Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation

Loma Linda University105 enrolled

Overview

This develops a novel behavioral tobacco cessation program for pregnant smokers in San Bernardino County.

This study seeks to address the disparities in the maternal smoking cessation outcomes of previous research by developing an innovative maternal tobacco cessation program that expands the outreach by integrating home visits by community health workers (CHW) into the prenatal healthcare model. The overall aim is to conduct a pilot randomized control trial to test the feasibility, acceptability, and efficacy of a Healthcare Provider-Community Health Worker (HCP-CHW) intervention model that expands outreach by adding eight home visits by CHWs to provide tobacco cessation support services before and after the quit date.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

105

Conditions

Tobacco Use Tobacco Use Cessation Tobacco Use in Childbirth

Interventions

HCP-CHW Integration into Prenatal Care for Smoking CessationBEHAVIORAL

CHWs will be integrated into primary care, and subjects will receive CHW home visits (up to 8) that will provide brief behavioral smoking cessation interventions before, during, and after a quit date. This brief behavioral intervention will include watching a video and reviewing self-help materials.

Control ArmOTHER

Standard of Care which provides referrals to community-based smoking cessation resources.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * \< 24 weeks pregnant * age \> 18 years, * current smokers (100 cigarettes in their lifetime and \>3 cigarettes per day in the last 7 days; including poly-tobacco use, combining cigarettes with non-combustible products) confirmed by expired carbon monoxide (CO) * willing to quit smoking and set a quit date in the next 2 weeks upon enrolling * enrolled in prenatal care at Loma Linda University Health (LLUH) or Riverside University Health System (RUHS) Exclusion Criteria: * severe mental health problems that prevent informed consent and/or CHW intervention * women who were on Nicotine Replacement Therapy (NRT) or enrolled in a cessation program within 30 days * unwillingness to participate in audio-recorded key informant interviews or focus groups

Locations (2)

Loma Linda University Medical Center

Loma Linda, California, United States

RECRUITING

Riverside University Health Systems

Moreno Valley, California, United States

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Self-Report Tobacco Abstinence

The 7 Day Point Prevalence Abstinence (PPA) questionnaire will be administered to subjects to assess the following: Tobacco use within past seven days

Time frame: Change between baseline enrollment and 1 month postpartum visit, typically ten months

Secondary Outcomes

Carbon Monoxide Level

Breathalyzer test will be administered to subjects to determine CO level. Subjects will then be classified per CO level as: Nonsmoker = 0 to 3 Borderline = 4 to 6 Smoker = 7 and above Smoker Low Addiction = 7 to 10 Smoker Moderate Addiction = 11 to 15 Smoker Heavily Addicted = 16 to 25 Smoker Very heavily Addicted = 26+

Time frame: Change between baseline and 1 month postpartum visit, typically ten months

Arm 1 Satisfaction with CHW visit

The acceptability of the intervention will be assessed using composite Likert scale measures of process outcomes such as 1) overall patient satisfaction, 2) increasing patient motivation and confidence, and 3) willingness to recommend the program to others. Likert scale interpretations for overall satisfaction: 1=Very Dissatisfied; 2=Dissatisfied; 3=Neutral; 4=Satisfied; 5=Very Satisfied. Likert scale interpretation for patient motivation and confidence: 1=Strongly Disagree (The intervention did not increase motivation/confidence at all); 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree (The intervention significantly increased motivation/confidence). Likert scale interpretation for Willingness to Recommend the Program to Others: 1=Not at all likely; 2=Unlikely; 3=Neutral; 4=Likely; 5=Very Likely.

Time frame: Baseline; during the intervention; through study completion, an average of 10 months.

Central Contacts

Anne Berit Petersen

CONTACT

909 558 1000 abpetersen@llu.edu

Pramil Singh

CONTACT

psingh@llu.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.