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

Aged Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05875623
• Other study ID #: REVMED RCT
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2023
• Est. completion date: June 2025

Study information

• Verified date: October 2023
• Source: Monash University
• Contact: Chee Tao Chang, Msc
• Phone: +6052085000
• Email: chee.chang[@]monash.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aged
• Deprescriptions
• Inappropriate Prescribing
• Polypharmacy
• Potentially Inappropriate Medications

Intervention

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

Locations

Country	Name	City	State
Malaysia	Shaun Lee	Subang Jaya	Selangor

Sponsors (2)

Lead Sponsor	Collaborator
Monash University	Hospital Raja Permaisuri Bainun

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of potentially inappropriate medications		Admission up to 18 months
Primary	Number of chronic medications		Admission up to 18 months