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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

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ABSTRACT

Background: 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.

Methods/design: 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.

Discussion: 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.

Trial registration: ClinicalTrials.gov NCT02533089. Registered 20 August 2015. Protocol Date/Version 29 May 2016/Version 2.

Electronic supplementary material: The online version of this article (doi:10.1186/s13063-016-1563-2) contains supplementary material, which is available to authorized users.

No MeSH data available.


Lay Health Worker side of point-of-care tool, English version
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Fig2: Lay Health Worker side of point-of-care tool, English version

Mentions: The current strategy builds on our earlier work, in which we identified a gap in LHW TB knowledge and job-specific training [9–11]. The multifaceted KT strategy will employ peer trainer-led educational outreach, a point-of-care reminder tool, and a peer mentoring network, chosen on the basis of evidence for the effectiveness of this approach with midlevel healthcare workers in South Africa [12–14], mapping of barriers to implementation identified through our formative qualitative study [10], and experience with and feedback from our prior studies [9, 11]. Improved patient TB knowledge and positive patient-provider interactions, two common barriers to adherence [15–18], are targeted through improved LHW skills in patient education and adherence counseling. Although evidence for communities of practice is poor [19], we include a peer mentorship network based on previous feedback from peer trainers to evaluate its potential role and cost implications. See Table 1 and Figs. 2 and 3 for detailed descriptions of the intervention and the point-of-care tool. The full manual is available upon request from the corresponding author.Table 1


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
Lay Health Worker side of point-of-care tool, English version
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC5015212&req=5

Fig2: Lay Health Worker side of point-of-care tool, English version
Mentions: The current strategy builds on our earlier work, in which we identified a gap in LHW TB knowledge and job-specific training [9–11]. The multifaceted KT strategy will employ peer trainer-led educational outreach, a point-of-care reminder tool, and a peer mentoring network, chosen on the basis of evidence for the effectiveness of this approach with midlevel healthcare workers in South Africa [12–14], mapping of barriers to implementation identified through our formative qualitative study [10], and experience with and feedback from our prior studies [9, 11]. Improved patient TB knowledge and positive patient-provider interactions, two common barriers to adherence [15–18], are targeted through improved LHW skills in patient education and adherence counseling. Although evidence for communities of practice is poor [19], we include a peer mentorship network based on previous feedback from peer trainers to evaluate its potential role and cost implications. See Table 1 and Figs. 2 and 3 for detailed descriptions of the intervention and the point-of-care tool. The full manual is available upon request from the corresponding author.Table 1

View Article: PubMed Central - PubMed

ABSTRACT

Background: 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.

Methods/design: 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.

Discussion: 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.

Trial registration: ClinicalTrials.gov NCT02533089. Registered 20 August 2015. Protocol Date/Version 29 May 2016/Version 2.

Electronic supplementary material: The online version of this article (doi:10.1186/s13063-016-1563-2) contains supplementary material, which is available to authorized users.

No MeSH data available.