Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12622000516785p
Ethics application status
Submitted, not yet approved
Date submitted
4/03/2022
Date registered
31/03/2022
Date last updated
31/03/2022
Date data sharing statement initially provided
31/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of text messaging service on management of post-operative pain in opioid-naïve surgical patients
Scientific title
Evaluation of a persona-based text messaging service ‘Nellie’ for opioid-naïve surgical patients in the management of post-operative pain
Secondary ID [1] 306594 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-operative pain 325502 0
Condition category
Condition code
Anaesthesiology 322912 322912 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A prospective randomised two-arm study of opioid-naïve surgical patients consented and enrolled to the Nellie persona-based text message post-operative self-management service by the clinical pharmacy team compared to a control cohort.
This study will take place in the surgical units of an Australian Major Hospital (Frankston hospital Surgical Short Stay Unit, Acute Medical and Surgical Unit and 5GN) with real-time follow-up and monitoring at home for 30 days post-discharge via SMS .
We will compare the ‘Nellie intervention’, a persona-based, interactive and automated text messaging service with a ‘Nellie control’ arm, randomized in a 1:1 ratio.

Nellie Intervention population will be invited to accept self-management smart messaging service with timed protocol text reminders on medication management, education on pain and reminders to return unused opioid medication. Education resource links are form betterhealth available at https://www.betterhealth.vic.gov.au/health/conditionsandtreatments/pain-and-pain-management-adults

Real time data is collected on the Nellie dashboard once patients participate in the messaging.

If a patient request further support or information they will be directed to their GP. There is no direct patient contact follow-up with phone calls beyond standard care.

Message schedule for intervention group
Day 0 Welcome message,
"Hi, I'm Nellie, your self-care service. I wish to confirm if you want to join in. Get started by replying "accept". Don't reply if you didn't ask to join in."
Evening message triggered by patient replying with 'accept"
"Hi, it's Nellie. Thanks for joining. I'm here to help you manage your own health better. At times I'll send advice for you to act on. You can opt out at any time by replying STOP."
Day 1 to 7, 14,21 and 30 "HowRu? Survey" references (1-6).
Day 1 to 4 at 10:30 and 18:00 information to limit opioid use examples include:
"Hi, Okay, keep taking your anti-inflammatory (if prescribed) along with regular paracetamol for now. Only use the Oxycodone, Tramadol or Tapentadol if required for severe pain not managed by your simple pain relief. The aim of pain relief medicine is to give you more function – you may not become 100% pain free. For more tips to help with your pain, you can text the word PAIN at any time, Nell"

"Hi again, please avoid taking your pain medication at a dose higher than prescribed, as you may get more side effects like dizziness, drowsiness or constipation. Take care, Nell."

"Remember, your body will continue to recover & the need for pain medication will gradually decrease. If you need some ideas about how to help with your pain, you can text the word Pain at any time. Take it easy, Nellie"

"Hi, it's important that you know that you don't need to complete all of the pain medication you've been given. Only take it while you need it, Nell."

"Hey, when you feel that your pain is controlled, stop your anti-inflammatory (if prescribed) & take paracetamol as required."

"Hi there, it's really important that you only use your pain medication to relieve pain. There's a high risk of them causing you harm if you take it for other reasons, Nell."

"Morning! If you're still in pain after you've finished your supplied medications, see your GP for advice. You can get some ideas about how to manage pain by replying to this message with the word PAIN, Nell."

Pain extra information message optionally triggered by the patient replying with the word "pain".
"Physical therapies can help to relieve pain. Gentle walking, stretching, strength or aerobic exercises may help to relieve pain. They can also help you stay mobile and improve your mood. Start slowly at first and gradually build up over a few days."

