Skip to content

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

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)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16030620
Enrollment
100
Registered
2024-01-21
Start date
2024-02-14
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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. Other

Interventions

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

Sponsors

Murdoch Children's Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 100 Years

Inclusion criteria

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.

Exclusion criteria

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).

Design outcomes

Primary

MeasureTime frame
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,

Secondary

MeasureTime frame
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.

Countries

Australia

Contacts

Public ContactRenee Jones
reneej1@student.unimelb.edu.au+61 4 03598052

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 4, 2026