Long-Term CareNCT02579577
Decision Making and Future Planning for Children With Complex Illness
An observational study of Long-Term Care and Palliative Care, run by University of Nottingham at 3 sites in United Kingdom.
Trial summary
The population of children with life-limiting illnesses (LLI) in England is increasing and there is growing need to improve the quality of children's palliative care. Families of children with LLI are confronted with many care decisions for their children, such as whether and when to commence artificial nutrition or… Read more about this study
- Who is it for?
- Ages 28 days and olderHealthy volunteers can take part
- Conditions the study is for
- Long-Term Care, Palliative Care
- What is being tested?
- Observation, Interviews and Medical notes review
- How many people
- 32 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Oct 2015to 31 Jan 2017
- 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 28 days and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Each case will be centred around a child with a life-limiting illness and their parents who will have been identified as eligible by their usual care team. Additional significant others who are important in their decision making and future planning will be identified by the family and will ideally include at least one health professional. However, the composition of each case will be determined by the child and family and may involve only them. Nominated 'significant others' may include extended family, peers, ministers of religion, key workers etc.
Who may be able to join
- Their child must be between 28 days and 18 years old
- Their child must have a LLI within categories 2-4 (Association for Children with Life-threatening and Terminal Conditions and their Families, 2004) (see page 8)
- Child must be under the care of a consultant at either of the two NHS Trusts included in the study
- The parent must be aware of the child's LLI diagnosis
- Participants must speak English. This is both due to resource constraints and due to the sensitive topic such that difficulties in translating questions sensitively may cause greater distress to participants.
- Children will be classed as participants if their parent is a participant and consents to their child's medical notes being accessed.
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- For children to participate in the interview component of the study, they must be over the age of 7 years and cognitively able to provide their own assent (or consent, if over 16 years old)
- Parents must have agreed to the child's participation if they are under 16 years old
- Participants must speak English or be able to communicate in some way using alternative or augmentative communication.
- Significant others must have been identified by the eligible child and/or parents as being important in their decision making and future planning
- Participants must speak English
- Participants must be over the age of 7 years and provide their own assent alongside parental consent (if under 16 years old) or provide consent if they are over the age of 16 years (in the case of a friend or sibling being nominated as a 'significant other').
Who cannot join
- Families and significant others of children with ACT Category 1 life-threatening illnesses (Conditions for which curative treatment may be feasible but can fail)
- Participants who do not meet the inclusion criteria.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Sherwood Forest Hospitals NHS Trust
Mansfield
Nottingham University Hospitals NHS Trust
Nottingham
Sheffield Children's Hospital
Sheffield
About this study
Official title: Decision Making and Future Planning for Children With Complex Illnesses: a Qualitative Multi-stakeholder, Longitudinal Study.
The population of children with life-limiting illnesses (LLI) in England is increasing and there is growing need to improve the quality of children's palliative care. Families of children with LLI are confronted with many care decisions for their children, such as whether and when to commence artificial nutrition or ventilation. They may also have the opportunity to consider the care that may be appropriate for their child in the future. Despite the important decisions families and professionals are required to make, there is little empirical evidence regarding the process of decision making and future planning for this population. Few studies have investigated the perspectives of multiple stakeholders and none have addressed multiple perspectives longitudinally. Therefore the relational and contextual aspects of decision making and future planning for children with LLI have as yet not been identified.
A multiple embedded case study utilising ethnographic methods (semi-structured interviews, observation and notes review) is proposed to address this knowledge gap. Families of children with LLI cared for in either of two participating hospitals will be recruited and followed up for up to 12 months. The family will be invited to nominate 'significant others' (e.g. relatives, friends, health care professionals) who assist them in decision making and future planning, to participate in the study. Outpatient clinic appointments or ward rounds during periods of hospitalisation will be observed and semi-structured interviews will be conducted approximately three times with each participant. Medical notes will be reviewed at the end of the study.
This research will enable a better understanding of the experiences and preferences for engaging in decision making and future planning from the perspectives of all stakeholders. It will also provide an awareness of the communication practices involved in discussions and the networks of care surrounding children with LLI, including specific support needs in relation to their role.
- Conditions
- Long-Term Care, Palliative Care
- Being tested
- Observation, Interviews, Medical notes review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observation of clinic appointments and ward rounds if the child is admitted to hospital during the study period.
InterviewsOther
Semi-structured interviews will be conducted approximately 3 times during the study period with each participant.
Medical notes reviewOther
The child's electronic medical record will be accessed periodically to identify any planned appointments or periods of hospitalisation and their medical notes will also be reviewed at the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Decision making cohort | Any people identified as being important within the network of care for children with life-limiting illnesses. Receives: Other: Observation; Other: Interviews; Other: Medical notes review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-Structured Interview Responses
Interviews will be semi-structured, with a broad opening question asking the participant about the child at the centre of the case; both in terms of their illness and their context (family, personality, values and goals). Although the topics of decision making and future planning will be covered within the interview, the way in which these are initiated are likely to be different for each participant and asked in relation to the responses given to the opening question.