"Relaxation is known to help with pain. Examples are meditation and yoga. Try it now, sit or lie down in a quiet spot and focus on breathing in and out deeply for at least a minute. How does that feel? Other ways to do this are to listen to relaxing music, read a book or watch something good on TV.
For more information about how to manage pain, go to betterhealthpain"

Day 7, 14, 21 and 30 Check-in message for reducing opioid use at 14:00
"Hi, strong opioids are not normally needed for more than a week. It's important to reduce your use as soon as your pain improves.
Are you still taking Oxycodone, Tapentadol or Tramadol for your pain? Reply for Y or N (if you haven't)"
If patient replies Y
"Okay, there is a risk of addiction developing to opioids like Oxycodone, Tapentadol or Tramadol especially if taken for more than a few days. It's important to be careful & to switch to other ways of managing your pain as soon as you can. For more information about how to manage your pain see betterhealthpain"
If patient replies N
"Okay thanks. If you have any leftover Oxycodone, Tapentadol or Tramadol it is wise to return them to your local pharmacy for safe disposal. Your medication should not be shared with anyone. This may result in serious harm, Nell."

Day 7 Advice to return unused medicines
"If you have any leftover Oxycodone, Tapentadol or Tramadol it is wise to return them to your local pharmacy for safe disposal. Your medication should not be shared with anyone. This may result in serious harm, Nell."

Day 30 at 15:00
"Hi, did you return any leftover Oxycodone, Tapentadol or Tramadol tablets to the local pharmacy? Reply Y (if you did) or No (if you didn't), or ALL USED (if you had none left to return)."
NetPromoter satisfaction survey
"Thanks for participating. The messages from me will now end. Remember, you can speak to your GP if you are concerned - they are there to help. Take care, Nellie."

All patients (control and intervention) will receive standard clinical care and discharge medication counselling by the Pharmacy Team. Both populations will be invited to text responses to patient outcome questions according to the timed protocol via mobile text messages relating to pain, opioid use, satisfaction with Nellie and disposal of unused opioid medications via R-outcomes on the Nellie platform. R-outcomes is a family of short generic patient-reported outcome and experience measures (PROMs and PREMs respectively). PROMs are about the subject of care; PREMs are about the service provided.

The Nellie platform is a web-based dashboard for clinicians to access and manage their patients, as well as being able to be tailored at the individual patient level. Message protocols are carefully designed to promote Nellie’s supportive persona, while delivering evidence-based key messages. The interactive nature of Nellie’s programs require patients to respond to Nellie’s requests for information and reply with algorithm-generated and appropriate responses. Evidence from evaluations of the UK version of the Nellie platform (which is called “Florence”) indicate that the use of smart messaging is more effective in influencing patient behaviour than standard informational text messaging alone.

References
1. Benson T. Measure what we want: a taxonomy of short generic person-reported outcome and experience measures (PROMs and PREMs). BMJ Open Quality 2020;9:e000789. doi:10.1136/ bmjoq-2019-000789
2. Benson T, Sladen J, Liles A, et al. Personal Wellbeing Score (PWS)—a short version of ONS4: development and validation in social prescribing BMJ Open Quality 2019;8:e000394. doi: 10.1136/bmjoq-2018-000394 available at https://bmjopenquality.bmj.com/content/8/2/e000394
3. Edwards KJ, Walker K, Duff J. Instruments to measure the inpatient hospital experience: A literature review. Patient Experience Journal. 2015; 2(2):77-85. doi: 10.35680/2372-0247.1088.
4. Simple telehealth Florence, Nellie, Annie available at http://www.simple.uk.net/
5. Patient reported outcome measures (PROMs) available at https://r-outcomes.com/
6. Outcome report tools and resources available at https://www.semphn.org.au/resources/qi.html
7. Cottrell E, Cox T, O’Connell P, et al. Patient and professional user experiences of simple telehealth for hypertension, medication reminders and smoking cessation: a service evaluation. BMJ Open 2015;5:e007270.doi:10.1136/bmjopen-2014-007270
8. Cottrell E, McMillan K, Chambers R. A cross-sectional survey and service evaluation of simple telehealth in primary care: what do patients think?. BMJ Open. 2012;2:e001392. Doi:10.1136/bmjopen-2021-001392
Intervention code [1] 323023 0
Rehabilitation
Intervention code [2] 323024 0
Prevention
Comparator / control treatment
Nellie control (NC) population will be invited to accept post-operative messages, an initial acceptance message on day 1 (day of discharge) and a final message on day 30. NC but will not receive ongoing self-management smart messages according to a timed protocol with text reminders on medication management, education on pain and reminders to return unused opioid medication.
All patients (control and intervention) will receive standard clinical care and discharge medication counselling by the Pharmacy Team which includes:

