End of LifeNCT06526637
User Testing of an End of Life Medication Support Intervention for Lay Carers (Palliate).
A study testing Paper Package, V1 + Preparation Sheet and V2 + Video Training in people with End of Life and Support, Family, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The aim of this study is to evaluate the acceptability, safety and efficiency of the Palliate intervention. The Palliate intervention is a nurse-led process that includes training and documentation materials to support lay carers in administering top up medications to loved ones at the end of life at home. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- End of Life, Support, Family
- What is being tested?
- Paper Package, V1 + Preparation Sheet and V2 + Video Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Sep 2024to 1 Nov 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals aged 18 years or older and able to communicate in English.
Who cannot join
- Individuals aged less than 18 years old and/or unable to communicate in English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: User Testing of the Palliate Intervention, Supporting Lay Carers to Prepare and Administer Anticipatory Medications to Loved Ones at Home at the End of Life.
The aim of this study is to evaluate the acceptability, safety and efficiency of the Palliate intervention.
The Palliate intervention is a nurse-led process that includes training and documentation materials to support lay carers in administering top up medications to loved ones at the end of life at home. The Palliate intervention was designed based on the CARiAD* intervention using user testing and has been successfully piloted and rolled out in Central and North West London National Health Service (NHS) Foundation Trust.
*CARer-ADministration of as-needed sub-cutaneous medication for breakthrough symptoms in homebased dying patients.
- Conditions
- End of Life, Support, Family
- Being tested
- Paper Package, V1 + Preparation Sheet, V2 + Video Training
- Keywords
- Palliative Care
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paper PackageOther
Paper based (as per current practice at Central and North West London (CNWL) NHS Foundation Trust) version of Palliate.
V1 + Preparation SheetOther
Paper based version of Palliate plus a preparation sheet, that provides visual cues as to what equipment is required for the preparation and administration of the medications.
V2 + Video TrainingOther
Hybrid - paper based materials, preparation sheet, and video instructions available via an interactive portable document format (PDF) version of the training materials.
| Study group | Role | What they receive |
|---|---|---|
| Version 1 of Palliate | Active comparator | Participants will be randomised to receive this version of Palliate training and materials. Receives: Other: Paper Package |
| Version 2 of Palliate | Experimental | Participants will be randomised to receive this version of Palliate training and materials. Receives: Other: V1 + Preparation Sheet |
| Version 3 of Palliate | Experimental | Participants will be randomised to receive this version of Palliate training and materials. Receives: Other: V2 + Video Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Participant scores of acceptability of the intervention as per the responses on the Theoretical Framework of Acceptability (TFA) questionnaire. Free text or verbal responses noted when completing the questionnaire will be thematically analysed as informed by the TFA.
The TFA questionnaire is an eight-item questionnaire. Raw total scores range from 8 (the worst possible score) to 40 (the best possible score).
Measured: Through study completion per participant (≤ 5 weeks)
Secondary outcomes (6)
Usability
Participant scores of usability as per the System Usability Scale (SUS) questionnaire.
The SUS is a ten-item attitude Likert scale giving a global view of subjective assessments of usability. Scores range from 0 (the worst possible score) to 100 (the best possible score).
Measured: Through study completion per participant (≤ 5 weeks)
Incidence of error
Medication Error will be defined as any of the following - Wrong medication
Wrong dose - if >10% deviation from the prescribed dose.
Wrong indication - was the selected medication and dose correct for the symptoms presented.
Administration error - incorrect process of administration
Documentation error - failure to document or incorrect documentation.
(Wrong patient- n/a, Wrong route- n/a, Wrong concentration- n/a, Wrong diluent- n/a)
Measured: Through study completion per participant (≤ 5 weeks)
Efficiency
Time taken to prepare and administer each medication. This will be defined as - Start = the moment the participant begins reading the scenario Finish = the moment the medication has been administered Time for documentation will also be recorded.
Measured: Through study completion per participant (≤ 5 weeks)
Factors contributing to error, potential errors and acceptability of the intervention
Hierarchical Task Analysis - The workflow of reading the scenario, through to preparation, administration and documentation of the medications will be micro-analysed and mapped. Medication events that are found to be erroneous, take longer than anticipated or deem to be problematic by the participant or researcher/s will be analysed against the workflow map to identify which step in the process was the likely cause of the issue.
Measured: Through study completion per participant (≤ 5 weeks)
Learnability/ Retained learning
Differences in the incidence of error and time to complete task between a, each medication preparation and administration and b, between the first and second visit.
