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Low-dose High-frequency Training of Facility Health Care Providers in Mali

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ClinicalTrials.gov Identifier: NCT03656237
Recruitment Status : Recruiting
First Posted : September 3, 2018
Last Update Posted : September 23, 2019
Sponsor:
Collaborators:
Canadian Red Cross
Global Affairs Canada
Croix Rouge Malienne
University of the Sciences, Techniques and Technologies of Bamako
Direction Nationale de la Santé Mali
Information provided by (Responsible Party):
Diego Bassani, The Hospital for Sick Children

Brief Summary:

This 3-arm cluster randomized trial has the following objectives:

Primary Aim

To evaluate the effectiveness of an on-site case-based focused low-dose high-frequency training strategy in a primary health care facility labour room, during the provision of care to mothers and newborns, through childbirth and within seven days post-partum for the healthcare providers and the community health workers linked to the health facility in decreasing perinatal mortality.

Secondary Aims

To determine if introduction of an on-site case-based focused low-dose high-frequency training methodology in comparison to MNCH refresher training in a classroom setting reduces:

  • Perinatal morbidity incidence
  • Post-partum Hemorrhage

To determine if introduction of an on-site case-based focused low-dose high-frequency training methodology in comparison to MNCH refresher training in a classroom setting increases ENC practices:

  • Early initiation and exclusive breast feeding
  • Thermal protection (prevention of hypothermia)
  • Clean cord care
  • Delayed bathing
  • Resuscitation-Initiation of breathing

To determine if introduction of a case-based focused low-dose high-frequency training methodology in comparison to MNCH refresher training in a classroom setting for CHWs decreases:

  • Delayed Identification of danger signs during pregnancy, labour and perinatal period
  • Delayed referral of complicated cases during pregnancy, labour and perinatal period

To determine the cost effectiveness of a case-based focused low-dose high-frequency training methodology in comparison to MNCH refresher training in a classroom setting


Condition or disease Intervention/treatment Phase
Perinatal Mortality Other: Usual Training Other: Audits + LDHF Training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster Randomized Trial (Clusters are the community health units - CSCOMs)
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Impact of Case-based Focused Low-dose High-frequency hands-on Training of Facility Health Care Providers and Community Health Workers on Maternal and Newborn Health in Mali, a Cluster Randomized Trial.
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : August 10, 2020
Estimated Study Completion Date : August 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Usual training + Audits + LDHF training

Usual training of health workers, in classroom, following standard curriculum

+ Mortality and Morbidity Audits in facility every two weeks followed by LDHF training focused on gaps in knowledge or practice identified during the audits

Other: Usual Training
Training in a classroom setting of health care providers
Other Name: Classroom Training

Other: Audits + LDHF Training
Clinical audits followed by case-based low-dose high-frequency training
Other Name: Mort. Morb. Audit + Low-dose High-freq. training

Experimental: Audits + LDHF training
Mortality and Morbidity Audits in facility every two weeks followed by LDHF training focused on gaps in knowledge or practice identified during the audits
Other: Audits + LDHF Training
Clinical audits followed by case-based low-dose high-frequency training
Other Name: Mort. Morb. Audit + Low-dose High-freq. training

Active Comparator: Usual Training
Control Arm exposed to usual training of health workers, in classroom, following standard curriculum
Other: Usual Training
Training in a classroom setting of health care providers
Other Name: Classroom Training




Primary Outcome Measures :
  1. Perinatal Mortality [ Time Frame: First 7 days of life ]
    Deaths occurring within 7 days of birth and fetal deaths (stillbirth) per 1000 CSCOM births


Secondary Outcome Measures :
  1. Resuscitation-Initiation of breathing [ Time Frame: Immediately at birth ]
    Either the stimulation of the newborn, or the clearing of the airways using a suction bulb/catheter or using a bag and mask to resuscitate, per 1000 live births in a CSCOM.

  2. Early initiation of breastfeeding [ Time Frame: An hour after birth ]
    If child was breastfed within an hour of birth, per 1000 live births in a CSCOM.

  3. Exclusive breastfeeding [ Time Frame: First 7 days of life ]
    If child was given breastmilk and no other food or drink for the first 7 days of life, per 1000 live births in a CSCOM.

  4. Thermal protection (dried and wrapped) [ Time Frame: Immediately at birth ]
    If newborn was dried and wrapped immediately after birth, per 1000 live births in a CSCOM

  5. Thermal protection (Kangaroo mother care) [ Time Frame: Immediately at birth ]
    Immediately after birth was the newborn put on the chest of the mom - skin to skin, per 1000 live births in a CSCOM.

  6. Clean cord care [ Time Frame: First 7 days of life ]
    Newborns who had alcohol or chlorhexidine applied to the umbilical cord but nothing else, per 1000 live births in a CSCOM.

  7. Delayed first bath [ Time Frame: First 24 hours of life ]
    Newborn not bathed within first 24 hours of life, per 1000 live births in a CSCOM.

  8. Newborn weighed [ Time Frame: First 24 hours of life ]
    Newborn weight checked after birth, per 1000 CSCOM births.

  9. Severe Infection [ Time Frame: First 7 days of life ]
    Diagnosis of a severe infection, per 1000 CSCOM live births.

  10. Neonatal hypothermia [ Time Frame: First 7 days of life ]
    Diagnosis of neonatal hypothermia, per 1000 CSCOM live births.

  11. Umbilical cord infection [ Time Frame: First 7 days of life ]
    Diagnosis of umbilical cord infection per 1000 CSCOM live births.

  12. Perinatal bleeding [ Time Frame: First 7 days of life ]
    Diagnosis of perinatal bleeding per 1000 CSCOM live births

  13. Postpartum hemorrhage [ Time Frame: Immediately after delivery ]
    Postpartum hemorrhage of >= 500ml during childbirth in a CSCom, per 1000 deliveries

  14. Obstructed labor - referral [ Time Frame: During delivery ]
    # of women referred to a higher-level facility from a CSCOM due to obstructed labor, per 1000 deliveries.

  15. Post-partum hemorrhage - referral [ Time Frame: Immediately after delivery ]
    # of deliveries referred to a higher-level facility from a CSCOM due to post-partum hemorrhage, per 1000 deliveries.

  16. Low birth weight - referral [ Time Frame: First 7 days of life ]
    # of referrals for low birth weight from a CSCOM to a higher-level facility, per 1000 live births.

  17. Moderate to severe hypothermia - referral [ Time Frame: First 7 days of life ]
    # of referrals for moderate to severe hypothermia from a CSCOM to a higher level facility, per 1000 live births.

  18. Severe infection - referral [ Time Frame: First 7 days of life ]
    # of referrals for severe infection from a CSCOM to a higher level facility, per 1000 live births.

  19. Moderate to severe umbilical cord infection - referral [ Time Frame: First 7 days of life ]
    # of referrals for moderate to severe umbilical cord infection from a CSCOM to a higher level facility, per 1000 live births.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All CSComs providing basic obstetric care with at least one health care provider trained in AMTSL, ENC and PNC with data collection/ utilization in Koulikoro, Kolokani, Banamba and Dioïla study clusters.
  • All community health workers reporting to an included CSCom.
  • All CSCom deliveries (both mother and newborn) in study clusters and live home births referred to a facility within the perinatal period.
  • Mother intending to maintain residence in study area for first week of newborn's life.

Exclusion Criteria:

  • CSComs not providing basic obstetric care or not having trained maternal and neonatal health care providers in AMTSL, ENC and PNC and not collecting/utilizing data.
  • CHW's will be excluded if linked to an in-eligible CSCom or if they have not been trained in the standard MoH CHW training curriculum.
  • Failure to provide consent to enroll in study (intervention or control clusters).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656237


Contacts
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Contact: Diego G Bassani, Ph.D. +14168137654 ext 303033 diego.bassani@sickkids.ca
Contact: Jean-Luc Kortenaar, MPH +14168137654 jean-luc.kortenaar@sickkids.ca

Locations
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Mali
iCCM Sites Recruiting
Koulikoro, Mali
Contact: Diego Bassani, MD    (416)-813-7654 ext 3033    diego.bassani@sickkids.ca   
Principal Investigator: Diego Bassani, PhD         
Sponsors and Collaborators
The Hospital for Sick Children
Canadian Red Cross
Global Affairs Canada
Croix Rouge Malienne
University of the Sciences, Techniques and Technologies of Bamako
Direction Nationale de la Santé Mali
Investigators
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Principal Investigator: Diego G Bassani, Ph.D. The Hospital for Sick Children

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Responsible Party: Diego Bassani, Director, International Program Evaluation Unit (IPE), Center for Global Child Health, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03656237     History of Changes
Other Study ID Numbers: 1000060635
First Posted: September 3, 2018    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Perinatal Death
Pregnancy Complications
Death
Pathologic Processes