Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000340639
Ethics application status
Approved
Date submitted
20/03/2014
Date registered
31/03/2014
Date last updated
4/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Patient Participation In Postoperative Care Activities in Patients undergoing Total Knee Replacement Surgery: Multimedia Intervention for Managing patient Experience (MIME)
Scientific title
Patient Participation In Postoperative Care Activities in Patients undergoing Total Knee Replacement Surgery: Multimedia Intervention for Managing patient Experience (MIME)
Secondary ID [1] 283107 0
Nil Known
Universal Trial Number (UTN)
U1111-1147-3501
Trial acronym
MIME - Multimedia Intervention for Managing patient Experience
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute postoperative care
 289951 0
Patient participation
 291472 0
Total Knee Replacement Surgery 291473 0
Condition category
Condition code
Public Health 290517 290517 0 0
Health promotion/education

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.

The multimedia package has tailored information about expected recovery on each day from Day 1 to 5 after TKR surgery. The TKR 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 TKR 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 TKR surgery.

This trial will cross over when patient numbers have been reached in each cluster (approximately 3 weeks). The wash out period between intervention and control will be 2 weeks.
Intervention code [1] 287826 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] 290540 0
Pain intensity

Measured using the Numerical Rating Scale 0-10
Timepoint [1] 290540 0
Day 3 after TKR surgery
Primary outcome [2] 291756 0
pain experience

Measured using the American Pain Society Outcome Questionnaire
Timepoint [2] 291756 0
Day 3 after TKR surgery
Secondary outcome [1] 304755 0
Overall satisfaction

Measured using Global satisfaction questions and NET Promoter Scale


Timepoint [1] 304755 0
Pre Admission, Day 3 after TKR surgery and 4 weeks after discharge from acute care
Secondary outcome [2] 307431 0
Patient experience

Measured using the Picker Patient Experience Questionnaire (PPE-15)
Timepoint [2] 307431 0
Pre Admission, Day 3 after TKR surgery and 4 weeks after discharge from acute care
Secondary outcome [3] 307432 0
Perceived Participation

Measured using Modified perceived involvement in care scale (PICS)
Timepoint [3] 307432 0
Day 3 after TKR surgery and 4 weeks after discharge from acute care
Secondary outcome [4] 307433 0
Perceived quality of care

Measured using Modified Patients Perceptions of Quality of Care (PPQ-SF)
Timepoint [4] 307433 0
Day 3 after TKR surgery and 4 weeks after discharge from acute care

Eligibility
Key inclusion criteria
Primary TKR
greater than 18 years of age
No cognitive impairment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous TKR surgery
Unable to provide consent

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)
Patient participant recruitment will take place using one of two methods:
Method 1 – Consultants’ rooms:
*Orthopaedic consultant will be provide potential participants with written information about the study and obtain verbal consent for the researcher to contact them by telephone after their visit and before surgery and provide them with a study pack,
*If the patient agrees to receive further information about this study they will be telephoned by a member of the research team to provide information about the study, expectations of participation, answer any questions they may have and invite participation in the study,
*Patients who agree to participate will be invited to complete and return via mail, a Participant Information and Consent Form and written questionnaire before admission for surgery.

Method 2 – Preadmission clinic:
*The preadmission clinic coordinator will speak to all patients scheduled for TKR 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 coordinator, consultant surgeons and/or the secretary in the consultants rooms are not aware which ward the patient/s will be admitted following TKR 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 three orthopaedic wards at the hospital through normal hospital procedures.
The wards will be randomly assigned to one of three sequences of control (A) and intervention(B). The randomization was determined by a coin toss. Ward 1 will use the sequence ABB, Ward 2 will use the sequence BAB and Ward 3 will use the sequence BBA. Crossover will occur three times during the sequence with a 2 week ‘washout’ period in between. Each cohort within a cluster (data collection period) will be accrued and monitored over a period for 2 – 4 weeks. Each wash out period (usual care on both wards, no data collection) between cohorts will last 2 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 the multi-media 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
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 1.5 and VW, VC and VP are 0.025, 0.025 and 4 respectively.

Cohort size 20; n=180 Power (1-B) 0.81
Cohort size 25; n=225 Power (1-B) 0.87

(= equal to in all instances)

Pre-admission patient questionnaire will measure preference for participation and patient expectations.

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 after discharge) will ask questions regarding their perceptions of quality of care, preference for participation, patient experience and patient satisfaction.

This mixed methods study will involve both qualitative and quantitative data analysis techniques.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/03/2014
Actual
12/03/2014
Date of last participant enrolment
Anticipated
31/10/2014
Actual
26/06/2015
Date of last data collection
Anticipated
Actual
27/11/2015
Sample size
Target
220
Accrual to date
Final
241
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1534 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 7582 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 287994 0
University
Name [1] 287994 0
Deakin University
Country [1] 287994 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy
Burwood, Victoria, 3125
Country
Australia
Secondary sponsor category [1] 286713 0
None
Name [1] 286713 0
Address [1] 286713 0
Country [1] 286713 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289919 0
Epworth HealthCare Human Research Ethics Committee
Ethics committee address [1] 289919 0
Ethics committee country [1] 289919 0
Australia
Date submitted for ethics approval [1] 289919 0
Approval date [1] 289919 0
01/07/2013
Ethics approval number [1] 289919 0
598-13
Ethics committee name [2] 290224 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [2] 290224 0
Ethics committee country [2] 290224 0
Australia
Date submitted for ethics approval [2] 290224 0
Approval date [2] 290224 0
03/09/2013
Ethics approval number [2] 290224 0
2013-195

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

Contacts
Principal investigator
Name 42526 0
Prof Mari Botti
Address 42526 0
Epworth Deakin Centre for Clinical Nursing Research
185 Hoddle Street
Richmond, Victoria, 3121
Country 42526 0
Australia
Phone 42526 0
+61 3 94266565
Fax 42526 0
Email 42526 0
[email protected]
Contact person for public queries
Name 42527 0
Jo McDonall
Address 42527 0
Epworth Deakin Centre for Clinical Nursing Research
185 Hoddle Street
Richmond, Victoria, 3121
Country 42527 0
Australia
Phone 42527 0
+61 3 94266565
Fax 42527 0
Email 42527 0
[email protected]
Contact person for scientific queries
Name 42528 0
Mari Botti
Address 42528 0
Epworth Deakin Centre for Clinical Nursing Research
185 Hoddle Street
Richmond, Victoria, 3121
Country 42528 0
Australia
Phone 42528 0
+61 3 94266565
Fax 42528 0
Email 42528 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbasePatient participation in postoperative care activities in patients undergoing total knee replacement surgery: Multimedia Intervention for Managing patient Experience (MIME). Study protocol for a cluster randomised crossover trial.2016https://dx.doi.org/10.1186/s12891-016-1133-5
EmbasePatient activation intervention to facilitate participation in recovery after total knee replacement (MIME): A cluster randomised cross-over trial.2019https://dx.doi.org/10.1136/bmjqs-2018-008975
N.B. These documents automatically identified may not have been verified by the study sponsor.