Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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
ACTRN12623001041640
Ethics application status
Approved
Date submitted
11/09/2023
Date registered
26/09/2023
Date last updated
26/09/2023
Date data sharing statement initially provided
26/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Digital health solution to enable healthcare consumers to identify and communicate their needs and preferences with healthcare staff.
Scientific title
Feasibility of the MyNeeds digital health solution to enable consumers to identify and communicate their needs and preferences with healthcare staff across a health service care continuum.
Secondary ID [1] 310567 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Barriers to partnering with healthcare consumers in person-centred approaches to care planning and care delivery. 331409 0
Condition category
Condition code
Physical Medicine / Rehabilitation 328160 328160 0 0
Other physical medicine / rehabilitation
Public Health 328161 328161 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name of intervention:
MyNeeds digital health intervention. This digital health intervention was co-designed with healthcare consumers and health service staff using an Experience Based Co-design (EBCD) process. The EBCD process involved a number of steps over a 12-month period, including: 16 focus groups conducted at the program level with a total of 92 staff representing medical, nursing, allied health, pharmacy and support staff; individual in-depth interviews with 12 healthcare consumers; establishment of staff priority areas for the codesign workshops; establishment of consumer priority areas for the codesign workshops; three 120-minute face to face and two virtual codesign workshops with 12 staff members and 7 consumers where the intervention was codesigned (inclusive of content and workflows); and two digital codesign workshops with 7 consumers to refine the layout and design of the MyNeeds intervention. Consumes had the opportunity to interact with the MyNeeds intervention in these digital codesign workshops through their own SMART devices and provide feedback that was used to refine the intervention in preparation for this feasibility study.
There are two key processes involved with the MyNeeds digital health intervention: 1) the electronic capture of broad needs and preferences directly from healthcare consumers or their support people; and 2) the integration of these needs and preferences data captured within the MyNeeds Intervention with the health service electronic health record at the patient level.
Health service clinicians are able to view consumer needs and preferences in the electronic health record prior to, and during clinical encounters. Health service clinicians are then able to use this information to inform individualised care planning in partnership with the consumer, and if applicable their support people.

Materials used:
Electronic smart device (such as smart phone or tablet) or computer connected to the internet (either wireless or hard-wired internet). Arden Street Labs Virtual Care Solution, known as Monitor++, that houses the electronic consumer needs and preferences intervention. This virtual care solution is already imbedded into systems at the healthcare organisation where feasibility testing will occur. The electronic health record in use at the health network where feasibility testing will occur. Daily reports from Monitor++ will capture all occasions that a consumer initially populates the MyNeeds intervention, and every occasion that needs and preferences are updated. These reports will be monitored by project staff.

Who will deliver the intervention:
Healthcare consumers and/or their support people populate the electronic consumer facing survey and view and/or edit the consumer needs and preferences summary page with or without assistance (if required). Populating the MyNeeds consumer facing survey takes approximately 10 t0 15 minutes. Automated electronic process to integrate the consumer needs and preferences data with the electronic health record.

Mode of delivery:
Consumers use their own smart device (if available), or a hospital supplied device (if the consumer doesn’t have access to their own smart device). Health service clinicians access the consumer needs and preferences data through existing processes to access the electronic health record.

Location:
The intervention can be accessed by consumers from any location where a smart device is connected to the internet including: emergency departments; hospital wards; community health settings; outpatient clinics; private residences; and residential aged care facilities. Health service clinicians access data collected in the intervention within the healthcare setting that they routinely access health service electronic health records.

Timing and dose:
The initial consumer needs and preferences survey is populated once. Consumers can then log in and view, and/or update their preferences as often as they choose. There is no requirement for a consumer to update their needs and preferences, nor is there a limit on the number of times that they can update these preferences. Health service staff will have access the consumer needs and preferences data as often as they are logged into the health services electronic health record and have the consumers individual electronic health record open. This feasibility study will run for a total period of 6 months, including two-six week testing periods across an acute medical and an inpatient rehabilitation unit.

Procedures and personalisation:
Consumers receiving healthcare will be informed of the intervention and invited to register for the intervention. Consumers will have the option to receive assistance with registration and populating the MyNeeds intervention from a support person, a member of the project team, or from a ward-based consumer volunteer. The medical decision maker or next of kin will be approached in cases where the consumer is too unwell to populate the MyNeeds intervention independently or with support. In such cases the medical decision maker or next of kin will populate the MyNeeds intervention as a proxy for the consumer. Consumers will be able to tailor the information that they enter, and the frequency that they update the information in the MyNeeds intervention.
Intervention code [1] 326971 0
Early detection / Screening
Intervention code [2] 327040 0
Prevention
Intervention code [3] 327041 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336040 0
Feasibility: Acceptability Domain (consumer perspective).
The extent to which consumers judge the MyNeeds intervention to be acceptable, suitable, and/or satisfying will be assessed using the 10-item Simplified System Usability Scale (SUS) 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. In addition to the 10 Simplified SUS questions, three open-ended questions specifically developed for this study, will be included to measure consumer acceptability of the Consumer Digital Needs and Preferences Tool. The additional questions are as follows: “What did you like about the Digital Needs and Preferences tool?”; “What did you dislike about the Digital Needs and Preferences tool?” and “Please share any other comments you have about the Digital Needs and Preferences tool?” The SUS and additional open-ended questions will be administered by a research assistant.
Timepoint [1] 336040 0
Following the first occasion that consumers use the MyNeeds intervention.
Primary outcome [2] 336041 0
Feasibility: Demand Domain (consumer perspective).
Consumer demand for the intervention will be determined by measuring the proportion of eligible participants who: agree to participate; and initiate signing into the MyNeeds intervention. 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 participate will also be collected and documented by volunteers and research assistants using field notes.
Timepoint [2] 336041 0
At the end of the testing period on each ward.
Primary outcome [3] 336042 0
Feasibility: Implementation Domain (consumer perspective).
Implementation will be determined by measuring the completeness of data in the MyNeeds intervention. Specifically, the proportion of consumers who agree to participate who: commence but don’t complete populating all sections of MyNeeds intervention; and complete populating all sections of the MyNeeds intervention. These data will be obtained from back-end system extracts from the MyNeeds digital health intervention.
Timepoint [3] 336042 0
Following the first occasion that consumers use the MyNeeds intervention.
Secondary outcome [1] 426593 0
Feasibility: Acceptability Domain (consumer perspective) (primary outcome)
A sample of between 6 and 12 purposefully selected diverse consumers will be invited to participate in either a face to face or virtual individual qualitative interview to better understand their experience of using the MyNeeds intervention in this feasibility trial. The semi-structured interview guide will include questions relating to satisfaction and acceptability of the MyNeeds intervention. A senior member of the research team will facilitate these interviews.
Timepoint [1] 426593 0
At the end of the testing period on each ward.
Secondary outcome [2] 426594 0
Feasibility: Acceptability Domain (staff perspective) (primary outcome).
Face to face or virtual focus groups will be conducted with a sample of between 8 and 12 purposefully selected diverse multidisciplinary clinicians / staff working on the test ward. Each focus group will have 4 to 8 participants per group. The semi-structured interview guide will include questions relating to overall acceptability and satisfaction with the intervention including: satisfaction with the integration of consumer data with clinical systems; and overall perceived appropriateness of this intervention. A senior member of the research team will facilitate these focus group sessions.
Timepoint [2] 426594 0
At the end of the testing period on each ward.
Secondary outcome [3] 426595 0
Feasibility: Acceptability Domain (staff perspective) (primary outcome)
The extent that staff perceive the MyNeeds intervention to support person-centred care planning and delivery will be assessed using the 17 item Individualised care scale (ICS), together with the following study specific open-ended question: "Please share any other comments you have about having access to consumer needs and preferences in the electronic health record". The questionnaire will be distributed electronically to all clinical and clinical support staff working on the ward by a research assistant.
Timepoint [3] 426595 0
At the end of the testing period on each ward.
Secondary outcome [4] 426596 0
Feasibility: Demand Domain (consumer perspective) (primary outcome)
A sample of between 6 and 12 purposefully selected diverse consumers will be invited to participate in either a face to face or virtual individual qualitative interview to better understand their experience of using the MyNeeds intervention in this feasibility trial. The semi-structured interview guide will include questions relating to current and anticipated future demand of the MyNeeds intervention. A senior member of the research team will facilitate these interviews.
Timepoint [4] 426596 0
At the end of testing period on each ward.
Secondary outcome [5] 426597 0
Feasibility: Demand Domain (staff perspective) (primary outcome)
Demand from a staff perspective will be measured by: 1) the proportion of staff who access consumer needs and preferences data for at least one consumer; 2) the total number of consumers that each staff member accesses needs and preferences data on at least one occasion; and 3) number of occasions that staff access needs and preferences data for an individual consumer. These data will be obtained from back-end system extracts from the MyNeeds digital health intervention.
