Process Evaluation of the PRISM and OPTIMISE II trials
Research type
Research Study
Full title
Process Evaluation of the PRISM and OPTIMISE II trials: Understanding complexity in the implementation and delivery of interventions within perioperative care
IRAS ID
229106
Contact name
Tim Stephens
Contact email
Sponsor organisation
Queen Mary, University of London
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Research Summary
This mixed methods process evaluation has been designed to understand more about how certain treatments are used and experienced by staff and patients. In particular we are focusing on two organ support therapies, currently being evaluated in two clinical trials (the PRISM and OPTIMISE II trials) as a case study of what happens when a complicated treatment is introduced into the already complex post-operative patient pathway.The study will use both operational data from the trial itself and also a case study approach, focusing on eight hospitals, where additional qualitative research will be undertaken (periods of observation and focus groups with staff). We also want to understand the treatment from the patients perspective so will invite patients who have participated in one the trials (the PRISM trial) to take part in a short telephone interview too.
Analysis of these data will help us to understand how complex treatments such as the one used in this trial can be effectively introduced into practice in ways that are acceptable for staff and patients.
Lay Summary
In the prospective mixed methods process evaluation, we found wide variations in the experiences of patients who received (continous positive airway pressure; CPAP, a form on non-invasive breathing support) and the clinical staff who delivered the intervention. The main influences on this variability were the characteristics of the intervention itself and the local context (eg, hospital culture, systems, and resources). We found that a substantial proportion of patients did not like or were unable to tolerate CPAP. Claustrophobia, nausea, pain, feeling too hot, excessive dryness of the mouth or eyes, and inability to communicate with relatives were the most common barriers to CPAP delivery. Patient accounts ranged from vague recollections of receiving CPAP to vivid descriptions of how unpleasant they found it. Of the patients who could recall receiving the intervention clearly, none completed 4 h of treatment. Hospitals that were more successful in delivering the intervention were more likely to have integrated CPAP into postoperative care at the perceived optimal time, early after surgery when patients often remained drowsy. Additionally, staff at the more successful hospitals seemed highly invested in delivering the intervention and helping patients to tolerate CPAP.REC name
Wales REC 6
REC reference
18/WA/0408
Date of REC Opinion
22 Nov 2018
REC opinion
Favourable Opinion