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出境医 / 临床实验 / The Impact of Clinical Pharmacist in the Identification and Management of Treatment Related Problems in the Surgery Ward

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Surgical Patients Other: clinical pharmacist intervention Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Clinical Pharmacist in the Identification and Management of Treatment Related Problems in the Surgery Ward
Actual Study Start Date : September 29, 2019
Actual Primary Completion Date : February 6, 2020
Actual Study Completion Date : February 6, 2020
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Surgeons' attitudes and satisfaction towards the provided clinical pharmacy services [ Time Frame: 19-week ]
    Measured by a self-administered questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Locations
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Jordan
University of Jordan
Amman, Jordan
Sponsors and Collaborators
University of Jordan
Investigators
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Study Director: Hiba I. Al Fahmawi, PharmD, MSc School of Pharmacy, The University of Jordan, Amman, Jordan
Tracking Information
First Submitted Date  ICMJE June 8, 2021
First Posted Date  ICMJE June 28, 2021
Last Update Posted Date June 28, 2021
Actual Study Start Date  ICMJE September 29, 2019
Actual Primary Completion Date February 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2021)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2021) 		Surgeons' attitudes and satisfaction towards the provided clinical pharmacy services [ Time Frame: 19-week ]
Measured by a self-administered questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Clinical Pharmacist in the Identification and Management of Treatment Related Problems in the Surgery Ward
Official Title  ICMJE The Impact of Clinical Pharmacist in the Identification and Management of Treatment Related Problems in the Surgery Ward
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Surgical Patients
Intervention  ICMJE Other: clinical pharmacist intervention
clinical pharmacist intervention
Study Arms  ICMJE
  • 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
    Intervention: Other: 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
Publications *
  • 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. Epub 2006 Oct 26.
  • 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.
  • 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.
  • Hepler CD. Clinical pharmacy, pharmaceutical care, and the quality of drug therapy. Pharmacotherapy. 2004 Nov;24(11):1491-8. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2021) 		100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 6, 2020
Actual Primary Completion Date February 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Jordan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04941820
Other Study ID Numbers  ICMJE 80/2019/1943
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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.
Responsible Party Hiba Al Fahmawi, University of Jordan
Study Sponsor  ICMJE University of Jordan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hiba I. Al Fahmawi, PharmD, MSc School of Pharmacy, The University of Jordan, Amman, Jordan
PRS Account University of Jordan
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP