The methods involved an interventional educational program to improve the participants’ skills to audit safe practices and a cross-sectional study using a questionnaire to collect data on the participants’ perceptions about their willingness to be auditors. Navarra’s Department of Health Research Ethics Committee’s approval was obtained for the study (approval number: Pyto2015/62), and all participants provided written informed consent. Two focus groups were organized during the development phase of the study involving 33 patients who were not involved in the main study. The opinions of the patients in these focus groups were used to design the study including the development of the training methods and materials (sent for publication pending acceptance).
Main Study Participants
A consecutive sample of 136 participants was recruited between March and October 2018 from the oncology and haematology day hospital of a tertiary hospital in Spain. Patients were eligible to participate if: they were older than 18 years; it was not their first treatment appointment; the treatment lasted several hours; the healthcare professionals in charge considered their physical and psychological status as acceptable for participation; and they were able and willing to give their informed consent to participate.
Patients’ family members were recruited after being informed about the study and providing their consent to participate. For this study, we considered as relatives not only family but also friends or informal caregivers. The research was conducted while patients were being treated or just immediately after being treated in order to emulate real conditions.
We selected day hospital oncology P&Fs because they have multiple contacts with the healthcare organization and thus it can be feasible to train them. Likewise, non-compliance of professionals with safe practices can have serious consequences for the patients’ health.
Educational material production
The research materials comprised: training brochures, videos (assessment and evaluation), evaluation grids, and a questionnaire to assess P&Fs’ willingness to audit. The training brochures explained how healthcare professionals must implement the four safe practices selected for evaluation. The videos were filmed in the real places where patients receive treatment. There were two different stories, depending on the type of P&F. They showed a patient who goes to the day hospital to receive chemotherapy or to receive transfusion. Both videos were in a story-like format intending to show, in the most realistic way, the interaction between a patient and healthcare professionals during treatment. The right way to implement the safe practices was highlighted in the training video. The actors were different in all videos in order to make a distinction between the training and the assessment video. Additionally, the content of the materials used were adapted according to the treatment (oncology or haematology).
The evaluation grid had 7 or 8 questions depending on the treatment (Figure 1). The questions dealt with the observation of the fulfilment of the four safe practices studied in the video.
All the materials were validated through testing with 48 convenience individuals (not involved in the main study) to ensure that a) all the materials were easily comprehensible and b) that the training enabled the individuals to detect the patient safety incidents in the videos.
The videos and training leaflets were produced in the hospital by personnel working on the study and volunteers that collaborate as actors in our medical installations. The digitization unit helped with video recording and editing.
Procedure and data collection
Initially, the P&Fs watched an assessment video only once. Immediately after viewing it, they completed an evaluation grid. Then, they were provided with a training brochure. Afterwards, participants watched a training video. Participants could watch this last video as many times as they wished. After reading the material and watching the videos, the participants once again watched the assessment video and filled a second evaluation grid. Later, they completed the questionnaire about their willingness to become auditors.
The participants could ask questions during this process. All the videos were played on a tablet. The whole process lasted between 60 and 90 minutes. Depending on the time availability of the participants, debriefing (feedback) was done once the process had finished. Due to their time not all participants were able to take part in this feedback process. The benefit, or otherwise, of this debriefing was not studied here but is something that would be of interest in future research.
Measures
A variable named “potential auditor” was created in order to analyse the P&Fs’ degree of willingness to audit healthcare professionals practice. Participants who answered that they would audit at least 3 out of 4 safe practices were considered potential auditors. A variable called “good auditor” was also created to measure participants who correctly answered more than 75% of the items. This cut-off point was chosen based on the margin of error that the organization was willing to assume.
The dependent variables were: “potential auditor” and “good auditor.” The independent variables were gender, age, type of participants, type of treatment, and number of healthcare encounters, adverse events suffered, education level, and general perception of hospital safety.
Data analyses
Data were analysed using SPSS version 20.0 for Windows. Wilcoxon and McNemar tests were used to compare before-after results; Pearson’s chi-square test or Fisher’s exact test was used for discrete variables and Student’s t-test for continuous ones; and logistic regression (backstep) was used to measure the influence of different variables on P&Fs’ willingness to audit and being a good auditor. A p value <0.05 was considered to be significant.