Efficacy and cost-effectiveness of task-shared care for people with severe mental disorders in Ethiopia (TaSCS): a single-blind, randomised, controlled, phase 3 non-inferiority trial

TY - JOUR

T1 - Efficacy and cost-effectiveness of task-shared care for people with severe mental disorders in Ethiopia (TaSCS)

T2 - a single-blind, randomised, controlled, phase 3 non-inferiority trial

AU - Hanlon, Charlotte

AU - Medhin, Girmay

AU - Dewey, Michael E.

AU - Prince, Martin

AU - Assefa, Esubalew

AU - Shibre, Teshome

AU - Ejigu, Dawit A.

AU - Negussie, Hanna

AU - Timothewos, Sewit

AU - Schneider, Marguerite

AU - Thornicroft, Graham

AU - Wissow, Lawrence

AU - Susser, Ezra

AU - Lund, Crick

AU - Fekadu, Abebaw

AU - Alem, Atalay

N1 - Funding Information: This work was fully funded by the National Institute of Mental Health of the US National Institutes of Health as part of the Africa Focus on Intervention Research for Mental Health (AFFIRM) [Award Number U19MH095699]. None of the authors are employed by NIH. The content of the paper is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. We are particularly grateful for the technical support of Pamela Collins, Adam Haim, LeShawndra Price, and colleagues from the NIMH in the process of designing and implementing this study. We would like to thank Dan Chisholm and Hanani Tabana for their work in support of health economic aspects of the trial. We are grateful to the study participants for generously sharing their time and experiences during the conduct of this study. CH, AA, CL, MP, and GT are funded through the ASSET research programme, supported by the UK's National Institute of Health Research (NIHR; NIHR Global Health Research Unit on Health Systems Strengthening in Sub-Saharan Africa at King's College London [16/136/54]) using UK aid from the UK Government. CH also receives support from NIHR through grant NIHR200842. GT is supported by the NIHR Applied Research Collaboration South London at King's College London NHS Foundation Trust. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research, or the Department of Health and Social Care, England. CH receives support from AMARI as part of the DELTAS Africa Initiative [DEL- [15-01]. GT is supported by the Guy's and St Thomas' Charity for the On Trac project (EFT151101), and by the UK Medical Research Council in relation to the Emilia (MR/S001255/1) and Indigo Partnership (MR/R023697/1) awards. LW is supported by the US National Institute of Mental Health as part of the School Health Implementation Network: Eastern Mediterranean Region (SHINE; Award Number U19 MH10999801) and the Collaborative Care for Child and Youth Mental Health Problems in a Middle-Income Country study (Award Number R23MH106645). MS is supported by the UKRI/GCRF funded Strengthening Responses to Dementia in developing countries (STRiDE). Funding Information: This work was fully funded by the National Institute of Mental Health of the US National Institutes of Health as part of the Africa Focus on Intervention Research for Mental Health (AFFIRM) [Award Number U19MH095699]. None of the authors are employed by NIH. The content of the paper is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. We are particularly grateful for the technical support of Pamela Collins, Adam Haim, LeShawndra Price, and colleagues from the NIMH in the process of designing and implementing this study. We would like to thank Dan Chisholm and Hanani Tabana for their work in support of health economic aspects of the trial. We are grateful to the study participants for generously sharing their time and experiences during the conduct of this study. CH, AA, CL, MP, and GT are funded through the ASSET research programme, supported by the UK's National Institute of Health Research (NIHR; NIHR Global Health Research Unit on Health Systems Strengthening in Sub-Saharan Africa at King's College London [16/136/54]) using UK aid from the UK Government. CH also receives support from NIHR through grant NIHR200842. GT is supported by the NIHR Applied Research Collaboration South London at King's College London NHS Foundation Trust. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research, or the Department of Health and Social Care, England. CH receives support from AMARI as part of the DELTAS Africa Initiative [DEL- [15-01]. GT is supported by the Guy's and St Thomas' Charity for the On Trac project (EFT151101), and by the UK Medical Research Council in relation to the Emilia (MR/S001255/1) and Indigo Partnership (MR/R023697/1) awards. LW is supported by the US National Institute of Mental Health as part of the School Health Implementation Network: Eastern Mediterranean Region (SHINE; Award Number U19 MH10999801) and the Collaborative Care for Child and Youth Mental Health Problems in a Middle-Income Country study (Award Number R23MH106645). MS is supported by the UKRI/GCRF funded Strengthening Responses to Dementia in developing countries (STRiDE). Publisher Copyright: © 2022 Elsevier Ltd

