ObjectiveTo assess implementation and to identify barriers and facilitators to implementation, sustainability and scalability of an implementation strategy to provide lay health workers (LHWs) with ...the knowledge, skills and tools needed to implement an intervention to support patient tuberculosis (TB) treatment adherence.DesignMixed-methods design including a cluster randomised controlled trial and process evaluation informed by the RE-AIM framework.SettingForty-five health centres (HCs) in four districts in the south east zone of Malawi, who had an opportunity to receive cascade training.ParticipantsForty-five peer-trainers (PTs), 23 patients and 20 LHWs.InterventionImplementation strategy employing peer-led educational outreach, a clinical support tool and peer support network to implement a TB treatment adherence intervention.Outcome measuresProcess data were collected from study initiation to the end-of-study PT meeting, and included: LHW and patient interviews, quarterly PT meeting notes, training logs and study team observations and meeting notes. Data sources were first analysed in isolation, followed by method, data source and analyst triangulation. Analyses were conducted independently by two study team members, and themes revised through discussion and involvement of additional study team members as needed.ResultsForty-one HCs (91%) trained at least one LHW. Of 256 LHWs eligible to participate at study start 152 (59%) completed training, with the proportion trained per HC ranging from 0% to 100% at the end of initial cascade training. Lack of training incentives was the primary barrier to implementation, with intrinsic motivation to improve knowledge and skills, and to improve patient care and outcomes the primary facilitators of participation.ConclusionWe identified important challenges to and potential facilitators of implementation, scalability and sustainability, of the TB treatment adherence intervention. Findings provide guidance to scale-up, and use of the implementation strategies employed, to address LHW training and supervision in other areas.Trial registration numberNCT02533089.
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.
Lay health workers (LHWs) play a pivotal role in addressing the high TB burden in Malawi. LHWs report lack of training to be a key barrier to their role as TB care providers. Given the cost of ...traditional off-site training, an alternative approach is needed. Our objective was to evaluate the effectiveness of a KT intervention tailored to LHWs needs.
The study design is a pragmatic cluster randomized trial. The study was embedded within a larger trial, PALMPLUS, and compared three arms which included 28 health centers in Zomba district, Malawi. The control arm included 14 health centers randomized as controls in the larger trial and maintained as control sites. Seven of 14 PALMPLUS intervention sites were randomized to the LHW intervention (PALM/LHW intervention arm), and the remaining 7 PALMPLUS sites maintained as a PALM only arm. PALMPLUS intervention sites received an educational outreach program targeting mid-level health workers. LHW intervention sites received both the PALMPLUS intervention and the LHW intervention employing on-site peer-led educational outreach and a point-of-care tool tailored to LHWs identified needs. Control sites received no intervention. The main outcome measure is the proportion of treatment successes.
Among the 28 sites, there were 178 incident TB cases with 46/80 (0.58) successes in the control group, 44/68 (0.65) successes in the PALMPLUS group, and 21/30 (0.70) successes in the PALM/LHW intervention group. There was no significant effect of the intervention on treatment success in the univariate analysis adjusted for cluster randomization (p = 0.578) or multivariate analysis controlling for covariates with significant model effects (p = 0.760). The overall test of the intervention-arm by TB-type interaction approached but did not achieve significance (p = 0.056), with the interaction significant only in the control arm RR of treatment success for pulmonary TB relative to non-pulmonary TB, 1.18, 95% CI 1.05-1.31.
We found no significant treatment effect of our intervention. Given the identified trend for effectiveness and urgent need for low-cost approaches to LHW training, further evaluation of tailored KT strategies as a means of LHW training in Malawi and other LMICs is warranted.
ClinicalTrials.gov NCT01356095 .
Like many sub-Saharan African countries, Malawi is facing a critical shortage of skilled healthcare workers. In response to this crisis, a formal cadre of lay health workers (LHW) has been ...established and now carries out several basic health care services, including outpatient TB care and adherence support. While ongoing training and supervision are recognized as essential to the effectiveness of LHW programs, information is lacking as to how these needs are best addressed. The objective of this qualitative study was to explore LHWs responses to a tailored knowledge translation intervention they received, designed to address a previously identified training and knowledge gap.
Forty-five interviews were conducted with 36 healthcare workers. Fourteen to sixteen interviews were done at each of 3 evenly spaced time blocks over a one year period, with 6 individuals interviewed more than once to assess for change both within and across individuals overtime.
Reported benefits of the intervention included: increased TB, HIV, and job-specific knowledge; improved clinical skills; and increased confidence and satisfaction with their work. Suggestions for improvement were less consistent across participants, but included: increasing the duration of the training, changing to an off-site venue, providing stipends or refreshments as incentives, and adding HIV and drug dosing content.
Despite the significant departure of the study intervention from the traditional approach to training employed in Malawi, the intervention was well received and highly valued by LHW participants. Given the relative low-cost and flexibility of the methods employed, this appears a promising approach to addressing the training needs of LHW programs, particularly in Low- and Middle-income countries where resources are most constrained.
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.
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