Impact of Medications Review on Potentially Inappropriate Medications and Clinical Outcomes Among Hospitalized Older Adults

Impact of Medications Review on Potentially Inappropriate Medications and Clinical Outcomes Among Hospitalized Older Adults: A Randomized Controlled Trial (REVMED RCT) Protocol

The goal of this randomized controlled trial is to assess the effectiveness of a pharmacist-led medication review using the locally developed Malaysian Potentially Inappropriate Prescribing Screening tool in Older Adults (MALPIP), an explicit criteria in hospitalized older adults. The main questions it aims to answer are:

1. The effectiveness of the intervention in reducing the number of PIMs and chronic medications after discharge
2. The impact of the intervention on quality of life, falls events, emergency department visits, readmissions and survivals

Researchers will compare the control group to see if there is corresponding changes to the outcomes specified above.

Study Overview

• Status: Recruiting
• Conditions: Aged; Polypharmacy; Inappropriate Prescribing; Deprescriptions; Potentially Inappropriate Medications
• Intervention / Treatment: Other: MALPIP criteria

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chee Tao Chang, Msc; Phone Number: 5146 +6052085000; Email: chee.chang@monash.edu
• Study Contact Backup: Name: Shaun Lee, PhD; Email: shaun.lee@monash.edu

Study Locations

• Malaysia
  • Selangor
    • Subang Jaya, Selangor, Malaysia, 47500
      • Recruiting
      • Shaun Lee
      • Contact: Shaun Lee; Email: shaun.lee@monash.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 60 years and above
• Taking more than five regular drugs
• Having at least one chronic medical condition
• Ability to understand and speak Malay, English, or Mandarin language

Exclusion Criteria:

• Admitted for end-of-life care
• Diagnosed with terminal illness
• Diagnosed with active cancer
• Participated in another drug trial
• Refused or unable to give consent
• Visited the Emergency Department without admission to ward
• Readmitted and have been previously enrolled in the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; In the intervention group, the clinical pharmacist will apply the MALPIP criteria on all the admission and discharge medications. The pharmacists can access the full MALPIP list at https://sites.google.com/moh.gov.my/malpip/home. The intervention will consist of 4 steps: i) pharmacist review using MALPIP criteria to detect PIM, ii) discussion with doctors for deprescribing decision iii) discussion with patients and documentation of shared decision iv) follow up patients at 6, 12, and 18 months. Pharmacists will perform the reviewing and checking by themselves and discuss the suggestions with doctors during daily medical ward rounds. The attending doctors will decide whether to deprescribe based-on pharmacists suggestions. Then, the pharmacists will discuss the deprescribing proposal with the patients and record the decision.	Other: MALPIP criteria; In the intervention group, the clinical pharmacist will apply the MALPIP criteria on all the admission and discharge medications. The intervention will consist of 4 steps: i) pharmacist review using MALPIP criteria to detect PIM, ii) discussion with doctors for deprescribing decision iii) discussion with patients and documentation of shared decision iv) follow up patients
No Intervention: Control; In the control arm, pharmacists, patients and doctors are not purposefully blinded but are not aware of the intervention (i.e. the MALPIP tool). Designated pharmacist at the control sites identifies patients who match the eligibility requirements and enroll them into the trial after obtaining consent. Patients in the control arm will receive routine care and support that they entitled to from the medical team and clinical pharmacists. Preadmission medication will be reconciled by a clinical pharmacist using the standard procedures, including medication history assessment form (CP1), pharmacotherapy review (CP2) and the clinical pharmacy report form (CP3).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of potentially inappropriate medications	Admission up to 18 months
Number of chronic medications	Admission up to 18 months

Collaborators and Investigators

• Sponsor: Monash University
• Collaborators: Hospital Raja Permaisuri Bainun
• Investigators: Principal Investigator: Chee Tao Chang, Msc, Monash University Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: REVMED RCT

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