Introduction
As there was no existing or required commissioned pilot, we proposed to run a pilot before scaling up to a full-scale trial. The aim of the first phase of this research was to ascertain the feasibility and acceptability of the proposed trial.34
Phase 1 was initially planned to run for 3 months but was extended to 4 months from November 2010 to February 2011. We also addressed emerging challenges in operationalising different approaches to PN, which are separately reported in Chapter 9.
We used an evaluation framework recommended by Thabane et al.35 to assess the key elements of phase 1: process, resources, management and scientific assessment. Key performance indicators, results and actions are summarised in .
Key performance indicators for phase 1 (adapted from Thabane et al., 2010)
Objectives of phase 1
To establish the current processes for chlamydia testing, treatment and PN in general practice.
To monitor the impact of recruiting at time of test versus time of diagnosis.
To assess the feasibility of our proposed approach to recruitment.
To monitor the numbers of eligible, tested, consented and diagnosed patients.
To assess any time and resource problems.
To assess potential human and data management problems.
To assess the intervention as intended.
Setting
Six pilot practices, accounting for approximately 10% of the sites required for the main trial, were recruited to take part in the pilot. These practices were identified through the MRC General Practice Research Framework register and PCRN South East as having a sufficient population of young people in the target population. Three practices were from the South East, one was from Yorkshire and Humberside, one was from the East Midlands and one was from the South West. The three practices piloting each approach were randomised to patient, provider and contract referral arms. In addition, two approaches to consent were piloted: CAT and CAD.
Target recruitment
Based on the original sample size calculations for the main trial we aimed to recruit 25 patients per year per practice. It was, therefore, estimated that it should be feasible to recruit 5–10 patients per practice over 3 months. This would require writing invitations to 300 patients in each practice. Each practice sent invitations to approximately 300 16- to 24-year-olds, who were selected at random from the practice register.
Patients were invited by letter to take a chlamydia test at the practice and the trial was mentioned in the invitation letter. Sixteen- to 24-year olds who were attending the practices for other reasons were to be invited to test opportunistically, as were patients who were aged ≥ 16 years who presented with a symptomatic STI or had been diagnosed elsewhere and were attending the practice for treatment.
Results of the evaluation
Process
Current process in practice
During the trial, practices were asked to ensure that all test results came back to the practice and that all results and treatment of patients diagnosed with a STI be dealt with by the practice. Before the trial started we established the practice’s current processes. The pre-trial testing and treatment procedures in the pilot practices were as follows:
Three practices offered in-house STI services ‘quite often’ and three practices offered them ‘occasionally’.
All the practices were registered as NCSP practices.
In five of the six practices the chlamydia test results went directly to the local NCSP CSO.
In five practices antibiotics for positive chlamydia patients aged 15–24 years were given by the local NCSP chlamydia co-ordinator.
One practice gave antibiotics directly to chlamydia patients diagnosed with a STI.
In five practices patients paid for their prescription if they were diagnosed with a STI or STI symptoms; in the other practice patients did not pay for this treatment.
Approaches to recruitment: letter versus opportunistic recruitment
The response to invitation letters was exceptionally poor, with only 11 out of 2218 of 16- to 24-year-olds having a test in response to the letter (0.5%). Nine tests were generated from CAD practices and two tests from CAT practices. Overall, during the 4-month period (November 2010 to February 2011) 30 tests were conducted in total (), 11 generated by letter and 19 through opportunistic recruitment in the six pilot practices. This amounted to less than two tests per month per practice.
Summary of recruitment in phase 1
Feedback from practices showed that they had focused effort exclusively on sending out the letters and waiting for a response, and had not proactively approached 16- to 24-year-olds when they came into the surgery for another reason.
Approaches to consent: consent at test versus consent at diagnosis
Consent at test practices
All patients who took a chlamydia test were asked to take part in the trial and agreed ().
Consent at test practices
Consent at diagnosis practices
Recruitment at the time of diagnosis was problematic ().
Consent at diagnosis practices
Trial processes
Trial materials were reported by practice staff to be of a high standard and well designed and the trial name ‘Spread the Word’ was popular. However, using separate patient information leaflets and reason-for-test forms for opportunistic versus symptomatic patients was found confusing.
Practices reported that the NCSP testing and laboratory processes were different from the everyday process used in practice for general laboratory requests, and organising for NCSP results to be returned to the practice was time-consuming and not straightforward. In one practice this had demoralised the practice nurse to the extent that she did not want to continue in the trial.
Staff did not feel comfortable approaching patients to screen opportunistically and believed that patients would be embarrassed if they were asked to take a chlamydia test.
The web tool processes were straightforward and the web tool was considered to be simple and easy to use.
Partner notification pathway
One patient was diagnosed and consented into the trial. The HA initially spoke to the patient and was asked to call back; however, the HA was unable to make contact with this patient again.
Resources
Practices reported that the training session was well organised and training materials were comprehensive and easy to use. The web tool was felt to be simple and easy to use, and we did not experience any problems with incorrect data input from practices. However, staff did report that they often forgot to invite patients to screen and that there was insufficient time to approach patients during appointments, in addition to the reluctance described above.
Management
Five out of six practices reported very little interaction with the local NCSP staff and office. They were not aware of NCSP targets and there was some misapprehension that the trial team were part of the NCSP.
Practice nurses reported that it was difficult to engage their colleagues in the trial and to promote chlamydia screening throughout the practice and that often they were working alone. They reported that very few 16- to 24-year-old patients were seen in their practices, and that they did not see many chlamydia cases.
We were unable to assess the web tool as a PN management tool, as we did not have sufficient numbers of diagnosed patients to be managed through the pathway.
Scientific
In developing manuals in consultation with the HAs who would provide PN, it became apparent that it was hard to define a process of contract referral in a way that was clearly distinct from provider referral. HAs described their practice as a process of negotiation with the patient, leading towards the choice of a mode of PN.
Because insufficient numbers of patients were diagnosed with chlamydia we were unable to assess the PN pathway.
Summary
The small number of tests conducted coupled with the low positivity rate meant we did not have a sufficient number of patients diagnosed with a STI come through the trial to test all trial procedures.
It was agreed by the trial team and Trial Steering Committee that we needed to explore the barriers to testing and identify improved recruitment strategies in practice in order to boost recruitment if the trial was to be scaled up successfully.
