Condition category
Not Applicable
Date applied
27/06/2019
Date assigned
08/07/2019
Last edited
08/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Multiple diseases, medications and age-related changes put older adults at increased risk of harm from drugs. The majority of drug-related hospital visits are due to errors in prescribing and monitoring. Currently available text-based drug information resources can be lengthy for time-pressed clinicians and may not provide sufficient specific information regarding older adults. The researchers have developed concise, evidence-based, geriatric drug information resources (GPIDs) that use graphic design to facilitate learning. The aim of this study is to assess the efficiency and effectiveness of GPIDs. This is achieved by measuring the amount of time it will require prescribing clinicians to answer 5 case-based questions regarding prescribing for complex older adults using either GPIDs or usual drug information resources. Other aims include measuring knowledge retention using a knowledge-retention test, and assessing user-friendliness and overall reading experience of the GPIDs. The researchers will also investigate how various learning styles may impact the effectiveness and efficiency of the GPIDs.

Who can participate?
Prescribing clinicians (physicians, pharmacists, nurse practitioners) of any age currently practicing in Canada

What does the study involve?
The study involves randomly allocating prescribing clinicians (physicians, pharmacists and nurse practitioners) to one of two groups and instructing both to solve 5 identical case-based questions: one group is instructed to use only GPIDs and the other group is instructed to use their usual drug information resources. After this intervention, the researchers examine the required time for each group to answer the 5 questions. Next, both groups complete a series of questionnaires and tests in the following order: demographic questions, Health Professionals Inventory of Learning Styles (HPILS), knowledge retention test, open-ended questions about the GPIDs and finally questions about perceived user-friendliness and overall reading experience.

What are the possible benefits and risks of participating?
There are no risks or direct benefits related to participation in the study.

Where is the study run from?
The study is being run by the principle investigators based out of McMaster University and GeriMedRisk (Waterloo, Ontario) and takes place on the Surveymonkey platform.

When is the study starting and how long is it expected to run for?
October 2017 to July 2019

Who is funding the study?
Peer-reviewed grant from the Centre for Aging and Brain Health Innovation (CABHI)

Who is the main contact?
1. Dr Joanne Ho
joanneho@mcmaster.ca
2. Dr Jennifer Tung
Jennifer.tung@gerimedrisk.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Joanne Ho

ORCID ID

http://orcid.org/0000-0002-8252-2034

Contact details

3rd floor
10B Victoria St. S.
Kitchener
N2G 1C5
Canada
+1 (0)855 261 0508
joanneho@mcmaster.ca

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Assessment of geriatric pharmacology information design: a randomized control trial

Acronym

Study hypothesis

It is hypothesized that using geriatric pharmacology information design materials (GPIDs) will facilitate learning about prescribing medications to older adults. It is hypothesized that prescribing clinicians will find GPIDs to be a more user-friendly, efficient and effective format of learning about geriatric pharmacology compared to current, text-based formats.

Ethics approval

Approved 25/06/2018, Hamilton Integrated Research Ethics Board (HiREB) (293 Wellington Street North, Suite 102, Hamilton ON, L8L 8E7, Canada; Tel: +1 (0)905 521 2100 ext 70014; Email: erebhelpdesk@hhsc.ca), Project #: 4790

Study design

Multicentre double-blind randomized control trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Other

Patient information sheet

Not available in wed format, please use contact details to request a participant information sheet

Condition

Prescribing practices for older adults

Intervention

The study involves randomly assigning prescribing clinicians (physicians, pharmacists and nurse practitioners) to one of two treatment groups and instructing both to solve 5 identical case-based questions: one group will be instructed to use only GPIDs and the other group will be instructed to use their usual drug information resources. After this intervention, the researchers will examine the required time for each group to answer the 5 questions. Next, both groups will complete a series of questionnaires and tests in the following order: demographics questions, Health Professionals Inventory of Learning Styles (HPILS), knowledge retention test, open-ended questions about the GPIDs and finally questions about perceived user-friendliness and overall reading experience.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Time required by prescribing clinicians to complete 5 case-based questions about prescribing to older adults (start defined as time when online survey was accessed, stop defined as time when online survey completion button pressed; as measured by Survey Monkey). Measured at a single timepoint.

Secondary outcome measures

Measured at a single timepoint:
1. Learning styles measured using the Health Professionals’ Inventory of Learning Styles (H-PILS)
2. Knowledge retention test scores (defined as the % of correct answers to the case-based short answer questions in part 2 of the survey)
3. User-friendliness of the infographics, assessed using a series of closed-ended questions about their reading experience followed by open-ended feedback questions

Overall trial start date

20/10/2017

Overall trial end date

31/07/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Prescribing clinicians

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

Health professionals involved in the development of the Geriatric Pharmacology Information Design Materials

Recruitment start date

10/02/2019

Recruitment end date

31/07/2019

Locations

Countries of recruitment

Canada

Trial participating centre

McMaster University
3rd Floor, 10B Victoria Street South
Kitchener
N2G 1C5
Canada

Sponsor information

Organisation

McMaster University

Sponsor details

1280 Main St. W.
Hamilton
L8S 4L8
Canada
+1 (0)905 525 9140
erebhelpdesk@hhsc.ca

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Centre for Aging and Brain Health Innovation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal by 31/07/2020. The study protocol can be available upon request to investigators whose use of the data has been approved by an approved review committee for a meta-analysis beginning 9 months and ending 36 months following article publication. Proposals should be directed to joanneho@mcmaster.ca. A data sharing agreement will need to be signed.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/07/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/07/2019: Trial's existence confirmed by ethics board.