The General Objective of This Study is to Monitor, Assess... | NCT07002606

Studies
The General Objective of This Study is to Monitor, Assess, and Prevent the Potential Medication Errors Among Inpatients in the Tertiary Healthcare Facility of Nepal. This Study Aims to Develop and Implement the Medication Errors Reporting System in Hospital Settings.

NCT07002606

Sponsor

Kathmandu University School of Medical Sciences

Status

Not yet recruiting

Last Update Posted

Jun 3, 2025Actual

Enrollment

62Estimated

Phase

Not provided

Conditions

Prescription With Medication Errors

Interventions

medication errors reporting guidelines

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
PhD- 80/8 t-HS-04	Other Grant/Funding Number	University Grant Commission

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2025Estimated

Primary Completion Date

Apr 1, 2026Estimated

Completion Date

Apr 1, 2027Estimated

First Submitted Date

May 25, 2025

First Submission Date that Met QC Criteria

May 25, 2025

First Posted Date

Jun 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2025

Last Update Posted Date

Jun 3, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rudip Thapa, Assistant Professor (Pharmacology), Kathmandu University School of Medical SciencesPrincipal Investigator

Lead Sponsor

Kathmandu University School of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to develop and implement Medication errors reporting system using the error reporting guidelines. The main question it aims to answer is:

"Does development and implementation of Medication errors reporting guideline will help to reduce the errors rate and improve the patient safety?"

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

62Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
medication errors reporting guidelines	Other	the intervention is designed to reduce the medication errors and develop the culture of reporting the Medication errors in clinical settings.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
reduction in Mediation error rate	The newly developed Medication errors reporting guidelines will be implemented and will be used to evaluate the reduction in medication errors incident rates.	6 months after the implementation of the Medication errors reporting guidelines

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

For the quantitative part, the inclusion criteria are patients of all age groups and prescriptions issued to inpatients.
For the qualitative part of the study, inclusion criteria are healthcare professionals aged more than 18 years working in Dhulikhel Hospital.

Exclusion criteria:

The exclusion criteria will be incomplete and unclear prescriptions.
The healthcare persons who accepted the consent but couldn't complete the survey will be excluded from the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Healthcare professionals including Doctors, Nurses and Pharmacist who are working in Dhulikhel Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rudip Thapa Assistant Professor, M.Sc. (Medical) Pharmacology	Contact	+9779851218678		thaparudip@student.kusms.edu.np

Overall Officials

Name	Affiliation	Role
Dr. Sony Shakya Professor in Pharmacology, PhD	Kathmandu University School of Medical Science	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.