Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000576628
Ethics application status
Approved
Date submitted
5/05/2023
Date registered
25/05/2023
Date last updated
16/05/2024
Date data sharing statement initially provided
25/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of routine collection of patient reported outcome measures
Scientific title
Feasibility of routine collection of patient reported outcome measures (PROMs) using a co-designed collection system in general medicine and rehabilitation ward patients
Secondary ID [1] 309392 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rehabilitation 329623 0
General medicine 329997 0
Geriatric Medicine 329998 0
Health Services Research 330045 0
Condition category
Condition code
Physical Medicine / Rehabilitation 326546 326546 0 0
Other physical medicine / rehabilitation
Public Health 326714 326714 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name of the intervention: Co-designed PROMs collection system. This system, including the PROMs collected, modes of delivery of PROMs, who assists with delivery of PROMs and timing of collection of PROMs (described below) was co-designed with healthcare consumers.

Materials used: The PROMs will be the Euroqol 5-Dimension Quality of Life tool (EQ-5D-5L) with added items on fatigue and cognition. The added cognitive item is scored on the same response levels as the EQ-5D-5L. The added fatigue item is from the Rivermead Post-Concussion Symptoms Questionnaire. Completion of PROMs will take 5-10 minutes.

Who will deliver the intervention: The PROM will be administered by a volunteer and/or research assistant (i.e. not a health professional) and/or self-completion.

Mode of Delivery: electronic (tablet, smart phone) or face to face using a paper based version of the PROM in hospital; and electronic (tablet, smart phone) or telephone in private residences and residential aged care facilities.

Location: The PROM will be administered at hospital wards (acute and sub-acute); private residences; and residential aged care facilities.

Timing and dose: PROMs are administered on 2 occasions: 1) at discharge from hospital (acute or sub-acute) and 2) at 3-6 months following discharge. Patients will receive one follow-up at 3-6 months regardless of how any times they are admitted to hospital during the trial period. This follow-up will be 3-6 months following discharge from hospital at first admission.

