Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001317785
Ethics application status
Approved
Date submitted
3/10/2022
Date registered
11/10/2022
Date last updated
23/01/2023
Date data sharing statement initially provided
11/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Measuring the efficacy of sending personalised, mobile-accessible discharge instructions for opioid pain medicines to patients going home from the hospital ED and surgical outpatient clinic.
Scientific title
Multi-site Observational Intervention Trial on the efficacy of Personalised, mobile-accessible Instructions for Opioids at Discharge from the emergency department and Surgical outpatient department (OPIOIDS Trial)
Secondary ID [1] 308092 0
Nil known
Universal Trial Number (UTN)
Trial acronym
OPIOIDS Trial
Linked study record
ACTRN: 12618000667213 is a pilot study of this current study.

Health condition
Health condition(s) or problem(s) studied:
Medication adherence 327786 0
Condition category
Condition code
Emergency medicine 324856 324856 0 0
Other emergency care
Surgery 324857 324857 0 0
Other surgery
Public Health 324891 324891 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this study is the implementation of the What the Doctor Said system (“WTDS system”). The system is web-based system and functions with diagnosis "templates" which doctors edit to send personalised discharge instructions to their patient’s mobile phone.

The patient discharge instructions include information such as opioid medication dosage, duration and side effects details, further relevant medication resources, follow up appointment details as well as symptoms and signs to watch out for.

After seeing the patient, doctors working in the ED or surgical outpatient department setting use a desktop computer to create discharge instructions. These instructions are then sent via an embedded link in a text message to the patient. The patient opens the instructions on their phone before leaving the ED or surgical outpatient department setting. The instructions take no longer than 5 minutes for a patient to read.

The study will be implemented in three phases, Pre phase, Implementation phase and Post phase.

Pre phase
The Pre phase will run over 4 weeks. In the ED settings the Pre phase will commence in March 2023 and in the surgical outpatient settings the Pre Phase will commence in August 2023. During this time, patients will receive 'usual' advice for discharge instructions (commonly this is verbal advice but in some instances may be accompanied by written advice).

a) Patients
Patients will be asked to complete 2 short surveys on their experience of receiving discharge instructions for opioids. Survey 1 will be sent at 24 to 48 hours post visit to the ED or surgical outpatient department. Survey 2 will be sent 5 to 7 days after their visit. Both surveys will take no longer than 10 minutes to complete in total.

b) Doctors
i) Surveys
Doctors will be asked to complete a short survey on their experience giving discharge instructions for opioids in the ED or surgical outpatient department. The survey will take no longer than 5 minutes to complete.

ii) Usability testing (Pre phase only)
8 to 10 doctors will be asked by senior clinical staff if they are prepared to volunteer to participate in usability testing of the doctor desktop interface of the What the Doctor Said system. This session will take approximately 40 minutes to complete and will take place in a room or area of the ED or outpatient department where a standard desktop computer is available. The session will consist of three parts:
- questions around the doctor participant's experience providing patient discharge instructions for opioids
- direct observation of the doctor participant using the desktop interface of the WTDS system to create instructions for a patient based on a fictional scenario
- asking the doctor participant to rate the usability of the desktop interface using the System Usability Scale ("SUS"), a widely used Likert-type 10 question survey measuring a user’s satisfaction where responses are converted into an overall usability score out of 100.

Intervention phase
This phase will run over 8 weeks and will run directly after the Pre phase. No recruiting of participants will occur during this phase. During this phase the WTDS system will be made accessible to credentialed doctors working in the ED and surgical outpatients settings at East Metropolitan Health.

During this phase, patients who see a credentialed doctor working in the ED and surgical outpatients settings will receive personalised discharge instructions for opioids on their phone via the WTDS system and will also be provided with a printed copy of these instructions.

Post-phase
This phase will run over 4 weeks and will run directly after the Implementation phase.

a) Patients
Patients will be asked to complete 2 short surveys on their experience of receiving discharge instructions for opioids. Survey 1 will be sent at 24 to 48 hours post visit to the ED or surgical outpatient department. Survey 2 will be sent 5 to 7 days after their visit. Both surveys will take no longer than 10 minutes to complete in total.

b) Doctors
Doctors will be asked to complete a short survey on their experience giving discharge instructions for opioids in the ED or surgical outpatient department. The surveys will take no longer than 5 minutes to complete.
Intervention code [1] 324541 0
Treatment: Other
Comparator / control treatment
This is multi-site intervention trial. The comparator treatment is 'usual' care, during the Pre phase. The Pre phase will run over 4 weeks. In the ED settings the Pre phase will commence in March 2023 and in the surgical outpatient settings the Pre Phase will commence in August 2023. During this time, patients will receive 'usual' advice for discharge instructions (commonly this is verbal advice but in some instances may be accompanied by written advice).
Control group
Active

