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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34DA046005-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study tests an intervention for tobacco cessation (named B-EPIC) in an established community medication assisted treatment (MAT) clinic for pregnant and postpartum women with opioid dependence. Half of the participants will receive the intervention for tobacco cessation, which is standard cessation counseling from the provider plus additional cessation support from a Certified Tobacco Treatment Specialist (CTTS). The other half of participants will receive standard tobacco cessation from their provider. The project will also determine the economic impact of the B-EPIC intervention on healthcare expenditures.
The study will use a prospective, 2-group, randomized, comparative effectiveness design to determine if the B-EPIC tobacco intervention is superior to tobacco 'treatment as usual (TAU)' for opioid dependent pregnant women maintained on buprenorphine; the outcomes for the first aim will be quitting smoking and/or reducing cigarette consumption during pregnancy. The project design also will determine the economic impact the B-EPIC intervention (10-months) has on healthcare expenditures.
After informed consent, eligible participants will be randomized (1:1) to the B-EPIC group (tobacco intervention) or TAU tobacco treatment (control group). All will continue to receive opioid dependence treatment with buprenorphine, regardless of treatment assignment.
Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the American College of Obstetricians and Gynecologists (ACOG) 5'A's approach by their healthcare provider. This standard tobacco cessation counseling takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment.
Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed. The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. The intervention will be led by a certified tobacco treatment specialist (CTTS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tobacco Intervention | Experimental | Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention. |
|
| Treatment As Usual | Active Comparator | Participants in this group will be randomized to tobacco treatment as usual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) | Behavioral | Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Number of Cigarettes Smoked Per Day | Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report the number of cigarettes smoked per day. Data will be presented as the change in the number of cigarettes smoked per day compared between groups. | up to 50 weeks (third trimester (28-36.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
| Change in Urine Cotinine Concentration Level | Participants will provide a urine sample to be measured by litmus analysis during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The litmus levels range from 0 (minimum) to 6 (maximum). Data will be presented as the change in cotinine levels by the litmus measure over the course of the study compared between groups. | up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
| Change in Electronic Cigarette Usage Per Day | Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report electronic cigarette (e-cig) usage per day. Data will be presented as the change in e-cig usage per day compared between groups. | up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
| Change in Cigarette Dependence | Participants will complete the Fagerstrom Test for Cigarette Dependence during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks seven questions related to cigarette dependency. For scoring, yes/no questions are scored from 0 to 1, and multiple choice questions from 0 to 3. Items are then summed to yield a total score of 0-10. The higher the total score, the more intense the patient's nicotine dependence. Any score greater than 8 is considered high dependency, a score of 5-7 is considered moderately dependent, 3-4 is low to moderate dependence and 1-2 is low dependence. Data will be presented as the change in cigarette dependency over time compared between groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Maternal Depression Over Time | Participants will complete the Edinburgh Postnatal Depression Scale (EPDS) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 10 multiple choice questions with scores for each question ranging from 0-3. Scores are then summed for a total score, ranging from 0-30. Questions 1, 2 & 4 are scored 0-3 with the first answer to each question scored as 0 and the fourth answer scored as 3. Questions 3 & 5-10 are reverse scored, with the first answer to each question scored as 3 and the fourth answer scored as 0. A score of 10 or greater is interpreted as "possible depression". A score of greater than 0 on item 10 indicates "suicidal thoughts". Data will be presented as the change in depression over time compared between groups. |
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Inclusion Criteria:
Exclusion Criteria:
All participants in this study will be pregnant females.
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Ashford | University of Kentucky | Principal Investigator |
| Amanda Fallin-Bennett | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States | ||
| University of Kentucky Polk Dalton Clinic |
There is no plan to share data.
