Evaluation of the Effectiveness of Pharmacists in Implementing the SCRIPT Protocol

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02433860
• Other study ID #: A20010724157261
• Status: Completed
• Phase: N/A
• First received: October 16, 2014
• Last updated: September 20, 2017
• Start date: January 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2017
• Source: Providence Medical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant

• nicotine use

• English speaking

• 18 years of age or older

Exclusion Criteria:

• Males due to pregnancy status not applicable

Related Conditions & MeSH terms

• Pregnancy

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Providence Holy Family Hospital Anticoagulation and Pharmacotherapy Clinic	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Providence Medical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quit rates for nicotine for pregnant women	1. The quit rates of pregnant women in this program will be compared to SCRIPT studies to evaluate the effectiveness of pharmacists providing this program.	2 yrs