Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000121460
Ethics application status
Approved
Date submitted
28/11/2024
Date registered
3/02/2025
Date last updated
3/02/2025
Date data sharing statement initially provided
3/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Physician-Pharmacist Partnership Intervention for Deprescribing (P3iD) among Older Adults Attending a Falls and Syncope Clinic: Protocol for a Randomised Controlled Trial
Scientific title
Effect of A Physician-Pharmacist Partnership Intervention for Deprescribing (P3iD) on Total Number of Prescribed Medications among Older Adults Attending a Falls and Syncope Clinic: Protocol for a Randomised Controlled Trial
Secondary ID [1] 313428 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overprescribing 335815 0
Condition category
Condition code
Public Health 332444 332444 0 0
Health service research
Injuries and Accidents 332445 332445 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will receive an in-depth medication review of approximately 30 minutes performed by a pharmacist, which will focus on identifying PIMs as opportunities for deprescribing. In the intervention group, PIMs identified will be deprescribed using the P3ID intervention. P3ID intervention consists of 5 steps:

Step 1: PIM identification
a) Participant selection
Researcher reviews electronic medical record (EMR) before follow-up to obtain medication list and identify any potentially inappropriate medications (PIMs). The researcher will then contact selected potential participants, asking them to arrive an hour before their scheduled appointment at the clinic and reminding them to bring their medications for review.
b) Medication review
The participant completes the written consent form and a baseline demographic questionnaire, Patients were then asked to complete the Patient Medication Adherence Instrument (PMAI-9), a self-reported measure designed to assess medication adherence from the patient's perspective. The pharmacist conducts a medication review using the STOPPFall criteria to identify PIMs and asks about any medication-related issues and self-monitoring practices (e.g., blood pressure or glucose levels). The pharmacist then completes the Healthcare professional-Medication Adherence Instrument (HMAI-9), a self-reported tool designed to evaluate medication adherence from the healthcare professional's perspective.

Step 2: Decisions on prioritization on cessation
Algorithm for deciding order and mode in which drug use could be discontinued will be applied to determine deprescribing strategy.

Step 3: Medication withdrawal
a) Physician-pharmacist discussion
Pharmacist discusses deprescribing opportunities with physician.
b) Doctor-patient consultation
If physicians decides to deprescribe, discussion is held with patients

Step 4: Monitoring and support
a) Doctor’s feedback to the pharmacist
Physician will inform the pharmacist of patients’ latest medication regimen
b) Medication counselling
Pharmacist counsel patients and reinforce instructions given by physician.

Step 5: Documentation
Physician documents consultation and shared decision at EMR
Intervention code [1] 330033 0
Treatment: Drugs
Intervention code [2] 330444 0
Behaviour
Comparator / control treatment
Participants in the control group will continue to receive usual care, where medications will be reviewed and prescribed by their physician
Control group
Active

Outcomes
Primary outcome [1] 340000 0
Total number of prescribed medications
Timepoint [1] 340000 0
Baseline, 3 month and 6 month post-baseline
Secondary outcome [1] 442261 0
Number of medications deprescribed
Timepoint [1] 442261 0
Baseline, 3 month and 6 month post-baseline
Secondary outcome [2] 442262 0
Fall occurrence and falls rate
Timepoint [2] 442262 0
Diary returns at 3 month and 6 month post-baseline
Secondary outcome [3] 442263 0
Medication adherence
Timepoint [3] 442263 0
Baseline, 3 month and 6 month post-baseline

Eligibility
Key inclusion criteria
1)Patients:
Individuals aged 60 years and over with at least one chronic disease requiring pharmacological treatment and prescribed one or more medications, attending the falls and syncope clinic with one or more PIM according to the STOPPFall criteria. For those who may lack mental capacity, assent will be obtained from their next of kin. Since medication review and deprescribing are generally considered appropriate for older adults, no exclusion criteria are anticipated

2) Doctors:
Geriatricians, internal and family physicians undergoing subspecialty training in geriatric medicine and medical officers working at the centre will be recruited.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients
For patients who may lack mental capacity, consent will be sought from the physician overseeing the participant’s care, who will also be recruited into the study. If the physician determines that participation in the RCT is unsuitable for the participant based on clinical judgment, the participant will be excluded. Additionally, if a potential participant’s physician declines to participate and the participant chooses to remain under their care, the participant will also be excluded.

2) Doctors
Doctors who declined to participate in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computerized random number generator in Microsoft Office® Excel® (Washington, United States of America)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/12/2024
Date of last participant enrolment
Anticipated
31/05/2026
Actual
Date of last data collection
Anticipated
3/12/2026
Actual
Sample size
Target
140
Accrual to date
25
Final
Recruitment outside Australia
Country [1] 26757 0
Malaysia
State/province [1] 26757 0

Funding & Sponsors
Funding source category [1] 317861 0
University
Name [1] 317861 0
Universiti Malaya-Department of Medicine Research Support Fund, Faculty of Medicine
Country [1] 317861 0
Malaysia
Primary sponsor type
University
Name
Universiti Malaya-Department of Medicine Research Support Fund, Faculty of Medicine
Address
Country
Malaysia
Secondary sponsor category [1] 320194 0
None
Name [1] 320194 0
Address [1] 320194 0
Country [1] 320194 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316542 0
Medical Research Ethics Committee of University Malaya Medical Centre
Ethics committee address [1] 316542 0
Ethics committee country [1] 316542 0
Malaysia
Date submitted for ethics approval [1] 316542 0
23/08/2023
Approval date [1] 316542 0
12/06/2024
Ethics approval number [1] 316542 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138214 0
Dr Sheron Goh Sir Loon
Address 138214 0
Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, 50603, Universiti Malaya, Kuala Lumpur, Malaysia
Country 138214 0
Malaysia
Phone 138214 0
+60149369680
Fax 138214 0
Email 138214 0
sherongoh@um.edu.my
Contact person for public queries
Name 138215 0
Sheron Goh Sir Loon
Address 138215 0
Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, 50603, Universiti Malaya, Kuala Lumpur, Malaysia
Country 138215 0
Malaysia
Phone 138215 0
+60149369680
Fax 138215 0
Email 138215 0
sherongoh@um.edu.my
Contact person for scientific queries
Name 138216 0
Sheron Goh Sir Loon
Address 138216 0
Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, 50603, Universiti Malaya, Kuala Lumpur, Malaysia
Country 138216 0
Malaysia
Phone 138216 0
+60149369680
Fax 138216 0
Email 138216 0
sherongoh@um.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.