Title: Feasibility study for a randomised controlled trial of patient reported outcome measures (PROMs) in the assessment and follow-up monitoring of patients with depression in primary care.
Funder: Department of Health (England)

Abstract: Background Depression is a common and disabling disorder which is very unpleasant for sufferers and very costly to the nation. It is predicted depression will cost the UK more than £12 billion per year by 2020 in service costs, sickness benefits, and work absence. Depression is largely treated in general practice, but GPs are not good at assessing the severity of depression and do not target their treatment on those patients who would most benefit. Patient reported outcome measures (PROMs) have been shown to improve outcomes in specialist psychiatric and psychological practice but have not been subjected to a randomised trial in UK primary care. Aims To carry out a randomised controlled trial of PROMs in the assessment and follow-up monitoring of patients treated for depression in primary care. Objectives: To test the use of specific validated questionnaires as patient reported outcome measures (PROMs) in consultations for the assessment and follow-up of patients treated for depression. (This is now possible because since April 2013 the QOF no longer requires questionnaires to be completed as a routine requirement for practices to be awarded their QOF points). To compare outcomes for patients assessed with PROMs with those assessed without PROMs, in terms of depressive symptoms, social functioning, quality of life, and costs to the NHS. The objectives of the feasibility study are to determine key elements of the best design for the main study, including: The willingess and ability of general practitioners (GPs) and practice nurses (PNs) to recruit and randomise patients to the two arms of the study during consultations at which depression is diagnosed. The willingness of general practices to be randomised to intervention or control arms of the study as whole practices, in a cluster randomised design The willingness of general practice patients to complete PROMs in the intervention arm The acceptability of the proposed research outcome measures to patients, including questionnaires for depressive symptoms, social functioning, quality of life, and service use The mean number of eligible patients found per practice Rates of recruitment to the study in the two different designs, adherence to the intervention, and follow-up for research assessments The intra-cluster correlation coefficient (ICC) between practices for depressive symptoms Response rates to research outcome measures administered face-to-face, followed up by post and by telephone. Plan Feasibility and acceptability will be assessed through analysis of rates of recruitment, drop-out and follow-up. Estimation of sample size required for the main study will be carried out on the basis of determining the variance in the main outcome measure of depressive symptoms, together with the intra-cluster correlation coefficient for this outcome between practices. The acceptability of the trial procedures and the chosen PROMs will also be explored through qualitative interviews with 20 participants and 20 health professionals, 10 of each in each arm, which will be analysed using thematic analysis. Potential benefits to patients and the NHS If PROMs are beneficial even to a modest extent then they are likely to be cost-effective given their low cost, and the benefits at a population level would be considerable, given the high prevalence, associated disability, long-term nature, and costs to the health service and to the nation of depression. The NHS would save money spent on unnecessary antidepressants and referrals for psychological therapies for people with only mild depression, and the nation would also benefit from the earlier recovery of people with moderate to severe depression, reducing the amounts paid to them in sickness benefits and also gaining financially from their earlier return to work. Most importantly, patients will benefit from feeling better more quickly.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;7.3 MANAGEMENT AND DECISION MAKING
Health categories: MENTAL HEALTH