Trial Outcomes & Findings for Phone-Based Postpartum Continuing Care for Smoking Cessation (NCT NCT01684592)

Results Overview

Self-reported number of tobacco products smoked per day

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

130 participants

Primary outcome timeframe

6 months postpartum

Results posted on

2018-03-13

Participant Flow

The sample was drawn from a population of low-income pregnant women attending their first prenatal visit at an obstetrics clinic in Baltimore, MD. In total, 790 women (i.e., smokers and non-smokers) were assessed for eligibility from March-December 2013, with 180 meeting eligibility criteria. Of those screened, 130 participants were enrolled.

Randomization occurred at week 26 gestation, after intake data was collected.

Participant milestones

Participant milestones
Measure	Standard Care Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive) Standard care: All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from Maryland Women's Clinic (MWC) during pregnancy. The 5 A's brief intervention was modified by the American College of Obstetricians and Gynecologists (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.	Standard Care Plus PPCC Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum 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.
Overall Study STARTED	64	64
Overall Study COMPLETED	38	40
Overall Study NOT COMPLETED	26	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phone-Based Postpartum Continuing Care for Smoking Cessation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Care n=64 Participants Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive) 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.	Standard Care Plus PPCC n=64 Participants Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum 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.	Total n=128 Participants Total of all reporting groups
Age, Continuous	25.6 years STANDARD_DEVIATION 4.7 • n=5 Participants	26.3 years STANDARD_DEVIATION 5.3 • n=7 Participants	26.0 years STANDARD_DEVIATION 5.0 • n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants	64 Participants n=7 Participants	128 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	53 Participants n=5 Participants	50 Participants n=7 Participants	103 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	64 participants n=5 Participants	64 participants n=7 Participants	128 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months postpartum

Self-reported number of tobacco products smoked per day

Outcome measures

Outcome measures
Measure	Standard Care n=64 Participants Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive) 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.	Standard Care Plus PPCC n=64 Participants Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum 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.
Number of Tobacco Products Per Day	6.4 tobacco products Interval 4.0 to 8.0	6.9 tobacco products Interval 5.0 to 9.0

SECONDARY outcome

Timeframe: 3 months postpartum

Self-reported number of tobacco products smoked per day

Outcome measures

Outcome measures
Measure	Standard Care n=64 Participants Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive) 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.	Standard Care Plus PPCC n=64 Participants Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum 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.
Number of Tobacco Products Per Day	7.1 tobacco products Interval 5.0 to 9.0	7.9 tobacco products Interval 6.0 to 10.0

SECONDARY outcome

Timeframe: 3 months postpartum

Self-reported number of days smoked in past 90 days

Outcome measures

Outcome measures
Measure	Standard Care n=64 Participants Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive) 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.	Standard Care Plus PPCC n=64 Participants Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum 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.
Past 90-day Tobacco Use	60.7 days Interval 49.0 to 72.0	57.5 days Interval 45.0 to 70.0

SECONDARY outcome

Timeframe: 6 months postpartum

Self-reported number of days smoked tobacco in past 90 days.

Outcome measures

Outcome measures
Measure	Standard Care n=64 Participants Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive) 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.	Standard Care Plus PPCC n=64 Participants Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum 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.
Past 90-day Tobacco Use	59.2 days Interval 47.0 to 71.0	55.3 days Interval 41.0 to 69.0

SECONDARY outcome

Timeframe: Baby's birth to 6 months postpartum

Population: Only 7 women reported having breastfed at 6 month postpartum

Based on the days of smoking while breastfeeding (or within 30 minutes of breastfeeding) times the frequency of use on day.

Outcome measures

Outcome measures
Measure	Standard Care n=3 Participants Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive) 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.	Standard Care Plus PPCC n=4 Participants Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum 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.
Times Mother Smoked While Breastfeeding	7.13 times smoked in past 90 days Standard Deviation 4.6	0 times smoked in past 90 days Standard Deviation 0

SECONDARY outcome

Timeframe: Baby's birth to 6 months postpartum

Population: Only current smokers responded to this question

Based on the number of days of smoking in the same room with infant in the past 90.

Outcome measures

Outcome measures
Measure	Standard Care n=33 Participants Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive) 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.	Standard Care Plus PPCC n=36 Participants Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum 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.
Times Mother Smoked in the Room With Infant	.70 number of days smoked Standard Deviation 3.5	.06 number of days smoked Standard Deviation .3

SECONDARY outcome

Timeframe: 6 months postpartum

Infant urine was collected at 6 months postpartum using the "cotton roll" method of urine collection. Cotinine was measured with NicCheck I Test Strips that determine the urinary concentration of nicotine and its metabolites based on a colorimetric reaction. The test strip is dipped into participant's urine and changes color (varying shades of pink) in the presence of cotinine. Cotinine level is determined by matching the test strip with a color chart provided by the manufacturer. The intensity of color on the strip at the end of 15 minutes may be compared to those on the color chart, to differentiate between "low" (score 1-6) versus "high" (score 7-14) nicotine consumption. Absence of a color is considered a negative result (score 0). Based on comparison with gas chromatography urine cotinine values, individuals with cotinine values of 200 ng/mL and above are classified as smokers.

Outcome measures

Outcome measures
Measure	Standard Care n=38 Participants Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive) 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.	Standard Care Plus PPCC n=40 Participants Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum 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.
NicCheck Test Results for Cotinine Level From Infant Urine	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0

Adverse Events

Standard Care

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care Plus PPCC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard Care n=64 participants at risk Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive) 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.	Standard Care Plus PPCC n=64 participants at risk Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum 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.
Pregnancy, puerperium and perinatal conditions Miscarriage	7.8% 5/64 • Number of events 5	0.00% 0/64

Other adverse events

Adverse event data not reported

Additional Information

Dr. Victoria Coleman-Cowger

Battelle

Phone: 4103722748

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place