NCT05210335

Brief Summary

Optimal perioperative and long-term success in cardiac-surgery require precise management of drug treatment. This study was aimed to determine prevalence, types and associated factors of drug related problems (DRPs) at both preoperative and postoperative stages in patients at cardiac-surgery by using risk analysis method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

1.7 years

First QC Date

January 14, 2022

Last Update Submit

January 14, 2022

Conditions

Drug Related ProblemsClinical PharmacyCardiac SurgeryRisk Assesment

Keywords

Drug related problemsClinical pharmacyCardiac surgeryRisk assesment

Outcome Measures

Primary Outcomes (3)

  • Obtaining drug related problems preoperative and postoperative periods

    Obtaining valid drug related problems and their characteristic is the primary outcome as a part of the risk analysis.

    6 months (1 November 2019-30 March 2020)

  • Building risk analysis model

    In line with the valid drug related problems expert panel build the model

    3 months (30 March 2020-30 June 2020)

  • Obtaining clinical pharmacist affect

    Obtaining clinical pharmacist affect as a part of the risk analysis model

    6 months (1 August 2020- 30 January 2021)

Secondary Outcomes (1)

  • Obtaining clinical pharmacist intervention on other factors

    6 months (1 August 2020- 30 January 2021)

Study Arms (2)

Observational part

NO INTERVENTION

This part covers the list for comprehensive medication use at admission, medication reconciliation and medication review at preoperative surgical ward, postoperative intensive care, postoperative surgical ward and discharge made by clinical pharmacist. The identification and classification of drug related problems was made at each ward according to PCNE classification system. The expert panel (2 surgeon, 2 nurse, 1 pharmacist) scored all the drug related problems as a part of the risk analysis model development. Patients quality of life, nutritional status, cognitive functions and frailty status also recorder at admission, discharge and 1 month after surgery.

Interventional part

EXPERIMENTAL

This part covers the list for comprehensive medication use at admission, medication reconciliation and medication review at preoperative surgical ward, postoperative intensive care, postoperative surgical ward and discharge made by clinical pharmacist. Clinical pharmacist made recommendation about drug related problems regarding solutions, record intervention type and problem status differently from observational part. As a component of the risk analysis model the affect of clinical pharmacist was shown clearly. Patients quality of life, nutritional status, cognitive functions and frailty status also recorder at admission, discharge and 1 month after surgery.

Other: Clinical pharmacist's recommendation to physicians about drug related problems

Interventions

Clinical pharmacist's recommendation to physicians about drug related problemsOTHER

Clinical pharmacist's recommendation to physicians about drug related problems

Interventional part

Eligibility Criteria

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

You may qualify if:

  • Patients are aged 18 years or older
  • admitted to the hospital for a planned elective cardiac surgery during the study period were considered eligible.

You may not qualify if:

  • Patients who refused to participate,
  • transferred from different wards
  • have urgent surgery planned were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Pharmacy Department of Clinical Pharmacy

Ankara, Altındağ, 06100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 14, 2022

First Posted

January 27, 2022

Study Start

November 1, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

January 27, 2022

Record last verified: 2022-01

Locations

TU(1)