Timepoint [5] 426597 0
At the end of testing period on each ward.
Secondary outcome [6] 426598 0
Feasibility: Demand domain (staff perspective) (primary outcome)
Face to face or virtual focus groups will be conducted with a sample of between 8 and 12 purposefully selected diverse multidisciplinary clinicians / staff working on the test ward. Each focus group will have 4 to 8 participants per group. The semi-structured interview guide will include questions relating to current and perceived future demand for the MyNeeds intervention from a staff perspective. A senior member of the research team will facilitate these focus group sessions.
Timepoint [6] 426598 0
At the end of the testing period on each ward.
Secondary outcome [7] 426599 0
Feasibility: Practicality Domain (primary outcome)
The practicality domain will be evaluated by measuring the direct costs associated with implementing the digital health intervention (including IT infrastructure, development and licencing costs), costs associated with supporting the intervention post implementation (including IT / electronic health record support), and staff costs associated with assisting consumer participants engage with the intervention. Data relating to costs will be collected by senior researchers on the project. Costs relating to staffing will be estimated using the time that IT support staff and/or research assistants spent supporting consumer participants (i.e., times that volunteers were not available) and award rates for IT, and non-clinician health professionals, including ward clerks and allied health assistants.
Timepoint [7] 426599 0
Post-implementation of the digital health intervention, and at the end of the testing period on each ward.
Secondary outcome [8] 426600 0
Feasibility: Practicality Domain (staff perspective) (primary outcome)
Face to face or virtual focus groups will be conducted with a sample of between 8 and 12 purposefully selected diverse multidisciplinary clinicians / staff working on the test ward. Each focus group will have 4 to 8 participants per group. The semi-structured interview guide will include questions relating to practicality of this model of care, including positive and negative effects, from a staff perspective. A senior member of the research team will facilitate these focus group sessions.
Timepoint [8] 426600 0
At the end of the testing period on each ward.
Secondary outcome [9] 426601 0
Feasibility: Practicality Domain (consumer perspective) (primary outcome)
Consumer perspective of practicality will be explored in the consumer interviews conducted with a sample of between 6 and 12 purposefully selected consumers. The semi-structured interview guide will include questions relating to the practicality of the intervention including ease of use, supports required to facilitate use, and positive and negative effects from a consumer perspective. A senior member of the research team will facilitate these interviews.
Timepoint [9] 426601 0
At the end of testing period on each ward.
Secondary outcome [10] 426602 0
Feasibility: Implementation Domain (consumer perspective) (primary outcome)
The implementation domain from a consumer perspective will be measured by reporting the proportion of individual items on the MyNeeds intervention populated across all participants for each ward. This data will be extracted from the back end of the MyNeeds intervention as a de-identified summary report.
Timepoint [10] 426602 0
At the end of the testing period on each ward,
Secondary outcome [11] 426603 0
Feasibility: Implementation Domain (consumer perspective) (primary outcome)
The implementation domain will be measured by reporting the time to complete populating the MyNeeds intervention (including time to register and complete individual sections). A research assistant or ward-based consumer volunteer will record detailed observational notes regarding the consumer’s initial attempt to log-in and use the MyNeeds intervention using a study specific purposefully designed behavioural observation recording template with predefined categories. This will be supplemented by back-end system extracts regarding time spent logged into the system.
Timepoint [11] 426603 0
During the first occasion that consumers use the MyNeeds intervention.
Secondary outcome [12] 426604 0
Feasibility: Implementation Domain (consumer perspective) (primary outcome)
The consumer perspective of the ease of implementation will be explored in the consumer interviews conducted with a sample of between 6 and 12 purposefully selected consumers. The semi-structured interview guide will include questions relating to consumer perception of the factors impacting ease or difficulty of implementation of the intervention from a consumer perspective. A senior member of the research team will facilitate these interviews.
Timepoint [12] 426604 0
At the end of the testing period on each ward.
Secondary outcome [13] 426605 0
Feasibility: Implementation Domain (staff perspective) (primary outcome)
Face to face or virtual focus groups will be conducted with a sample of between 8 and 12 purposefully selected diverse multidisciplinary clinicians / staff working on the test ward. Each focus group will have 4 to 8 participants per group. The semi-structured interview guide will include questions regarding staff perspective of factors impacting ease or difficulty of implementation. A senior member of the research team will facilitate these focus group sessions.
Timepoint [13] 426605 0
At the end of the testing period on each ward.
Secondary outcome [14] 426606 0
Feasibility: Implementation Domain (staff perspective) (primary outcome)
Face to face or virtual interviews will be conducted with IT / digital health staff to establish the level of support required to assist both staff and consumers from a technology perspective, and well as to discuss any system failures that occurred during the testing period. These qualitative data will be supplemented by system extracts regarding any system failures. A senior member of the research team will facilitate these focus interviews.
Timepoint [14] 426606 0
At the end of the testing period on each ward.
Secondary outcome [15] 426607 0
Feasibility: Integration Domain (primary outcome)