Measured: Up to 24 months
Observational fieldnotes
Observations will occur at clinic appointments and ward rounds and will aim to identify the communication processes involved in decision making and how each individual involved participates.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-Term CareStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bridget Johnston, Professor, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579577
- Sponsor's protocol ID
- 15068
- Status last verified
- May 2016
- First submitted
- 31 Jul 2015
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Making and Future Planning for Children With Complex Illnesses: a Qualitative Multi-stakeholder, Longitudinal Study.
- ClinicalTrials.gov ID
- NCT02579577
- Acronym / sponsor ID
- 15068
- Conditions
- Long-Term Care, Palliative Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 19 Oct 2015 (estimated)
- 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.
The population of children with life-limiting illnesses (LLI) in England is increasing and there is growing need to improve the quality of children's palliative care. Families of children with LLI are confronted with many care decisions for their children, such as whether and when to commence artificial nutrition or ventilation. They may also have the opportunity to consider the care that may be appropriate for their child in the future. Despite the important decisions families and professionals are required to make, there is little empirical evidence regarding the process of decision making and future planning for this population. Few studies have investigated the perspectives of multiple stakeholders and none have addressed multiple perspectives longitudinally. Therefore the relational and contextual aspects of decision making and future planning for children with LLI have as yet not been identified.
A multiple embedded case study utilising ethnographic methods (semi-structured interviews, observation and notes review) is proposed to address this knowledge gap. Families of children with LLI cared for in either of two participating hospitals will be recruited and followed up for up to 12 months. The family will be invited to nominate 'significant others' (e.g. relatives, friends, health care professionals) who assist them in decision making and future planning, to participate in the study. Outpatient clinic appointments or ward rounds during periods of hospitalisation will be observed and semi-structured interviews will be conducted approximately three times with each participant. Medical notes will be reviewed at the end of the study.
This research will enable a better understanding of the experiences and preferences for engaging in decision making and future planning from the perspectives of all stakeholders. It will also provide an awareness of the communication practices involved in discussions and the networks of care surrounding children with LLI, including specific support needs in relation to their role.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decision making cohort | – | Other: Observation, Other: Interviews, Other: Medical notes reviewAny people identified as being important within the network of care for children with life-limiting illnesses. |
Who may qualify
- Ages
- 28 days and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Each case will be centred around a child with a life-limiting illness and their parents who will have been identified as eligible by their usual care team. Additional significant others who are important in their decision making and future planning will be identified by the family and will ideally include at least one health professional. However, the composition of each case will be determined by the child and family and may involve only them. Nominated 'significant others' may include extended family, peers, ministers of religion, key workers etc.
Key inclusion criteria (12 listed)
- Their child must be between 28 days and 18 years old
- Their child must have a LLI within categories 2-4 (Association for Children with Life-threatening and Terminal Conditions and their Families, 2004) (see page 8)
- Child must be under the care of a consultant at either of the two NHS Trusts included in the study
- The parent must be aware of the child's LLI diagnosis
- Participants must speak English. This is both due to resource constraints and due to the sensitive topic such that difficulties in translating questions sensitively may cause greater distress to participants.
Key exclusion criteria (2 listed)
- Families and significant others of children with ACT Category 1 life-threatening illnesses (Conditions for which curative treatment may be feasible but can fail)
- Participants who do not meet the inclusion criteria.
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 |
|---|---|---|
| ObservationObservation of clinic appointments and ward rounds if the child is admitted to hospital during the study period. | Other | Decision making cohort |
| InterviewsSemi-structured interviews will be conducted approximately 3 times during the study period with each participant. | Other | Decision making cohort |
| Medical notes reviewThe child's electronic medical record will be accessed periodically to identify any planned appointments or periods of hospitalisation and their medical notes will also be reviewed at the end of the study. | Other | Decision making cohort |
Primary outcome
Semi-Structured Interview Responses
Time frame: Up to 24 months
Interviews will be semi-structured, with a broad opening question asking the participant about the child at the centre of the case; both in terms of their illness and their context (family, personality, values and goals). Although the topics of decision making and future planning will be covered within the interview, the way in which these are initiated are likely to be different for each participant and asked in relation to the responses given to the opening question.
Observational fieldnotes
Time frame: Up to 24 months
Observations will occur at clinic appointments and ward rounds and will aim to identify the communication processes involved in decision making and how each individual involved participates.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
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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.
Bridget Johnston, Professor principal investigator
University of Nottingham
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long-Term Care and Palliative Care, run by University of Nottingham at 3 sites 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 12 inclusion and 2 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: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semi-Structured Interview Responses (time frame: Up to 24 months). The study lists 2 primary outcomes in all. 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 3 May 2017.