The impact of a knowledge translation intervention employing educational outreach and a point-of-care reminder tool vs standard lay health worker training on tuberculosis treatment completion rates: study protocol for a cluster randomized controlled trial.
Despite availability of effective treatment, tuberculosis (TB) remains an important cause of morbidity and mortality globally, with low- and middle-income countries most affected. In many such settings, including Malawi, the high burden of disease and severe shortage of skilled healthcare workers has led to task-shifting of outpatient TB care to lay health workers (LHWs). LHWs improve access to healthcare and some outcomes, including TB completion rates, but lack of training and supervision limit their impact. The goals of this study are to improve TB care provided by LHWs in Malawi by refining, implementing, and evaluating a knowledge translation strategy designed to address a recognized gap in LHWs' TB and job-specific knowledge and, through this, to improve patient outcomes.



We are employing a mixed-methods design that includes a pragmatic cluster randomized controlled trial and a process evaluation using qualitative methods. Trial participants will include all health centers providing TB care in four districts in the South East Zone of Malawi. The intervention employs educational outreach, a point-of-care reminder tool, and a peer support network. The primary outcome is proportion of treatment successes, defined as the total of TB patients cured or completing treatment, with outcomes taken from Ministry of Health treatment records. With an alpha of 0.05, power of 0.80, a baseline treatment success of 0.80, intraclass correlation coefficient of 0.1 based on our pilot study, and an estimated 100 clusters (health centers providing TB care), a minimum of 6 patients per cluster is required to detect a clinically significant 0.10 increase in the proportion of treatment successes. Our process evaluation will include interviews with LHWs and patients, and a document analysis of LHW training logs, quarterly peer trainer meetings, and mentorship meeting notes. An estimated 10-15 LHWs and 10-15 patients will be required to reach saturation in each of 2 planned interview periods, for a total of 40-60 interview participants.



This study will directly inform the efforts of knowledge users within TB care and, through extension of the approach, other areas of care provided by LHWs in Malawi and other low- and middle-income countries.



ClinicalTrials.gov NCT02533089 . Registered 20 August 2015. Protocol Date/Version 29 May 2016/Version 2.
Department of Medicine, University of Toronto, Toronto, ON, Canada. lisa.puchalskiritchie@utoronto.ca.|Department of Emergency Medicine, University Health Network, Toronto, ON, Canada. lisa.puchalskiritchie@utoronto.ca.|Li Ka Shing Knowledge Institute, St. Michael's Hospital, 30 Bond Street, Toronto, ON, M5B 1W8, Canada. lisa.puchalskiritchie@utoronto.ca.
Lisa M
LM
Puchalski Ritchie
Dignitas International, P.O. Box 1071, Zomba, Malawi.|Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.
Monique
M
van Lettow
National Tuberculosis Control Program, Ministry of Health, P.O. Box 30377, Lilongwe, Malawi.
Austine
A
Makwakwa
Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.|Sunnybrook Health Sciences Center, Toronto, ON, Canada.|Dignitas International, 550 Queen Street East, Suite 335, Toronto, ON, Canada.
Adrienne K
AK
Chan
Li Ka Shing Knowledge Institute, St. Michael's Hospital, 30 Bond Street, Toronto, ON, M5B 1W8, Canada.
Jemila S
JS
Hamid
Dignitas International, P.O. Box 1071, Zomba, Malawi.
Harry
H
Kawonga
Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.|Dignitas International, 550 Queen Street East, Suite 335, Toronto, ON, Canada.|George Institute for Global Health, Sydney, Australia.|The University of Sydney, Sydney, Australia.
Alexandra L C
AL
Martiniuk
Department of Medicine, University of Toronto, Toronto, ON, Canada.|Sunnybrook Health Sciences Center, Toronto, ON, Canada.|Dignitas International, 550 Queen Street East, Suite 335, Toronto, ON, Canada.
Michael J
MJ
Schull
Dignitas International, P.O. Box 1071, Zomba, Malawi.
Vanessa
V
van Schoor
Department of Family Medicine, Western University, London, ON, Canada.|Department of Family Medicine, Schulich School of Medicine & Dentistry, Western University, 1151 Richmond Street, London, ON, N6A 5C1, Canada.
Merrick
M
Zwarenstein
Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, 55 College Street, Suite 425, Toronto, ON, M5T 3M6, Canada.
Jan
J
Barnsley
Department of Medicine, University of Toronto, Toronto, ON, Canada.|Li Ka Shing Knowledge Institute, St. Michael's Hospital, 30 Bond Street, Toronto, ON, M5B 1W8, Canada.
Sharon E
SE
Straus
D002985:Clinical Protocols; D003150:Community Health Workers / Q000193:education*; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008295:Malawi; D019095:Point-of-Care Systems; D036301:Qualitative Research; D018401:Sample Size; D057170:Translational Research, Biomedical; D014376:Tuberculosis / Q000628:therapy*
Cluster randomized trial; Community health workers; Educational outreach; Lay health workers; Peer support network; Reminders; TB; Tuberculosis