Evaluation of the Effectiveness of Pharmacists in Implementing the SCRIPT Protocol

NCT02433860 | Completed

• 1 other identifier: A20010724157261
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

pregnant nicotine users

EXPERIMENTAL

watch video and tobacco cessation counselling using SCRIPT protocol

Behavioral: pharmacist nicotine cessation counseling using SCRIPT protocol

Interventions

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.

Also known as: Pharmacist counselling using SCRIPT

pregnant nicotine users

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Males due to pregnancy status not applicable

Sponsors & Collaborators

• Providence Medical Research Center: lead

Study Sites (1)

Providence Holy Family Hospital Anticoagulation and Pharmacotherapy Clinic

Spokane, Washington, 99207, United States

Location

Study Officials

• Jennifer Taylor, PharmD

  Providence Holy Family, SHMC and PMP ACC/PHAC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: May 5, 2015
• Study Start: January 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 25, 2017

Record last verified: 2017-09

Locations

US (1)