PY - 2022/1

Y1 - 2022/1

N2 - Background: There have been no trials of task-shared care (TSC) using WHO's mental health Gap Action Programme for people with severe mental disorders (psychosis or affective disorder) in low-income or middle-income countries. We aimed to evaluate the efficacy and cost-effectiveness of TSC compared with enhanced specialist mental health care in rural Ethiopia. Methods: In this single-blind, phase 3, randomised, controlled, non-inferiority trial, participants had a confirmed diagnosis of a severe mental disorder, recruited from either the community or a local outpatient psychiatric clinic. The intervention was TSC, delivered by supervised, non-physician primary health care workers trained in the mental health Gap Action Programme and working with community health workers. The active comparison group was outpatient psychiatric nurse care augmented with community lay workers (PSY). Our primary endpoint was whether TSC would be non-inferior to PSY at 12 months for the primary outcome of clinical symptom severity using the Brief Psychiatric Rating Scale, Expanded version (BPRS-E; non-inferiority margin of 6 points). Randomisation was stratified by health facility using random permuted blocks. Independent clinicians allocated groups using sealed envelopes with concealment and outcome assessors and investigators were masked. We analysed the primary outcome in the modified intention-to-treat group and safety in the per-protocol group. This trial is registered with ClinicalTrials.gov, number NCT02308956. Findings: We recruited participants between March 13, 2015 and May 21, 2016. We randomly assigned 329 participants (111 female and 218 male) who were aged 25–72 years and were predominantly of Gurage (198 [60%]), Silte (58 [18%]), and Mareko (53 [16%]) ethnicity. Five participants were found to be ineligible after randomisation, giving a modified intention-to-treat sample of 324. Of these, 12-month assessments were completed in 155 (98%) of 158 in the TSC group and in 158 (95%) of 166 in the PSY group. For the primary outcome, there was no evidence of inferiority of TSC compared with PSY. The mean BPRS-E score was 27·7 (SD 4·7) for TSC and 27·8 (SD 4·6) for PSY, with an adjusted mean difference of 0·06 (90% CI –0·80 to 0·89). Per-protocol analyses (n=291) were similar. There were 47 serious adverse events (18 in the TSC group, 29 in the PSY group), affecting 28 participants. These included 17 episodes of perpetrated violence and seven episodes of violent victimisation leading to injury, ten suicide attempts, six hospital admissions for physical health conditions, four psychiatric admissions, and three deaths (one in the TSC group, two in the PSY group). The incremental cost-effectiveness ratio for TSC indicated lower cost of –US$299·82 (95% CI –454·95 to –144·69) per unit increase in BPRS-E scores from a health care sector perspective at 12 months. Interpretation: WHO's mental health Gap Action Programme for people with severe mental disorders is as cost-effective as existing specialist models of care and can be implemented effectively and safely by supervised non-specialists in resource-poor settings. Funding: US National Institute of Mental Health.

AB - Background: There have been no trials of task-shared care (TSC) using WHO's mental health Gap Action Programme for people with severe mental disorders (psychosis or affective disorder) in low-income or middle-income countries. We aimed to evaluate the efficacy and cost-effectiveness of TSC compared with enhanced specialist mental health care in rural Ethiopia. Methods: In this single-blind, phase 3, randomised, controlled, non-inferiority trial, participants had a confirmed diagnosis of a severe mental disorder, recruited from either the community or a local outpatient psychiatric clinic. The intervention was TSC, delivered by supervised, non-physician primary health care workers trained in the mental health Gap Action Programme and working with community health workers. The active comparison group was outpatient psychiatric nurse care augmented with community lay workers (PSY). Our primary endpoint was whether TSC would be non-inferior to PSY at 12 months for the primary outcome of clinical symptom severity using the Brief Psychiatric Rating Scale, Expanded version (BPRS-E; non-inferiority margin of 6 points). Randomisation was stratified by health facility using random permuted blocks. Independent clinicians allocated groups using sealed envelopes with concealment and outcome assessors and investigators were masked. We analysed the primary outcome in the modified intention-to-treat group and safety in the per-protocol group. This trial is registered with ClinicalTrials.gov, number NCT02308956. Findings: We recruited participants between March 13, 2015 and May 21, 2016. We randomly assigned 329 participants (111 female and 218 male) who were aged 25–72 years and were predominantly of Gurage (198 [60%]), Silte (58 [18%]), and Mareko (53 [16%]) ethnicity. Five participants were found to be ineligible after randomisation, giving a modified intention-to-treat sample of 324. Of these, 12-month assessments were completed in 155 (98%) of 158 in the TSC group and in 158 (95%) of 166 in the PSY group. For the primary outcome, there was no evidence of inferiority of TSC compared with PSY. The mean BPRS-E score was 27·7 (SD 4·7) for TSC and 27·8 (SD 4·6) for PSY, with an adjusted mean difference of 0·06 (90% CI –0·80 to 0·89). Per-protocol analyses (n=291) were similar. There were 47 serious adverse events (18 in the TSC group, 29 in the PSY group), affecting 28 participants. These included 17 episodes of perpetrated violence and seven episodes of violent victimisation leading to injury, ten suicide attempts, six hospital admissions for physical health conditions, four psychiatric admissions, and three deaths (one in the TSC group, two in the PSY group). The incremental cost-effectiveness ratio for TSC indicated lower cost of –US$299·82 (95% CI –454·95 to –144·69) per unit increase in BPRS-E scores from a health care sector perspective at 12 months. Interpretation: WHO's mental health Gap Action Programme for people with severe mental disorders is as cost-effective as existing specialist models of care and can be implemented effectively and safely by supervised non-specialists in resource-poor settings. Funding: US National Institute of Mental Health.

UR - http://www.scopus.com/inward/record.url?scp=85121141132&partnerID=8YFLogxK

U2 - 10.1016/S2215-0366(21)00384-9

DO - 10.1016/S2215-0366(21)00384-9

M3 - Article

AN - SCOPUS:85121141132

SN - 2215-0366

VL - 9

SP - 59

EP - 71

JO - The Lancet Psychiatry

JF - The Lancet Psychiatry

IS - 1

ER -