Measured: Through study completion per participant (≤ 5 weeks)
Actual and perceived barriers and opportunities from the participants regarding the use of the Palliate intervention
Guided by the theoretical framework of acceptability- Short semi-structure interviewers following participation in the user testing. And/or completion of a questionnaire with a combination of open and closed questions.
Measured: Through study completion per participant (≤ 5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start26 Sep 2024
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End of LifeStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will use direct observational methods in a workshop setting. Participants will be randomised to receive one of three Palliate training and material versions. Randomisation will be completed ahead of study commencement using a random number generator to allow the researcher time to prepare and set up the selected training information and materials. Randomisation will be conducted in blocks of three to ensure an even number randomised to each of the study arms (intervention version 1,2 and 3).
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Oak Foundation
- Responsible party
- Sponsor
- Investigators
- Leila Shepherd, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526637
- Sponsor's protocol ID
- OFIL-20-279
- Status last verified
- Mar 2026
- First submitted
- 25 Jul 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Testing of the Palliate Intervention, Supporting Lay Carers to Prepare and Administer Anticipatory Medications to Loved Ones at Home at the End of Life.
- ClinicalTrials.gov ID
- NCT06526637
- Acronym / sponsor ID
- OFIL-20-279
- Conditions
- End of Life, Support, Family
- Keywords
- Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Oak Foundation
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 30 Jul 2024 (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.
The aim of this study is to evaluate the acceptability, safety and efficiency of the Palliate intervention.
The Palliate intervention is a nurse-led process that includes training and documentation materials to support lay carers in administering top up medications to loved ones at the end of life at home. The Palliate intervention was designed based on the CARiAD* intervention using user testing and has been successfully piloted and rolled out in Central and North West London National Health Service (NHS) Foundation Trust.
*CARer-ADministration of as-needed sub-cutaneous medication for breakthrough symptoms in homebased dying patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study will use direct observational methods in a workshop setting. Participants will be randomised to receive one of three Palliate training and material versions. Randomisation will be completed ahead of study commencement using a random number generator to allow the researcher time to prepare and set up the selected training information and materials. Randomisation will be conducted in blocks of three to ensure an even number randomised to each of the study arms (intervention version 1,2 and 3).
| Arm | Type | Receives |
|---|---|---|
| Version 1 of Palliate | Active comparator | Other: Paper PackageParticipants will be randomised to receive this version of Palliate training and materials. |
| Version 2 of Palliate | Experimental | Other: V1 + Preparation SheetParticipants will be randomised to receive this version of Palliate training and materials. |
| Version 3 of Palliate | Experimental | Other: V2 + Video TrainingParticipants will be randomised to receive this version of Palliate training and materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals aged 18 years or older and able to communicate in English.
Key exclusion criteria (1 listed)
- Individuals aged less than 18 years old and/or unable to communicate in English.
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 |
|---|---|---|
| Paper PackagePaper based (as per current practice at Central and North West London (CNWL) NHS Foundation Trust) version of Palliate. | Other | Version 1 of Palliate |
| V1 + Preparation SheetPaper based version of Palliate plus a preparation sheet, that provides visual cues as to what equipment is required for the preparation and administration of the medications. | Other | Version 2 of Palliate |
| V2 + Video TrainingHybrid - paper based materials, preparation sheet, and video instructions available via an interactive portable document format (PDF) version of the training materials. | Other | Version 3 of Palliate |
Primary outcome
Acceptability
Time frame: Through study completion per participant (≤ 5 weeks)
Participant scores of acceptability of the intervention as per the responses on the Theoretical Framework of Acceptability (TFA) questionnaire. Free text or verbal responses noted when completing the questionnaire will be thematically analysed as informed by the TFA. The TFA questionnaire is an eight-item questionnaire. Raw total scores range from 8 (the worst possible score) to 40 (the best possible score).
6 secondary outcomes
Usability
Time frame: Through study completion per participant (≤ 5 weeks)
Incidence of error
Time frame: Through study completion per participant (≤ 5 weeks)
Efficiency
Time frame: Through study completion per participant (≤ 5 weeks)
Factors contributing to error, potential errors and acceptability of the intervention
Time frame: Through study completion per participant (≤ 5 weeks)
Learnability/ Retained learning
Time frame: Through study completion per participant (≤ 5 weeks)
Actual and perceived barriers and opportunities from the participants regarding the use of the Palliate intervention
Time frame: Through study completion per participant (≤ 5 weeks)
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 27 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Leila Shepherd, PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paper Package, V1 + Preparation Sheet and V2 + Video Training in people with End of Life and Support, Family, run by Imperial College London 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 1 inclusion and 1 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 27 Mar 2026. 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?
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?
Acceptability (time frame: Through study completion per participant (≤ 5 weeks)). 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 27 Mar 2026.