Impact of a tuberculosis treatment adherence intervention versus usual care on treatment completion rates: results of a pragmatic cluster randomized controlled trial.

Community Health Workers Counseling Humans Peer Group Treatment Adherence and Compliance Tuberculosis / drug therapy
Cluster randomized trial Community health workers Educational outreach Lay health workers Peer support network Reminders Tuberculosis

Journal

Implementation science : IS
ISSN: 1748-5908
Titre abrégé: Implement Sci
Pays: England
ID NLM: 101258411

Informations de publication

Date de publication:
11 12 2020
Historique:
received: 12 02 2020
accepted: 01 12 2020
entrez: 14 12 2020
pubmed: 15 12 2020
medline: 26 11 2021
Statut: epublish

Résumé

With the global shortage of skilled health workers estimated at 7.2 million, outpatient tuberculosis (TB) care is commonly task-shifted to lay health workers (LHWs) in many low- and middle-income countries where the shortages are greatest. While shown to improve access to care and some health outcomes including TB treatment outcomes, lack of training and supervision limit the effectiveness of LHW programs. Our objective was to refine and evaluate an intervention designed to address common causes of non-adherence to TB treatment and LHW knowledge and skills training needs. We employed a pragmatic cluster randomized controlled trial. Participants included 103 health centres (HCs) providing TB care in four districts in Malawi, randomized 1:1 stratified by district and HC funding (Ministry of Health, non-Ministry funded). At intervention HCs, a TB treatment adherence intervention was implemented using educational outreach, a point-of-care reminder tool, and a peer support network. Clusters in the control arm provided usual care. The primary outcome was the proportion of patients with successful TB treatment (i.e., cure or treatment completion). We used a generalized linear mixed model, with district as a fixed effect and HC as a random effect, to compare proportions of patients with treatment success, among the trial arms, with adjustment for baseline differences. We randomized 51 HCs to the intervention group and 52 HCs to the control group. Four intervention and six control HCs accrued no eligible patients, and 371 of 1169 patients had missing outcome, HC, or demographic data, which left 74 HCs and 798 patients for analysis. Randomization group was not related to missing outcome, however, district, age, and TB type were significantly related and included in the primary analysis model. Among the 1153 patients with HC and demographic data, 297/605 (49%) and 348/548 (64%) in the intervention and control arms, respectively, had treatment success. The intervention had no significant effect on treatment success (adjusted odds ratio 1.35 [95% confidence interval 0.93-1.98]). We found no significant effect of the intervention on TB treatment outcomes with high variability in implementation quality, highlighting important challenges to both scale-up and sustainability. ClinicalTrials.gov NCT02533089 . Registered August 20, 2015.

Sections du résumé

BACKGROUND
With the global shortage of skilled health workers estimated at 7.2 million, outpatient tuberculosis (TB) care is commonly task-shifted to lay health workers (LHWs) in many low- and middle-income countries where the shortages are greatest. While shown to improve access to care and some health outcomes including TB treatment outcomes, lack of training and supervision limit the effectiveness of LHW programs. Our objective was to refine and evaluate an intervention designed to address common causes of non-adherence to TB treatment and LHW knowledge and skills training needs.
METHODS
We employed a pragmatic cluster randomized controlled trial. Participants included 103 health centres (HCs) providing TB care in four districts in Malawi, randomized 1:1 stratified by district and HC funding (Ministry of Health, non-Ministry funded). At intervention HCs, a TB treatment adherence intervention was implemented using educational outreach, a point-of-care reminder tool, and a peer support network. Clusters in the control arm provided usual care. The primary outcome was the proportion of patients with successful TB treatment (i.e., cure or treatment completion). We used a generalized linear mixed model, with district as a fixed effect and HC as a random effect, to compare proportions of patients with treatment success, among the trial arms, with adjustment for baseline differences.
RESULTS
We randomized 51 HCs to the intervention group and 52 HCs to the control group. Four intervention and six control HCs accrued no eligible patients, and 371 of 1169 patients had missing outcome, HC, or demographic data, which left 74 HCs and 798 patients for analysis. Randomization group was not related to missing outcome, however, district, age, and TB type were significantly related and included in the primary analysis model. Among the 1153 patients with HC and demographic data, 297/605 (49%) and 348/548 (64%) in the intervention and control arms, respectively, had treatment success. The intervention had no significant effect on treatment success (adjusted odds ratio 1.35 [95% confidence interval 0.93-1.98]).
CONCLUSION
We found no significant effect of the intervention on TB treatment outcomes with high variability in implementation quality, highlighting important challenges to both scale-up and sustainability.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02533089 . Registered August 20, 2015.