Standard Care Pharmacy Practice for Post-operative patients
1. Medications prescribed are clinically appropriate for patient
2. Legal dispensing/supply requirements of prescriptions are followed (this includes checking SafeScript)
3. Provide patient education:
• Discuss the discharge medication plan with the patient, including how long they should expect to be taking analgesia, what duration of pain relief to expect from each analgesic and the aim of therapy (e.g. to allow rehabilitation and mobility).
• Discuss the individual medications and how to take them
• Discuss what to do if they continue to have pain or their pain resolves and they don’t feel they need to take the medications
• Explain how to dispose of unwanted medication
• Provide the patient with the ‘Department of Surgery, Medication Information for Discharge’ leaflet.
Control group
Active

Outcomes
Primary outcome [1] 330658 0
The primary outcome is the proportion of patients taking opioids post-discharge.
The data will be linked from the Nellie platform system to the demographic data obtained from the electronic health record.
Timepoint [1] 330658 0
Proportion of patients taking opioids post-discharge at day 30.
Secondary outcome [1] 407102 0
Proportion of patients engaged with Nellie as measured via the response rate to SMS messages post-discharge.
Response rate to SMS messages = Total number of responses to SMS messages /Total number of message with expected responses at 30 days post-discharge.
Response rate will be assessed using the outcome data from the Nellie platform.
Adequate patient response is defined as answering greater than 50% of text messages received, a threshold used previously in the literature for electronic survey compliance.

Reference
1. Nota SPFT, Strooker JA, Ring D. Differences in response rates between mail, e-mail, and telephone follow-up in hand surgery research. Hand (NY). 2014;9(4): 504–510.
Timepoint [1] 407102 0
Response rate to SMS messages = Total number of responses to SMS messages /Total number of message with expected responses at 30 days post-discharge.
Secondary outcome [2] 407103 0
The proportion of patients with pain and comfort via The "HowRU?" SMS survey.
Descriptors such as pain, feeling low or worried, limited in what you can do, require help from others will be measured on a scale of 1-4
1 = no pain (none),
2 = minimal pain (a little),
3 = moderate pain (Quite a lot),
4 = severe pain (extreme)
and dichotomised into “no pain/discomfort” for a score of 1
and ‘some pain/discomfort’ for scores of 2-4.
Timepoint [2] 407103 0
Day 1 to 7, 14, 21 and 30 post-discharge.
Secondary outcome [3] 407104 0
Proportion of patient reported satisfaction with Nellie via 10 point Likert PROM survey of satisfaction via Net Promoter score (NPS).
Satisfaction in care will be measured from 0 (extremely dissatisfied) to 10 (extremely satisfied) and will be dichotomised into “highly satisfied” for scores of 9-10 and “not highly satisfied” for scores of 0-8.

Timepoint [3] 407104 0
Proportion of patient reported satisfaction with Nellie via 10 point Likert PROM survey at Day 30 post-discharge.
Secondary outcome [4] 407721 0
Proportion of patient-reported safe disposal or return of unused opioids to local pharmacy post-discharge.
It is assessed via SMS response to message question at day 14,21 and 30 post-discharge via the Nellie platform..
Timepoint [4] 407721 0
Day 14, 21 and 30 post-discharge days.

Eligibility
Key inclusion criteria
Inclusion
Adult patients (18 years or older) undergoing surgery requiring at least overnight stay and prescribed opioid medication while in hospital post-surgery AND expected to need opioid analgesia for more than 48 hours after discharge
Surgery Categories and Types
General Surgery
• Inguinal hernia repair
• Laparoscopic cholecystectomy
• Umbilical hernia repair
• Epigastric hernia repair
• Appendectomy Breast surgery
• Simple mastectomy
• Lumpectomy
Colorectal surgery
• Left/sigmoid resection
• Ileocolic resection
• Low anterior resection
• Total colectomy Endocrine neck surgery
• Parathyroidectomy
• Thyroidectomy
Urology
• Laparoscopic prostatectomy
• TURP Vascular
• Varicose veins
• Femoral-popliteal bypass
• Toe amputation
Plastic
• Wound debridement
• Skin lesion excisions Gynaecology
• Laparoscopic hysterectomy
• Vaginal hysterectomy
• Total abdominal hysterectomy
• Posterior/anterior repairs
• Laparoscopic oophorectomy

