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

NCT05875623 | Active Not Recruiting

• 1 other identifier: REVMED RCT
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Conditions

Deprescriptions; Aged; Inappropriate Prescribing; Potentially Inappropriate Medications; Polypharmacy

Outcome Measures

Primary Outcomes (2)

• Number of potentially inappropriate medications

  Admission up to 18 months

• Number of chronic medications

  Admission up to 18 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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).

Interventions

MALPIP criteria OTHER

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

Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Monash University: lead
• Hospital Raja Permaisuri Bainun: collaborator

Study Sites (1)

Shaun Lee

Subang Jaya, Selangor, 47500, Malaysia

Location

Related Publications (1)

• Chang CT, Teoh SL, Cheah WK, Lee PJ, Azman MA, Ling SH, Chuah ASC, Sabki NH, George D, Oh HL, Goh JY, Lee SH, Foong WK, Lee JCY, Chan HK, Teoh LR, Lim XJ, Rajan P, Lee SWH. Impact of deprescribing intervention on potentially inappropriate medications and clinical outcomes among hospitalized older adults in Malaysia: a randomized controlled trial (REVMED RCT) protocol. J Pharm Policy Pract. 2023 Oct 3;16(1):113. doi: 10.1186/s40545-023-00621-5.

  PMID: 37789376 DERIVED

Study Officials

• Chee Tao Chang, Msc

  Monash University Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: July 6, 2023
• Primary Completion: August 28, 2025
• Study Completion: December 30, 2025
• Last Updated: May 8, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)