Title: Patient-reported outcome measures for monitoring primary care patients with depression: PROMDEP randomised controlled trial
Funder: Department of Health and Social Care

Abstract: Design: Parallel group cluster randomised trial with 1:1 allocation to intervention and control. Inclusion: Patients age 18+ years, with a new episode of depressive disorder/symptoms. If possible, patients will be recruited opportunistically at consultations for new episodes of depression. Records will also be searched for newly presenting patients, to reduce the risk of selection bias. Exclusions: current depression treatment, comorbid dementia/psychosis/substance misuse/suicidal ideas. Intervention: Administration of PHQ-9 soon after diagnosis, and at follow-up 10-35 days later. We will target GP reflective motivation and psychological capability with guidance on assessment and treatment, informed by NICE guidelines. GPs will be trained in interpreting scores, along with asking open-ended questions and exploring the patient's life context, and asked to take them into account in their treatment decisions. Patients will be given written feedback on their scores and suggested treatments to discuss with GPs. Control practice patients will not complete the PHQ-9. They will complete research outcome measures but not be given feedback on the results. Baseline measures: depression on the Beck Depression Inventory BDI-II, sociodemographics, duration and past history of depression, GAD-7 for anxiety. Outcomes: Primary outcome: BDI-II at 12 weeks. Secondary outcomes: BDI-II at 26 weeks; changes in drug treatments and referrals; social functioning (Work & Social Adjustment Scale) & quality of life (EQ-5D) at 12 & 26 weeks; service use over 26 weeks (modified Client Services Receipt Inventory) to calculate NHS costs; patient satisfaction at 26 weeks (Medical Informant Satisfaction Scale). Sample size: Assuming baseline mean BDI-II 24.0; SD 10.0 (from feasibility RCT); follow-up mean of 14.0 at 12 weeks in intervention group, 17.0 in controls (difference 3.0 = effect size of 0.3 and MCID of 17.5% of control group score); mean 6 patients per practice; ICC 0.03; 5% significance; 90% power; needs 235 patients analysed per group. Cluster design effect 1.15; assuming 20% loss to follow-up gives 235x1.15x2/0.8 =676 total, from 113 practices across three centres. Randomisation: by CTU statistician with computerised sequence generation. Blinding: of practitioners and patients is impossible given the nature of the intervention. Self-report outcome measures will prevent researcher rating bias. Analysis: Differences at 12 and 26 weeks between intervention and controls in depression, social functioning and quality of life will be analysed using linear mixed models, adjusted for sociodemographics, baseline depression, anxiety, and clustering, including practice as a random effect. Patient satisfaction, quality of life (QALYs) and costs over 26 weeks will be compared between arms. Qualitative process analysis: Interviews with 15-20 GP/NPs and 15-20 patients per arm to reflect on trial results and implementation issues, using Normalization Process Theory as a framework for the interview schedules and qualitative analyses. Practitioner/patient dyads to be interviewed as soon as possible after patient assessments at follow-up consultations, to explore recall of practitioner-patient discussion of scores and identify variations in the use of the PHQ-9.

Lay abstract: We want to look at whether giving personal feedback to people being treated for depression might help them get better more quickly. One way of doing this is by using patient reported outcome measures (or 'PROMs') which involve patients filling out questionnaires to record their symptoms of depression and feeding back the questionnaire results to the health professionals looking after them, at follow-up appointments. Some benefit for patients from reduced depression has been shown to result from monitoring their progress with PROMs, at least in specialist psychological therapy and mental health settings, but this approach has not yet been researched in UK general practices. General practice is the setting in which most people with depression are treated in the UK, so it's important to test whether PROMs can be helpful in that setting. In a previous study in general practices in southern England between 2014 and 2016, we found that it was feasible to allocate patients at random to either assessment with PROMs or usual care, so we could test the value of follow-up monitoring of depression with PROMs. The practices recruited patients with depression through sending letters to patients who had recently been seen for a new episode of depression, which proved an acceptable method to practices and patients. Patients were happy to complete our chosen questionnaires on symptoms, daily activities, quality of life, satisfaction with care, and use of GP and specialist services, and most attended follow-up as requested. Lower levels of depression symptoms at 12 weeks among patients in the PROM group suggested that completing PROMs at diagnosis and follow-up assessment may improve the outcome of depression treatment for patients, even though some GPs did not use the results to inform patient care. The lessons learned from the previous feasibility study have been taken into account in the design of the larger definitive study described in this protocol. We will provide more engaging and instructive training materials for GPs using PROMs, indicating specific actions to be taken following assessment. We are using the PHQ-9, a PROM that is acceptable to GPs and identified as useful by them. Most GPs we talked to have used the PHQ-9 questionnaire, found it helpful where the diagnosis was uncertain, and feel they understood the implications of scores for their treatment decisions. We will also provide written feedback on PROM results for patients, listing possible treatment options. As patients do not always see the same GP at follow-up as they did at diagnosis, all the GPs in a practice will be trained to follow the same procedures in their appointments with people with depression, to make sure they can stick to what we are asking them to do in the study. We will identify and recruit practices with a track record of recruiting patients with depression, and ensure all the GPs are trained in the study procedures, including new GPs who join practices during the study. Rates of following up patients will be maximised through obtaining their permission to text, phone and email them to maintain better contact, more often. This is an important study. If using PROMs is helpful in improving patient outcomes for depression then they are likely to be good value for money, given their low cost. The benefits could be considerable, given that depression is so common, can be so disabling, and costs the nation billions of pounds.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH