Maternal-child Health Services Clinical Trial
Official title:
Monitoring and Evaluation of an MNCH Mentoring Intervention in Two Districts of Karnataka
Our hypothesis is that an on-site mentoring program for staff at primary health care centers in northern Karnataka, will improve the quality of maternal, neonatal and child health care, and improve clinical outcomes.
By providing on-site mentoring for improved clinical care and service delivery, we
hypothesize that the quality of services and care will improve and patients will have better
clinical outcomes. Specifically we believe that routine on-site clinical and service
delivery mentoring will strengthen clinical knowledge, skills and practices among staff
nurses and ANMs (in year 2), will strengthen appropriate referrals and follow up care, will
improve other aspects of service quality, and provider and client satisfaction. The
evaluation will assess change during the first year of the intervention that focuses on
clinical mentoring of staff nurses and on quality improvement in the PHCs as a whole. The
evaluation will focus on success indicators as shown in Appendix 1. Due to the short time
frame for evaluation, success indicators will be principally at the levels of inputs,
outputs, and outcomes focusing on adherence to the Sukshema Critical Care package, although
we also hope to assess some key health outcomes, in terms of reduction of "near-miss" cases.
A. Pre and post MM intervention evaluation strategy The "pre-intervention" evaluation will
have two phases. The first phase will take place in all 122 sites before any intervention
activities begin (Figure 1). This evaluation will focus on site readiness to provide quality
services, provider knowledge, attitudes and reported or observed (or simulated) practices,
supervision and mentoring, record keeping, and provider and client satisfaction. The NRHM
SBA guidelines, PHC 24/7 guidelines, MHFW NSSK guidelines, and the Sukshema critical care
package will all be used to determine expectations of clinical quality of care at this
level.
The focus of the first year of the MM intervention is enhanced clinical skills in the
intra-partum and postpartum periods and thus assessments of actual clinical practices are
important. However, data on actual practices in the intrapartum and postpartum periods will
be difficult to collect by observation during this baseline (especially those with
complications). Most of the PHCs conduct only a few deliveries each week, and it will be
therefore almost impossible to obtain a representative sample of observations. Therefore we
will assess intrapartum and postpartum clinical practices largely though the audit of case
sheets and registers. However, these case sheets are currently either not available or not
used. Thus our strategy necessitates delay of this part of the second phase of the baseline
until after the update training where all staff will be given and instructed in the use of
new and improved case sheets. All sites will be given the opportunity to practice using
these patient case sheets for one month before they are collected by project staff and used
as a basis for assessing both compliance with the new case sheets, adequacy of reporting,
and actual case management. Actual case observations will be done during routine MM visits
where possible. The post intervention phase of the assessment will take place in all sites
once year after the first (planned 6) MM visits and will repeat the baseline survey.
Pre and post MM intervention evaluation survey tools
The survey will use four types of survey tools pre and post MM intervention and one
additional tool after one year in the intervention sites only:
A1. Questionnaires for all staff nurses on duty (including night duty) at the PHCs during
the evaluation that will assess knowledge of intrapartum, postpartum, newborn care and
infection prevention, and solicit provider perspectives on mentoring and supervision. In
some cases, the questions will be in the form of case studies or asking for simulated
demonstrations of practices.
A2. Facility audits and observations in all PHCs to assess site readiness to provide quality
services and provide checks of drugs used: equipment and drugs, staffing and training
levels, availability and correct use of case sheets, registers and referral slips. This tool
will also have a section for observing practices in the postnatal ward.
A3. Postpartum client questionnaires with all women who have delivered up to one month
before the survey traced to their homes that will assess client recall of information and
services given and client satisfaction. Delivery registers will be checked and all women who
delivered in the PHC n the previous month will be traced to their homes for interview.
A4. Case sheet and register audits for all cases for the one month before survey dates to
assess completeness of reporting and appropriate client management A5. Focus Group
Discussions with SNs in a sample of intervention PHCs: During the post MM intervention
survey we will conduct focus group discussions (FGDs) with staff at a selection of
intervention sites to understand their experiences with the MM intervention and to gather
their suggestions for improvement.
Data collection: The field staff will consist of three supervisors per district, plus 13
teams of 2 interviewers, one of whom will manage the facility audits and staff surveys, and
one the postpartum client questionnaires for each of the 122 PHCs. It will be necessary for
each team to spend 2 days in each PHC, thus each team will be able to complete the survey
work in 3-4 weeks. Simultaneous data collection will be carried out in both districts.
