Implementation process
Plymouth Hospitals NHS Trust serves a population of 460,000, and extrapolating from this figure it is estimated that there are about 4,500 patients with RA in the PHNT catchment area. Initially, all patients attending routine review at PHNT will be assessed for eligibility. People with RA who are 18 years or over, have had their disease for more than two years and are able to initiate telephone contact if needed will be deemed eligible. People will be excluded if they have no access to a telephone, or are thought unable themselves or through a relative or friend to initiate telephone contact via the advice line when their disease requires clinical review. All eligible patients will be educated about the patient-initiated review system prior to their enrolment into the system. However, due to the finite capacity of education sessions per week, all eligible patients will not be able to enroll into the system at once, and it will take more than twelve months to educate all the patients. Hence, we will use this timeframe as an opportunity to evaluate the new system of care against the comparator traditional clinician-driven system using a stepped-wedge study design. For this, a subgroup of patients suitable to have their care transferred to the patient-initiated review system will be randomised into two groups using computer generated numbers. The patients will either immediately enroll into the patient-initiated review system (Direct Access group (DA)), or will have regular clinician-initiated appointments (Regular Clinician initiated group (RC)) prior to transferring to the patient-initiated review system.
Direct access group
After randomisation, people in the DA group will be provided with an initial information sheet explaining the system, and will be offered a choice of dates to attend a DA patient education session over the following weeks. The education sessions will comprise small groups of eight people with RA led by a rheumatology specialist nurse, and will focus on issues such as the operation of the DA system, what patients can expect from the system, when and how to call the advice line, when and how to ask for appointments, and any other queries regarding the system [2]. These patients will not be offered routine clinical review, and their GP will be informed about this and sent a short summary of managing common problems experienced by people with established RA. Patients or their GP can arrange prompt clinical advice and a review in clinic where required by calling a rheumatology nurse-led advice line where appointments can be accessed with a maximum delay of ten working days. The education session was piloted on fifty patients and following the feedback from the pilot session, changes were made before delivering it to the patients who are randomised. Any patients declining entry to the DA system will continue to have their care delivered through the traditional review system.
Regular clinician initiated group
The RC group will receive planned appointments at regular intervals over the year prior to transferring to DA at the end of the 12 months implementation process (Figure 1). Patients in both groups who do not request an appointment or who do not attend a routinely scheduled medical appointment over 12 months will be contacted for a review by the rheumatology specialist nurse.
Implementation evaluation
The evaluation of the implementation process will be undertaken collaboratively between the PHNT Rheumatology Department and the Collaboration of Leadership and Applied Health Research and Care for the South West Peninsula (PenCLAHRC). The study will assess the following outcome measures.
Primary outcome measure
Patient satisfaction
As a surrogate of service quality, patient satisfaction will be assessed at baseline and at the end of 12 months using the Short-Form Patient Satisfaction Questionnaire (PSQ-18) [14].
Secondary outcome measures
Service use
Number of visits to the rheumatology consultant, rheumatology specialist nurse, physiotherapist and occupational therapist will be recorded over the period of 12 months. In a random sample of 50 patients (25 from each group), the cost of the total number of visits to hospital rheumatologists, visits to GPs and allied health professionals for problems related to arthritis and the associated travel costs will be calculated using NHS trust figures and published unit cost data [4].
Clinical measures
Clinical outcomes will be measured at baseline before patients enter the DA system (during the education session) and at the end of 12 months follow-up. Outcome measures will include the RA disease activity score (DAS-CRP), patient’s global opinion of disease activity (10cm scale, measured from The London Handicap Scale (LHS)), clinician’s global opinion of disease activity (10cm scale, measured from LHS), pain over the preceding 24 hours, early morning stiffness, tender joint count, swollen joint count, disability (Health Assessment Questionnaire), C reactive protein (CRP), plasma viscosity (PV), haemoglobin, rheumatoid factor (RF), rheumatoid factor titre (RFT), presence or absence of erosive disease by most recent routine X-rays, and disease duration.
Waiting times
As the RC group will attend the clinician-initiated outpatient clinic at regular intervals; service availability upon request will be measured for the DA group only. Waiting time will be assessed by calculating the number of days from the advice line call to the medical appointment.
Semi-structured, in-depth interviews will be carried out with a subset of patients from both groups as well as with the health professionals and administrators involved in providing the service. Interviews will particularly focus on assessing barriers and facilitators of providing a patient-initiated service, reasons for implementation success/failure, psychological benefits/drawbacks and effects on wider life impacts, and perceived or real changes in the interaction between patients and the rheumatology team delivering their medical care. All the interviews will be recorded and later transcribed. Once all the transcripts have been analysed, a matrix will be designed which will enable the emergence of major themes and create an understanding of the individual and group coding. The interviews will add depth to the analysis of quantitative data and will be supplemented through the observation of a sample of patient education sessions given by a rheumatology specialist nurse. The observation of these sessions will allow us to gather first-hand information about the social processes between the specialist rheumatology nurse and patients in an educational context. This will help inform the semi-structured interviews as the qualitative researcher will have first-hand knowledge of how patients were educated about the new appointment system and what were their early thoughts about such process change.
Sample size and statistical analysis
The assumptions underlying the sample size calculation are derived from a published RCT [6]. In order to detect a decrease in the number of consultations from 2.5 per year in the RC group to 2 per year in the DA group at the 5% significance level with 90% power to detect this difference, we calculated that the current evaluation will require 190 subjects in each group followed up for a period of 12 months. Changes in other outcome measures between the two groups will be compared using simple tests of association such as chi-squared (χ
2) test and Student’s t-test (depending on data properties). The qualitative data analysis technique described by Miles and Huberman [15] will be used to analyse the interview data. This means affixing codes to a set of field notes drawn from data collection and sorting through the material to identify relationships between themes. All interview recordings will be transcribed and checked for accuracy. The researcher will listen to the interview recordings and make comments on the transcript and read and re-read them to identify relevant codes. Once all transcripts have been analysed in this way a matrix will be designed which will enable the emergence of major themes and create an understanding of the individual and group coding. Computer aided software such as NVivo (a qualitative data analysis tool that helps to organise and analyse unstructured, i.e. non-numerical data) will be used to interrogate the data at different levels.