Palliative MedicinePARAMOUNTNCT04519632
Paediatric Palliative Care Pain Management in the Community
An observational study of Palliative Medicine and Pediatric ALL, run by University of Southampton at 1 site in United Kingdom.
Trial summary
To describe the the barriers and facilitators experienced by carers and healthcare professionals when managing medicines for pain relief for infants, children, and young people approaching the end of life in out of hospital settings. Read more about this study
- Who is it for?
- Ages 6 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Palliative Medicine, Pediatric ALL
- What is being tested?
- Qualitative study
- How many people
- 68 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jul 2019to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Parents and carers of infants, children and young people at the end-of-life being cared for in the community, the healthcare professionals supporting them, and the children and young people who receive this care
Who may be able to join
- Carers of infants, children, and young people up to 18 years being cared for outside hospital at the end of life (defined as those patients who score as 'orange' or 'red' on the Spectrum of Palliative Care Needs tool and/or who have a symptom management plan (including pain management) written by a specialist palliative care team.
- Self-reported full or partial responsibility for managing the patient's medicines, in particular having to select PRN (pro re nata or 'taken as needed') for pain and being responsible for the clinical decision making and the physical process of administering medicines.
- Healthcare professionals in primary, secondary and tertiary care who are involved in the care of children at end-of-life (defined as those patients who score as 'orange' or 'red' on the Spectrum of Palliative Care Needs tool) outside hospital, some of whom may be caring for the families taking part.
- Children and young people aged 6-18 years who are being cared for outside hospital at the end of life defined as those patients who score as 'orange' or 'red' on the Spectrum of Palliative Care Needs tool).
Who cannot join
- Carers judged by consultants or nurses to lack capacity to consent.
- Carers judged by nurses to be 'struggling' too much (however, these carers will still be able to approach the researcher directly if they wish to take part as posters will be used to advertise the study).
- CYP judged by carers or nurses to lack capacity to take part in an interview, who are too unwell or those who might find it too distressing.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Southampton
Southampton, SO17 1BJ
Simone Holley, PhD, s.l.holley@soton.ac.uk
About this study
Official title: End-of-Life Pain Management by Carers and Healthcare Professionals in Infants, Children and Young People in Out of Hospital Settings
To describe the the barriers and facilitators experienced by carers and healthcare professionals when managing medicines for pain relief for infants, children, and young people approaching the end of life in out of hospital settings.
Read the detailed description
This study aims to hear about the experiences of patients, carers and healthcare professionals when managing pain relief medicines for infants, children and young people (ICYP) at the end of their lives, when they are not in hospital.
The study plans to develop a guide to help educate and empower both carers and healthcare professionals in the best ways to manage pain in this group of patients. This guide will contain basic, easily understood information depending upon both the patient's and carers' needs. Family carers are important in looking after their ICYP with life-threatening illnesses, so they can be cared for at home if they wish. Even with varying levels of support from hospice, hospital or family doctors, such responsibility can be rewarding and scary.
Community based healthcare professionals often have little experience to be able to support good end of life pain care in these patients when at home and there may be problems which prevent them from giving effective treatment. If pain and other symptoms are not well controlled by medicines families often move from their chosen place of care. Carers need to be able to check symptoms to decide which medicines to give and how well they are working, without having any special training; some may have unhelpful views about medicines such as morphine.
Not much research has looked at the problems that carers and healthcare professionals come across when trying to manage a child's pain when they are not in hospital.
Research has already shown that being able to provide the right medicine at the right time means children can be looked after where they want, without unnecessary hospital admissions. It is hoped that the guide will make carers feel more confident in managing pain relief safely, so lessening any worries. Future research is planned to show the value of the guide in a larger study.