Procedures and personalisation: As early as possible during their hospital stay, patients will be informed of PROMs data collection and will be provided with the opportunity to indicate their preference for mode of collection. Participants with cognitive impairment will complete the PROM via proxy (i.e. family member, next of kin, carer completes the PROM on their behalf).
Intervention code [1] 325828 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334388 0
Feasibility: Demand Domain- Demand for the PROMs collection system will be determined by measuring the proportion of participants who complete the PROM at 1) discharge from the health service and 2) at follow up. Completion rates will be captured by data obtained from the National Centre for Healthy Ageing, Healthy Ageing Data Platform which contains curated research grade structured data derived from multiple Peninsula Health electronic health record systems. Information on reasons why patients refused to complete PROMs/use the PROMs collection system will also be collected and documented by volunteers and research assistants using field notes.
Timepoint [1] 334388 0
Time of discharge from acute or sub-acute hospital and 3-6 month follow up.
Primary outcome [2] 334574 0
Feasibility: Implementation Domain- Implementation will be determined by measuring the item completion/completeness of data (i.e. missing PROM data) at baseline and follow-up. This information will be captured by the electronic system used to collect PROMs.
Timepoint [2] 334574 0
Time of discharge from acute or sub-acute hospital and 3-6 month follow up.
Primary outcome [3] 334576 0
Feasibility: Implementation Domain- Implementation domain will be determined by measuring the proportion of participants who complete the PROM via electronic interface and the proportion who complete paper-based PROM at discharge from hospital. This data will be collected by research assistants and volunteers.
Timepoint [3] 334576 0
Time of discharge from acute or sub-acute hospital and 3-6 month follow up.
Secondary outcome [1] 420474 0
Feasibility: Implementation Domain (Primary Outcome) Implementation domain will be determined by measuring the proportion of participants who complete the PROM via electronic interface and the proportion who complete the PROM via telephone. This data will be collected by research assistants and volunteers.
Timepoint [1] 420474 0
Time of discharge from acute or sub-acute hospital and 3-6 month follow up.
Secondary outcome [2] 421264 0
Feasibility: Implementation Domain (Primary Outcome) Implementation domain will be determined by measuring the proportion of participants who are administered the PROM via a volunteer and the proportion who are administered the PROM via a research assistant. This information will be collected by research assistants and volunteers.
Timepoint [2] 421264 0
Time of discharge from acute or sub-acute hospital and 3-6 month follow up.
Secondary outcome [3] 421265 0
Feasibility: Implementation Domain (Primary Outcome) Implementation domain will be evaluated by measuring the time taken for participants to complete the PROM. This information will be routinely captured by the electronic system used to collect PROMs and also collected by research assistants at time of administration of the PROM.
Timepoint [3] 421265 0
Time of discharge from acute or sub-acute hospital and 3-6 month follow up.
Secondary outcome [4] 421266 0
Feasibility: Implementation Domain (Primary Outcome) Implementation domain will be evaluated by participants' suggestions for improving the ease of use of the collection system. This information will be collected from participants by research assistants
Timepoint [4] 421266 0
Time of discharge from acute or sub-acute hospital and 3-6 month follow up.
Secondary outcome [5] 421267 0
Feasibility: Practicality Domain (Primary Outcome) Practicality domain will be evaluated by measuring the costs associated with IT infrastructure, staff assisting participants to use the collection system, and completing participant follow up. Data relating to costs will be routinely collected by senior researchers on the project. Costs relating to staffing will be estimated using the time that research assistants spent administering PROMs to participants (i.e., times that volunteers were not available) and award rates for non-clinician health professionals, including ward clerks and allied health assistants.
Timepoint [5] 421267 0
Time of discharge from acute or sub-acute hospital and 3-6 month follow up.
Secondary outcome [6] 421268 0
Feasibility: Practicality Domain (Primary Outcome) Practicality domain will be evaluated by measuring time staff/volunteers spend assisting participants to use the collection system, and completing participant follow-up via telephone. This information will be routinely collected by research assistants and volunteers.
Timepoint [6] 421268 0
Time of discharge from acute or sub-acute hospital and 3-6 month follow up.
Secondary outcome [7] 421269 0
Feasibility: Practicality Domain (Primary Outcome) Practicality domain will be evaluated by measuring the proportion of participants who require assistance with completing the PROM. This data will be routinely collected by research assistants and volunteers.
Timepoint [7] 421269 0
Time of discharge from acute or sub-acute hospital and 3-6 month follow up.
Secondary outcome [8] 421270 0
Feasibility: Practicality Domain (Primary Outcome) Practicality domain will be evaluated by measuring the details of the assistance provided to participants. This data will be routinely collected by research assistants and volunteers.
Timepoint [8] 421270 0
Time of discharge from acute or sub-acute hospital and 3-6 month follow up.
Secondary outcome [9] 421275 0
Feasibility: Acceptability Domain (Primary Outcome) Acceptability domain will be evaluated by measuring the acceptability of the PROM. This will be determined by using participant level of agreement on a four point Likert scale (‘strongly disagree’ to ‘strongly agree’), with pre-established survey items relating to experience with completing the PROM. The survey is administered by research assistants following completion of the PROM.
Timepoint [9] 421275 0
Time of discharge from acute or sub-acute hospital and 3-6 month follow up.
Secondary outcome [10] 421277 0
Feasibility: Acceptability (Primary Outcome): Volunteer perceptions of feasibility: Feasibility of the PROMs collection system according to the perspective of volunteers will be measured using a semi-structured interview guide. The semi-structured interview guide contains questions exploring the acceptability focus area of Bowen et al.’s framework: Acceptability, demand, implementation, practicality, adaptation. Interviews will be conducted by an investigator with experience conducting qualitative interviews. Interviews will be conducted with approximately 4-6 participants and will be conducted face-to-face.
Timepoint [10] 421277 0
Following completion of patient recruitment.
Secondary outcome [11] 421280 0
Feasibility: Demand (Primary Outcome): Volunteer perceptions of feasibility: Feasibility of the PROMs collection system according to the perspective of volunteers will be measured using a semi-structured interview guide. The semi-structured interview guide contains questions exploring the demand focus area of Bowen et al.’s framework: Acceptability, demand, implementation, practicality, adaptation. Interviews will be conducted by an investigator with experience conducting qualitative interviews. Interviews will be conducted with approximately 4-6 participants and will be conducted face-to-face.
Timepoint [11] 421280 0
Following completion of patient recruitment.
Secondary outcome [12] 421282 0
Feasibility: Implementation (Primary Outcome): Volunteer perceptions of feasibility: Feasibility of the PROMs collection system according to the perspective of volunteers will be measured using a semi-structured interview guide. The semi-structured interview guide contains questions exploring the implementation focus area of Bowen et al.’s framework: Acceptability, demand, implementation, practicality, adaptation. Interviews will be conducted by an investigator with experience conducting qualitative interviews. Interviews will be conducted with approximately 4-6 participants and will be conducted face-to-face.
Timepoint [12] 421282 0
Following completion of patient recruitment.
Secondary outcome [13] 421285 0
Feasibility: Practicality (Primary Outcome): Volunteer perceptions of feasibility: Feasibility of the PROMs collection system according to the perspective of volunteers will be measured using a semi-structured interview guide. The semi-structured interview guide contains questions exploring the practicality focus area of Bowen et al.’s framework: Acceptability, demand, implementation, practicality, adaptation. Interviews will be conducted by an investigator with experience conducting qualitative interviews. Interviews will be conducted with approximately 4-6 participants and will be conducted face-to-face.
Timepoint [13] 421285 0
Following completion of patient recruitment.
Secondary outcome [14] 421939 0
Feasibility: Adaptation (Primary Outcome): Volunteer perceptions of feasibility: Feasibility of the PROMs collection system according to the perspective of volunteers will be measured using a semi-structured interview guide. The semi-structured interview guide contains questions exploring the adaptation focus area of Bowen et al.’s framework: Acceptability, demand, implementation, practicality, adaptation. Interviews will be conducted by an investigator with experience conducting qualitative interviews. Interviews will be conducted with approximately 4-6 participants and will be conducted face-to-face.
Timepoint [14] 421939 0
Following completion of patient recruitment.
Secondary outcome [15] 421941 0
The number of presentations to other Peninsula Health services (including hospital readmissions) between admission and follow-up PROM administration will be provided by data platform staff.
Timepoint [15] 421941 0
During the 3-6 month follow up period for consumers who complete the PROM
Secondary outcome [16] 421942 0
Length of hospital stay. This information will be captured by data obtained from the National Centre for Healthy Ageing, Healthy Ageing Data Platform.
Timepoint [16] 421942 0
Time of discharge from acute or sub-acute hospital and 3-6 month follow up.
Secondary outcome [17] 421943 0
Feasibility: Acceptability Domain (Primary Outcome) Acceptability domain will be evaluated by measuring the acceptability of the electronic interface. This will be measured using the Simplified Systems Usability Scale for Cognitively Impaired and Older Adults. This scale consists of 10 items relating to usability of electronic hardware, software, mobile devices, websites and applications. The participant rates their level of agreement on a five-point Likert scale (‘strongly disagree’ to ‘strongly agree’) for each item. The survey system will be administered by research assistants following completion of the PROM.
Timepoint [17] 421943 0
Time of discharge from acute or sub-acute hospital and 3-6 month follow up.

Eligibility
Key inclusion criteria
Consumer Participants:
Consumer participants will include all patients aged 60 years or older on the participating acute general medicine and sub-acute inpatient general rehabilitation wards at Peninsula Health who are discharged to a private residence or residential aged care home during the study period. Patients with cognitive or communication impairments will complete the PROM via proxy (i.e., family member, next of kin, carer completes the PROM on their behalf) as per recommendations for use of the EQ-5D-5L. Therefore, participants will consist of two groups:

1) Patients aged 60 years or older with cognitive capacity to complete the PROM

And

2) Carers/Next of Kin of patients who are 60 years or older without capacity to complete the PROM

Volunteer Participants:
Volunteer participants will include all Peninsula Health volunteers who volunteer their time to assisting with the administration of PROMs on the participating wards during the trial.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Consumer Participants:

1) Not meeting the inclusion criteria
2) Death- no further PROMs or surveys will be administered
3) No cognitive or communicative capacity to participate and no Carer/NOK available to participate on their behalf

Volunteer Participants:
- Volunteers not affiliated with Peninsula Health will not be eligible for inclusion.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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)
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
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to describe the characteristics of the sample and feasibility outcomes.

Demographic and health information of patients who complete and who do not complete the PROM will be compared using appropriate parametric and/or non-parametric statistical tests depending on the distribution of the data.

Multivariable regression analysis will be conducted to determine factors independently associated with completing the PROM.

