Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT02433860
Status:
COMPLETED
Last Update Posted:
2017-09-25
First Post:
2014-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effectiveness of Pharmacists in Implementing the SCRIPT Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-20', 'studyFirstSubmitDate': '2014-10-16', 'studyFirstSubmitQcDate': '2015-05-04', 'lastUpdatePostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quit rates for nicotine for pregnant women', 'timeFrame': '2 yrs', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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?'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant\n* nicotine use\n* English speaking\n* 18 years of age or older\n\nExclusion Criteria:\n\n* Males due to pregnancy status not applicable'}, 'identificationModule': {'nctId': 'NCT02433860', 'briefTitle': 'Evaluation of the Effectiveness of Pharmacists in Implementing the SCRIPT Protocol', 'organization': {'class': 'OTHER', 'fullName': 'Providence Medical Research Center'}, 'officialTitle': 'Evaluation of the Effectiveness of Pharmacists in Implementing the Smoking Cessation and Reduction in Pregnancy and Treatment (SCRIPT) Protocol', 'orgStudyIdInfo': {'id': 'A20010724157261'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pregnant nicotine users', 'description': 'watch video and tobacco cessation counselling using SCRIPT protocol', 'interventionNames': ['Behavioral: pharmacist nicotine cessation counseling using SCRIPT protocol']}], 'interventions': [{'name': 'pharmacist nicotine cessation counseling using SCRIPT protocol', 'type': 'BEHAVIORAL', 'otherNames': ['Pharmacist counselling using SCRIPT'], 'description': '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.\n\nParticipant 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.\n\nParticipant 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.\n\nAt 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.', 'armGroupLabels': ['pregnant nicotine users']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99207', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Providence Holy Family Hospital Anticoagulation and Pharmacotherapy Clinic', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Jennifer Taylor, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Providence Holy Family, SHMC and PMP ACC/PHAC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Providence Medical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}