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Table 3 Outcomes and data collected as part of process evaluation

From: Protocol for the process evaluation of a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care home: the CHIPPS study

Aim

Outcome

Data collected

Data source

To improve quality of care for those over 65 years old resident in care homes

Falls

Fall rate per person at 3 months

Care home falls record

Fall rate per person at 6 months

Care home falls record

Quality of life

Self-reported quality of life

Face-to-face self-reported EQ-5D-5 L (only applicable for participants with capacity) at baseline, 3 months and 6 months

Carer-assessed quality of life

Proxy EQ-5D-5 L (quality of life) at baseline, 3 months and 6 months

Physical functioning

Carer-assessed physical functioning

Proxy Barthel Index (physical functioning) at baseline and 6 months

Health service utilisation and associated costs

Costs of care (medication, healthcare team contacts, monitoring and tests)

GP records at baseline and 6 months

DBI

Calculate DBI based on medications

GP records at baseline and 6 months

To assess intervention safety

Mortality

Information on numbers dying and time to death.

Monthly call to care homes

Hospitalisations

(Note: not always a negative marker of safety)

Information on numbers hospitalised

Monthly call to care homes

Global viewa

Perceptions of GPs

GP interview

Perceptions of care home staff

Care home staff interviews

Perception of residents/consultee/WPOA

Resident/consultee/WPOA interviews

Perceptions of PIPs

PIP interview

Adverse eventsa

New drug related symptoms

Stakeholder feedback using standard template

Serious adverse eventsa

See hospitalisations/deaths

Monthly call to care homes

Sudden unexpected serious adverse eventsa

See hospitalisations/deaths

Feedback from GPs/independent medical assessor on causal link with PIP intervention

  1. DBI Drug Burden Index; EQ-5D-5 L EuroQoL five-dimension, five-level questionnaire; GP general practitioner; PIP pharmacist independent prescriber; WPOA Welfare Power of Attorney
  2. a Other than those noted, these are also primary and secondary outcomes for main trial and will be compared across groups