Digital augmentation of aftercare for patients with anorexia nervosa: the TRIANGLE RCT and economic evaluation

Treasure J, Rowlands K, Cardi V, Ambwani S, McDaid D, Lord L, Clark Bryan D, Macdonald P, Bonin E, Schmidt U, Arcelus J, Harrison A, Landau S
Record ID 32018014378
English
Authors' objectives: High-risk patients with complex anorexia nervosa are managed in inpatient/day patient care, but re-admission rates are high, and new treatments are needed. To examine the effectiveness of a digital augmentation of aftercare (ECHOMANTRA). Transition Care In Anorexia Nervosa through Guidance Online from Peer and Carer Expertise aimed to examine whether offering a digital programme (ECHOMANTRA), containing information and online group support for patients with anorexia nervosa and their nominated supporters, could reduce patient distress and improve other outcomes in the 18-month period after leaving intensive treatment (inpatient or day care). The study also examined whether ECHOMANTRA is a good value for money to the National Health Service and the wider economy. Anorexia nervosa (AN) is a serious mental illness, typically developing in adolescence. It often runs a protracted course, leading to adverse outcomes, reduced quality of life and high costs. The incidence of female cases presenting to primary care in the UK pre COVID-19 was approximately 12 cases per 100,000, but a large increase followed the pandemic. Eating disorder-related disability-adjusted life-years are high both for patients and their carers. There is a large amount of uncertainty about optimal treatment for AN particularly for the subgroup with a protracted and severe form of illness admitted for inpatient/day patient care. Transitions from inpatient/day patient care can be difficult with up to 50% of patients suffering a relapse and mortality in the year following admission increased 10-fold. In two previous proof-of-concept studies conducted within National Institute for Health and Care Research-funded programmes, we found that a guided self-management approach for patients and a task-sharing approach for carers had benefits on both patient and carer outcomes. In a small feasibility study, we found that an intervention combining these interventions improved outcomes. The aim of this study was to examine the effectiveness of a digital augmentation of transition treatment (ECHOMANTRA) offered to patients and their nominated carer/support person (participant dyads) in addition to usual care for AN. The specific aims were to assess: patient distress at 12 months (primary outcome) other patient outcomes, including patient distress at 18 months, patient motivation and ability to change, eating disorder symptoms, social and work adjustment, and days in hospital cost-effectiveness of ECHOMANTRA for patients at 12 months carer distress and skills at 12 and 18 months adverse events (AEs) during the study process aspects of the study, including adherence to treatment and patients and their carer/supporters’ experiences of receiving and supporting treatment, respectively, in the trial by conducting nested qualitative studies and online surveys about both treatment as usual (TAU) alone and with ECHOMANTRA augmentation.
Authors' results and conclusions: There was no evidence of an intervention effect on the Depression Anxiety Stress Scale-21 outcome for patients (n = 370) at 12 months, estimated effect 0.48, 95% confidence interval −0.20 to 0.23, standardised estimate (0.02, p = 0.87). In the economic analysis, the intervention was dominated by treatment as usual from both a health system and wider societal perspective, as ECHOMANTRA cost more and resulted in fewer quality-adjusted life-years gained. However, the uptake of the interactive component of the intervention (i.e. the facilitated and moderated online groups) was limited, with only 20% of the dyad members attending the pre-set minimal adherence level (i.e. both the patient and carer attending at least four online forum group sessions). The feedback about the intervention was predominantly positive. For example, the group facilitators were rated highly. However, some feedback was that the intervention offered too little, too late, and that a more personalised intervention would be more helpful. This guided self-management and task-sharing intervention was reviewed positively by some patients and supporters; however, there was no evidence that the intervention improved outcomes over usual aftercare. There were no differences between groups in the outcomes measured, which included patient distress, eating disorder symptoms, quality of life, social and work adjustment and carer distress and skills. ECHOMANTRA did not demonstrate good value for money. However, only 