The effect of giving feedback on maternal and newborn health services to community leaders and health providers in Uttar Pradesh, India

• Register: ISRCTN
• Last refreshed on: 26 August 2019
• Main ID: ISRCTN11070792
• Date of registration: 24/09/2015
• Prospective Registration: Yes
• Primary sponsor: London School of Hygiene and Tropical Medicine (UK)
• Public title: The effect of giving feedback on maternal and newborn health services to community leaders and health providers in Uttar Pradesh, India
• Scientific title: Information, accountability, and the effect of feedback on the coverage of maternal and newborn health services: a cluster randomised controlled trial in Uttar Pradesh, India
• Date of first enrolment: 30/09/2015
• Target sample size: 1434
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN11070792
• Study type: Interventional
• Study design: Single-centre cluster randomised controlled trial (Other)
• Phase: Not Applicable

Countries of recruitment

India

Contacts

• Name: Timothy Powell-Jackson

Key inclusion & exclusion criteria

Inclusion criteria:
Participants for the intervention will differ depending on whether they are allocated to the public or private reporting variant of the intervention.

Participants in study arms receiving private performance feedback will be providers of maternal, newborn and child health services operating within the cluster. Potential participants will be identified from a health provider census. Informed written consent will be obtained from providers, and project staff will schedule a meeting time for individual feedback at a time convenient for the provider.

Participants in the clusters receiving public feedback will be community members from the cluster. There will be up to two feedback sessions per cluster. Participants will be community leaders and persons with influence in the area of maternal and newborn health. Targeted participants include: PRI (rural) and ward members (urban), teachers, ASHA, AWW, health providers and religious leaders. Written consent will be obtained from the Pradhan of the Gram Panchayat or, if unavailable, an alternative community representative. We intend to leverage the cluster’s Gram Panchayat members to help identify relevant community stakeholders, including women.

Exclusion criteria:
In the clusters with private feedback:
1. Health providers that do not currently provide maternal or newborn health services
2. Private rural health providers beyond the target of three per cluster

In the clusters with public feedback:
1. People who do not have influence in the cluster over the uptake or provision of maternal and newborn health services


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Maternal and newborn health services
Pregnancy and Childbirth

Intervention(s)

There are 178 study clusters that will be allocated evenly across the four study arms, subject to integer constraints. Each cluster includes on average 30 women who have given birth in the previous two years. There is no specific target number of participants. In the clusters involving private feedback, all of the following providers will be targeted: ASHAs, public providers, social franchise private providers, private AYUSH, and private MBBS. In addition, a maximum of three private rural health providers that provided antenatal care in the past three months in the cluster will also be eligible. A list of potential eligible providers in each cluster will be created from a provider mapping survey conducted for another study. This will be used by fieldworkers as the starting point to identify providers. Fieldworkers will check with key informants in the cluster to confirm whether the list is complete. For private rural health providers, providers will be screened in order of proximity to the community. The first three rural health providers that are eligible and give consent will participate. In the clusters involving public feedback, each cluster feedback session will involve 10-15 participants. At a minimum, at least two of PRI, Teacher, AWW or ASHA should be present for the feedback presentation to go ahead.

This study is a single-centre cluster randomised controlled trial. It has a two by two factorial design. Randomization will be stratified by receipt of a related social franchising intervention and baseline coverage of antenatal care. It is not possible to mask participants to allocation, but fieldworkers collecting outcome data will be masked to allocation. Allocation will also be masked for data analysis. Clusters will be randomly assigned to form four arms:
1. Private feedback to health providers
2. Public feedback to the community
3. Private and public feedback

Primary Outcome(s)

The proportion of women that received at least four antenatal care visits. The feedback intervention will take place October 2015 and September 2016. Outcomes will be measured at baseline (February 2015), then May 2016 (month 15), and then June 2017 (month 28). We will pool data from the second and third round of data collection when we analyse the impact of the intervention.

Secondary Outcome(s)

1. Proportion of women that gave birth at a health facility
2. Proportion of women that received counselling on all three danger signs (vaginal bleeding, convulsions, prolonged labour)
3. Proportion of newborns that were immediately breastfed within one hour of birth
4. Proportion of newborns that received clear cord care (clean instrument to cut, clean instrument to tie cord, nothing put on cord)
5. Proportion of women who received visit from ASHA during pregnancy
6. Proportion of women fully immunised with tetanus toxoid
7. Proportion of babies registered and received certificate

The feedback intervention will take place October 2015 and September 2016. Outcomes will be measured at baseline (February 2015), then May 2016 (month 15), and then June 2017 (month 28). We will pool data from the second and third round of data collection when we analyse the impact of the intervention.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Merck Sharp & Dohme Corp (USA) through MSD for Mothers

Ethics review

Status:
Approval date:
Contact:

1. The Intervention Research Ethics Committee of the London School of Hygiene and Tropical Medicine, 03/07/2015, ref: 10006 2. The institutional review board of the Public Health Care Society in New Delhi, 18/04/2014

Results

• Results available: Yes
• Date Completed: 30/06/2017