Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001241224
Ethics application status
Approved
Date submitted
27/04/2018
Date registered
23/07/2018
Date last updated
3/03/2020
Date data sharing statement initially provided
29/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Multimedia (MyStay) Intervention for managing patient experience (MIME) following total hip replacement surgery: a cluster randomised trial.
Scientific title
Multimedia (MyStay) Intervention for managing patient experience (MIME) following total hip replacement surgery: a cluster randomised trial.
Secondary ID [1] 292201 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a follow-up study however looking at a different population group - the multimedia intervention has been designed for patients following Total Hip Replacement surgery. The intervention, outcomes and conduct of the trial will be similar to that of ACTRN12614000340639.

Health condition
Health condition(s) or problem(s) studied:
Orthopeadic surgery - Hip replacement surgery 303680 0
Acute postoperative care 303681 0
Condition category
Condition code
Musculoskeletal 303060 303060 0 0
Osteoarthritis
Surgery 306702 306702 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The multimedia intervention comprises modules in a chapter based format that combines text, sound, graphics and animation to provide information to patients in relation to postoperative recovery and goals of care.
The multimedia intervention is designed to be a nurse-led intervention that is delivered to patients as a stand-alone program packaged for iPad presentation where the patient can navigate through the program daily. On Day 1 the nurses will discuss the program with the patients and help them navigate through, it is expected this will take approximately 5 minutes with each patient.
Monitoring of the intervention application and adherence to the intervention will be by direct observation daily by the nurse researcher who will visit the study wards each day.
The multimedia package has tailored information about expected recovery on each day from Day 1 to 5 after THR surgery. The THR the multimedia program runs for approximately:
* Day 1 - 10 minutes
* Day 2 - 5 minutes
* Day 3, 4 & 5 - 3-5 minutes
Patients will have the iPad with them for the duration of their stay and will be able to access the information as many times as they would like. They can also stop and start the program based on their needs. The iPad will be locked securely to the patients bedside.

The package provides information from Day 1 - Day 5 after THR surgery. It is expected that this multimedia intervention will facilitate an interaction between patients and nurses about goals and plans of care for the day based on the goals of recovery after THR surgery.
This trial will cross over when patient numbers have been reached in each cluster (approximately 6 weeks). The wash out period between intervention and control will be 4 weeks.
Participants in the intervention group will receive usual/standard/routine care in addition to the intervention.
Intervention code [1] 298357 0
Treatment: Other
Comparator / control treatment
In routine care, information regarding goals of recovery is provided to patients through a variety of means pre-admission education and throughout their recovery, however the information is not provided in a systematic way. Nurses deliver care according to the goals of recovery identified in care pathways but patients are not necessarily made aware of these pathways.
Control group
Active

Outcomes
Primary outcome [1] 302439 0
Pain Intensity using numerical rating scale (NRS)
Timepoint [1] 302439 0
Day 3 after THR surgery
Secondary outcome [1] 336005 0
Length of Stay in acute care - will be measured using Hospital Information Systems records following discharge. Length of stay will be calculated by counting Day of surgery (Day 0) to Day of discharge (Day X). Intervention efficacy measure.
Timepoint [1] 336005 0
discharge
Secondary outcome [2] 336006 0
Pain experience - Revised American Pain Society Questionnaire - Patient quality and safety measure
Timepoint [2] 336006 0
Day 3 after THR surgery
Secondary outcome [3] 336007 0
Hip pain and function - measured using the Oxford Hip Score - patient quality and safety measure. This is a composite measure - the OHS tool measures this in one questionnaire
Timepoint [3] 336007 0
4 week follow up has been changed to 6 week follow up
Secondary outcome [4] 336008 0
Incidence of complications - DVT - This will data will be obtained via Hospital medical record audit and also a question on the follow up patient questionnaire. Patient safety measure
Timepoint [4] 336008 0
4 week follow up has been changed to 6 week follow up
Secondary outcome [5] 336009 0
Patient Satisfaction - This is measured using the patient satisfaction measure and the NET promoter scale. Quality of care measure. Patient satisfaction will be measured using an 11 point likert scale 0-10 With "0" being dissatisfied to "10" extremely satisfied with care received.
Timepoint [5] 336009 0
4 week follow up has been changed to 6 week follow up
Secondary outcome [6] 336010 0
Patient Activation - this will be measured using the Patient Activation Measure (PAM) tool - patient quality care measure
Timepoint [6] 336010 0
4 week follow up has been changed to 6 week follow up
Secondary outcome [7] 336011 0
Preference for participation - measured using the Control Preference Scale (CPS) - patient quality of care measure
Timepoint [7] 336011 0
4 week follow up has been changed to 6 week follow up
Secondary outcome [8] 368836 0
EuroQOL (Eq-5D-5L) will be used to measure general health and quality of life.
Timepoint [8] 368836 0
6 weeks and 6 months post acute hospital discharge.

Eligibility
Key inclusion criteria
Elective admission for primary, unilateral, total hip replacement surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive impairment or lack of proficiency in English language that would interfere with informed consent or ability to complete questionnaires.

