Campbell 2014.
Methods | Randomised trial | |
Participants | 13,707 patients (total group); mean age in intervention group 41.5 (25.2), in control group 44.7 (25.0); 40% male in intervention group, 41% male in control group 42 practices at 4 centres |
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Interventions |
Intervention: nurse‐led computer‐supported telephone triage Control: GP‐led telephone triage Detailed description of the intervention: Compared 3 groups delivering telephone triage: GP‐led triage, nurse‐led computer‐based triage, and usual care triage
Supervision, oversight: unknown |
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Outcomes |
Patient outcomes:
Process of care measures:
Resource utilisation: Costs: costs over 28 days with regard to primary outcome contacts |
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Notes |
Country: UK Study period: 25 months Nurse role: nurse in charge of computer‐supported telephone triage for patients requesting a same‐day appointment Nurse title: nurse (nurse practitioners and practice nurses) Nurse educational background: EQF level unknown Nurse years of experience: unknown Nurse additional training: training in the use of Odyssey Patient Access and in telephone consultation skills. Following this was a pretrial period of 1 month, during which nurses were expected to practise using the decision support in their daily work; towards the end of this period, their use of the system was assessed |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The sequence process included a random component. "Participating practices were randomly assigned (1:1:1), via a computer‐generated randomisation sequence, to GP triage, nurse triage with computer decision support, or usual care. The randomisation sequence [was] minimized for research centre, deprivation (deprived [below average Index of Multiple Deprivation 2010, based on practice postcode] or not‐deprived [average or above]) and list size (small [< 3500 patients], medium [3500–8000 patients], or large [> 8000 patients]) of the trial team". However, 10 of the 15 practices allocated to NP triage withdrew. "To maintain balance between groups, any practices that withdrew after randomisation were replaced with a waiting‐list practice that was from the same location, and of similar size and deprivation when possible. Because of the small numbers of waiting‐list practices, replacements were purposively allocated according to minimisation criteria". |
Allocation concealment (selection bias) | Low risk | Patients and investigators enrolling patients could not foresee assignment. "A stochastic element within the minimisation algorithm maintained concealment. Allocation was done by a statistician independent form". "Allocations were concealed from practices until after they had agreed to participate; this concealment also applied to practices replacing practices that had withdrawn from the study for whatever reason". |
Baseline characteristics | Low risk | Characteristics of patients were similar in both groups. "Practice and patient characteristics were well balanced between groups". |
Baseline outcome measurement | Low risk | Baseline primary outcome measurement was not relevant. Baseline secondary outcome health status was not measured, and differences in baseline health status could bias the outcome ‘health status’. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Practitioners and patients were not blinded. It is unclear whether the outcome was influenced by lack of blinding of patients and care providers. "Patients, clinicians, and researchers were not masked to allocation, but practice assignment was concealed from the trial statistician". |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Researchers were not blinded; however, the trial statistician was blinded. "Patients, clinicians, and researchers were not masked to allocation, but practice assignment was concealed from the trial statistician". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Follow‐up of patients < 80%; however per‐protocol and intention‐to‐treat analyses showed similar results. "Findings from our per‐protocol analysis showed intensification of the noted effects of both GP triage and nurse triage (data not shown)". |
Selective reporting (reporting bias) | Low risk | Protocol was available. Predefined outcomes measurements were reported. |
Contamination | Low risk | Not likely, because allocation was by practice |
Bias due to lack of power | Low risk | "7046 patients per group would need to be recruited from 42 practices". In the GP triage, 6781 patients were eligible for intervention (6697 + 84). This is a relatively small difference with the calculated power. Trial authors commented: "The trial was fully powered and we exceeded our recruitment target in gaining access to the primary outcome data, partly because of a process of obtaining initial verbal consent to participate". |