The integration domain will be evaluated by interviewing IT / digital health staff to establish the extent that the intervention can be integrated with current IT systems and workflows across the health service organisation. A senior member of the research team will facilitate these focus interviews.
Timepoint [15] 426607 0
At the end of the testing period on each ward.
Secondary outcome [16] 426608 0
Patient reported outcomes (PROMS) measured using the EQ5D-5L instrument,
PROMS will be measured using the EuroQol five dimensions, five response level version (EQ-5D-5L). This will be assessed as a composite outcome, with EQ5D data from the 5 domains used to calculate a summary index score. The EQ-5D-5L will be administered by the research assistant electronically.
Timepoint [16] 426608 0
At the patient level at discharge from the test ward.
Secondary outcome [17] 426609 0
Patient reported experience outcomes (PREMs)
Consumer participants will be asked three questions taken from the Victorian Healthcare Experience Survey (VHES) relating to their experience whilst receiving care on the ward, together with an open-ended question asking: "Is there anything else you would like us to know?" For the three questions from the VHES the participant rates their level of agreement on a Likert scale for the following: "Did you feel listened to by staff?"; "Were you involved as much as you wanted to be in making decisions about your care?"; and "Overall, how would you rate the care you received from the hospital?" The PREM will be administered by the research assistant electronically.
Timepoint [17] 426609 0
At the patient level at discharge from the test ward.
Secondary outcome [18] 426610 0
Discharge Destination
Discharge destination will be extracted from 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. Discharge destination will include the following options: (1) home, (2) relative/ friend’s home, (3) residential care, (4) inpatient transition care program, (5) subacute rehabilitation/ geriatric evaluation and management, or (6) other. For patients who transition from the test ward to another inpatient ward, final discharge destination from hospital will also be captured.
Timepoint [18] 426610 0
At hospital discharge for the current admission.
Secondary outcome [19] 426611 0
Hospital presentations
The number of presentations to other Peninsula Health services (including any unplanned hospital readmissions) in the 30-days post discharge will be extracted from 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.
Timepoint [19] 426611 0
Up to and including 30-days post discharge from hospital for the current admission.
Secondary outcome [20] 426612 0
Length of hospital stay.
Number of days spent admitted on test ward, and the total number of days admitted for the entire admission (across all wards / units for the current hospital admission) will be extracted from 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.
Timepoint [20] 426612 0
Following discharge from the hospital for the current admission.
Secondary outcome [21] 426613 0
Any adverse events occurring within the current hospital admission.
Any adverse events, with or without harm, recorded in the Victorian Health Incident Management System (VHIMS) as part of routine clinical documentation will be extracted (across all wards / units for the current hospital admission).
Timepoint [21] 426613 0
Following discharge from the hospital for the current admission.
Secondary outcome [22] 426896 0
Patient reported outcomes (PROMS) measured using visual analogue scores (VAS) from the EQ5D-5L instrument,
PROMS will be measured using the EuroQol five dimensions, five response level version (EQ-5D-5L) and VAS scores (participants self-report of overall current health) extracted from this instrument. The EQ-5D-5L will be administered by the research assistant electronically.
Timepoint [22] 426896 0
At the patient level at discharge from the test ward.
Secondary outcome [23] 426897 0
Patient reported outcomes (PROMS) measured using the 'mobility' dimension of the EQ5D-5L instrument,
PROMS will be measured using the EuroQol five dimensions, five response level version (EQ-5D-5L). Participant responses for the mobility dimension of the EQ5D will be extracted. The EQ-5D-5L will be administered by the research assistant electronically.
Timepoint [23] 426897 0
At the patient level at discharge from the test ward.
Secondary outcome [24] 426901 0
Patient reported outcomes (PROMS) measured using the 'self-care' dimension of the EQ5D-5L instrument,
PROMS will be measured using the EuroQol five dimensions, five response level version (EQ-5D-5L). Participant responses for the self-care dimension of the EQ5D will be extracted. The EQ-5D-5L will be administered by the research assistant electronically.
Timepoint [24] 426901 0
At the patient level at discharge from the test ward.
Secondary outcome [25] 426902 0
Patient reported outcomes (PROMS) measured using the 'usual activities' dimension of the EQ5D-5L instrument,
PROMS will be measured using the EuroQol five dimensions, five response level version (EQ-5D-5L). Participant responses for the usual activities dimension of the EQ5D will be extracted. The EQ-5D-5L will be administered by the research assistant electronically.
Timepoint [25] 426902 0
At the patient level at discharge from the test ward.
Secondary outcome [26] 426903 0
Patient reported outcomes (PROMS) measured using the 'pain/discomfort' dimension of the EQ5D-5L instrument,
PROMS will be measured using the EuroQol five dimensions, five response level version (EQ-5D-5L). Participant responses for the pain/discomfort dimension of the EQ5D will be extracted. The EQ-5D-5L will be administered by the research assistant electronically.
Timepoint [26] 426903 0
At the patient level at discharge from the test ward.
Secondary outcome [27] 426904 0
Patient reported outcomes (PROMS) measured using the "anxiety/depression" dimension of the EQ5D-5L instrument,
PROMS will be measured using the EuroQol five dimensions, five response level version (EQ-5D-5L). Participant responses for the anxiety/depression dimension of the EQ5D will be extracted. The EQ-5D-5L will be administered by the research assistant electronically.
Timepoint [27] 426904 0
At the patient level at discharge from the test ward.

