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Completed

NCT Number: NCT02433860

Evaluation of the Effectiveness of Pharmacists in Implementing the SCRIPT Protocol

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Providence Holy Family Hospital Anticoagulation and Pharmacotherapy Clinic

Spokane, Washington, 99207, United States

About this study

  • 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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Males due to pregnancy status not applicable

Treatment and study plan

pharmacist nicotine cessation counseling using SCRIPT protocol

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.

Other names: Pharmacist counselling using SCRIPT

Primary outcomes

  1. quit rates for nicotine for pregnant women

    Time frame: 2 yrs

    • The quit rates of pregnant women in this program will be compared to SCRIPT studies to evaluate the effectiveness of pharmacists providing this program.

Sponsors and collaborators

Lead sponsor

Providence Medical Research Center

Other

Registry information

Official study title

Evaluation of the Effectiveness of Pharmacists in Implementing the Smoking Cessation and Reduction in Pregnancy and Treatment (SCRIPT) Protocol

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 5, 2015
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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