Identifiants

DOI: 10.1186/s13012-020-01067-y PMID: 33308257 PMC: PMC7731739
pubmed: 33308257
doi: 10.1186/s13012-020-01067-y
pii: 10.1186/s13012-020-01067-y
pmc: PMC7731739
doi:

Banques de données

ClinicalTrials.gov
['NCT02533089']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

107

Subventions

Organisme : CIHR
ID : KAL-139700
Pays : Canada

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Auteurs

Lisa M Puchalski Ritchie (LM)

Department of Medicine, University of Toronto, 6 Queen's Park Crescent West, Third Floor, Toronto, ON, M5S 3H2, Canada. lisa.puchalskiritchie@utoronto.ca.
Li Ka Shing Knowledge Institute, St. Michaels Hospital, St. Michael's Hospital, 30 Bond St, Toronto, ON, M5B 1W8, Canada. lisa.puchalskiritchie@utoronto.ca.
Department of Emergency Medicine, University Health Network, Toronto General Hospital, 200 Elizabeth Street, RFE G-480, Toronto, M5G 2C4, Canada. lisa.puchalskiritchie@utoronto.ca.
Institute of Health Policy, Management and Evaluation, University of Toronto, 155 College Street, Toronto, M5T 3M7, Canada. lisa.puchalskiritchie@utoronto.ca.
ORCID: 0000-0002-1791-5368

Monique van Lettow (M)

Dignitas International, Zomba, Malawi.
Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, M5T 3M7, Canada.

Austine Makwakwa (A)

National TB Program, Ministry of Health, Lilongwe, Malawi.

Ester C Kip (EC)

Dignitas International, Zomba, Malawi.

Sharon E Straus (SE)

Department of Medicine, University of Toronto, 6 Queen's Park Crescent West, Third Floor, Toronto, ON, M5S 3H2, Canada.
Li Ka Shing Knowledge Institute, St. Michaels Hospital, St. Michael's Hospital, 30 Bond St, Toronto, ON, M5B 1W8, Canada.

Harry Kawonga (H)

Dignitas International, Zomba, Malawi.

Jemila S Hamid (JS)

School of Epidemiology and Public Health, University of Ottawa, Room 101, 600 Peter Morand Crescent, Ottawa, ON, I1G 5Z3, Canada.

Gerald Lebovic (G)

Li Ka Shing Knowledge Institute, St. Michaels Hospital, St. Michael's Hospital, 30 Bond St, Toronto, ON, M5B 1W8, Canada.
Institute of Health Policy, Management and Evaluation, University of Toronto, 155 College Street, Toronto, M5T 3M7, Canada.

Kevin E Thorpe (KE)

Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, M5T 3M7, Canada.
Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, 30 Bond St, Toronto, ON, M5B 1W8, Canada.

Merrick Zwarenstein (M)

Department of Family Medicine, Western University, London, ON, Canada.
Department of Family Medicine, Schulich School of Medicine & Dentistry, Western University, 1151 Richmond St, London, ON, N6A 5C1, Canada.

Michael J Schull (MJ)

Department of Medicine, University of Toronto, 6 Queen's Park Crescent West, Third Floor, Toronto, ON, M5S 3H2, Canada.
Division of Infectious Diseases, Department of Medicine, Sunnybrook Health Sciences Center, University of Toronto, c/o H2-66, 2075 Bayview Avenue, Toronto, ON, M4N 3M5, Canada.
Dignitas International Toronto, C/O ICES attention Michael Schull, 2075 Bayview Avenue, G106, Toronto, ON, M4N 3M5, Canada.

Adrienne K Chan (AK)

Department of Medicine, University of Toronto, 6 Queen's Park Crescent West, Third Floor, Toronto, ON, M5S 3H2, Canada.
Institute of Health Policy, Management and Evaluation, University of Toronto, 155 College Street, Toronto, M5T 3M7, Canada.
Dignitas International, Zomba, Malawi.
Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, M5T 3M7, Canada.
Division of Infectious Diseases, Department of Medicine, Sunnybrook Health Sciences Center, University of Toronto, c/o H2-66, 2075 Bayview Avenue, Toronto, ON, M4N 3M5, Canada.

Alexandra Martiniuk (A)

Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, M5T 3M7, Canada.
George Institute for Global Health, Sydney, Australia.
The University of Sydney, Edward Ford Building, Sydney, NSW, Australia.

Vanessa van Schoor (V)

Dignitas International, Zomba, Malawi.

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Classifications MeSH

questionsmedicales.fr › Établissements, main d'oeuvre et services de soins de santé › Personnel de santé › Auxiliaires de santé › Agents de santé communautaire › Impact of a tuberculosis treatment adherence...
questionsmedicales.fr › Établissements, main d'oeuvre et services de soins de santé › Services de santé › Services de santé mentale › Assistance › Impact of a tuberculosis treatment adherence...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Impact of a tuberculosis treatment adherence...
questionsmedicales.fr › Comportement et mécanismes comportementaux › Processus de groupe › Groupe de pairs › Impact of a tuberculosis treatment adherence...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Prestations des soins de santé › Attitude envers la santé › Adhésion et observance thérapeutiques › Impact of a tuberculosis treatment adherence...
questionsmedicales.fr › Infection › Infections bactériennes et mycoses › Infections bactériennes › Infections bactériennes à Gram positif › Infections à Actinomycetales › Infections à Mycobacterium › Tuberculose › Impact of a tuberculosis treatment adherence...