Skip to main content

Table 1 Components and methods of process evaluation, adapted from Grant et al. [31]

From: Process evaluation of a cluster-randomised trial testing a pressure ulcer prevention care bundle: a mixed-methods study

Evaluation domain Research questions Research methods Data collection tools
Recruitment of clusters How are clusters sampled and recruited? Are they representative? Descriptive analysis of recruited clusters and their representativeness Hospital demographics were collected by CIs at each site
Recruitment and reach in individuals Who actually receives the intervention in each setting? Are they representative? Descriptive analysis of screening log data Recruiting RAs at each site recorded total number of patients screened vs. total number of patients recruited and barriers to participation, reasons for dropout
Delivery to clusters What intervention is actually delivered to each cluster? Is it the one intended by researchers? Descriptive analysis of intervention delivery (i.e. training sessions) to nursing staff at each site CIs kept a log of information sessions delivered to nursing staff at each site, including number of participants and time spent at each session, who delivered the session and when (in relation to study timeline)
Delivery to individuals What intervention is actually delivered to individuals? Is it the one intended by researchers? Descriptive analysis of intervention delivery (i.e. DVD, brochure, poster) Interventionist RAs recorded which intervention components were delivered to each patient and total time spent with each patient
Response of clusters How is the intervention adopted by clusters? Qualitative analysis of nurse interviews A semi-structured interview guide was used to explore nurses’ perspectives of the intervention (four to five nurses per intervention site) (citation masked for peer review)
Response of individuals How does the target population respond? Qualitative analysis of patient interviews A semi-structured interview guide was used to explore patients’ perspectives of the intervention (four to five patients per intervention site) (citation masked for peer review)
Maintenance How and why are these processes sustained over time (or not)? Qualitative analysis of nurse and patient interviews See above (for nurses and patients)
Effectiveness What are the effects on primary and secondary outcomes? Exploratory analyses of effect of trial processes (i.e. above domains) on trial outcomes Main findings from the INTACT trial and results from above process evaluation domains comprised data for these analyses. However, the study was not powered for these exploratory analyses
Unintended consequences Are there unintended changes in processes and outcomes, both related to the trial intervention and unrelated care? Qualitative analysis of observed data, qualitative analysis of patient and staff interviews Semi-structured interview guides and observational tools/logs (described above)
Context What is the wider context in which the trial is being conducted? Consideration of state and national contexts of each hospital setting regarding PUP (i.e. national standards, state penalties, hospital policies and procedures) when interpreting findings Literature search of local, state and national hospital standards, policies and procedures relating to PUP
Theory What theory has been used to develop the intervention? Can a theory be considered to interpret the effects of the intervention? N/A–consideration of theory used to develop the intervention was considered in interpretation of findings. Additional theories were sought to explain findings of each component of the process evaluation
  1. CIs chief investigators, RAs research assistants