The study employed a quantitative, prospective, quasi-experimental design. The researcher observed the performance of nurses during the process of preparation and administration of intravenous drugs at two nursing departments of internal medicine at a 953 beds University Medical Centre in The Netherlands.
The study included data collection at baseline (pre-test: 8 weeks), an intervention period while the new protocol was implemented in one of the two wards (2 weeks), and a post-implementation test (post-test: 8 weeks). Nurses’ performance in the preparation and administration of drugs was the main focus of the study.
Nurses were eligible for the study if:
They were Registered Nurses at the departments of internal medicine;
They were fully qualified for the preparation and administration of intravenous drugs;
They declared themselves competent in the preparation and administration of intravenous drugs;
They gave permission for observation by the researcher.
As nurses were also observed during the administration of drugs, patient encounters were part of the observations.
Therefore, an additional inclusion criterion for the observations was:
Protocol and observation list
A multidisciplinary team including two researchers, a hospital pharmacist, a nurse practitioner, a ward nurse, an infection control practitioner and an occupational hygienist developed the new protocol, using the knowledge of experts and the evidence from the scarce literature [17–19]. An observation list was directly derived from this protocol. The observation list is a specification of the protocol and consisted of 47 variables (Appendix). The variables represent the steps a nurse has to take in the preparation (30) and administration (17) of intravenous drugs. Some of the steps during the process of preparation and administration had to be repeated more than once. All 47 aspects on the list were observed during all occasions where nurses prepared and administered intravenous drugs.
With the observation list the option “yes”, “no”, “not applicable” or “missing” could be checked. When the observer was not sure of his observation then one or more aspects were scored as “missing”. If the operation of a step was not complete, for example, the nurse did not wait before the disinfection solution to dry, that item was scored as a “no”. All variables were given equal weights. Scores on the items were combined in an overall quality score to represent the number of items that were correctly performed. This overall quality score was expressed on a 0–100 quality scale. When all 47 aspects were performed correctly, the quality score for preparation and administration was 100. The scores “not applicable” and “missing” were not used in calculating the overall quality score.
In addition, more general data such as date, department, time of prescription and time of administration were collected. Furthermore, characteristics of the administration process (bolus dose injections, intermittent infusion or continuous infusion) were always registered.
At both the pre- and post-test phases, nurses were observed by a single observer for a maximum number of four times, in order to include as many different nurses as possible. During the process of preparing and administering intravenous drugs, nurses were observed by using the observation list. Nurses were aware of the observation but unaware of its true purpose [20, 21].
The names of the nurses, the number of observation by the individual nurse and the phase of the study were registered.
Observation took place on different days of the week, at different times of the day and night, and at both hospital wards. The observer was present during a preset series of shifts, to represent the variation of working hours in nursing practice.
It was determined beforehand when intervention would be necessary. The project team decided that in case of preparation of the wrong drug, preparation of the wrong dose, preparation with the wrong diluent, administration using the wrong route and administration to the wrong patient, the researcher should not only score the errors, but also intervene by talking to the nurse about these potentially harmful errors.
The intervention was the implementation of the protocol regarding the preparation and administration of intravenous drugs at one of the departments, the intervention department. Implementation took place, during a one-time 45 min department meeting by means of a presentation of the pre-test results and a 15 min film with and without the presentation of errors in the preparation and administration of intravenous drugs. In addition, questions were answered and current practices versus the new protocol were discussed. For instance, one of the items discussed was the disinfecting of the hands in combination with the wearing of gloves. Nurses thought that when they wore gloves they do not have to disinfect their hands.
Following the presentation, the new protocol was available to all the nurses at the ward. To give all the nurses the opportunity to study the new protocol, the post-test took place 2 weeks after the introduction.
At the item level, differences between the two groups and measurements were analyzed using cross table and chi-square tests. The standard deviations for the two groups were not statistically different. Overall quality scores were checked for normal distributions and satisfied this condition. For both pre- and post-test scores, potential differences in nurses’ level quality score between the two departments were analyzed using the independent samples T-test for statistically significance (P ≤ 0.05). As nurses could be observed several times, clustering of data at the level of nurses was present in this study. Therefore, the mean quality scores of nurses over 1–4 observations were used in the analyses of the effects of the protocol implementation. In addition, we explored the relevance of the type of administration route for quality scores using a One Way ANOVA technique (P ≤ 0.05).
Approval from the local Medical Ethics Committee was obtained.