The clinical effectiveness and cost-effectiveness of a ‘stepping into day treatment’ approach versus inpatient treatment as usual for anorexia nervosa in adult specialist eating disorder services (DAISIES trial): a study protocol of a randomised controlled multi-centre open-label parallel group non-inferiority trial

Abstract

Background Anorexia nervosa (AN) is a serious and disabling mental disorder with a high disease burden. In a proportion of cases, intensive hospital-based treatments, i.e. inpatient or day patient treatment, are required, with day patient treatment often being used as a ‘step-down’ treatment after a period of inpatient treatment. Demand for such treatment approaches has seen a sharp rise. Despite this, the relative merits of these approaches for patients, their families, and the NHS and wider society are relatively unknown. This paper describes the rationale for, and protocol of, a two-arm multi-centre open-label parallel group non-inferiority randomised controlled trial, evaluating the effectiveness and cost-effectiveness of these two intensive treatments for adults with severe AN: inpatient treatment as usual and a stepped care day patient approach (the combination of day patient treatment with the option of initial inpatient treatment for medical stabilisation). The main aim of this trial is to establish whether, in adults with severe AN, a stepped care day patient approach is non-inferior to inpatient treatment as usual in relation to improving body mass index (BMI) at 12 months post-randomisation. Methods 386 patients with a Diagnostic and Statistical Manual 5th edition diagnosis of severe AN or related disorder, with a BMI of ≤16 kg/m2 and in need of intensive treatment will be randomly allocated to either inpatient treatment as usual or a stepped care day patient approach. Patients in both groups will receive treatment until they reach a healthy weight or get as close to this point as possible. Assessments will be conducted at baseline (prior to randomisation), and at 6 and 12 months post-randomisation, with additional monthly symptom monitoring. The primary outcome will be BMI at the 12-month post-randomisation assessment. Other outcomes will include psychosocial adjustment; treatment motivation, expectations and experiences; cost-effectiveness; and carer burden. Discussion The results of this study will provide a rigorous evaluation of two intensive treatment approaches which will inform future national and international treatment guidelines and service provision. Trial registration ISRCTN ISRCTN10166784. Registered 28 February 2020. ISRCTN is a primary registry of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) network and includes all items from the WHO Trial Registration Data Set.

Autopsy of a failed trial part 1: A qualitative investigation of clinician's views on and experiences of the implementation of the DAISIES trial in UK‐based intensive eating disorder services

“…Ethical approval was granted by the Wales Research Ethics Committee 5 (Reference: 20/WA/0072). Data collection for this study was conducted as part of the process evaluation for the DAISIES trial (Irish et al, 2022). A qualitative design was used, underpinned by a critical realist philosophical orientation (Bhaskar, 2016; Fletcher, 2017) which separates ontology and epistemology, positing an objective reality understandable via subjective socially constructed knowledge.…”

Autopsy of a failed trial part 2: Outcomes, challenges, and lessons learnt from the DAISIES trial

“…Full details of the trial design, methodology, planned baseline and outcome assessments, and study procedure are described in the protocol paper (Irish et al, 2022). Brief descriptions of the study design and methodology are presented in Supporting Information S1: Supplement 1.…”

“… A purposely designed record form to assess carers' demographic characteristics (e.g., gender, employment, nature of relationship to study participant) at baseline. Instruments assessing carers' perceived burden of ED, mood, anxiety and stress symptoms at baseline, 6 and 12 months post‐randomisation (for details see protocol paper (Irish et al, 2022) …”

“…Instruments assessing carers' perceived burden of ED, mood, anxiety and stress symptoms at baseline, 6 and 12 months post‐randomisation (for details see protocol paper (Irish et al, 2022)…”

“…However, DPT can lead to difficulty in weight gain for recovery and provides less support and monitoring than IP‐TAU. It may also put greater pressure on families (Irish et al, 2022; Serrano‐Troncoso et al, 2020; Webb et al, 2022b).…”