance of abstinence, relapse prevention, and reduced smoking through proactive re-intervention (i.e., RMC) with the 5 A's at times when postpartum women are more likely to relapse, and provide education and monitoring of the infant's direct and indirect exposure to nicotine through breastfeeding and secondhand smoke. We will evaluate PPCC's effectiveness relative to a passive referral to a 24/7 hotline, which is current standard care.

Approximately one hundred thirty women in their first or second trimester of pregnancy who were nicotine-dependent in the past year, currently smoke, or quit within the past 90 days will be recruited at their first prenatal appointment at the Maryland Women's Center (MWC) in Baltimore, Maryland. All women will receive the clinic's standard of care for smoking cessation--the 5 A's --during pregnancy from their physician. Half will be randomly assigned to an experimental group getting PPCC for 6 months postpartum and half to a control group receiving only a referral to a passive 24/7 state quit line postpartum. It is expected that in the 6 months following childbirth women in the experimental PPCC (relative to those in the control group) will: a) smoke fewer cigarettes, b) smoke fewer days, c) go longer before postpartum relapse, d) have less time between relapse and talking to a health professional about smoking, e) have less time between relapse and resumption of abstinence , f) smoke fewer times while breastfeeding, g) smoke fewer times while in the same room as the infant, and h) reduce their infant's cotinine levels.

The aims of this pilot project are to develop PPCC from existing evidence-based approaches, demonstrate the feasibility of implementing the PPCC intervention with at least 80% compliance and at least 80% follow-up at each wave, and evaluate the effect size associated with receiving standard care vs. standard care + PPCC in order to understand the promise of and appropriate power required for a larger clinical trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • first or second trimester of pregnancy
  • age 18 or older
  • self-reported tobacco use in the past 90 days or nicotine-dependence in the past year

Exclusion Criteria:

  • intend to terminate their pregnancy
  • intend to move out of the city within the next 12 months
  • are unable to provide informed consent and participate in English
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684592

Locations
United States, Illinois
Chestnut Global Partners
Bloomington, Illinois, United States, 61701
United States, Maryland
Maryland Women's Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Chestnut Health Systems
University of Maryland
Investigators
Principal Investigator: Victoria H Coleman-Cowger, PhD Chestnut Health Systems
Study Director: Mishka Terplan, MD University of Maryland
  More Information

Publications:
Responsible Party: Chestnut Health Systems
ClinicalTrials.gov Identifier: NCT01684592     History of Changes
Other Study ID Numbers: 1R34DA032683-01A1
Study First Received: September 11, 2012
Last Updated: March 4, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by Chestnut Health Systems:
smoking cessation
relapse prevention
pregnancy
postpartum

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on April 17, 2014