Eligibility
Key inclusion criteria
Consumer participants:
All consumers admitted to the participating wards during the testing period who are: expected to be an inpatient on the test unit for >24 hours; inpatient admission on the test unit includes stay during Monday to Friday; able to communicate in simple English; and not participating in another unrelated trial.

Staff participants:
All clinical staff working on the participating wards during the study period and who have access to clinical systems as part of their usual role will be eligible to participate in this feasibility study. Clinical staff will include any medical, nursing, pharmacy, and allied health professional, and assistants (nursing, pharmacy, or allied health assistants) working on the test wards during the study period.

Volunteer Participants:
Volunteer participants will include all Peninsula Health volunteers who volunteer their time to assisting healthcare consumer participants with the MyNeeds intervention on the participating wards during the feasibility study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Consumer participants:
Consumers will not be invited to participate if they: don't meet the inclusion criteria; are admitted and discharged to the ward on the weekend; expected to be admitted to the ward for <24 hours; currently participating in another unrelated trial; or are unable to communicate in simple English.

Staff participants:
Staff who do not have access to the electronic health record as part of their usual role working on the test ward.

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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 participants and feasibility outcomes.

Demographic and health information of consumers who agree to participate and initiate populating the MyNeeds intervention will be compared to those who do not participate 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 the use of the MyNeeds intervention, including any differences in: participants who agree to participate but don't complete the sign in process; commence but didn’t complete populating all fields of the MyNeeds intervention; and those who commence and complete populating all fields in the MyNeeds intervention.

Data from surveys (i.e. systems usability scale) will be analysed descriptively by reporting the proportion of responses on Likert scale items. Data on demand (agree to participate and initiate signing into the MyNeeds intervention), implementation (completeness of populating all items on the MyNeeds intervention, assistance required) will be analysed descriptively by reporting proportions. The time taken by participants to populate the MyNeeds intervention, and by staff/volunteers to assist will be analysed descriptively using mean (SD) or median (IQR). Costs associated with implementing the MyNeeds digital health intervention 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 MyNeeds intervention performs between the two populations and contexts to evaluate the adaptation domain of Bowen et al.'s feasibility framework.

Responses to open-ended survey questions and volunteer/researcher observation field notes 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.

Transcripts from consumer interviews, IT staff interviews and ward staff focus groups 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. Finally, 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 assessed. This sample size is larger than the sample used in feasibility testing other consumer facing digital health interventions.







Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/09/2023
Actual
Date of last participant enrolment
Anticipated
1/03/2024
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25506 0
Frankston Hospital - Frankston
Recruitment hospital [2] 25507 0
Golf Links Road Rehabilitation Centre - Frankston
Recruitment postcode(s) [1] 41319 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 314775 0
Other Collaborative groups
Name [1] 314775 0
National Centre for Healthy Ageing
Country [1] 314775 0
Australia
Primary sponsor type
Hospital
Name
Peninsula Health
Address
2 Hastings Road, Frankston, VIC, 3199
Country
Australia
Secondary sponsor category [1] 316763 0
None
Name [1] 316763 0
Address [1] 316763 0
Country [1] 316763 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313784 0
Peninsula Health HREC
Ethics committee address [1] 313784 0
2 Hastings Road, FRANKSTON, Victoria, 3199
Ethics committee country [1] 313784 0
Australia
Date submitted for ethics approval [1] 313784 0
09/10/2020
Approval date [1] 313784 0
09/11/2020
Ethics approval number [1] 313784 0
69684

Summary
Brief summary
Models of health care have traditionally been episodic and diagnosis centred. In an era of increased chronic illness, multi-morbidity and disability, there is a clear need for health care to transition towards integrated, person-centred and goal-oriented care. However, aligning care planning and delivery with healthcare consumers’ needs and preferences is operationally challenging, particularly across settings and clinical specialties.

The aim of this study is to assess the feasibility of (i) healthcare consumers using a recently codesigned consumer digital health intervention, the MyNeeds intervention, to capture needs and preferences directly from healthcare consumers, and (ii) healthcare staff accessing and using this consumer data to inform person-centred care planning.

This study is a non-randomised feasibility study that will be conducted sequentially across two inpatient wards: an acute medical ward; and an inpatient general subacute ward at an Australian metropolitan public health network.

Primary outcome will be feasibility assessed using Bowen’s framework across the following focus areas: acceptability; demand; practicality; implementation; adaption; and integration.

All consumers admitted to wards one and two during a six-week feasibility testing period will be screened for eligibility and all eligible consumers invited to participate. Consumers will be eligible unless they are: admitted and discharged after hours or on weekends; predicted to be discharged within 24 hours of admission; or currently participating in another unrelated trial where the fidelity of either trial could be impacted. All clinical and clinical support staff working on the test wards during the feasibility testing period will be eligible and invited to participate.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129342 0
Mrs Rebecca Barnden
Address 129342 0
Peninsula Health, 2 Hastings Road, FRANKSTON, Victoria, 3199
Country 129342 0
Australia
Phone 129342 0
+61 3 9784 1727
Fax 129342 0
Email 129342 0
rebecca.barnden@monash.edu
Contact person for public queries
Name 129343 0
Mrs Rebecca Barnden
Address 129343 0
Peninsula Health, 2 Hastings Road, FRANKSTON, Victoria, 3199
Country 129343 0
Australia
Phone 129343 0
+61 3 9784 1727
Fax 129343 0
Email 129343 0
rebecca.barnden@monash.edu
Contact person for scientific queries
Name 129344 0
Mrs Rebecca Barnden
Address 129344 0
Peninsula Health, 2 Hastings Road, FRANKSTON, Victoria, 3199
Country 129344 0
Australia
Phone 129344 0
+61 3 9784 1727
Fax 129344 0
Email 129344 0
rebecca.barnden@monash.edu

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


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.