Research Study Protocol: Using health information systems to address patients concerns in general practice: the COAC Intervention development and feasibility study
Authors: Murphy Mairead , Salisbury Chris , Palmer Tom , Wong Geoff , Hancock Jude , Morris Richard 
Published: September 2021

Abstract
BackgroundProblems are missed in up to 50% of primary care consultations. This is costly for the NHS, both in terms of reconsultation rates and in missed opportunities to increase patient empowerment. Research suggests that interventions at each end of the consultation can help to address patient concerns. At consultation initiation, sharing the results from electronic patient-reported outcome measures (ePROMs) with clinicians can help to elicit concerns. At consultation closure, providing the patient with written information to supplement spoken can improve recall and adherence.Aims and ObjectivesAim: To develop and test a complex intervention designed to more comprehensively address patients’ concerns in general practice, thereby reducing re-consultation rates, improving patients’ well-being and health knowledge, reducing health concerns and increasing patients’ confidence in their health provision and health plan. The aims will be achieved through two studies. Firstly a complex intervention will be designed, which uses an ePROM at consultation opening and a report printed or texted at consultation closure. Secondly, this intervention will be tested to establish the feasibility both of the intervention and of a randomised control trial (RCT) of the intervention.Methods1. Intervention Design Study: This will involve:1. Design of an online questionnaire system using practice SMS/email systems and online survey software to allow patient self-completion of a pre-consultation questionnaire and a report showing low-scoring questionnaire items, which is shared with GPs or nurses.2. Testing the pre-consultation system with 45 patients in 3 rounds, using a person-based approach, with iterative adjustments made based on patient, administrator, receptionist, nurse and GP feedback after each round.3. Design of an electronic template, integrated with the patient record, to provide a printable consultation-closure report to patients on issues raised in the consultation, advice given, treatment, follow-up and safety-netting.4. Testing the consultation-closure report iteratively with 45 patients in 3 rounds, using a person-based approach, with iterative adjustments made based on patient and GP/nurse feedback after each round.2. Feasibility Study: The intervention will be tested in a cluster-randomised framework as follows:1. Refinement of the intervention and update to programme theory.2. Randomisation of six practices: four randomised to intervention, and two to control.3. Recruitment of 30 patients per practice: 120 intervention and 60 control.4. Data Collection of quantitative data via GP/nurse-report, patient-report and health records. Interview of GPs, nurses, practice manager, administrators and receptionists and up to 30 patients.5. Realist evaluation of the data to identify and understand the mechanisms by which outcomes have occurred within the programme theory.6. Data analysis of recruitment rates, follow-up rates, data completeness, re-consultation rates within one/three months and other outcomes measures to assess feasibility of a future RCT.7. Evaluation of pre-agreed success criteria to decide whether to continue to RCT, stop, or modify the intervention.Timelines for deliveryStudy 1 will be completed from October 2019 – March 2021 and study 2 from April 2021 – April 2022.Anticipated impact and disseminationResults will be disseminated through targeted communications in social media, the University of Bristol website, policy briefings, academic papers, patient participation groups, community associations and seminars and conferences. The study output resources will be made available for immediate use. If progression criteria are met, we will aim to complete a randomised control trial within five years.