The Impact of Clinical Pharmacist in the Identification and Management of Treatment Related Problems in the Surgery Ward

June 25, 2021 updated by: Hiba Al Fahmawi, University of Jordan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan
        • University of Jordan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admission for elective, urgent, or emergency surgery
  • age 18 years or older
  • Expected length of stay of 3 days or more in the general surgical ward or the SICU

Exclusion Criteria:

  • Pregnancy, breastfeeding, drug or alcohol abuse, active malignancy, or admission for plastic surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clinical pharmacist intervention + usual care arm
Patients in the clinical pharmacist intervention + usual care arm received the clinical pharmacist intervention as well as usual care provided by the surgical team
Other: clinical pharmacist intervention
clinical pharmacist intervention
No Intervention: Usual care arm (Control arm)
Patients in the control arm received usual care by the surgical team without a coordinated contribution from the clinical pharmacist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptance rate of clinical pharmacist's recommended interventions
Time Frame: 19-week
(Number of recommendations accepted by surgeons) / (total number of recommendations submitted to surgeons by the clinical pharmacist) *100
19-week
Implementation rate of clinical pharmacist's recommended interventions
Time Frame: 19-week
(Number of recommendations implemented by surgeons and patients) / (total number of recommendations submitted to surgeons and patients by the clinical pharmacist) *100
19-week
The impact of the clinical pharmacist on the identification and management of TRPs in the surgery ward
Time Frame: 19-week
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
19-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgeons' attitudes and satisfaction towards the provided clinical pharmacy services
Time Frame: 19-week
Measured by a self-administered questionnaire
19-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jordan

Investigators

  • Study Director: Hiba I. Al Fahmawi, PharmD, MSc, School of Pharmacy, The University of Jordan, Amman, Jordan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2019

Primary Completion (Actual)

February 6, 2020

Study Completion (Actual)

February 6, 2020

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

June 25, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Actual)

June 28, 2021

Last Update Submitted That Met QC Criteria

June 25, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 80/2019/1943

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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