Effects of Pharmacist-led Medication Reconciliation Services on Geriatric Patients

September 19, 2024 updated by: Majed Shafaamri, University of Jordan

Effects of Pharmacist-led Medication Reconciliation Services on Geriatric Patients At a Leading Military Hospital in Jordan

This study aims to assess the effects of Pharmacist-led medication reconciliation on hospitalized elderly patients aged above 65 at a leading tertiary military hospital in Jordan.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A four-month randomized controlled trial was conducted at King Hussein Medical Hospital (KHMH), one of the Royal Military Medical Services (RMS) tertiary hospitals located in central Amman. During the study period, 128 patients were selected using convenience sampling. Later, medication histories were compared between pre-admission and admission records to obtain the Best Possible Medication History (BPMH) and identify medication discrepancies, which were categorized as either intentional (documentation errors) or unintentional discrepancies.

The already selected patients were randomly allocated into two groups (intervention and control groups). Then, Pharmacist-led medication reconciliation services were provided to the intervention group and standard care was provided to the control group. Also at discharge the number of medication discrepancies was documented. Linear regression analysis was performed to assess risk factors associated with the occurrence of unintentional discrepancies.

Within 30 days post-discharge, patients were assessed for any hospital re-admissions, emergency department visits and medication-related side effects.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Newly admitted patient within no more than 24 hours and anticipated to stay in the hospital for more than 48 hours.
  • Geriatrics patients defined as those aged (≥65 years) (Orimo et al., 2006).
  • Prescribed at least one chronic medication prior to the study admission.

Exclusion Criteria:

  • Patient admitted to the critical care or isolation units or in unconscious or comatose states.
  • Patients if they were discharged against medical advice.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Patients did not receive Pharmacist-led medication reconciliation services
Experimental: Intervention group
Patients received Pharmacist-led medication reconciliation services
Other: Pharmacist-led medication reconciliation services

Upon admission, information about patients Best Possible Medication History (BPMH) was extracted. Information on current medications, both regular and as-needed, was also recorded. All data were cross-referenced with the electronic records and verified through patients or caregivers interviews to create a comprehensive medication list.

Then, comparison was conducted between standard care medication list and Pharmacist-led medication reconciliation list to identify any possible medication discrepancies. Also, during hospital stay and upon discharge emerging medication discrepancies were assessed and resolved.

Moreover, the impacts on healthcare resources utilization within 30 days post-discharge was measured. This includes evaluating hospital re-admissions, emergency department visits, and the occurrence of any adverse drug events (ADEs).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Describing prevalence and nature of medication discrepancies in elderly patients and investigating contributing factors to medication discrepancies.
Time Frame: Up to 20 weeks
Linear regression analysis was performed to assess risk factors associated with the occurrence of medication discrepancies in elderly patients.
Up to 20 weeks
Analysis of the effects of Pharmacist-led medication reconciliation services on resolving medication discrepancies upon discharge
Time Frame: Up to 16 weeks
Number of resolved medication discrepancies was documented upon discharge after providing pharmacist-led medication reconciliation services.
Up to 16 weeks
Evaluating the impacts of Pharmacist-led medication reconciliation services on hospital re-admissions within 30 days of discharge
Time Frame: Up to 20 weeks
Elderly patients were assessed for number of hospital re-admissions within 30 days of discharge at control and intervention groups.
Up to 20 weeks
Evaluating the impacts of Pharmacist-led medication reconciliation services on emergency department visits within 30 days of discharge
Time Frame: Up to 20 weeks
Elderly patients were assessed for number of emergency department visits within 30 days of discharge at control and intervention groups.
Up to 20 weeks
Evaluating the impacts of Pharmacist-led medication reconciliation services on medications side effects within 30 days of discharge
Time Frame: Up to 20 weeks
Elderly patients were assessed for incidence of medications side effects within 30 days of discharge at control and intervention groups.
Up to 20 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Jordan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jordanian Royal Medical Services
Royal Medical Services, Jordanian Armed Forces

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eman A Hammad, Department of Biopharmaceutics and Clinical Pharmacy, School of Pharmacy, University of Jordan

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 13, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 13, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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