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| Name | Class |
|---|---|
| Unity Health Toronto | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KT intervention | Experimental | Multifaceted KT strategy employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KT intervention | Other | Multifaceted KT intervention employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Default Cases (Treatment Interrupted >= 2 Consecutive Months) | secondary outcome =proportion of default cases (treatment interrupted >= 2 consecutive months) | 1 year |
| Proportion of Successes Among HIV Co-infected Cases |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa M Puchalski Ritchie, MD,PhD | Li Ka Shing Knowledge Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 4 Districts, SE zone of Malawi (Balaka, Machinga, Mangochi, Mulanje) | Malawi | Malawi | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34215610 | Derived | 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. | |
| 33308257 |
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109 health centers assessed for eligability, 6 health centers excluded as TB care not provided at the health center: all patients registered for TB care with treatment start and end dates within the study period included
103 health centers enrolled, a total of 1153 patients
| ID | Title | Description |
|---|---|---|
| FG000 | KT Intervention | Multifaceted KT strategy employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network. KT intervention: Multifaceted KT intervention employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | KT Intervention | Multifaceted KT strategy employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network. KT intervention: Multifaceted KT intervention employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 1 year |
|
1 year
Outcome data taken from ministry of health TB records, therefore only information of death during period of TB treatment available, no other adverse event data available
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KT Intervention | Multifaceted KT strategy employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network. KT intervention: Multifaceted KT intervention employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network. |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. L M Puchalski Ritchie | Li Ka Shing knowledge institute | 416 864 6060 | lisa.puchalskiritchie@utoronto.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2016 | Mar 10, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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secondary outcome = proportion of successes among HIV co-infected cases
| 1 year |
| 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. |
| 27604571 | 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. |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| TB type = pulmonary TB | Count of Participants | Participants |
|
|
|
| Secondary | Proportion of Default Cases (Treatment Interrupted >= 2 Consecutive Months) | secondary outcome =proportion of default cases (treatment interrupted >= 2 consecutive months) | analysis not conducted due to small proportion of default cases | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Proportion of Successes Among HIV Co-infected Cases | secondary outcome = proportion of successes among HIV co-infected cases | analysis not conducted due to large proportion of missing data | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 49 |
| 605 |
| 0 |
| 605 |
| 0 |
| 605 |
| EG001 | 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. | 61 | 548 | 0 | 548 | 0 | 548 |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |