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

NCT ID: NCT05875623

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-06
• Study Completion Date: 2025-12-30

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. 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MALPIP criteria

Intervention Type: 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

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Raja Permaisuri Bainun

OTHER_GOV

Sponsor Role: collaborator

Monash University

OTHER

Sponsor Role: lead

Responsible Party

Shaun Lee Wen Huey

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chee Tao Chang, Msc

Role: PRINCIPAL_INVESTIGATOR

Monash University Malaysia

Locations

Shaun Lee

Subang Jaya, Selangor, Malaysia

Countries

Malaysia

References

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.

Reference Type: DERIVED

PMID: 37789376 (View on PubMed)

Other Identifiers

REVMED RCT

Identifier Type: -

Identifier Source: org_study_id