Training Lay Healthcare Workers to Optimize TB Care and Improve Outcomes in Malawi

NCT ID: NCT02533089

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-02-28

Brief Summary

Task shifting of less complex healthcare tasks to lay health workers (LHWs) is increasingly employed strategy to address the global shortage of skilled health workers. Despite availability of effective treatment, tuberculosis (TB) remains an important cause of mortality with 1.3 million lives lost globally to TB in 2012. The greatest proportion of new TB cases occurs in Africa and over 95% of TB deaths occur in low income countries (LICs). In response to the combined high TB burden and severe healthcare worker shortages in these settings, outpatient TB care is among the tasks commonly shifted to LHWs.

LHWs are community members who have received some training but are not healthcare professionals. Randomised trials show LHWs improve access to basic health services and TB treatment outcomes, however, insufficient training and supervision are recognized barriers to their effectiveness.

The investigators' goal is to improve TB care provided by LHWs in Malawi by implementing and evaluating a knowledge translation (KT) strategy designed to facilitate incorporation of evidence into LHW practice. The investigators will employ a mixed methods design including a pragmatic cluster randomized controlled trial to evaluate effectiveness of the strategy and qualitative methods to understand barriers and facilitators to scalability and sustainability of the program.

Conditions

Tuberculosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH

Study Groups

KT intervention

Multifaceted KT strategy employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network.

Group Type: EXPERIMENTAL

KT intervention

Intervention Type: OTHER

Multifaceted KT intervention employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network.

Control

Control sites will receive no intervention, with LHW training left to the discretion of the health centers TB focus LHW. Control sites will not have access to the point of care tool.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

KT intervention

Multifaceted KT intervention employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• all health centers in participating districts that routinely provide TB care will be included.
• LHWs who have received the intervention and patients receiving care at participating health centers will be eligible to participate in interviews

Exclusion Criteria

• health centers that do not routinely provide TB care
• LHWs unwilling or unable to give informed consent.
• TB patients less than 18 years of age unaccompanied by a parent or guardian, patients/guardians or LHWs unwilling or unable to give informed consent, patients presenting to a health center they are not routinely followed at.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: collaborator

Dignitas International

OTHER

Sponsor Role: lead

Responsible Party

Lisa M Puchalski Ritchie

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa M Puchalski Ritchie, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Li Ka Shing Knowledge Institute

Locations

4 Districts, SE zone of Malawi (Balaka, Machinga, Mangochi, Mulanje)

Malawi, Malawi, Malawi

Countries

Malawi

References

Puchalski Ritchie LM, Kip EC, Mundeva H, van Lettow M, Makwakwa A, Straus SE, Hamid JS, Zwarenstein M, Schull MJ, Chan AK, Martiniuk A, van Schoor V. Process evaluation of an implementation strategy to support uptake of a tuberculosis treatment adherence intervention to improve TB care and outcomes in Malawi. BMJ Open. 2021 Jul 2;11(7):e048499. doi: 10.1136/bmjopen-2020-048499.

Reference Type: DERIVED

PMID: 34215610 (View on PubMed)

Puchalski Ritchie LM, van Lettow M, Makwakwa A, Kip EC, Straus SE, Kawonga H, Hamid JS, Lebovic G, Thorpe KE, Zwarenstein M, Schull MJ, Chan AK, Martiniuk A, van Schoor V. Impact of a tuberculosis treatment adherence intervention versus usual care on treatment completion rates: results of a pragmatic cluster randomized controlled trial. Implement Sci. 2020 Dec 11;15(1):107. doi: 10.1186/s13012-020-01067-y.

Reference Type: DERIVED

PMID: 33308257 (View on PubMed)

Puchalski Ritchie LM, van Lettow M, Makwakwa A, Chan AK, Hamid JS, Kawonga H, Martiniuk AL, Schull MJ, van Schoor V, Zwarenstein M, Barnsley J, Straus SE. 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. Trials. 2016 Sep 7;17(1):439. doi: 10.1186/s13063-016-1563-2.

Reference Type: DERIVED

PMID: 27604571 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TB KT intervention

Identifier Type: -

Identifier Source: org_study_id