Data from surveys (i.e. feasibility assessment survey and systems usability scale) will be analysed descriptively by reporting the proportion of responses on Likert scale items. Data on demand (completion of PROM), implementation (item completeness, use of electronic interface, administration of PROM by volunteers) will be analysed descriptively by reporting proportions. The time taken by participants to complete the PROM, and by staff/volunteers to assist with PROM completion will be analysed descriptively using mean (SD) or median (IQR). Costs associated with implementing the co-designed PROM collection system will also be analysed descriptively using mean (SD) or median (IQR). Results from the descriptive analysis will be stratified by ward (acute vs. sub-acute) to compare the extent to which the co-designed PROMs collection system performs between the two populations; this will evaluate the adaptation domain of Bowen et al.'s feasibility framework.

Responses to open-ended questions and volunteer/researcher field notes (participant suggestions for improving the ease of use of the collection system, details of the assistance provided to participants, reasons for completing PROM in paper form, and reasons for not completing the PROM/using the collection system) will be analysed using content analysis. This will involve two researchers familiarising themselves with the data by reading and re-reading responses to open-ended questions. The researchers will then independently classify the text into meaning units (e.g. words and sentences related to each other through their content and context). The meaning units will then be condensed and labelled with a code. If applicable, codes will be sorted into categories through discussion between the two researchers. The researchers will then re-read responses to confirm the codes/categories and ensure no new codes/categories arise. The proportion of participants who report each code/category will be calculated and reported.

Transcripts of volunteer interviews will be analysed using a thematic analysis approach. The first step will involve two researchers familiarising themselves with the data by reading and re-reading the transcripts. The two researchers will then independently code the data using qualitative data management software (NVivo). Two other researchers will read the transcripts to gain an overall impression of the data. All four researchers will then meet to discuss codes and generate initial themes by identifying patterns amongst the codes. Two researchers will re-read the transcripts to assess whether the initial themes are an accurate representation of the data. Last, the four reviewers will meet to conduct a final review of the themes, confirming the name and definition of each theme.

Sample size considerations:
We aim to recruit at least 60 participants across each ward (120 in total). While there are no clear guidelines on the sample size required for feasibility studies this size should enable the primary outcome of feasibility to be addressed, and is comparable to previous feasibility evaluations of PROMs collection systems.

We also aim to recruit 4-8 volunteers. Given the narrow aims of the study, the specific target population, the high-quality data collection method, and interview questions informed by established theory we anticipate that we will have sufficient information power to generate valid findings on volunteers’ perspectives on the feasibility of the PROMs collection system.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/07/2023
Actual
31/07/2023
Date of last participant enrolment
Anticipated
29/11/2023
Actual
28/11/2023
Date of last data collection
Anticipated
31/05/2024
Actual
1/03/2024
Sample size
Target
120
Accrual to date
Final
131
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24480 0
Frankston Hospital - Frankston
Recruitment hospital [2] 24481 0
Golf Links Road Rehabilitation Centre - Frankston
Recruitment postcode(s) [1] 40065 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 313586 0
Hospital
Name [1] 313586 0
Peninsula Health
Country [1] 313586 0
Australia
Primary sponsor type
Hospital
Name
Peninsula Health
Address
2 Hastings Road
Frankston, VIC
3199
Country
Australia
Secondary sponsor category [1] 315371 0
None
Name [1] 315371 0
Address [1] 315371 0
Country [1] 315371 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312764 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [1] 312764 0
Ethics committee country [1] 312764 0
Australia
Date submitted for ethics approval [1] 312764 0
07/12/2022
Approval date [1] 312764 0
14/02/2023
Ethics approval number [1] 312764 0

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

Contacts
Principal investigator
Name 125826 0
Dr David Snowdon
Address 125826 0
Peninsula Health
2 Hastings Road
Frankston, VIC
3199
Country 125826 0
Australia
Phone 125826 0
+61 422764579
Fax 125826 0
Email 125826 0
[email protected]
Contact person for public queries
Name 125827 0
Lucy Marsh
Address 125827 0
Peninsula Health
2 Hastings Rd
Frankston, VIC
3199
Country 125827 0
Australia
Phone 125827 0
+61 437407729
Fax 125827 0
Email 125827 0
[email protected]
Contact person for scientific queries
Name 125828 0
David Snowdon
Address 125828 0
Peninsula Health
2 Hastings Rd
Frankston, VIC
3199
Country 125828 0
Australia
Phone 125828 0
+61 422764579
Fax 125828 0
Email 125828 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sharing individual participant data could have an negative impact on participation rates and therefore compromises the objectives of improving quality of care for patients through routine collection of PROMs.


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.