Asking children and young people about their general health and well being as part of routine clinical outpatient care - a pilot randomised controlled trial

ISRCTN	ISRCTN16030620
DOI	https://doi.org/10.1186/ISRCTN16030620
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	RCH HREC #103264
Sponsor	Murdoch Children's Research Institute
Funder	EuroQol Research Foundation

Submission date: 15/01/2024
Registration date: 21/01/2024
Last edited: 13/06/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Sometimes it can be hard for children and young people to talk about how their overall health and life is going. Answering some set questions might help. Additionally, filling out a general health questionnaire might help the service providers at the hospital outpatient clinics to better care for children and young people. This study aims to find out if asking children and young people about their general health using a standard set of questions, called the 'EQ-5D-Y-5L', at their outpatient appointments, is feasible and acceptable, and if it improves the way health care is provided.

Who can participate?
Children and young people aged 4 to 17 years (inclusive) who have an appointment with one of the participating outpatient appointments during the 5-week trial period are eligible to take part. The service providers (i.e., doctors and nurses) who treat children aged 4 to 17 years (inclusive) attending the participating outpatient clinics are also eligible to take part.

What does the study involve?
Children and young people who choose to take part in the study will be in one of two groups: a group who is asked to complete a general health questionnaire as part of their appointment at The Royal Children’s Hospital or a group not asked to complete the general health questionnaire. These group allocations will be decided by chance, similar to tossing a coin. There will be an equal chance of being in either group. This is called randomisation. Additionally, children and young people who choose to take part in the study, alongside their parent/caregiver, will be asked to complete three 5-minute online surveys:
Survey 1) Before outpatient clinic appointment and before any intervention (known as a 'baseline' survey),
Survey 2) 1 day after outpatient clinic appointment (known as a 1-day follow-up survey), and
Survey 3) 4 weeks after your appointment (known as a 4-week follow-up survey).

Service providers who take part in the study will be asked to complete a 1-minute weekly online survey, and a final 10-minute online follow-up survey. Service providers will also be asked to take part in a qualitative focus group after the completion of the trial.

What are the possible benefits and risks of participating?
We cannot guarantee that participants will get any benefits from this project. However, there is a chance that participants will be assisted by answering the general health questionnaire if they are randomly allocated to the group asked to complete this questionnaire. The time patients/caregivers and service providers spend on this study may be an inconvenience. Patients/caregivers will receive a $20 online gift voucher after completing the final follow-up survey (approximately 4-weeks after your hospital appointment). Service providers will receive a coffee vouchers after completing the final follow-up survey and/or focus group.

Where is the study run from?
The Royal Children’s Hospital Melbourne, Murdoch Children’s Research Institute and the University of Melbourne (Australia)

When is the study starting and how long is it expected to run for?
June 2023 to August 2024

Who is funding the study?
EuroQol Research Foundation (the Netherlands)

Who is the main contact?
Renee Jones, reneej1@student.unimelb.edu.au

Contact information

Ms Renee Jones
Public, Scientific, Principal investigator

Health Services and Economics
Murdoch Children's Research Institute
The Royal Children's Hospital
50 Flemington Road
Melbourne
3052
Australia

ORCID ID	0000-0002-5332-5226
Phone	+61 4 03598052
Email	reneej1@student.unimelb.edu.au

Study information

Primary study design	Interventional
Study design	Pilot single centre non-blinded randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A pilot randomised controlled trial of a generic Paediatric Patient Reported Outcome Measure (P-PROM) intervention for use in Routine Outpatient Care for Kids (ROCK)
Study acronym	P-PROM ROCK Pilot RCT Study
Study objectives	The use of a generic paediatric patient reported outcome measure (P-PROM) intervention in routine outpatient care at The Royal Children’s Hospital will be feasible, acceptable, and useful compared with standard care.
Ethics approval(s)	Approved 15/01/2024, The Royal Children's Hospital Melbourne, Human Research Ethics Committee (50 Flemington Road, Melbourne, 3052, Australia; +61 3 9345 5044; rch.ethics@rch.org.au), ref: HREC/103264/RCHM-2024
Health condition(s) or problem(s) studied	Children in this study may have a range of chronic health conditions. Participating children will be from the following specialist paediatric outpatient clinics: asthma clinic, sleep clinic, encopresis clinic, and chronic constipation clinic.
Intervention	Current interventions as of 13/06/2024: Randomisation will occur at the child level, whereby patients in participating outpatient clinics who have an outpatient appointment in the 10-week trial period, consented to take part, and completed the baseline survey will be randomly allocated to either the control (standard care) or intervention arm (generic P-PROM) at a 1:1 ratio. Randomisation will be done using an online tool. Participating child patients allocated to the intervention arm will be asked to complete a generic P-PROM, the EQ-5D-Y-5L, prior to their outpatient clinic appointment. The patient will then be asked to highlight any domain(s) they would like to discuss with their service provider at their upcoming appointment. The results of this P-PROM will be displayed back to the patient and their treating service provider. If the patient highlighted any domain(s) for discussion, this will appear as an alert on the display shown to the service provider. After completing the generic P-PROM, patients will automatically receive resources to support getting help for any concerns they might have with any of the domains covered by the EQ-5D-Y-5L. Service providers will also receive resources and training. The intervention was co-designed with key stakeholders, including clinicians, caregivers of patients, and adolescent patients. Participating child patients allocated to the control arm will receive standard care, whereby they will attend their appointment as usual. The trial will run for a 5-10 week period in each outpatient clinic (depending on the frequency of clinics), however, the treatment period for each child is the time associated with their appointment at the outpatient clinic. The follow-up for each child will be at least 4-weeks after their appointment. All participating child participants or the caregivers of child participants will be asked to complete a baseline questionnaire (pre-appointment), a 1-day post-appointment questionnaire and a 4-week post-appointment questionnaire. All participating service providers will be asked to complete a weekly survey and a post-trial follow-up survey (completed after the 5-week trial period). Participating service providers will also be asked to take part in a post-trial focus group. Previous interventions: Randomisation will occur at the child level, whereby patients in participating outpatient clinics who have an outpatient appointment in the 5-week trial period, consented to take part, and completed the baseline survey will be randomly allocated to either the control (standard care) or intervention arm (generic P-PROM) at a 1:1 ratio. Randomisation will be done using an online tool. Participating child patients allocated to the intervention arm will be asked to complete a generic P-PROM, the EQ-5D-Y-5L, prior to their outpatient clinic appointment. The patient will then be asked to highlight any domain(s) they would like to discuss with their service provider at their upcoming appointment. The results of this P-PROM will be displayed back to the patient and their treating service provider. If the patient highlighted any domain(s) for discussion, this will appear as an alert on the display shown to the service provider. After completing the generic P-PROM, patients will automatically receive resources to support getting help for any concerns they might have with any of the domains covered by the EQ-5D-Y-5L. Service providers will also receive resources and training. The intervention was co-designed with key stakeholders, including clinicians, caregivers of patients, and adolescent patients. Participating child patients allocated to the control arm will receive standard care, whereby they will attend their appointment as usual. The trial will run for a 5-week period in each outpatient clinic, however, the treatment period for each child is the time associated with their appointment at the outpatient clinic. The follow-up for each child will be at least 4-weeks after their appointment. All participating child participants or the caregivers of child participants will be asked to complete a baseline questionnaire (pre-appointment), a 1-day post appointment questionnaire and a 4-week post-appointment questionnaire. All participating service providers will be asked to complete a weekly survey and a post-trial follow-up survey (completed after the 5-week trial period). Participating service providers will also be asked to take part in a post-trial focus group.
Intervention type	Behavioural
Primary outcome measure(s)	Acceptability outcomes: 1. patient/caregiver reported attitude about completing the generic P-PROM, measured by asking patients/caregivers a question adapted from the TFA in the 1-day follow-up survey. 2. patient/caregiver reported burden to complete the generic P-PROM, measured by asking patients/caregivers a question adapted from the TFA in the 1-day follow-up survey. 3. patient/caregiver reported relevance of generic P-PROM questions, measured by asking patients/caregivers a question adapted from a previous similar P-PROM study in the 1-day follow-up survey. 4. patient/caregiver reported ease understanding the summary display of the generic P-PROM results, measured by asking patients/caregivers a question adapted from a previous similar P-PROM study in the 1-day follow-up survey. 5. patient/caregiver reported perceived usefulness of generic P-PROM results in the clinical encounter, measured by asking patients/caregivers a question adapted from the TFA and a previous similar P-PROM study in the 1-day follow-up survey. 6. patient/caregiver reported perceived opportunity cost of discussing the generic P-PROM in the clinical encounter, measured by asking patients/caregivers a question adapted from the TFA in the 1-day follow-up survey. 7. patient/caregiver reported perception of intervention coherence of the generic P-PROM (i.e., clarity regarding how generic P-PROM could improve child’s care), measured by asking patients/caregivers a question adapted from the TFA in the 1-day follow-up survey. 8. patient/caregiver reported self-efficacy completing the generic P-PROM in future, measured by asking patients/caregivers a question adapted from the TFA in the 1-day follow-up survey. 9. patient/caregiver reported helpfulness of resources provided alongside the generic P-PROM, measured by asking patients/caregivers a study designed question in the 1-day follow-up survey. 10. patient/caregiver reported acceptability of completing and using generic P-PROM in outpatient care, measured by asking patients/caregivers a question adapted from the TFA in the 1-day follow-up survey. 11. patient/caregiver reported ease using the patient portal system to complete the generic P-PROM, view results, and view resources, measured by asking patients/caregivers a study designed question in the 1-day follow-up survey and by data automatically captured via portal (such as time taken to complete and number of clicks). 12. service provider reported ease locating generic P-PROM results, measured by asking service providers a study designed question in the follow-up survey. 13. service provider reported ease interpreting results of generic P-PROM, measured by asking service providers a study designed question in the follow-up survey. 14. service provider reported usefulness of results in clinical encounter, measured by asking service providers a question adapted from the TFA in the follow-up survey. Also measured by asking service providers a study designed question in a weekly during trial survey. 15. service provider reported intervention coherence of generic P-PROM (i.e., clarity regarding how generic P-PROM could improve care provided to children), measured by asking service providers a question adapted from the TFA in the follow-up survey. 16. service provider reported helpfulness of training at beginning of trial, measured by asking service providers a study designed question in the follow-up survey. 17. service provider reported helpfulness of resources document (clinician decision support tool/ clinician & family resources), measured by asking service providers a study designed question in the follow-up survey. 18. service provider reported confidence addressing patient concerns arising from the generic P-PROM, measured by asking service providers a study designed question in the follow-up survey. 19. service provider reported attitude about use of generic P-PROM in routine outpatient care, measured by asking service providers a question adapted from the TFA in the follow-up survey. 20. service provider reported burden using generic P-PROM in routine outpatient care, measured by asking service providers a question adapted from the TFA in the follow-up survey. 21. service provider reported self-efficacy using generic P-PROM in outpatient care routinely in future, measured by asking service providers a question adapted from the TFA in the follow-up survey. 22. service provider reported opportunity cost of using generic P-PROM in outpatient care, measured by asking service providers a question adapted from the TFA in the follow-up survey. 23. service provider reported acceptability of using generic P-PROM in outpatient care, measured by asking service providers a question adapted from the TFA in the follow-up survey. 24. service provider perception on acceptability of intervention measured via qualitative focus groups. Added 13/06/2024: 25. patient/caregiver perception on the acceptability of intervention measured via qualitative interviews Feasibility of the generic P-PROM intervention, measured by: 1. the proportion of patients allocated to the intervention who actually complete the generic P-PROM. 2. the proportion of patients/caregivers allocated to the intervention who report wanting to discuss at least one of the domains of the generic P-PROM with their service provider. 3. the proportion of generic P-PROM results opened or viewed by a service provider where a generic P-PROM result was available. 4. format of generic P-PROM completion (via patient portal system (web versus app) or paper). 5. calculating the resources required to implement the intervention, including electronic medical record team support time, clinician time for training, clinician time to discuss and action generic P-PROM results, and researcher time to get patients/caregivers to complete generic P-PROM. Resources will be converted into Australian dollars to provide an estimate of intervention cost. 6. additional consultation time arising from the generic P-PROM intervention compared to standard care, based on service provider report in a weekly survey and follow-up survey (study designed question). Additionally, based on research assistant's recording the duration of a random subset of face-to-face encounters. 7. service provider perception on feasibility of intervention from qualitative focus groups. Added 13/06/2024: 8. patient/caregiver perception on feasibility of intervention measured via qualitative interviews.
Key secondary outcome measure(s)	1. the discussion of relevant quality-of-life domains in clinical encounter, measured by asking patients/caregivers if quality of life domains that were relevant to them were discussed in their most recent clinical encounter in the 1-day follow-up survey (study design question). Additionally, this will be measured by assessing notes from the electronic medical record that indicate relevant quality of life domains were discussed with patient. 2. holistic care provided in clinical encounter, measured by asking patients/caregivers if their most recent clinical encounter included discussion of aspects of health beyond just the physical condition they were present for (such as emotional, social, school, hobbies, and spiritual wellbeing) in the 1-day follow-up survey (study designed question). 3. new health problem detected, measured by calculating the proportion of clinical encounters in which a new health problem was detected for a patient, based on patient/caregiver report in the 1-day follow-up survey and from electronic medical record notes that indicate a new problem was identified. 4. change in practice or support provided to patient (i.e., change medication, referral, connection with support service, connection with online resource) for a health/quality of life problem(s) in their most recent clinical encounter. Measured by asking patients/caregivers a study designed question in the 1-day follow-up survey and by assessing electronic medical record noted about if support was provided. 5. patient satisfaction with care in routine outpatient care based on responses to patient satisfaction questionnaire (PSQ). 6. patient - clinician communication, measured by asking patients/caregivers a study designed question in the 1-day follow-up survey. 7. improvements in child health related quality of life, measured using the CHU9D and based on change between baseline and 4-week follow-up.
Completion date	01/08/2024

Eligibility

Participant type(s)	Patient, Health professional
Age group	Mixed
Lower age limit	4 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	100
Total final enrolment	87
Key inclusion criteria	All participants must meet one of the following criteria to be enrolled in this trial: 1. Is a child aged 4-17 years (inclusive) at the time of randomisation and who has an appointment (either new or review and either face to face or telehealth) with one of the participating outpatient clinics during the 5-week trial period. 2. Is a service provider (including clinicians, nurses, allied health staff) who provides outpatient care to children aged 4-17 years (inclusive) in one of the participating outpatient clinics during the trial period.
Key exclusion criteria	1. Patient with a social flag on their electronic medical record (because they will not be able to access the patient portal system). 2. Any participant not able to communicate in English or require a translator as per their electronic medical record (because the patient portal system is only available in English).
Date of first enrolment	14/02/2024
Date of final enrolment	26/05/2024

Locations

Countries of recruitment

Australia

Study participating centre

The Royal Children's Hospital, Melbourne

50 Flemington Road
Melbourne
3052
Australia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The dataset generated during the current study is not expected to be available due to the confidential nature of the data within the dateset, including medical records and private health information.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Statistical Analysis Plan	version 1	19/01/2024	19/01/2024	No	No

Additional files

P-PROM ROCK Pilot RCT_Statistical anlysis plan_v1_19Jan2024.pdf: Statistical Analysis Plan

Editorial Notes

13/06/2024: The following changes were made to the study record:
1. The interventions and primary outcome measures were updated.
2. Total final enrolment added.
3. The recruitment start date was changed from 01/03/2024 to 14/02/2024.
4. The recruitment end date was changed from 31/05/2024 to 26/05/2024.
19/01/2024: Trial's existence confirmed by The Royal Children's Hospital Melbourne, Human Research Ethics Committee.