Outcomes
Primary outcome [1] 332673 0
Level of satisfaction with discharge instructions as reported on Likert scale on patient survey.
Timepoint [1] 332673 0
At 24 to 48 hours after ED or surgical outpatient department visit.
Primary outcome [2] 332674 0
Compliance with opioid medication instructions as assessed with self-report on patient survey designed specifically for this study.
Timepoint [2] 332674 0
At 24 to 48 hours after visit to ED or surgical outpatient department.
Primary outcome [3] 332675 0
Recall of opioid side-effects as assessed on patient survey designed specifically for this study.
Timepoint [3] 332675 0
24 to 48 hours after ED or surgical outpatient department visit.
Secondary outcome [1] 414332 0
Number of unscheduled follow ups to the ED or family doctor as assessed on patient survey designed specifically for this study.
Timepoint [1] 414332 0
At 5 to 7 days after ED or surgical outpatient department visit.
Secondary outcome [2] 414333 0
Difference in pain as assessed on Numerical Rating Scale (NRS) for pain on patient survey.
Timepoint [2] 414333 0
At 24 to 48 hours after ED or surgical outpatient department visit.
Secondary outcome [3] 414334 0
Doctor opioid prescribing patterns in the ED and surgical outpatient department as assessed by research assistant collecting data directly from doctor and patient survey designed specifically for this study.
Timepoint [3] 414334 0
After analysis of all usability testing data at end of 12 month trial period.
Secondary outcome [4] 414335 0
Methods of information seeking for further opioid medications information on patient survey designed specifically for this study.
Timepoint [4] 414335 0
At 24 to 48 hours after ED or surgical outpatient department visit.
Secondary outcome [5] 414336 0
Usability of desktop interface for creation of personalised, mobile-accessible patient discharge instructions as assessed through collection of question responses from doctors, direct observation of doctors using the WTDS system interface using a standard desktop and assessment of the interface with the System Usability Scale for usability.
Timepoint [5] 414336 0
After analysis of all usability testing data at end of 12 month trial period.

Eligibility
Key inclusion criteria
a) Patient participants
• aged 18 years and over
• acute musculoskeletal complaints not requiring admissions (strains, sprains, extremity fractures not requiring operative management, gouty arthritis)
• visceral complaints not requiring admission (abdominal pain, renal colic, gynaecological pain with negative pregnancy test, or biliary colic)
• post-operative pain associated with common general acute orthopaedic, plastics or surgical procedures (forearm fracture, wrist fracture, clavicle fracture, rib fracture, finger or thumb fracture, skin laceration, burn injury, cholecystectomy, appendicectomy)

b) Doctor participants
• physician currently employed or on rotation as a permanent staff member in the ED or surgical OPD
• no prior knowledge of the What the Doctor Said system for providing opioid instructions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a) Patient participants
• unwilling or unable to comply with follow up
• non-English speaking
• chronic pain syndrome
• clinical suspicion of drug-seeking behaviour
• patients who have undergone complex surgical procedures

b) Doctor participants
• prior participation in the pilot study at Sir Charles Gairdner Hospital or involvement with interface usability testing of the WTDS system

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical methods to be employed
Patient demographic and clinical data will be summarised using means and standard deviations medians and interquartile ranges for continuous data and frequency distributions for categorical data. Univariate group comparisons between independent pre and post implementation groups will be done using t-tests or non-parametric Mann-Whitney U tests for continuous data and Chi squared or Fisher’s Exact tests for categorical data. Logistic regression models will be used to compare categorical outcomes (including satisfaction ratings, recall of pain relief medication advice and receipt of information on medication side effects) between pre and post implementation groups, with results summarised as odds ratios and 95% confidence intervals (CIs). Linear regression models will be used to compare continuous outcomes between pre and post implementation groups, with results summarised as estimated marginal means and 95% CIs. All models will be adjusted for covariates that may be associated with outcomes or are different in the univariate group comparisons. Statistical analysis will be conducted using Stata 17.0 (StataCorp, College Station, Texas) and alpha=0.05.

