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Completed

NCT Number: NCT06526637

User Testing of an End of Life Medication Support Intervention for Lay Carers (Palliate).

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.

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Key information

Conditions

End of Life Death Pathologic Processes Pathological Conditions, Signs and Symptoms Support, Family

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College London

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals aged 18 years or older and able to communicate in English.

Exclusion criteria

  • Individuals aged less than 18 years old and/or unable to communicate in English.

Treatment and study plan

Paper Package

Other

Paper based (as per current practice at Central and North West London (CNWL) NHS Foundation Trust) version of Palliate.

V1 + Preparation Sheet

Other

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 Training

Other

Hybrid - paper based materials, preparation sheet, and video instructions available via an interactive portable document format (PDF) version of the training materials.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Usability

    Time frame: Through study completion per participant (≤ 5 weeks)

    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).

  2. Incidence of error

    Time frame: Through study completion per participant (≤ 5 weeks)

    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)

  3. Efficiency

    Time frame: Through study completion per participant (≤ 5 weeks)

    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.

  4. Factors contributing to error, potential errors and acceptability of the intervention

    Time frame: Through study completion per participant (≤ 5 weeks)

    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.

  5. Learnability/ Retained learning

    Time frame: Through study completion per participant (≤ 5 weeks)

    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.

  6. 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)

    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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Oak Foundation

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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