Avoidable time-delays to research trials in primary care: a normalisation process theory evaluation and time-interval delay framework.

Problem

Primary care research is challenging. Randomised-controlled trials commonly do not meet recruitment targets and 56% of trials need a time extension. Changes in governance, including GP practice level capability and capacity (C&C) assessments, Research Ethics Committee (REC) and Health Research Authority (HRA) approvals give further challenges for research conducted in the stretched and busy environment of primary care. With time-dependent funding for trials, it is important to understand delays in primary care trials in order to identify solutions.

Approach

We conducted a normalisation process theory evaluation alongside a CRN portfolio primary care cluster feasibility Randomised Controlled Trial. NHS support costs were provided (NIHR rates). Time intervals were quantified from academic institutional ethics submission to first recruit. Potentially avoidable delays were analysed descriptively from field notes and attributed to relevant stakeholder-groups.

Findings

Our interval-delay framework shows potentially avoidable time-delays at four levels: 1) academic institution, 2) regulatory, 3) GP-practice and 4) patient. 1) The longest research institution delay was awaiting Sponsor approval of the project (38 days). 2) From REC application to HRA approval took 67 days; of which 14 days were solely for HRA. 3) GP-practice level delays included time from agreement for practice participation to site initiation visit (SIV) (average 46 days; range 17 to 67 days) and from SIV to first invitation sent (average 37 days; range 25 to 63 days), caused by difficulties in: time for SIVs, research-protected GP/nurse time and research nurse. 4) Time between invitation to first patient response was the longest delay at patient-level (average 62 days; range 16 to 149 days). This was due to delays in the screening process (and therefore invitations being sent) and due to patient reluctance to phone the research office. Patient reluctance was addressed successfully by inclusion of an expression-of-interest form and allowance of follow-up phone calls, which led to our first recruit.

Consequences

Delays represent a serious problem to the timely running of primary care trials. Stakeholders must be aware of the funder-requirements for time-bound studies and the pressures experienced by busy clinical practices. University sponsorship procedures have centralised authority but should ensure a delegated chain-of-command to prevent project approval delay. From these data, central HRA approval does not seem to have streamlined the process as intended. Despite NHS support costs, primary care clinician time is limited and identifying time for SIVs and screening for eligibility remain major problems contributing to significant delay. Patient contact delays may be remediated by maximising avenues for expression of interest e.g. face-to-face, phone, e-mail and return of expression-of-interest forms.