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Evaluation of the Effectiveness of Pharmacists in Implementing the SCRIPT Protocol

NCT ID: NCT02433860

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-09-30

Brief Summary

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There is a significant need for nicotine cessation programs for pregnant women in Spokane County. SCRIPT has been proven to be an effective method for smoking cessation in pregnant women. This study will evaluate the success of SCRIPT delivered by pharmacists. At the end of the study, the investigators hope to have three questions answered: 1) what is the quit rate of pregnant women in the Spokane area who receive the SCRIPT intervention delivered by pharmacists? 2) How does the quit rate compare to the quit rates of SCRIPT programs delivered by other health care providers as documented in the literature? And 3) Does the SCRIPT intervention have a significant effect on quit rates for pregnant women compared to current Spokane county quit rates? Urine cotinine tests will be used to document smoking status before delivery of the SCRIPT program, approximately one week after quit date and at \>36 wks gestation or at delivery for study participants.

Detailed Description

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1\. The goal of this project is to evaluate the success of pharmacists in delivering the SCRIPT smoking cessation program. The research questions that need to be addressed are: i. What is the quit rate of pregnant women in the Spokane area who receive the SCRIPT intervention delivered by a pharmacist? ii. How does this quit rate compare to the quit rates of other SCRIPT programs given by other health care providers (social workers, nurses, etc.)? iii. Does the SCRIPT intervention have a significant effect on quit rates for smoking pregnant women compared to current Spokane county quit rates?

Conditions

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Pregnancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pregnant nicotine users

watch video and tobacco cessation counselling using SCRIPT protocol

Group Type EXPERIMENTAL

pharmacist nicotine cessation counseling using SCRIPT protocol

Intervention Type BEHAVIORAL

Participant will be shown a short DVD "Commit to Quit: During and After Pregnancy. She will be given "a Pregnant Woman's Guide to Quitting" booklet.

Participant will be asked their nicotine use status and it will be confirmed with a CO meter test and cotinine urine test. Those not consenting to be part of the study will not receive the urinalysis.

Participant will be advised to quit smoking. The pharmacist will review the Guide with the participant. The participant will receive a phone call around the time of their quit/reduction date. The participant will meet again approximately one week after their quit/reduction date and receive a CO meter test and urine cotinine test.

At the end of the program pregnant women will answer a follow-up questionnaire. Those women participating in the research study will be given a cotinine urine test at approximately \> 36 weeks gestation or at delivery.

Interventions

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pharmacist nicotine cessation counseling using SCRIPT protocol

Participant will be shown a short DVD "Commit to Quit: During and After Pregnancy. She will be given "a Pregnant Woman's Guide to Quitting" booklet.

Participant will be asked their nicotine use status and it will be confirmed with a CO meter test and cotinine urine test. Those not consenting to be part of the study will not receive the urinalysis.

Participant will be advised to quit smoking. The pharmacist will review the Guide with the participant. The participant will receive a phone call around the time of their quit/reduction date. The participant will meet again approximately one week after their quit/reduction date and receive a CO meter test and urine cotinine test.

At the end of the program pregnant women will answer a follow-up questionnaire. Those women participating in the research study will be given a cotinine urine test at approximately \> 36 weeks gestation or at delivery.

Intervention Type BEHAVIORAL

Other Intervention Names

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Pharmacist counselling using SCRIPT

Eligibility Criteria

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Inclusion Criteria

* Pregnant
* nicotine use
* English speaking
* 18 years of age or older

Exclusion Criteria

* Males due to pregnancy status not applicable
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Providence Medical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Taylor, PharmD

Role: PRINCIPAL_INVESTIGATOR

Providence Holy Family, SHMC and PMP ACC/PHAC

Locations

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Providence Holy Family Hospital Anticoagulation and Pharmacotherapy Clinic

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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A20010724157261

Identifier Type: -

Identifier Source: org_study_id