Using Community Health Nurses and Workers for Home Visits to Pregnant Women to Improve Maternal and New Born Health in Ghana
Condition: Pregnant Women; Home Visits
Study type: Interventional

Summary: 
      Title: Using Community Health Workers (CHWs) and Nurses (CHNs) to increase Skilled Attendant
      at Birth (SAB) and improve Maternal and Neonatal Health in Rural Ghana

      Background: SAB is a key strategy for improving maternal and new born health since most of
      the complications occurring at childbirth could be better managed when the delivery is
      supervised by a doctor, midwife or nurse. The effect of home visits to pregnant women by a
      CHW/CHN partnership on SAB is yet to be evaluated in a trial in Ghana. This trial will
      determine the effectiveness of a CHW/CHN home visit intervention to pregnant women on
      increasing SAB and improving birth outcomes for mothers and their neonates.

      Methods: Following ethical approval, we will train CHWs and CHNs to provide a package of
      health education and support for delivery during three home visits to each pregnant woman.
      This partnership will be evaluated through a cluster randomized controlled trial in 20
      electoral areas in Ellembelle district of Ghana: 10 will be randomized to receive the CHW/CHN
      partnership intervention and 10 to the control arm (usual care), with a target recruitment of
      46-50 women per cluster. The CHWs and CHNs will receive technical and financial support
      throughout the study.

      Data on SAB, maternal utilization of safe practices during pregnancy, breast feeding
      initiation, exclusive breastfeeding, immunization coverage for mother and new born, maternal
      deaths and neonatal death rates will be collected. The impact of the CHW/CHN intervention on
      these indicators will be reported.

      Keywords: Community Health Nurse, Community Health Worker, Maternal, New born, Supervised
      delivery, Post-natal, Effectiveness
    

Detailed description: 
      Methods: Assignment of interventions (for controlled trials) Implementation of intervention,
      Randomization process Randomization of the 20 electoral areas will be done by a statistician.
      There will be block randomization of clusters depending on the availability of either a
      Community Health Nurse midwife or a staff midwife within the Electoral area. The block
      randomization will ensure adequate distribution of intervention and control arms across all
      the categories of healthcare services available.

      Participants will be assigned to intervention or control once informed consent is given,
      based on their electoral area. All participants in a cluster will be recruited at a health
      facility located within the electoral area. Participants will not know which group they
      belong at the time of consent to reduce selection bias. Following random allocation and
      assignment to either intervention or the control arm, the groups will continue their usual
      antenatal care of at least four ANC visits as part of the components of Focused Antenatal
      Care (FANC) services at facility level. Participants will also have access to all on-going
      health interventions available for all pregnant women. The interventional arm will in
      addition to their usual care, receive up to three home visits by the CHW/CHN where specific
      health information will be provided to the woman.

      The demographics of women in the two arms will be compared to determine if any differential
      take-up resulted in unbalanced groups. There may be other consequences of differential
      take-up that are not evidenced by a comparison of participant demographics; this will be a
      limitation of the research but cannot be further mitigated.

      Sample size In calculating the sample size, the weighted average of the baseline SAB rate of
      37% from 2017 actual data for four health sub-districts and the intra-cluster correlation of
      0.033, reported from three studies by Pagel et al in 2011 were used.

      Hence for each of the two arms, there will be 10 electoral areas (clusters) in which 46-50
      women will be recruited for a total sample size of 456 per arm. The total sample size of 912
      mothers means the trial would have 80% power to detect a relative increase of 35% in the rate
      of SAB with an alpha of 0.05.

      The study aims to recruit 46-50 women per cluster. Should no women drop-out of the study, the
      sample size required to detect the size of effect sought with enough statistical power would
      be 912 (46-50 per cluster).

      Blinding The data collectors will be blinded; they would not know which women were in the
      intervention or control arms. All data on the primary outcome will be verified by the
      researcher, who cannot be blinded. Also, it is impossible to blind the pregnant women and the
      CHW/CHNs.

      Involvement of District staff The CHWs and CHNs will conduct the visits; one visit in the
      second trimester and two in the third trimester- a total of three home visits per pregnant
      woman. The district officers will assist in supervising the CHW and CHN visits. Other staff
      who will be blinded, will be trained to collect outcomes data.

      Methods: Data collection, management, and analysis Data collection methods Initial data on
      participants' background characteristics will be documented at the health facility where
      recruitment occurs. This will be done by the researcher using a pre-tested data collection
      questionnaire (see Appendix 2) and assisted by midwives. Outcome data will be collected from
      the pregnant women at the end of the trial by blinded district officers for reliability and
      validity. This will be done using a questionnaire administered in the woman's home. The
      blinded data collection officers will collect outcomes data only. They will not know which
      group the women belong to but the researcher (who will only collect data to verify the
      primary outcome and visit acceptability) will.

