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

NCT02533089 | Completed Results

• 1 other identifier: TB KT intervention
• Study Type: interventional
• Target: 1,153
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Proportion of Cases Successfully Treated, Defined as the Total Number of Cases Cured and Completing Treatment.

  primary outcome =proportion of cases successfully treated, defined as the total number of cases cured and completing treatment.

  1 year

Secondary Outcomes (2)

• Proportion of Default Cases (Treatment Interrupted >= 2 Consecutive Months)

  1 year

• Proportion of Successes Among HIV Co-infected Cases

  1 year

Study Arms (2)

KT intervention

EXPERIMENTAL

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

Other: KT intervention

Control

NO INTERVENTION

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.

Interventions

KT intervention OTHER

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

KT intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dignitas International: lead
• Unity Health Toronto: collaborator

Study Sites (1)

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

Malawi, Malawi, Malawi

Location

Related Publications (3)

• 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.

  PMID: 34215610 DERIVED

• 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.

  PMID: 33308257 DERIVED

• 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.

  PMID: 27604571 DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Limitations and Caveats

outcome data limited to TB register outcome data. give small number of defaults \& high proportion of missing outcome data secondary outcomes not analyzed, factors related to missing outcome analyzed and included in primary analysis

Results Point of Contact

• Title: Dr. L M Puchalski Ritchie
• Organization: Li Ka Shing knowledge institute

lisa.puchalskiritchie@utoronto.ca

416 864 6060

Study Officials

• Lisa M Puchalski Ritchie, MD,PhD

  Li Ka Shing Knowledge Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: August 26, 2015
• Study Start: May 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: March 24, 2020
• Results First Posted: March 24, 2020

Record last verified: 2020-03

Locations

MA (1)