- Conditions
- Palliative Medicine, Pediatric ALL
- Being tested
- Qualitative study
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative studyOther
Qualitative interviews
| Study group | Role | What they receive |
|---|---|---|
| Parents | Qualitative interviews Receives: Other: Qualitative study | |
| Healthcare Professionals | Qualitative interviews Receives: Other: Qualitative study | |
| Children | Children and young people aged 6-18 years, Qualitative interviews Receives: Other: Qualitative study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative data obtained from semi-structured interviews
Barriers and facilitators to managing pain in infants, children, and young people at end of life as reported by parents, caregivers, healthcare professionals and children and young people.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start15 Jul 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative MedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust, Alder Hey Children's NHS Foundation Trust, Helen & Douglas House Hospice, Oxford, UK, Rainbow Hospice
- Responsible party
- Sponsor
- Investigators
- Christina Liossi, PhD, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519632
- Sponsor's protocol ID
- 47244
- Acronym
- PARAMOUNT
- Status last verified
- Aug 2020
- First submitted
- 27 Jun 2019
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End-of-Life Pain Management by Carers and Healthcare Professionals in Infants, Children and Young People in Out of Hospital Settings
- ClinicalTrials.gov ID
- NCT04519632
- Acronym / sponsor ID
- PARAMOUNT / 47244
- Conditions
- Palliative Medicine, Pediatric ALL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust, Alder Hey Children's NHS Foundation Trust, Helen & Douglas House Hospice, Oxford, UK, Rainbow Hospice
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To describe the the barriers and facilitators experienced by carers and healthcare professionals when managing medicines for pain relief for infants, children, and young people approaching the end of life in out of hospital settings.
Detailed description
This study aims to hear about the experiences of patients, carers and healthcare professionals when managing pain relief medicines for infants, children and young people (ICYP) at the end of their lives, when they are not in hospital.
The study plans to develop a guide to help educate and empower both carers and healthcare professionals in the best ways to manage pain in this group of patients. This guide will contain basic, easily understood information depending upon both the patient's and carers' needs. Family carers are important in looking after their ICYP with life-threatening illnesses, so they can be cared for at home if they wish. Even with varying levels of support from hospice, hospital or family doctors, such responsibility can be rewarding and scary.
Community based healthcare professionals often have little experience to be able to support good end of life pain care in these patients when at home and there may be problems which prevent them from giving effective treatment. If pain and other symptoms are not well controlled by medicines families often move from their chosen place of care. Carers need to be able to check symptoms to decide which medicines to give and how well they are working, without having any special training; some may have unhelpful views about medicines such as morphine.
Not much research has looked at the problems that carers and healthcare professionals come across when trying to manage a child's pain when they are not in hospital.
Research has already shown that being able to provide the right medicine at the right time means children can be looked after where they want, without unnecessary hospital admissions. It is hoped that the guide will make carers feel more confident in managing pain relief safely, so lessening any worries. Future research is planned to show the value of the guide in a larger study.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parents | – | Other: Qualitative studyQualitative interviews |
| Healthcare Professionals | – | Other: Qualitative studyQualitative interviews |
| Children | – | Other: Qualitative studyChildren and young people aged 6-18 years, Qualitative interviews |
Who may qualify
- Ages
- 6 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parents and carers of infants, children and young people at the end-of-life being cared for in the community, the healthcare professionals supporting them, and the children and young people who receive this care
Key inclusion criteria (4 listed)
- Carers of infants, children, and young people up to 18 years being cared for outside hospital at the end of life (defined as those patients who score as 'orange' or 'red' on the Spectrum of Palliative Care Needs tool and/or who have a symptom management plan (including pain management) written by a specialist palliative care team.
- Self-reported full or partial responsibility for managing the patient's medicines, in particular having to select PRN (pro re nata or 'taken as needed') for pain and being responsible for the clinical decision making and the physical process of administering medicines.
- Healthcare professionals in primary, secondary and tertiary care who are involved in the care of children at end-of-life (defined as those patients who score as 'orange' or 'red' on the Spectrum of Palliative Care Needs tool) outside hospital, some of whom may be caring for the families taking part.
- Children and young people aged 6-18 years who are being cared for outside hospital at the end of life defined as those patients who score as 'orange' or 'red' on the Spectrum of Palliative Care Needs tool).
Key exclusion criteria (3 listed)
- Carers judged by consultants or nurses to lack capacity to consent.
- Carers judged by nurses to be 'struggling' too much (however, these carers will still be able to approach the researcher directly if they wish to take part as posters will be used to advertise the study).
- CYP judged by carers or nurses to lack capacity to take part in an interview, who are too unwell or those who might find it too distressing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative studyQualitative interviews | Other | Children, Healthcare Professionals, Parents |
Primary outcome
Qualitative data obtained from semi-structured interviews
Time frame: Baseline
Barriers and facilitators to managing pain in infants, children, and young people at end of life as reported by parents, caregivers, healthcare professionals and children and young people.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Liossi, PhD principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative Medicine and Pediatric ALL, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simone Holley, PhD (00442380595083, s.l.holley@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative data obtained from semi-structured interviews (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.