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Participants may have been excluded prior to randomization for the following reason:
1. Withdrawal (changed mind)
Number of individuals consented and further screened for eligibility = 79; Number of participants randomized to intervention = 40; Number of participants randomized to treatment as usual = 38
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| ID | Title | Description |
|---|---|---|
| FG000 | Tobacco Intervention | Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention. Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 12, 2018 |
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|
| Treatment As Usual | Behavioral | Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy. |
|
| up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus postpartum visit (2-8.6 weeks after delivery)) |
| Change in Electronic Cigarette Dependence | Participants will complete the Penn State Electronic Cigarette Dependence Index (PSECDI) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks ten questions and responses are scored on a scale from zero to 20. Summed scores correlate to a dependence category; 0-3 is not dependent, 4-8 is low dependence, 9-12 is medium dependence, and above 12 is high dependence. Data will be presented as the change in electronic cigarette dependency over time compared between groups. | up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
| Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
| Change in Maternal Anxiety Over Time | Participants will complete the Generalized Anxiety Disorder 7-item (GAD-7) scale during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 7 questions scored between zero and 21. A score of 5-9 indicates mild severity, 10-14 is moderate, and 15 and greater is considered severe. Data will be presented as the change in anxiety over time compared between groups. | Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
| Change in Maternal Perceived Stress Over Time | Participants will complete the Perceived Stress Scale 4-item (PSS4) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 4 questions scored between zero and 16. Higher scores are correlated with more stress. Data will be presented as the change in stress over time compared between groups. | Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
| Lexington |
| Kentucky |
| 40536 |
| United States |
| FG001 | Treatment As Usual | Participants in this group will be randomized to tobacco treatment as usual. Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy. |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tobacco Intervention | Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention. Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS). |
| BG001 | Treatment As Usual | Participants in this group will be randomized to tobacco treatment as usual. Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Number of Cigarettes Smoked Per Day | Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report the number of cigarettes smoked per day. Data will be presented as the change in the number of cigarettes smoked per day compared between groups. | Overall number of participants analyzed in each Group is based on number of participants with cigarettes smoked per day data available at third trimester (28-36.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Enrollment (up to 31.6 weeks gestation) was not used in this analysis due to a change in the data collection format from categorical to continuous. Disruptions by COVID-19 created many challenges with longitudinal data collection. | Posted | Median | Inter-Quartile Range | cigarettes per day | up to 50 weeks (third trimester (28-36.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
|
|
| ||||||||||||||||||||||||||||
| Primary | Change in Urine Cotinine Concentration Level | Participants will provide a urine sample to be measured by litmus analysis during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The litmus levels range from 0 (minimum) to 6 (maximum). Data will be presented as the change in cotinine levels by the litmus measure over the course of the study compared between groups. | Overall number of participants analyzed in each Group is based on the number of participants with cotinine levels data available at enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change in the level of urine cotinine using NICALERT, an immunochromatographic assay test strip (Nymox Pharmaceutical Corporation, Montreal, Quebec). Disruptions caused by COVID-19 created many challenges in longitudinal data collection. | Posted | Mean | Standard Deviation | litmus levels | up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
| ||||||||||||||||||||||||||||||
| Primary | Change in Electronic Cigarette Usage Per Day | Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report electronic cigarette (e-cig) usage per day. Data will be presented as the change in e-cig usage per day compared between groups. | Overall number of participants analyzed in each Group is based on the number of participants with self-report electronic cigarette (e-cig) usage per day and with data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection. | Posted | Median | Inter-Quartile Range | e-cig use times per day | up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
| ||||||||||||||||||||||||||||||
| Primary | Change in Cigarette Dependence | Participants will complete the Fagerstrom Test for Cigarette Dependence during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks seven questions related to cigarette dependency. For scoring, yes/no questions are scored from 0 to 1, and multiple choice questions from 0 to 3. Items are then summed to yield a total score of 0-10. The higher the total score, the more intense the patient's nicotine dependence. Any score greater than 8 is considered high dependency, a score of 5-7 is considered moderately dependent, 3-4 is low to moderate dependence and 1-2 is low dependence. Data will be presented as the change in cigarette dependency over time compared between groups. | Overall number of participants analyzed in each Group is based on the number of participants with Fagerstrom Test for Cigarette Dependence data available at study time points enrollment (up to 31.6 weeks gestation) minus postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection. | Posted | Mean | Standard Deviation | Score on a scale | up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus postpartum visit (2-8.6 weeks after delivery)) |
| ||||||||||||||||||||||||||||||
