Introduction
Causal assumptions
The intervention
- reviewing a participating resident’s medication and developing and implementing a PCP
- assuming prescribing responsibilities
- supporting systematic ordering, prescribing and administration processes within each care home, GP practice and supplying pharmacy where needed
- providing training to staff in care home and GP practice
- communicating with GP practice, care home, supplying community pharmacy and study team
The control arm
The CHIPPS RCT process evaluation
Task | Aim (what is being assessed) | Data collected | Data source |
---|---|---|---|
Provide training for PIPs | Effectiveness of training | PIP views on training | Post- training feedback forms (at end of 2-day training session) |
PIP interview PIP questionnaire | |||
Competency | Competency assessments (feedback from independent assessors) | ||
Appropriateness of PCPs (20% sample; Additional file 1: Appendices 3,4) | |||
Views of stakeholders (interviews) | |||
PIP delivery of the intervention | Fidelity to intervention | Services provided and frequency with which provided | PIP activity logs |
Number of pharmaceutical care plans | |||
PIP questionnaire | |||
Quality of medication review | Review of 20% of pharmaceutical care plans |
Impact | Mechanism of impact | Data collected | Data source |
---|---|---|---|
Medication changes identified | PIP medication review | Recommendations for change and rationale | Pharmaceutical care plans |
PIP interview PIP questionnaire | |||
Medication changes made | PIP prescribing | Total no. medications per patient at baseline and 6 months | Pharmaceutical care plans |
GP records | |||
No. medications stopped per patient at 6 months | Pharmaceutical care plans | ||
GP records | |||
No. medications started per patient at 6 months | Pharmaceutical care plans | ||
GP records | |||
No. medications amended, e.g. dose change, formulation change | Pharmaceutical care plans | ||
GP records | |||
No. antipsychotics/psychotropics prescribed at baseline and 6 months | Pharmaceutical care plans | ||
GP records | |||
Categorised description of drugs changed, stopped, started | Resident medical records | ||
Biochemical monitoring | PIP medication review | Recommendations made for biochemical monitoring | Pharmaceutical care plans |
Medication errors | PIP medication review | Number of prescribing, dispensing and administration errors | Pharmaceutical care plans |
GP records | |||
Non-patient-facing activities improved, e.g. medication storage advice | PIP support for care home | Services provided and frequency | PIP activity log |
Views on usefulness of services | Care home staff interviews | ||
PIP interview PIP questionnaire | |||
Better/tailored training for staff | PIP training for care home staff | Training provided and frequency | PIP activity log |
Views on usefulness of training | Care home staff interviews | ||
PIP interview PIP questionnaire | |||
Quality of communication between care home, GP and community pharmacy improved | PIP input into improved communication | Views of care home staff | Care home staff interviews |
Views of GPs | GP interview | ||
Views of PIPs | PIP interview PIP questionnaire |
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 |
Contextual factor | Data collected | Data source | |
---|---|---|---|
Barriers to delivering the intervention | Feedback from stakeholders | Care home staff interview | |
GP interview | |||
PIP interview | |||
NoMAD [16] survey to GPs/PIPs and care home staff | |||
Other anecdotal feedback | |||
Facilitators to delivering the intervention | Feedback from stakeholders | Care home staff interviews | |
GP interview | |||
PIP interview | |||
NoMAD [16] survey to GPs/PIPs and care home staff | |||
Other anecdotal feedback | |||
Site and participant factors | Inter PIP variation | Competency | Variation in outcomes |
Review of PCPs for both safety and missed opportunity | |||
GP interview | |||
Care home interviews | |||
Employment status | Baseline PIP questionnaire | ||
Qualifications | Baseline PIP questionnaire | ||
Inter-site variation | Care home factors | Baseline care home survey | |
Resident factors | Baseline resident data | ||
Inter-location variation | Views of researchers | Meeting minutes | |
Normalisation of intervention into routine practice | Actions taken by participants to ensure the intervention works | Coherence (Making sense of the service) | NoMAD survey [16] to PIPs, care home staff, GPs |
GP interview Care home staff interviews | |||
PIP interview | |||
Cognitive participation (Engaging with the service) | NoMAD [16] survey to PIP, care home staff, GPs | ||
Interviews (GP and care home staff) | |||
PIP interview | |||
Collective action (delivering the service/responding to the service) | NoMAD [16] survey to PIP, care home staff, GPs | ||
GP interview Care home staff interviews | |||
PIP interview | |||
Reflexive monitoring (appraising and reviewing the service) | NoMAD [16] survey to PIP, care home staff, GPs | ||
GP interview Care home staff interviews | |||
PIP interview |
Methods
Design
Implementation
Mechanism of impact
Outcomes
Contextual factors
Quantitative
- Training feedback: At each PIP training event, PIPs are asked to complete a feedback form at the end of the 2-day face-to-face session
- Pre-intervention competency: Following the training, PIPs submit their competency framework to one of the study competency assessors who discuss these with the PIP and signs them off as ‘fit to practise’ as a CHIPPS PIP, prescribes further training or that they are not competent to deliver the study
- Review of PCPs: Following an agreed process (Additional file 1: Appendices 3 and 4) a random 20% of PCPs are reviewed for appropriateness by study team members who are specialists in care of the elderly. Whilst this process is primarily about safety, the assessment templates also capture data on missed opportunities.
- PIP activity log: Intervention PIPs are asked to keep an activity log of their daily activity detailing the time spent on tasks as listed in the service specification (Additional file 1: Appendix 2)
- PIP survey: Following each phase, intervention PIPs will be asked to complete a short questionnaire asking about their experiences and the extent to which they delivered aspects of the intervention focusing especially on non-medication review aspects of the service specification (the NoMAD survey [16]).
- Adverse events: Adverse events which are not deemed serious are reported using a standard template emailed to the Clinical Trials Unit. All study participants with a professional role (PIP GP, GP staff and care home staff) are made aware of this template and are asked to use this facility if they suspect any adverse event, whether or not there is a perceived causal relationship with the intervention
- PCPs: these are completed by the PIP as a clinical record of their actions including the rationale for these. Data extraction from these will inform the details of medication changes that underpin the global measures such as total number of medicines, British National Formulary categories most involved in changes, and overall Drug Burden Index (DBI). They will also include information on homely remedies and medications available from pharmacies (P medicines) and other retail outlets (general sale list medicines) which could result in therapeutic duplication
- Subgroup analyses: The following subgroup analyses will be conducted.i.Comparison of intervention effect by care home types, i.e. nursing versus residential.ii.Comparison of intervention effect by the employment status of the PIPs, i.e. those PIPs who were previously employed, and therefore had an established working relationship, with the study GP practice, and those who were not).For both of the above an interaction term (between treatment and subgrouping factor) will be added to the primary model and formally tested for a non-zero value.
- GEEs: Any effect of the PIP intervention is likely to be mediated through a decrease in the DBI. This will be tested using a GEE, adjusting for group membership (this is in order to remove any effect of the PIP intervention on falls mediated via a different causal route).
- NoMAD survey [16]: The NoMAD survey is an implementation measure based on the Normalisation Process Theory (NPT) [17, 18]. The survey form includes preliminary demography and general questions about experiences and satisfaction followed by four sections each relating to one of the NPT domains of coherence, cognitive participation, collective action and reflexive monitoring.