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

NCT03656237 | Completed

• 1 other identifier: 1000060635
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

This 3-arm cluster randomized trial (C-RCT) 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

Conditions

Perinatal Mortality

Outcome Measures

Primary Outcomes (1)

• Perinatal Mortality

  Deaths occurring within 7 days of birth and fetal deaths (stillbirth) per 1000 CSCOM births

  First 7 days of life

Secondary Outcomes (19)

• Resuscitation-Initiation of breathing

  Immediately at birth

• Early initiation of breastfeeding

  An hour after birth

• Exclusive breastfeeding

  First 7 days of life

• Thermal protection (dried and wrapped)

  Immediately at birth

• Thermal protection (Kangaroo mother care)

  Immediately at birth

Study Arms (3)

Usual training + Audits + LDHF training

EXPERIMENTAL

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; Other: Audits + LDHF Training

Audits + LDHF training

EXPERIMENTAL

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

Usual Training

ACTIVE COMPARATOR

Control Arm exposed to usual training of health workers, in classroom, following standard curriculum

Other: Usual Training

Interventions

Usual Training OTHER

Training in a classroom setting of health care providers

Also known as: Classroom Training

Usual Training; Usual training + Audits + LDHF training

Audits + LDHF Training OTHER

Clinical audits followed by case-based low-dose high-frequency training

Also known as: Mort. Morb. Audit + Low-dose High-freq. training

Audits + LDHF training; Usual training + Audits + LDHF training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Red Cross: collaborator
• Global Affairs Canada: collaborator
• Croix Rouge Malienne: collaborator
• University of the Sciences, Techniques and Technologies of Bamako: collaborator
• Direction Nationale de la Santé Mali: collaborator

Study Sites (1)

iCCM Sites

Koulikoro, Mali

Location

Related Publications (1)

• Zombre D, Kortenaar JL, Zareef F, Doumbia M, Doumbia S, Haidara F, McLaughlin K, Sow S, Bhutta ZA, Bassani DG. Combined Clinical Audits and Low-Dose, High-frequency, In-service Training of Health Care Providers and Community Health Workers to Improve Maternal and Newborn Health in Mali: Protocol for a Pragmatic Cluster Randomized Trial. JMIR Res Protoc. 2021 Dec 10;10(12):e28644. doi: 10.2196/28644.

  PMID: 34889776 DERIVED

MeSH Terms

Conditions

Perinatal Death

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Diego G Bassani, Ph.D.

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, International Program Evaluation Unit (IPE), Center for Global Child Health

Model Details: Cluster Randomized Trial (Clusters are the community health units - CSCOMs)

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: September 4, 2018
• Study Start: July 15, 2019
• Primary Completion: September 30, 2020
• Study Completion: October 30, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-02

Locations

MA (1)