Patient or carer acceptance of medicine use recommendations by a pharmacist after being discharged from hospital

ISRCTN ISRCTN21156862
DOI https://doi.org/10.1186/ISRCTN21156862
ClinicalTrials.gov (NCT) Nil Known
Clinical Trials Information System (CTIS) Nil known
Protocol serial number Nil known
Sponsor University of Sydney
Funder Wolper Jewish Hospital
Submission date
10/07/2022
Registration date
12/07/2022
Last edited
30/03/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Inappropriate use of medicines is common, and patients benefit from having their medicines reviewed by an independent third party who is skilled at reviewing medicines. This study aims to explain to patients leaving the hospital, both verbally and in writing, about any issues that an independent third party have with their medicines. Patients will then be encouraged to discuss these issues with their primary physician.

Who can participate?
Patients in hospital aged 65 years or older

What does the study involve?
The study involves interviewing participants just before they leave the hospital, preferably in the company of a caregiver, to discuss any issues with their medicines. These discussions will be in plain English, and any recommendations will be made both verbally and in writing. The study team asks that participants make an appointment with their doctor within 2 weeks of leaving the hospital to discuss those issues that concern them. The study team will then contact participants by telephone or visit them to find out the results of the recommendations.

What are the possible benefits and risks of participating?
Possible benefits are a correction to the use of inappropriate medicines and a reduction in the number of medicines participants take. The study team is unaware of any risks.

Where is the study run from?
The University of Sydney (Australia)

When is the study starting and how long will it run for?
From July 2019 until March 2020

Who is funding the study?
Wolper Jewish Hospital (Australia)

Who is the main contact?
The hospital's clinical pharmacist, who will attach a professional card to the participant's medication list detailing their name and phone number.

Contact information

Dr Ben Basger
Principal investigator

801/306 Oxford St
Bondi Junction
Sydney
2022
Australia

ORCiD logoORCID ID 0000-0002-7125-4492
Phone +61412852828
Email ben.basger@sydney.edu.au

Study information

Primary study designObservational
Study designSingle centre observational longitudinal cohort study
Secondary study designCohort study
Participant information sheet 42040_PIS_carers_v1_10Feb19.pdf
Scientific titleUptake of pharmacist recommendations by patients after discharge: Implementation study of a patient-centred medicines review service
Study objectivesIf patients and/or their carers receive medicine management recommendations in ways that are meaningful to them, they are capable of making an informed decision about the recommendation and actioning it.
Ethics approval(s)Approved 17/05/2019, The University of Sydney Human Research Ethics Committee (The University of Sydney, Sydney, NSW, Australia 2005; +61 2 9036 9161; human.ethics@sydney.edu.au), ref: 2019/209
Health condition(s) or problem(s) studiedIdentification, resolution, and prevention of medicine-related problems in older people
InterventionInpatients, and their carers where there was cognitive impairment, were recruited to receive a medicines review upon discharge from the hospital. Medicine management recommendations were delivered verbally and in writing in ways that were meaningful to them. Two to four weeks after discharge, they were followed up to record the implementation rate of the recommendations, accomplished through contact with their primary physician for prescription medicines, or by themselves for non-prescription medicines
Intervention typeBehavioural
Primary outcome measure(s)

Implementation rate of medicine management recommendations measured using interviews with participants at 2-4 weeks

Key secondary outcome measure(s)

The number of medicines deprescribed (either reduced in dose or ceased) measured using interviews with participants at 2-4 weeks

Completion date01/07/2020

Eligibility

Participant type(s)Patient
Age groupSenior
SexAll
Target sample size at registration100
Total final enrolment100
Key inclusion criteria1. Inpatients, and a carer for individuals where there is cognitive impairment
2. Aged ≥65 years
Key exclusion criteriaDoes not meet inclusion criteria.
Date of first enrolment01/07/2019
Date of final enrolment01/04/2020

Locations

Countries of recruitment

  • Australia

Study participating centre

Wolper Jewish Hospital
8 Trelawney St
Woollahra
Sydney
2025
Australia

Results and Publications

Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in non-publicly available repository, Available on request
IPD sharing planCurrent participant level data sharing statement as of 24/01/2023:
Raw data is available upon request from Dr Ben Basger at ben.basger@sydney.edu.au. Raw data consists of an Excel spreadsheet containing deidentified patient gender, age, number of medicines taken, and category of Drug Related Problem identified. Data collection forms and patient consent forms are being held securely in the medical records department of the hospital.


Previous participant level data sharing statement:
Raw data is available upon request from ben.basger@sydney.edu.au. Data collection forms and patient consent forms are being held securely in the medical records department of the hospital.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 29/03/2023 30/03/2023 Yes No
Participant information sheet information for carers
version 1
01/02/2019 12/07/2022 No Yes
Participant information sheet information for participants
version 1
10/01/2019 12/07/2022 No Yes
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Additional files

42040_PIS_patients_v1_10Jan19.pdf
information for participants
42040_PIS_carers_v1_10Feb19.pdf
information for carers

Editorial Notes

30/03/2023: Publication reference added.
24/01/2023: The participant level data sharing statement was updated.
12/07/2022: Trial’s existence confirmed by Wolper Jewish Hospital.