      The data collectors will be trained to respond appropriately in circumstances where mother
      experienced a distressful event during pregnancy and /or delivery (offering empathy and
      adapting the data collection process intended to avoid any further distress) and contact the
      researcher immediately. The researcher will then ensure the social welfare officer is linked
      with the affected woman and her family and the needed support provided.

      Data Quality All deliveries will be verified by the researcher at the facility or place where
      the birth occurred. Also, antenatal visits will be verified from the Maternal health record
      book.

      Data entries, coding, storage Data will be collected on paper by blinded data collection
      officers. The hard copies will be submitted to the researcher at the end of each day's field
      work and stored in locked file cabinets at the research unit of the district health
      directorate. Entries will be made in MS Excel by the researcher. The Excel database (which
      will be anonymous) will be updated to the Warwick email regularly and Supervisors copied. The
      hard copies or anonymous soft copies will be made available to the DMEC for data
      verification. Check codes using Excel formulae will be built into the database to help
      prevent data entry errors and data loss. The entered datasets will be validated by an
      independent statistician.

      Statistical analyses Statistical tables will be generated, and appropriate statistical tests
      used to analyze the variables of interest. Data analyses will be done using STATA version
      14.0. Dr Nicholas Parsons and Dr Peter Kimani have provided professional statistics support
      and, have agreed to provide further support with the Randomization process through the
      school's Statistics Clinic.

      The main measure of association to be determined is the Odds Ratios of SAB (OR) in
      intervention arm compared to control. The estimated effect of the intervention will be
      presented as OR together with its 95% confidence interval. Same will be computed for the
      controls. The ORs will be adjusted for clustering . The analysis for each outcome will be by
      intention-to-treat and will account for clustering by Electoral area.

      Description of subject involved The participants involved are pregnant women. Only women who
      reside in Ellembelle will be enrolled in the study. As such women should have lived
      continuously in the Electoral area for at least 3 months prior to enrolment into this study.
      Enrolment will proceed for eligible participants only after informed consent has been given.

      Trial monitoring The Trial Steering Committee (TSC) The TSC has seven members comprising, the
      investigator, the research supervisors who are experienced researchers at the University of
      Warwick, and four independent policy makers and research experts from the Ghana Health
      Service and Ghana's Ministry of Health. They will provide technical guidance on the conduct
      of the trial and support timely and efficient dissemination of findings.

      The members of the TSC are

        1. Dr Marion Okoh-Owusu (Researcher) Contact details: +233206301994; Email:
           m.okoh-owusu@warwick.ac.uk

        2. Dr Celia Brown (Research Supervisor- Warwick) Contact: celiataylor@warwick.ac.uk

        3. Prof Paramjit Gill (Research Supervisor- Warwick)

        4. Dr Abraham Hogson M.D, PHD (Research Division- Ghana)

        5. Dr Alberta Biritwum-Nyarko MD, MPH, MGCP (Ghana Health Service)

        6. Dr Emmanuel Odame MD, MPH, MGCP, (Ministry of Health, Ghana)

        7. The Senior Biostatistician, Ghana Health Service

      Data Monitoring and Ethics Committee (DMEC) The trial data will be monitored by the DMEC,
      which comprises three independent members from Ghana and supported by project supervisors.

      DMEC members are:

        1. Mr Isaac Korankye- Snr. Biostatistician (Ghana Health Service)

        2. Mr Francis Nuoh- Snr. Biostatistician, Ghana Health Service

        3. Mr Prince Oppong-Darko - (Health Information Officer)

        4. Dr Celia Brown (Research Supervisor- Warwick)

        5. Prof Paramjit Gill (Research Supervisor- Warwick)

      The DMEC will receive confidential data on the trial, monitor progress and give the relevant
      advice where needed. The CHW/CHN trial is a health education intervention delivered in the
      pregnant woman's home at the community level, and its evaluation depend on skilled births
      occurring within a year, hence the DMEC will not conduct any interim analyses.
    

Intervention name(s): Home visits
Intervention type(s): Other
Intervention description(s): An experimental design, a cluster randomized controlled trial (RCT) will be used. A total of 20 clusters will be randomized with block randomization of electoral areas with a) resident staff midwives and b) resident Community Health Nurse midwifes. All women residing in an electoral area will receive the same intervention for practicality and to prevent contamination.
Other intervention name(s): Follow up home visits
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One arm will receive the usual care and in addition, three home visits as the intervention compared to a control group, another arm, receiving only usual care
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Home visits; Community Health Nurse; Community Health Workers; Pregnant women; Effectiveness