Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001241224p
Ethics application status
Submitted, not yet approved
Date submitted
27/04/2018
Date registered
23/07/2018
Date last updated
23/07/2018
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 weeks after discharge and 6 months after discharge
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
four weeks after discharge
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 weeks after discharge
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
Pre-admission - prior to surgery. This may be one day prior up to 1 month prior to surgery.
Day 3 post THR surgery (Day 0 being day of surgery)
4 weeks after discharge from acute care
6 months after discharge from acute care
Secondary outcome [7] 336011 0
Preference for participation - measured using the Control Preference Scale (CPS) - patient quality of care measure
Timepoint [7] 336011 0
Pre admission - this could be one day prior to admission up to 1 month prior to admission
Day 3 post THR surgery (Day 0 is day of surgery)
4 weeks and 6 months after discharge from acute care

Eligibility
Key inclusion criteria
Elective admission for primary, unilateral, total hip replacement surgery.
Minimum age
18 Years
Maximum age
No limit
Gender
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)
The preadmission clinic coordinator will speak to all patients scheduled for THR prior to their attendance at the clinic and/or admission for surgery. She will explain to patients they may be approached at the clinic in relation to possible participation in a research study.

A member of the research team will attend the clinics and liaise with the clinic coordinator about potential participants. Suitable patients will be approached by the researcher who will invite them to read a study information sheet. She will also be available throughout the clinic and afterwards to meet with individuals to discuss the project and clarify requirements of participation. Those interested in participation will be provided with a Participant Information and Consent Form.

Written consent may be obtained from participants at this time and the pre admission questionnaire will be given to patients to either take home or complete whilst in the clinic. Alternatively the researcher will seek permission for a follow up telephone call to invite participation and will collect the completed written consent form when they are admitted to hospital.

Allocation concealment
The pre admission coordinators are not aware which ward the patient/s will be admitted following THR surgery. A central hospital admissions site, on the day of admission, will allocate patients to the wards, this area is not involved or aware of the study, and the allocation is based on available beds.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be admitted to one of the orthopaedic wards at the hospital through normal hospital procedures.
The wards will have been randomly assigned to a sequence of control (A) and intervention (B). The intervention “B”, will be allocated to 6 cohorts. The intervention appears at least once in each period and exactly twice in each of the three wards. The following three sequences will be randomised to the wards: ABBA, BAAB and ABAB. The randomization was determined by a coin toss. Each cohort within a cluster (data collection period) is expected to be accrued and monitored over a period for 6 weeks. Each wash out period (usual care on both wards, no data collection) between cohorts will last 4 weeks in duration.
Patient participants admitted to the control ward (A) during data collection period will receive usual care.
Patient participants admitted to the intervention (B) ward during data collection will receive usual care plus the multimedia intervention each day, commencing on Day 1 after surgery.
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 (4 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2018
Actual
Date of last participant enrolment
Anticipated
15/06/2020
Actual
Date of last data collection
Anticipated
30/01/2021
Actual
Sample size
Target
240
Accrual to date
Final
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
Address [1] 296739 0
89 Bridge Rd, Richmond VIC 3121
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
Submitted, not yet approved
Ethics committee name [1] 297966 0
Epworth HealthCare Human Research Ethics Committee
Ethics committee address [1] 297966 0
Epworth HealthCare, 89 Bridge Rd, Richmond VIC 3121
Ethics committee country [1] 297966 0
Australia
Date submitted for ethics approval [1] 297966 0
20/06/2018
Approval date [1] 297966 0
Ethics approval number [1] 297966 0
Ethics committee name [2] 300252 0
Deakin Universtiy Human Research Ethics Committee
Ethics committee address [2] 300252 0
Deakin University
221 Burwood Hwy,
Burwood, 3125, Victoria
Ethics committee country [2] 300252 0
Australia
Date submitted for ethics approval [2] 300252 0
09/07/2018
Approval date [2] 300252 0
Ethics approval number [2] 300252 0

Summary
Brief summary
The proposed study has as its focus, the important shared role patients can have in determining the outcomes of their healthcare in the context of postoperative recovery after orthopaedic surgery, specifically, total hip replacement (THR).
The research program has two major aims:
1) to test a multimedia intervention to improve patients’ participation in their postoperative care; and
2) to model various patient processes of care and system factors that may impact on patients’ overall experience and satisfaction with hospital care after surgery.
A nurse-led, multimedia intervention expected to increase both the capability (through information) and opportunity (through facilitation) of patients to participate in their goals of care will be introduced during the immediate postoperative period after elective THR surgery. Advances in information technology, hand held devices and multimedia techniques provide innovative ways to embed nurse-led approaches into the
processes of care that can facilitate patients’ participation in their care.
A cluster randomised, crossover designed study will be implemented in conjunction with mixed-methods data collection and analysis. The setting will be orthopaedic wards located at a major, private, metropolitan hospital. Patients undergoing primary THR surgery and able to provide consent will be recruited to the study, patients in the cross over groups will receive usual care as per the THR pathway.
The intervention will be the application of the nurse-led, multimedia goals of care education package designed to be delivered daily to patients at the bedside by nurses in order to improve patient participation during their recovery.
Data collection methods will include patient interviews and patient questionnaires.
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
Dr 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
Dr 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

No data has been provided for results reporting
Summary results
Not applicable