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| ID | Type | Description | Link |
|---|---|---|---|
| T32KT4784 | Other Grant/Funding Number | Tobacco-related Disease Research Program (TRDRP) |
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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| Riverside University Health System Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integrated HCP-CHW Intervention Arm | Experimental | CHW visit with brief tobacco cessation intervention. |
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| Control arm | Other | Standard of Care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCP-CHW Integration into Prenatal Care for Smoking Cessation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change between baseline enrollment and 1 month postpartum visit, typically ten months |
| Measure | Description | Time Frame |
|---|---|---|
| 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+ | Change between baseline and 1 month postpartum visit, typically ten months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Berit Petersen | Contact | 909 558 1000 | 42846 | abpetersen@llu.edu |
| Pramil Singh | Contact | psingh@llu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anne Berit Petersen, PhD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center | Recruiting | Loma Linda | California | 92350 | United States |
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| Label | URL |
|---|---|
| Study website | View source |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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The model compares the integration of CHW Home visits into healthcare provider-directed clinical care and a schedule of CHW home visits to provide behavioral smoking cessation for pregnant people and adult household members before, during, and after a quit date vs Standard of Care.
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| Control Arm | Other | Standard of Care which provides referrals to community-based smoking cessation resources. |
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| 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. | Baseline; during the intervention; through study completion, an average of 10 months. |
| Riverside University Health Systems | Not yet recruiting | Moreno Valley | California | 92555 | United States |
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