Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT04941820
Status:
COMPLETED
Last Update Posted:
2021-06-28
First Post:
2021-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Clinical Pharmacist in the Identification and Management of Treatment Related Problems in the Surgery Ward
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All patients were followed up prospectively for their length of hospital stay, and recommendations concerning each identified TRP were provided to the surgeons responsible for patients in the intervention group. Likewise, patient counseling and encouraging adherence to therapy were provided solely to patients in the intervention group. Patients in the control group received usual care by the surgical team without a coordinated contribution from the clinical pharmacist.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-25', 'studyFirstSubmitDate': '2021-06-08', 'studyFirstSubmitQcDate': '2021-06-25', 'lastUpdatePostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Acceptance rate of clinical pharmacist's recommended interventions", 'timeFrame': '19-week', 'description': '(Number of recommendations accepted by surgeons) / (total number of recommendations submitted to surgeons by the clinical pharmacist) \\*100'}, {'measure': "Implementation rate of clinical pharmacist's recommended interventions", 'timeFrame': '19-week', 'description': '(Number of recommendations implemented by surgeons and patients) / (total number of recommendations submitted to surgeons and patients by the clinical pharmacist) \\*100'}, {'measure': 'The impact of the clinical pharmacist on the identification and management of TRPs in the surgery ward', 'timeFrame': '19-week', 'description': 'Measured by comparing the means of differences in the number of TRPs identified at baseline and at the time of short-term follow-up in the intervention and usual care groups'}], 'secondaryOutcomes': [{'measure': "Surgeons' attitudes and satisfaction towards the provided clinical pharmacy services", 'timeFrame': '19-week', 'description': 'Measured by a self-administered questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['clinical pharmacist', 'general surgical ward', 'RCT', 'SICU'], 'conditions': ['Surgical Patients']}, 'referencesModule': {'references': [{'pmid': '17066238', 'type': 'BACKGROUND', 'citation': 'AbuRuz SM, Bulatova NR, Yousef AM. Validation of a comprehensive classification tool for treatment-related problems. Pharm World Sci. 2006 Aug;28(4):222-32. doi: 10.1007/s11096-006-9048-0. Epub 2006 Oct 26.'}, {'pmid': '30766431', 'type': 'BACKGROUND', 'citation': 'Basheti IA, Ayasrah SM, Ahmad M. Identifying treatment related problems and associated factors among hospitalized post-stroke patients through medication management review: A multi-center study. Saudi Pharm J. 2019 Feb;27(2):208-219. doi: 10.1016/j.jsps.2018.10.005. Epub 2018 Oct 19.'}, {'pmid': '26962456', 'type': 'BACKGROUND', 'citation': 'Bilal AI, Tilahun Z, Beedemariam G, Ayalneh B, Hailemeskel B, Engidawork E. Attitude and satisfaction of health care providers towards clinical pharmacy services in Ethiopia: A post-deployment survey. J Pharm Policy Pract. 2016 Mar 8;9:7. doi: 10.1186/s40545-016-0058-6. eCollection 2016.'}, {'pmid': '15537552', 'type': 'BACKGROUND', 'citation': 'Hepler CD. Clinical pharmacy, pharmaceutical care, and the quality of drug therapy. Pharmacotherapy. 2004 Nov;24(11):1491-8. doi: 10.1592/phco.24.16.1491.50950.'}]}, 'descriptionModule': {'briefSummary': 'Patients in the surgery ward are at risk of morbidity and mortality from various types of treatment-related problems (TRPs). The primary aim of this study is to assess the impact of the clinical pharmacist in the identification and management of TRPs in the surgery ward.', 'detailedDescription': 'Patients were randomly assigned to intervention (n=50) and usual care (n=50) arms. The clinical pharmacist assessed the types, frequencies, and clinical significance of TRPs for all recruited patients at baseline. Patients and treating surgeons in the intervention arm received recommendations concerning the identified TRPs, while the usual care arm did not. The number of TRPs was reevaluated at follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission for elective, urgent, or emergency surgery\n* age 18 years or older\n* Expected length of stay of 3 days or more in the general surgical ward or the SICU\n\nExclusion Criteria:\n\n* Pregnancy, breastfeeding, drug or alcohol abuse, active malignancy, or admission for plastic surgery'}, 'identificationModule': {'nctId': 'NCT04941820', 'briefTitle': 'The Impact of Clinical Pharmacist in the Identification and Management of Treatment Related Problems in the Surgery Ward', 'organization': {'class': 'OTHER', 'fullName': 'University of Jordan'}, 'officialTitle': 'The Impact of Clinical Pharmacist in the Identification and Management of Treatment Related Problems in the Surgery Ward', 'orgStudyIdInfo': {'id': '80/2019/1943'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinical pharmacist intervention + usual care arm', 'description': 'Patients in the clinical pharmacist intervention + usual care arm received the clinical pharmacist intervention as well as usual care provided by the surgical team', 'interventionNames': ['Other: clinical pharmacist intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care arm (Control arm)', 'description': 'Patients in the control arm received usual care by the surgical team without a coordinated contribution from the clinical pharmacist'}], 'interventions': [{'name': 'clinical pharmacist intervention', 'type': 'OTHER', 'description': 'clinical pharmacist intervention', 'armGroupLabels': ['Clinical pharmacist intervention + usual care arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amman', 'country': 'Jordan', 'facility': 'University of Jordan', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'overallOfficials': [{'name': 'Hiba I. Al Fahmawi, PharmD, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'School of Pharmacy, The University of Jordan, Amman, Jordan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jordan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Director', 'investigatorFullName': 'Hiba Al Fahmawi', 'investigatorAffiliation': 'University of Jordan'}}}}