Patients with the ability to consent and the ability to receive and send SMS text messages.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
1. Patients taking opioids at the time of or prior to admission (e.g. on long-term oxycodone, oxycodone/naloxone, morphine, buprenorphine, buprenorphine/naloxone, hydromorphone, methadone, tramadol and tapentadol)
2. Undergone major surgeries with prolonged hospital stays in the past 12 months
3. Patients who have a documented discharge pain plan by the Acute Pain Team
4. Patients who do not understand written and verbal English
5. Patients with substance use disorder history (e.g. alcohol dependence, intravenous drug use) as per hospital medical records.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We have based our primary outcome (the proportion who are still on opioids 30-days post discharge) on previously demonstrated rates of persistent opioid use following surgery which range from 3-10%. We propose a total sample size of 700 (350 people in each arm). This would provide a 90% confidence level with 80% power, of detecting a 3% absolute difference between the groups (e.g. if the rate of opioid use at 30-days post discharge was 6% in the control group and 3% in the active group), with an additional 20% to allow for attrition.

Nellie engagement, return of unused medications, patient comfort levels and any other categorical variables can be compared using Chi squared. The satisfaction with the Nellie system and other continuous variables will be compared using Mann-Whitney U test.

Descriptive statistics will be calculated for patient demographics for comparison between the control and intervention groups.
A two-tailed p-value of less than 0.05 will be considered statistically significant.
Data analysis will be through statistical software SPSS 19.
Analysis will be carried out by study investigators. Where required, assistance from a skilled biostatistician with be employed.
Sample Size
A target of 700 enrolled patients was established using a calculator with a 90% Confidence interval, power of 80%. The reported rate of opioid use beyond 30 days post-operatively is between 3 to 10% in the literature. 350 patients will be randomised to each arm. This allows for an attrition rate of 20%. Up to 1500 surgical patients are admitted to PH per month

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/04/2022
Actual
Date of last participant enrolment
Anticipated
31/05/2022
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310925 0
Hospital
Name [1] 310925 0
Peninsula Health
Country [1] 310925 0
Australia
Primary sponsor type
Hospital
Name
Peninsula Health Pharmacy Department
Address
2 Hastings Road,
Frankston,
Vic 3199
Country
Australia
Secondary sponsor category [1] 312221 0
Government body
Name [1] 312221 0
South Eastern Melbourne Primary Healthcare
Address [1] 312221 0
Level2/15 Corporate Drive, Heatherton Vic 3202
Country [1] 312221 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310485 0
Peninsula Health HREC
Ethics committee address [1] 310485 0
Ethics committee country [1] 310485 0
Australia
Date submitted for ethics approval [1] 310485 0
04/03/2022
Approval date [1] 310485 0
Ethics approval number [1] 310485 0

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

Contacts
Principal investigator
Name 117834 0
Ms Gillian Oates
Address 117834 0
Peninsula Health,
2 Hastings Road,
Frankston,
Vic 3199
Country 117834 0
Australia
Phone 117834 0
+6103 97847601
Fax 117834 0
Email 117834 0
[email protected]
Contact person for public queries
Name 117835 0
Gillian Oates
Address 117835 0
Peninsula Health,
2 Hastings Road,
Frankston,
Vic 3199
Country 117835 0
Australia
Phone 117835 0
+6103 97847601
Fax 117835 0
Email 117835 0
[email protected]
Contact person for scientific queries
Name 117836 0
Gillian Oates
Address 117836 0
Peninsula Health,
2 Hastings Road,
Frankston,
Vic 3199
Country 117836 0
Australia
Phone 117836 0
+6103 97847601
Fax 117836 0
Email 117836 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data obtained through this research may be provided by qualified researchers with academic interest in opioid addiction and post-operative pain. Data shared will be coded, with no personal health information included.
When will data be available (start and end dates)?
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions can be considered on a case-by-case basis.
Available to whom?
To qualified researchers engaging in independent scientific research and according to data sharing agreement. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Available for what types of analyses?
For the analysis of the data and meta-anaylsis.
How or where can data be obtained?
Access subject to approvals by PI Gillian Oates [email protected]. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.


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.