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| Name | Class |
|---|---|
| Oak Foundation | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Version 1 of Palliate | Active Comparator | Participants will be randomised to receive this version of Palliate training and materials. |
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| Version 2 of Palliate | Experimental | Participants will be randomised to receive this version of Palliate training and materials. |
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| Version 3 of Palliate | Experimental | Participants will be randomised to receive this version of Palliate training and materials. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paper Package | Other | Paper based (as per current practice at Central and North West London (CNWL) NHS Foundation Trust) version of Palliate. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Through study completion per participant (≤ 5 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Through study completion per participant (≤ 5 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leila Shepherd, PhD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London | London | United Kingdom |
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| ID | Term |
|---|---|
| D003643 | Death |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C065700 | myotrophin |
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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).
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| 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. |
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| 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. |
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| 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) |
| 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. | 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. | 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. | 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. | Through study completion per participant (≤ 5 weeks) |