NCT04941820

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
Last Updated

June 28, 2021

Status Verified

June 1, 2021

Enrollment Period

4 months

First QC Date

June 8, 2021

Last Update Submit

June 25, 2021

Conditions

Keywords

clinical pharmacistgeneral surgical wardRCTSICU

Outcome Measures

Primary Outcomes (3)

  • Acceptance rate of clinical pharmacist's recommended interventions

    (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

    (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

    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 Outcomes (1)

  • Surgeons' attitudes and satisfaction towards the provided clinical pharmacy services

    19-week

Study Arms (2)

Clinical pharmacist intervention + usual care arm

EXPERIMENTAL

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

Usual care arm (Control arm)

NO INTERVENTION

Patients in the control arm received usual care by the surgical team without a coordinated contribution from the clinical pharmacist

Interventions

clinical pharmacist intervention

Clinical pharmacist intervention + usual care arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jordan

Amman, Jordan

Location

Related Publications (4)

  • 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: 17066238BACKGROUND
  • 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: 30766431BACKGROUND
  • 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: 26962456BACKGROUND
  • 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.

    PMID: 15537552BACKGROUND

Study Officials

  • Hiba I. Al Fahmawi, PharmD, MSc

    School of Pharmacy, The University of Jordan, Amman, Jordan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

June 8, 2021

First Posted

June 28, 2021

Study Start

September 29, 2019

Primary Completion

February 6, 2020

Study Completion

February 6, 2020

Last Updated

June 28, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

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.

Locations