Title: A Randomised Controlled Multi-Centre Open-Label Parallel Group Non-Inferiority Trial of the Clinical Effectiveness, Acceptability and Cost-Effectiveness of a ‘Stepping into Day Treatment’ Approach versus Inpatient Treatment as Usual for Anorexia Nervosa in Adult Specialist Eating Disorder Services
Funder: Department of Health and Social Care

Abstract: Aims: In adults with severe anorexia nervosa who need immediate and intensive treatment, we will compare two approaches: (a) specialist inpatient treatment as usual and (b) specialist day patient treatment (either immediately or, if needed, after brief inpatient treatment to medically stabilise the patient), which we call ‘stepped care’. We will assess how effective and acceptable these two approaches are and whether they provide value for money._x000D_ _x000D_ Background: Anorexia nervosa is a disabling and deadly disorder. About 20-30% of patients with anorexia nervosa need intensive treatment (day patient or inpatient treatment or both) to help them improve or recover. We do not know whether either of these two intensive treatment approaches has advantages/disadvantages for patients, families, the NHS and wider society. _x000D_ _x000D_ Design and Methods: We will conduct a large clinical trial comparing the two intensive treatment approaches in routine NHS practice. We will start by assessing our ability to recruit participants (internal pilot trial; aiming to recruit ~62 patients over 4 months). If this goes well we then progress to the full study which will include 386 adults (containing the pilot participants) with severe anorexia nervosa, who are deemed to need intensive treatment. After baseline assessment, patients will be allocated by chance to either stepped care or inpatient care. The most important clinical outcome will be body mass index (BMI) at 12-months after randomisation. We will test whether stepped care is no worse than inpatient treatment (this is called a ‘non-inferiority’ study design). We will also assess a number of secondary outcomes, including eating disorder symptoms, other common symptoms, social functioning, quality of life, any relapses or re-admissions to hospital, as well as outcomes for carers. Additionally, we will evaluate treatment acceptability and participants’ treatment experience. Finally, we will look at the cost of the two different treatment approaches and explore whether day patient treatment is better value for money than inpatient treatment to the NHS. _x000D_ _x000D_ Patient and Public Involvement: We held two meetings with 12 patients with severe anorexia nervosa and with experience of day-treatment, inpatient treatment or of both settings and discussed this proposal in detail. Two patients and one carer commented on the full proposal. Patients strongly endorsed the design of the present study, in particular the stepped care aspect, as this was felt to offer individually tailored care. Measures of treatment motivation, perceived coercion, social support and loneliness were added to the study, based on patient-feedback. Five people will become patient/carer representatives in the study, to ensure all design decisions, study procedures and materials (e.g. information sheets) are informed by them. _x000D_ _x000D_ Dissemination: Study findings will be disseminated to health professionals, researchers, commissioners, policy makers and patients and carers. This will be done via scientific publications in open access journals, conference presentations (preferentially those that include patients and carers (i.e. conferences by Beat, National Carers Conference), and relevant web-sites. We will also work with our press office to disseminate study findings via traditional and social media. Patient representatives will have a key role in our dissemination programme. Finally, we will work closely with NHS England to implement findings.

Lay abstract: Aims: In adults with severe anorexia nervosa (AN) who need immediate and intensive treatment, we will compare clinical effectiveness, acceptability, cost and cost-effectiveness of two approaches: (a) specialist inpatient treatment as usual (IP-TAU) or (b) a stepped care day treatment [where people either enter specialist day patient treatment immediately or, if needed, initially have inpatient treatment to medically stabilise them, and then progress to day treatment (based on weekly reviews with clear rules for progression)]._x000D_ _x000D_ Background: Anorexia nervosa is a disabling and deadly disorder. About 20-30% of patients with AN need intensive treatment (either day or inpatient treatment) to achieve improvements or recovery. The relative merits of these two intensive treatment approaches for patients, families, the NHS and wider society are not known. _x000D_ _x000D_ Design and Methods: We will conduct a pragmatic two-arm multi-centre open-label parallel group non-inferiority randomised controlled trial (RCT) comparing the two intensive treatment approaches in routine NHS practice. To assess recruitment rates, an internal pilot trial (aiming to recruit 62 patients over 4 months) is included in the study design. If this is successful, we will continue with the full study which will include 386 adults (including pilot participants) with severe AN, deemed to need intensive treatment. After baseline assessment, patients will be randomly allocated at a 1:1 ratio to either stepped care day treatment or IP-TAU. Our primary clinical outcome will be body mass index (BMI) 12-months after randomisation. Our main hypothesis is that on this outcome, the stepped care approach will be non-inferior to IP-TAU. We will also assess secondary outcomes, such as AN-related readmissions, patients’ eating disorder and other psychopathology, social support and functioning, quality of life and carer outcomes. Additionally, we will evaluate participants’ motivation and attitude to treatment, their treatment experience and any harms. Finally, we will assess the relative cost-effectiveness of the treatments from the NHS and personal social services perspective preferred by NICE. _x000D_ _x000D_ Patient and Public Involvement (PPI): We have discussed this proposal with 12 patients with severe AN. All had experience of day-treatment, inpatient treatment or both. Patients strongly endorsed the design of the present study, in particular the stepped care aspect, as this was felt to offer individually tailored care. Measures of treatment motivation, perceived coercion, social support and loneliness were added to the study, based on patient-feedback. Two patients and a carer have reviewed and commented on the full proposal. Five people (3 patients, 2 carers) will become PPI representatives, to ensure all design decisions, study procedures and materials, and dissemination outputs are informed by them. _x000D_ _x000D_ Dissemination: Study findings will be disseminated to health professionals, researchers, commissioners, policy makers, patients and carers. This will be done via scientific publications in open access journals, conference presentations (preferentially those that include patients and carers) and relevant web-sites. We will also work with the KCL press office to disseminate study findings via traditional and social media. Patient representatives will have a key role in our dissemination programme. Finally, we will work closely with NHS England to implement findings.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: MENTAL HEALTH