D ATA MANAGEMENT

The remainder of the chapter will present the processes used in data management training for research assistants, data cleaning, project promotion and analysis. These components are all integral to the pragmatic RCT design.

Research assistant education and credentialing

Recruitment of research staff was achieved through engaging medical students and department nursing staff. Medical students, located in the study setting, were selected via an expression of interest to participate in research activities. The expression of interest flyer outlined the research objectives (Appendix D). Expressions of interest flyers were also placed in the staff tearoom and conveyed during nursing communication meetings at the beginning of each ED shift. Throughout January, the lead researcher attended and informed staff of the upcoming trial and reiterated the opportunity for staff to participate as research assistants. A total of four medical students and four registered nurses were in the initial cohort of staff who volunteered as research assistants (RA). A performa of the RA duties was also developed and formed part of the training module (Appendix E). The research assistants were allocated to either Clinical Research Assistants (CRA) or

Outcome Research Assistant (ORA) roles. The CRAs undertook the recruitment and baseline data work and the ORAs completed data collection and entry. This separation of functions between the CRAs and ORA roles assisted to reduce any bias during the phases of the data collection. In the naturalistic setting of the ED, it is important to try and minimise bias and reduce any threats to the validity of the results.

Education and training of RAs included a PowerPoint presentation outlining the methodology, recruitment of patients, informed consent and data collection procedures. The RCT protocol was published and available and used as a tool to assist with training. Once completed, all CRAs were buddied with the lead researcher for their first shift of recruitment to oversee accuracy of

recruitment, baseline data collection and the randomisation procedure. The initial cohort of medical students completed their ED rotation over a 8-week period from 01 January 2014 to 31

February 2014, which required a further re expression of interest, recruitment and training of RAs to continue patient enrolment. A total of six new staff participated in the second round of training and data collection supervised by the lead researcher.

Data collection tools

Data collection forms were designed to ensure consistent and time efficient data entry (Petrie, 2009) (Appendix H). Baseline and outcome hardcopy forms were used to reduce time required interviewing patients and delaying allocation of the trial interventions. All data collection forms were located in a dedicated office adjacent to the study area. The data collection forms were designed to include a separate box for categorical data and for codes assigned to either single or multi coded variables. Numerical data were also entered using a 24 hour clock in the 00:00 format. Once baseline data input was completed the randomisation card was stapled to the form and placed into a locked filing cabinet. The forms were collected at the end of each shift by the lead researcher and stored in compliance with the ethics requirements. The patient information and consent form template is reproduced in Appendix H.

A Microsoft Excel™ spreadsheet design was developed after creating a list of all variables to be collected and published in the protocol. The spreadsheet was also tested during the pilot study to ensure accuracy and ease of use.

Different RA groups within the study site undertook each stage of the data collection and entry.

Separating the different stages of the study i.e. recruitment and baseline data collection,

randomisation (computer generated), outcome data collection, data entry and data analysis, was used as an additional measure to reduce bias. A recruitment flowchart outlining data collection was developed and presented during the RA training program. The flowchart was also placed strategically next to recruitment packs for easy reference for all RAs in the research office.

Baseline data collection was undertaken by the RAs in the treatment area. Follow up outcome data were collected by the ORA. The RAs were located in an office away from the clinical

environment to reduce interruptions and minimise noise disturbance. The medical student utilised for the pilot study as the ORA, was used again for the data entry of all baseline and outcomes data into the spreadsheet.

5.5 Summary

The protocol publication for this research established awareness to the emergency services community, E-NPs and health services researchers of the forthcoming pragmatic RCT. This attempted to alert the scientific community and assist in subsequent translation of evidence into practice. Emergency nurse practitioner research has needed to move beyond retrospective, qualitative research to produce high quality evidence of efficiency, productivity and clinical outcomes to develop and sustain the role into the future.

Despite the rapid uptake of E-NP service in EDs, there have been limited rigorous prospective approaches to evaluate effectiveness. However, choosing the most appropriate methodology to undertake health services research requires both conventional and innovative methods (Craig et al. 2013). This trial is the first E-NP interventional research to evaluate outcomes relating to time to analgesia and pain scores as an indicator of quality-of-care outcomes. The protocol will also serve as an example of developing a protocol for a pragmatic randomized controlled trial for health services research and particularly NP services.