20% of participants allocated to ECHOMANTRA joined more than four online group sessions (the minimal recommended participation). ECHOMANTRA failed to show a benefit overall, which may reflect the limited uptake of the online groups and the broader access to carer support outside of the study. Together with participant feedback, these findings suggest that a more personalised programme, with more integration with clinical teams, may lead to increased engagement with the virtual elements of support offered by ECHOMANTRA. In the screening phase, 960 patients with AN across 31 specialist day patient/inpatient services were assessed between July 2017 and July 2020. Eight hundred patients were deemed eligible, 409 patient–carer dyads consented to take part in the study and 371 dyads were randomised. Of these, 186 were allocated to TAU alone, and 185 to TAU alone plus ECHOMANTRA. Patients were predominantly female, white, single, aged 25–26 years, with a median illness duration of 5 years and median BMI of 15.9 at baseline. The majority (76%) were recruited from inpatient care, including 19% currently admitted under the Mental Health Act (MHA) [16% had previous admissions (median 2) under the MHA]. Patient comorbidity included depression (62%), anxiety (59%), obsessive–compulsive disorder (16%), autistic spectrum disorder (5%) and attention deficit hyperactivity disorder (2%). Most carers were mothers aged 50 years, although 30% were males and 17% were partners. Most carers were white, married, spoke English as their first language, were university educated and in paid employment. Overall, 68% of the sample provided primary outcome data with more missing values in the intervention arm [TAU, n = 143/186 (76%); ECHOMANTRA + TAU, n = 110/185 (59%)]. Our pre-specified criterion for adherence with ECHOMANTRA was not met by 80% of dyads randomised to ECHOMANTRA + TAU. At 12 months, no differences were found between the two groups in either primary patient outcome [estimated effect 0.48, 95% confidence interval (CI) −0.20 to 0.23, standardised estimate 0.02, p = 0.87] or secondary patient and carer outcomes. Sensitivity analyses showed that the non-significant finding for the primary outcome was robust to changes in eligibility criteria (e.g. recruiting patients with atypical anorexia, or the onset of the pandemic). In the economic analysis, ECHOMANTRA was dominated by TAU, as it cost more (£5948, 95% CI −£6297 to £17,786) and resulted in fewer QALYs gained (−0.059, 95% CI −0.122 to 0.010). From the societal perspective, ECHOMANTRA was dominated by TAU with higher costs (£3351, 95% CI −£9253 to £15,371) and fewer QALYs gained (−0.059, 95% CI −0.122 to 0.010). From the health system and societal perspectives, there is an 11.5% and 25% probability of being cost-effective at a willingness-to-pay threshold of £20,000 per QALY gained. Over time, most outcome variables improved, although patients remained symptomatic. However, motivation for change reduced, and self-rated ability to change remained low. No differences in AEs were found between groups. Most of the adverse effects recorded were related to signs of relapse of the eating disorder, that is, weight loss. Five patients died during the study (three in TAU and two in ECHOMANTRA arms). Most patients were no longer in hospital in the period from 9 to 12 months. Implications for health care Engagement with ECHOMANTRA was poor and not associated with an improved transition outcome. The feedback from participants suggested that a more personalised and tailored form of intervention, with adjustments to adapt to the range of diversity in terms of social demographic factors, comorbidity and/or stage of illness, is needed. For example, a transition service adapted to the stage of illness (like the First episode and Rapid Early intervention for Eating Disorders (FREED) model of outpatient care) may be of value. Furthermore, flexible integration between the range of services and community support is essential to cover and respond to the variable range of needs in this patient group. Hopefully, the initiative to have joint commissioning of inpatient and outpatient services will facilitate this. For example, the Healthy Outcomes for People with Eating disorders (HOPE) model in Oxford (an early adopter of local-based commissioning) developed a care pathway with a thread of continuity across all services.
Authors' recommendations: Following the Medical Research Council process of developing complex interventions, the next steps for adult patients with AN would involve building upon trials using the Experienced Carers Helping Others (ECHO) and Maudsley Model of Anorexia Nervosa Treatment for Adults (MANTRA) approaches across Europe.
Authors' methods: Transition Care In Anorexia Nervosa through Guidance Online from Peer and Carer Expertise was a multicentre, parallel-group, superiority randomised controlled trial. ECHOMANTRA augmented treatment as usual was compared with treatment as usual. Patient–carer dyads were randomised using minimisation on a 1 : 1 ratio into ECHOMANTRA + treatment as usual (ECHOMANTRA) or treatment as usual alone. Specialised United Kingdom inpatient/day patient sites (n = 31) participated. Patient–carer dyads were randomised (n = 185 in ECHOMANTRA and n = 186 in treatment as usual). The digital ECHOMANTRA intervention included self-management tools (recovery tips videos) for patients and task-sharing materials for carers (skill-sharing video), supplemented with guided group chat sessions. All participants randomised to ECHOMANTRA + treatment as usual had access to the psychoeducational materials and joint patient/carer chat sessions were also offered. The primary outcome was patient distress at 12 months. Other outcomes included patient distress at 18 months, and eating disorder symptoms, social and work adjustment, and carer distress and skills at 12 and 18 months. Participants were diverse (e.g. 20% were being treated under the Mental Health Act), and a large proportion had a range of comorbidities (depression, anxiety, obsessive–compulsive disorder and autistic spectrum disorders), all factors impacting prognosis. Although efforts were made to enhance inclusion, diversity in terms of gender, sexuality and race was limited, and technological barriers and/or lack of a carer may have led to exclusion. The high level of non-adherence to the group support (80% dyads) may have contributed to the non-significant findings. Patients and a nominated supporter (371 pairs) were recruited and split into two groups at random: (1) usual treatment plus access to the ECHOMANTRA programme and (2) usual treatment alone. Patients and their supporters reported inadequate planning and support following discharge from hospital. Patients reported low confidence in their ability to recover, and a need for more continuity in their care. Carers echoed the need for a supportive transition process. Several aspects of the ECHOMANTRA programme were welcomed, with the mixed patient/supporter online groups and online group facilitators experienced as particularly helpful. Participants were generally positive about the written and recovery tip videos. However, several suggested that more personalised content and access options were needed. Design We undertook a pragmatic, multicentre, parallel-arm, randomised trial with both clinical and health economic evaluation. We further embedded a qualitative process evaluation to understand opportunities and barriers in ECHOMANTRA and usual care. Patients were randomised to receive TAU alone, or augmented with ECHOMANTRA, a digital intervention containing guided self-management for patients and support skills for carers. The primary outcome was patient distress at 12 months post randomisation. Thirty-one specialised inpatient or day patient eating disorder services in England and Scotland participated in the study. The final inclusion criteria were: AN patient aged 16 years or over. Patients with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnosis of AN or atypical AN, with a body mass index (BMI) of ≤ 18.5 kg/m2 at any stage in the recruitment window (i.e. from admission until 4 weeks post discharge). Patient must have a carer who is willing to participate. (Note that carer is inclusive of any family member or friend who is willing to participate and able to provide some aftercare support.) Informed consent is received any time after admission until 4 weeks post discharge from inpatient/day patient care. Patient–carer dyads are able to access an electronic device (e.g. mobile phone, computer, laptop, tablet) and the internet in order to use the study’s website. The final exclusion criteria were: When consented into the study, the patient is not either: admitted to hospital or attending day care for a minimum of 3 days/week The patient has an insufficient knowledge of English. The patient has severe mental or chronic physical illness needing treatment in its own right (e.g. psychosis, diabetes mellitus, cystic fibrosis etc.). The patient is pregnant. The patient–carer dyad has previously received treatments involving ECHOMANTRA materials. Baseline measures have not been completed by the dyad.
Details
Project Status: Completed
Year Published: 2025
URL for additional information: English
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: England, United Kingdom
MeSH Terms
  • Anorexia Nervosa
  • Aftercare
  • Digital Technology
  • Cost-Effectiveness Analysis
  • Caregivers
  • Social Support
  • Self-Management
  • Adult
  • Adolescent
  • Young Adult
Contact
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name: journals.library@nihr.ac.uk
Contact Email: journals.library@nihr.ac.uk
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