Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial

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dc.contributor.authorHanlon, Charlotte
dc.contributor.authorAlem, Atalay
dc.contributor.authorMedhin, Girmay
dc.contributor.authorShibre, Teshome
dc.contributor.authorEjigu, Dawit A
dc.contributor.authorNegussie, Hanna
dc.contributor.authorDewey, Michael
dc.contributor.authorWissow, Lawrence
dc.contributor.authorPrince, Martin
dc.contributor.authorSusser, Ezra
dc.contributor.authorLund, Crick
dc.contributor.authorFekadu, Abebaw
dc.date.accessioned2016-06-07T08:23:14Z
dc.date.available2016-06-07T08:23:14Z
dc.date.issued2016-02-11
dc.date.updated2016-05-18T15:47:03Z
dc.description.abstractBackground: Task sharing mental health care through integration into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in low-income countries. However, the effectiveness, acceptability, feasibility and sustainability of this service model for people with a severe mental disorder (SMD) have not been evaluated in a low-income country. Methods/Design: A randomised, controlled, non-inferiority trial will be carried out in a predominantly rural area of Ethiopia. A sample of 324 people with SMD (diagnoses of schizophrenia, schizoaffective disorder, bipolar disorder or major depressive disorder) with an ongoing need for mental health care will be recruited from 1) participants in a population-based cohort study and 2) people attending a psychiatric nurse-led out-patient clinic. The intervention is a task-sharing model of locally delivered mental health care for people with SMD integrated into PHC delivered over 18 months. Participants in the active control arm will receive the established and effective model of specialist mental health care delivered by psychiatric nurses at an out-patient clinic within a centrally located general hospital. The hypothesis is that people with SMD who receive mental health care integrated into PHC will have a non-inferior clinical outcome, defined as a mean symptom score on the Brief Psychiatric Rating Scale, expanded version, of no more than six points higher, compared to participants who receive the psychiatric nurse-led service, after 12 months. The primary outcome is change in symptom severity. Secondary outcomes are functional status, relapse, service use costs, service satisfaction, drop-out and medication adherence, nutritional status, physical health care, quality of care, medication side effects, stigma, adverse events and cost-effectiveness. Sustainability and costeffectiveness will be further evaluated at 18 months. Randomisation will be stratified by health centre catchment area using random permuted blocks. The outcome assessors and investigators will be masked to allocation status. Discussion: Evidence about the effectiveness of task sharing mental health care for people with SMD in a rural, low-income African country will inform the World Health Organisation’s mental health Gap Action Programme to scale-up mental health care globally.en_ZA
dc.identifier.apacitationHanlon, C., Alem, A., Medhin, G., Shibre, T., Ejigu, D. A., Negussie, H., ... Fekadu, A. (2016). Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial. <i>Trials</i>, http://hdl.handle.net/11427/19928en_ZA
dc.identifier.chicagocitationHanlon, Charlotte, Atalay Alem, Girmay Medhin, Teshome Shibre, Dawit A Ejigu, Hanna Negussie, Michael Dewey, et al "Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial." <i>Trials</i> (2016) http://hdl.handle.net/11427/19928en_ZA
dc.identifier.citationHanlon, C., Alem, A., Medhin, G., Shibre, T., Ejigu, D. A., Negussie, H., ... & Lund, C. (2016). Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial. Trials, 17(1), 76.en_ZA
dc.identifier.issn1745-6215en_ZA
dc.identifier.ris TY - Journal Article AU - Hanlon, Charlotte AU - Alem, Atalay AU - Medhin, Girmay AU - Shibre, Teshome AU - Ejigu, Dawit A AU - Negussie, Hanna AU - Dewey, Michael AU - Wissow, Lawrence AU - Prince, Martin AU - Susser, Ezra AU - Lund, Crick AU - Fekadu, Abebaw AB - Background: Task sharing mental health care through integration into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in low-income countries. However, the effectiveness, acceptability, feasibility and sustainability of this service model for people with a severe mental disorder (SMD) have not been evaluated in a low-income country. Methods/Design: A randomised, controlled, non-inferiority trial will be carried out in a predominantly rural area of Ethiopia. A sample of 324 people with SMD (diagnoses of schizophrenia, schizoaffective disorder, bipolar disorder or major depressive disorder) with an ongoing need for mental health care will be recruited from 1) participants in a population-based cohort study and 2) people attending a psychiatric nurse-led out-patient clinic. The intervention is a task-sharing model of locally delivered mental health care for people with SMD integrated into PHC delivered over 18 months. Participants in the active control arm will receive the established and effective model of specialist mental health care delivered by psychiatric nurses at an out-patient clinic within a centrally located general hospital. The hypothesis is that people with SMD who receive mental health care integrated into PHC will have a non-inferior clinical outcome, defined as a mean symptom score on the Brief Psychiatric Rating Scale, expanded version, of no more than six points higher, compared to participants who receive the psychiatric nurse-led service, after 12 months. The primary outcome is change in symptom severity. Secondary outcomes are functional status, relapse, service use costs, service satisfaction, drop-out and medication adherence, nutritional status, physical health care, quality of care, medication side effects, stigma, adverse events and cost-effectiveness. Sustainability and costeffectiveness will be further evaluated at 18 months. Randomisation will be stratified by health centre catchment area using random permuted blocks. The outcome assessors and investigators will be masked to allocation status. Discussion: Evidence about the effectiveness of task sharing mental health care for people with SMD in a rural, low-income African country will inform the World Health Organisation’s mental health Gap Action Programme to scale-up mental health care globally. DA - 2016-02-11 DB - OpenUCT DO - 10.1186/s13063-016-1191-x DP - University of Cape Town J1 - Trials KW - Mental disorder KW - community mental health care KW - primary healthcare KW - task-shifting KW - sub-Saharan Africa KW - developing countries LK - https://open.uct.ac.za PB - University of Cape Town PY - 2016 SM - 1745-6215 T1 - Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial TI - Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial UR - http://hdl.handle.net/11427/19928 ER - en_ZA
dc.identifier.urihttp://dx.doi.org/10.1186/s13063-016-1191-x
dc.identifier.urihttp://hdl.handle.net/11427/19928
dc.identifier.vancouvercitationHanlon C, Alem A, Medhin G, Shibre T, Ejigu DA, Negussie H, et al. Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial. Trials. 2016; http://hdl.handle.net/11427/19928.en_ZA
dc.languageengen_ZA
dc.language.rfc3066en
dc.publisherBioMed Centralen_ZA
dc.publisher.departmentCentre for Public Mental Healthen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsCreative Commons Attribution 4.0 International (CC BY 4.0)*
dc.rights.holderHanlon et al.
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_ZA
dc.sourceTrialsen_ZA
dc.source.urihttp://trialsjournal.biomedcentral.com/
dc.subjectMental disorder
dc.subjectcommunity mental health care
dc.subjectprimary healthcare
dc.subjecttask-shifting
dc.subjectsub-Saharan Africa
dc.subjectdeveloping countries
dc.titleTask sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trialen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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