Author:
Harrison Phillippa,Carr Ewan,Goldsmith Kimberley,Young Allan H.,Ashworth Mark,Fennema Diede,Duan Suqian,Barrett Barbara,Zahn Roland
Abstract
AbstractObjectivesTo develop and probe the first computerised decision-support tool to provide antidepressant treatment guidance to GPs in UK primary care.DesignA parallel group, cluster-randomised controlled feasibility trial, where individual participants were blind to treatment allocation.SettingSouth London NHS GP practices.ParticipantsTen practices and eighteen patients with treatment-resistant current major depressive disorder (MDD).InterventionsPractices were randomised to two treatment arms: 1) treatment-as-usual, 2) computerised decision support tool.ResultsTen GP practices participated in the trial, which was within our target range (8-20). However, practice and patient recruitment were slower than anticipated and only 18 of 86 intended patients were recruited. This was due to fewer than expected patients being eligible for the study, as well as disruption resulting from the Covid-19 pandemic. Only one patient was lost to follow-up. There were no serious or medically important adverse events during the trial. GPs in the ‘Decision tool’ arm indicated moderate support for the tool. A minority of patients fully engaged with the mobile app-based tracking of symptoms, medication adherence and side effects.ConclusionsOverall, the trial is not feasible in the current form and would need to be modified as follows to overcome its limitations: 1) inclusion of patients who have only tried one SSRI, rather than two, to improve recruitment and pragmatic relevance of the study, 2) approaching community pharmacists to implement tool recommendations rather than GPs, 3) further funding to directly interface between the decision support tool and self-reported symptom app, 4) increasing the geographic reach by not requiring detailed diagnostic assessments and replacing this with supported remote self-report.Ethics and disseminationThe study has received NHS ethical approval from the London - Camberwell St Giles Research Ethics Committee (ref:17/LO/2074).Trial registration numberClinicalTrials.govIdentifier:NCT03628027Strengths and limitations of this studyThe Antidepressant Advisor tool was incorporated into an existing GP healthcare record system for ease of use by GPsWe were unable to recruit a sufficient number of participants to estimate effect sizes for future trialsThe eligibility criteria for participants to have tried two antidepressants before entering the study limited the number of eligible participants
Publisher
Cold Spring Harbor Laboratory
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