| Primary | Change in Electronic Cigarette Dependence | Participants will complete the Penn State Electronic Cigarette Dependence Index (PSECDI) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks ten questions and responses are scored on a scale from zero to 20. Summed scores correlate to a dependence category; 0-3 is not dependent, 4-8 is low dependence, 9-12 is medium dependence, and above 12 is high dependence. Data will be presented as the change in electronic cigarette dependency over time compared between groups. | Overall number of participants analyzed in each Group is based on the number of participants with Penn State Electronic Cigarette Dependence Index (PSECDI) data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection. | Posted | Mean | Standard Deviation | scores on a scale | up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
| ||||||||||||||||||||||||||||||
| Secondary | Change in Maternal Depression Over Time | Participants will complete the Edinburgh Postnatal Depression Scale (EPDS) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 10 multiple choice questions with scores for each question ranging from 0-3. Scores are then summed for a total score, ranging from 0-30. Questions 1, 2 & 4 are scored 0-3 with the first answer to each question scored as 0 and the fourth answer scored as 3. Questions 3 & 5-10 are reverse scored, with the first answer to each question scored as 3 and the fourth answer scored as 0. A score of 10 or greater is interpreted as "possible depression". A score of greater than 0 on item 10 indicates "suicidal thoughts". Data will be presented as the change in depression over time compared between groups. | Overall number of participants analyzed in each Group is based on the number of participants with Edinburgh Postnatal Depression Scale (EPDS) data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection. | Posted | Mean | Standard Deviation | score on a scale | Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
| ||||||||||||||||||||||||||||||
| Secondary | Change in Maternal Anxiety Over Time | Participants will complete the Generalized Anxiety Disorder 7-item (GAD-7) scale during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 7 questions scored between zero and 21. A score of 5-9 indicates mild severity, 10-14 is moderate, and 15 and greater is considered severe. Data will be presented as the change in anxiety over time compared between groups. | Overall number of participants analyzed in each Group is based on the number of participants with Generalized Anxiety Disorder 7-item (GAD-7) data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection. | Posted | Mean | Standard Deviation | score on a scale | Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
| ||||||||||||||||||||||||||||||
| Secondary | Change in Maternal Perceived Stress Over Time | Participants will complete the Perceived Stress Scale 4-item (PSS4) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 4 questions scored between zero and 16. Higher scores are correlated with more stress. Data will be presented as the change in stress over time compared between groups. | Overall number of participants analyzed in each Group is based on the number of participants with Perceived Stress Scale 4-item (PSS4) data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection. | Posted | Mean | Standard Deviation | score on a scale | Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
|
Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tobacco Intervention | Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention. Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS). | 0 | 38 | 9 | 38 | 10 | 38 |
| EG001 | Treatment As Usual | Participants in this group will be randomized to tobacco treatment as usual. Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy. | 0 | 38 | 3 | 38 | 3 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Initial or prolonged hospitalization | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Initial or prolonged hospitalization | General disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incarceration | Social circumstances | Non-systematic Assessment |
| ||
| Positive response to depression evaluation | General disorders | Non-systematic Assessment |
| ||
| Treatment for dehydration | General disorders | Non-systematic Assessment |
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The B-EPIC study was significantly impacted by the COVID-19 pandemic in terms of recruitment, overall enrollment, and the ability to collect longitudinal data. In spite of the challenges, we were able to enroll 76% of the proposed number of participants in each group. However, power was estimated based on a sample size of 50 per group, and some group comparisons may not have reached significance due to a more limited power given the smaller sample size.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristin Ashford, PhD, Study MPI | University of Kentucky | 859-257-9333 | khashf0@uky.edu |
| May 10, 2022 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Treatment As Usual | Participants in this group will be randomized to tobacco treatment as usual. Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy. |
|
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| OG001 | Treatment As Usual | Participants in this group will be randomized to tobacco treatment as usual. Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy. |
|
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| OG001 | Treatment As Usual | Participants in this group will be randomized to tobacco treatment as usual. Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy. |
|
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| OG001 | Treatment As Usual | Participants in this group will be randomized to tobacco treatment as usual. Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy. |
|
|
| OG001 | Treatment As Usual | Participants in this group will be randomized to tobacco treatment as usual. Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy. |
|
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| OG001 | Treatment As Usual | Participants in this group will be randomized to tobacco treatment as usual. Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy. |
|
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| OG001 | Treatment As Usual | Participants in this group will be randomized to tobacco treatment as usual. Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy. |
|
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