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)
Consenting patients will be given a questionnaire to complete and return pre-operatively either via mail (reply-paid envelope provided) or a suitable time will be arranged with patients to complete questionnaires with a research team member over the phone. In the event where patients are referred to preadmission clinic but do not attend, nursing staff will request permission from patients to share their contact details with researchers who will then contact them about the study. Pre-admission nurses will collect patients’ names, contact numbers and operating dates to provide to the research team. Patients will be called and informed about the study and a recruitment pack mailed out to those interested in participating. In the event that patients are not referred to preadmission clinic they will be approached once admitted to hospital and prior to surgery. In these situations patients will be informed by their Surgeons’ rooms that research team members may approach them prior to surgery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The wards will have been randomly assigned to a sequence of control (A) and intervention (B). The intervention “B”, will be allocated to 4 cohorts. The intervention appears at least once in each period and exactly twice in each of the two wards. The following two sequences will be randomised to the wards: ABBA and BAAB (Figure 1). Each cohort within a cluster (data collection period) is expected to be accrued and monitored over a period for 6 weeks.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Wash out period between clusters for 4 weeks will occur to minimize cross contamination
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary endpoint for the assessment of patient experience is the “worst pain experienced in the past 24 hours” on day 3 following surgery. Worst pain will be measured using the 0-10 Numerical Rating Scale (NRS) in which 0 equates to “No pain”, 5 equates to “Moderate pain” and 10 equates to “Worst possible pain”.

Patients will be asked to choose a whole number from 0 to 10 that best describes their worst pain in the previous 24 hours.

We look at one scenario for the power of the F test (a=0.05) to detect a difference between the intervention and the control in day-3 worst pain. The effect size (delta) is 1.45 and VW, VC and VP are 0.06, 0.20 and 7.61 respectively.
Cohort size 30; n=360 Power (1-B) 0.80
Pre-admission patient questionnaire will measure preference for participation and patient demographics.
Patient semi structured interviews on Day 3 after surgery will ask questions related to their experience with participation in their care after surgery. A questionnaire will also be administered to investigate preference for participation, perceived participation in care and pain experience.
The follow up questionnaire (6 weeks and 6 months after discharge) will ask questions regarding their perceptions of quality of care, preference for participation, patient experience, hip pain and function and patient satisfaction.
This mixed methods study will involve both qualitative and quantitative data analysis techniques.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
1) Randomisation occurred where patients admitted to ward A were in the intervention group and those admitted to ward B were in the control group. Due to natural hospital patient flow there were inequalities in the number of people admitted to each ward with a 1:2 (intervention:control) ratio. This pattern of admissions was unexpected and if it continues would result in prolonged recruitment to reach target numbers in each period.
2) Potential contamination occurred in the control group where some control participants may have received access to the intervention due to a technical issue related to the availability of the intervention on the Point-of-Care system. The potential for contamination was reported to the research team halfway through the first cross over period.
3) There was poor uptake of the intervention during the trial due to staffing issues and poor communication between members of the clinical team.
Date of first participant enrolment
Anticipated
1/04/2019
Actual
17/04/2019
Date of last participant enrolment
Anticipated
1/10/2020
Actual
10/07/2019
Date of last data collection
Anticipated
1/04/2021
Actual
Sample size
Target
360
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10803 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 22543 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 296739 0
Hospital
Name [1] 296739 0
Epworth HealthCare
Country [1] 296739 0
Australia
Primary sponsor type
Hospital
Name
Epworth HealthCare
Address
89 Bridge Rd, Richmond VIC 3121
Country
Australia
Secondary sponsor category [1] 295711 0
University
Name [1] 295711 0
Deakin University
Address [1] 295711 0
221 Burwood Hwy
Burwood, Vic, 3125
Country [1] 295711 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297966 0
Epworth HealthCare Human Research Ethics Committee
Ethics committee address [1] 297966 0
Ethics committee country [1] 297966 0
Australia
Date submitted for ethics approval [1] 297966 0
20/06/2018
Approval date [1] 297966 0
23/10/2018
Ethics approval number [1] 297966 0
Ethics committee name [2] 300252 0
Deakin Universtiy Human Research Ethics Committee
Ethics committee address [2] 300252 0
Ethics committee country [2] 300252 0
Australia
Date submitted for ethics approval [2] 300252 0
09/07/2018
Approval date [2] 300252 0
12/12/2018
Ethics approval number [2] 300252 0
2018-394
Ethics committee name [3] 303039 0
Monash Health HREC
Ethics committee address [3] 303039 0
Ethics committee country [3] 303039 0
Australia
Date submitted for ethics approval [3] 303039 0
15/03/2019
Approval date [3] 303039 0
25/03/2019
Ethics approval number [3] 303039 0
RES-19-0000-227E

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

Contacts
Principal investigator
Name 75606 0
Prof Mari Botti
Address 75606 0
Deakin University
221 Burwood Hwy
Burwood, Vic, 3125
Country 75606 0
Australia
Phone 75606 0
+61 3 426 6565
Fax 75606 0
Email 75606 0
jo.mcdonall@deakin.edu.au
Contact person for public queries
Name 75607 0
Jo McDonall
Address 75607 0
Deakin University
221 Burwood Hwy
Burwood, Vic, 3125
Country 75607 0
Australia
Phone 75607 0
+61 3 9244 6630
Fax 75607 0
Email 75607 0
jo.mcdonall@deakin.edu.au
Contact person for scientific queries
Name 75608 0
Jo McDonall
Address 75608 0
Deakin University
221 Burwood Hwy
Burwood, Vic, 3125
Country 75608 0
Australia
Phone 75608 0
+61 3 9244 6630
Fax 75608 0
Email 75608 0
jo.mcdonall@deakin.edu.au

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


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.