A sample of n=120 (60 per phase) has 80% power to detect an OR of 1.61 in a logistic regression or an increase of 23% in proportion of outcome (eg satisfaction indicator) from an initial average 50% in a Fisher’s Exact test between two independent groups. (G*Power 3.1.9.7)

Usability testing
Quantifiable measures used will be:
• types of errors participants make before reaching an end-goal
• number of errors
• time on task

Software Usability Scale
A widely used Likert-type 10 question survey measuring a user’s satisfaction where responses are converted into an overall usability score out of 100.24 SUS scores can be converted into equivalent school grades, with scores above 90 representing a grade of “A” and a score of 0 to 60 representing a grade of “F” for usability.

Anticipated participant numbers
a) Patient participants
480 patient participants in total (60 x 4 sites Pre phase + 60 x 4 sites Post phase)

b) Doctors
Surveys
480 doctor participants in total (60 x 4 sites Pre phase + 60 x 4 sites Post phase)

Usability testing
40 doctor participants in total (10 x 4 sites Pre phase only)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
Date of last participant enrolment
Anticipated
30/11/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 23278 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 23279 0
Armadale Kelmscott Memorial Hospital - Armadale
Recruitment postcode(s) [1] 38649 0
6000 - Perth
Recruitment postcode(s) [2] 38650 0
6112 - Armadale

Funding & Sponsors
Funding source category [1] 312348 0
Commercial sector/Industry
Name [1] 312348 0
What the Doctor Said Pty Ltd
Country [1] 312348 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
What the Doctor Said Pty Ltd
Address
PO Box 75
West Perth WA 6872
Country
Australia
Secondary sponsor category [1] 313913 0
None
Name [1] 313913 0
None
Address [1] 313913 0
None
Country [1] 313913 0
Other collaborator category [1] 282438 0
Commercial sector/Industry
Name [1] 282438 0
What the Doctor Said Pty Ltd
Address [1] 282438 0
PO Box 75
West Perth, WA 6872
Country [1] 282438 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311711 0
Royal Perth Hospital HREC
Ethics committee address [1] 311711 0
10 Murray St
Perth WA 6000
Ethics committee country [1] 311711 0
Australia
Date submitted for ethics approval [1] 311711 0
03/10/2022
Approval date [1] 311711 0
19/12/2022
Ethics approval number [1] 311711 0
RGS5683

Summary
Brief summary
In Australia between 2015 and 2019, there were 2731 unintentional deaths due to prescription opioids1. Many consumers are unaware of how to use opioids safely and that opioids can cause addiction and harm. Many consumers are not receiving adequate instructions about opioids from doctors. When instructions are poor, consumers are less likely to receive the benefits of opioid medications and more likely to become opioid dependent.

Hospital settings such as the emergency department (“ED”) and the surgical outpatient department (“OPD”) are key risk areas for initiating treatment with opioids for acute pain after injury or surgery. Approximately 16% of patients who received their first opioid medication from a WA hospital between 2014 and 2015 were still taking opioids one year later.

The OPIOIDS Trial will be run as a multi-site intervention trial to assess the efficacy of personalised, mobile-accessible patient instructions for opioid medications at discharge from the ED and surgical OPD with patients and doctors.
Trial website
Trial related presentations / publications

Public notes

Contacts
Principal investigator
Name 122090 0
Dr Sumit Sinha-Roy
Address 122090 0
East Metropolitan Health Service
10 Murray Street
Perth, WA 6000
Country 122090 0
Australia
Phone 122090 0
+61 404 894 379
Fax 122090 0
Email 122090 0
Sumit.Sinha-Roy@health.wa.gov.au
Contact person for public queries
Name 122091 0
Dr Sumit Sinha-Roy
Address 122091 0
East Metropolitan Health Service
10 Murray Street
Perth, WA 6000
Country 122091 0
Australia
Phone 122091 0
+61 404 894 379
Fax 122091 0
Email 122091 0
Sumit.Sinha-Roy@health.wa.gov.au
Contact person for scientific queries
Name 122092 0
Dr Sumit Sinha-Roy
Address 122092 0
East Metropolitan Health Service
10 Murray Street
Perth, WA 6000
Country 122092 0
Australia
Phone 122092 0
+61 404 894 379
Fax 122092 0
Email 122092 0
Sumit.Sinha-Roy@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial will be shared after after results are published.
When will data be available (start and end dates)?
Immediately after publication and no end date.
Available to whom?
Only researchers who provide a methodologically sound proposal as approved by the Principal Investigators.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator Dr Sumit Sinha-Roy, 10 Murray Street, Perth 6000, Sumit.Sinha-Roy@health.wa.gov.au


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.