A week's training will be provided to the field teams that will include lectures on
technical topics, demonstration interviews, mock interviews and field practice. The training
will be provided to about 10% more persons than actually required for the survey, and the
required number will be selected based on their performance during the training. KHPT and
SJMC staff will conduct the training and will monitor the field work activities and quality
of data.
Data processing: Double data entry will be done at KHPT, who will prepare a report of the
pre-intervention survey and end-line survey comparison.
B. Routine continuous monitoring: First, project staff will routinely document staffing,
training, financial and other project inputs, data that will be crucial for assessing the
feasibility of scale up to other districts. During bi-monthly MM visits, staff will have a
proscribed list of data to collect. As well as keeping details of staff at the sites their
training background and any clinical mentoring given, the mentors will have a proscribed
list of clinical skills to observe; wherever possible during their 3 day visits, they will
observe women in labour, after delivery and in the postpartum ward, and where this is not
possible, they will use models and case studies to assess staff skills. There will be
continuous monitoring of the MM interventions through reports of MM visits that will
include: documentation of visits through trip reports that detail facility meetings, talks
given, happenings in the PHC or area and notes on any morbidity and mortality discussions;
completed clinical competency checklists for mentored individuals. They will also photocopy
the case sheets, which will have been used as a basis for discussion during the visit and
facility action plans, for review by KHPT clinical staff. The case sheets will also be
collected quarterly from the control sites by the KHPT district staff. These staff will
encourage use of the case sheets at each of their quarterly visits without any additional
training or mentoring.
Informed consent Verbal, witnessed informed consent will be sought from the head of the PHC
who will be asked to give permission to survey the PHC; from staff nurses who will be
interviewed in the PHCs and from postnatal women traced to the community.
Districts and sites Using a matched (for client volume) case control strategy, the MM
intervention will be piloted and evaluated in PHCs in two districts, Gulbarga and Bellary
that have a total of 122 24x7 PHCs (Gulbarga 70; Bellary 52). Sixty one PHCs (Gulbarga 35;
Bellary 26) will be randomly assigned to an MM intervention or experimental group
(stratified by taluka and 6-monthly patient delivery load), while the rest will serve as
control sites.
SBA + training The first part of the intervention involves all the 122 PHC 24/7 facilities
in the two districts for two reasons: first we feel that this training is generally needed
and will help to put the intervention and control site staff on the same level playing field
in terms of basic MNCH knowledge; second, we know from the Sukshema baseline survey
conducted in 2011 that few staff use adequate reporting mechanisms such as case sheets. As
these are needed both programmatically as job aids, and for programme evaluative purposes,
we will use this training as an opportunity to introduce new case sheets. After the first
phase of baseline survey (described below) and before the mentoring programme begins in the
intervention sites, Sukshema project staff will conduct a 3 day training update (called
SBA+) for all staff nurses and a one day SBA+ for all M.O.'s from all 122 PHCs in the two
districts, irrespective of whether they have previously attended the NRHM Skilled Birth
Attendant (SBA) training. The 3 day training will focus on the essential components on
intra-partum and postpartum (mother and baby) care identified in the Sukshema critical care
package that evidence shows can significantly reduce maternal and newborn morbidity and
mortality. The one day training for doctors will focus on identification of danger signs,
pre-referral management of complications, quality of care, case audits and improvement of
management and documentation. At these trainings, staff will be given, and instructed in the
use of enhanced case sheets for women and babies from labour through to discharge, including
use of the partograph. After this training, there will be no further interventions in the
control sites, except that Sukshema staff will visit every 3 months to collect copies of the
case sheets.
Sampling strategy The PHC intervention and control sites will be selected systematically in
each taluka, after stratification and matching by client volume per month.
MNCH mentoring In each district MNCH mentors (MMs), a new staff cadre, will be recruited and
trained (Gulbarga 5; Bellary 4), each responsible for the intervention in 6-7
experimental/intervention PHCs. We will also train 3 additional MMs to act as a back-up (2
in Gulbarga and one in Bellary), total 12 mentors. The MMs will attend some of the PHC staff
training but will also be trained for 4 weeks by project staff at St John's Medical College
in essential clinical competencies and in how to mentor staff in clinical skills, team
building and problem solving, service delivery improvement, as well as in how to be
effective mentors. The MNCH mentors will be senior nurses, selected based on specific
criteria such as clinical experience, training and mentoring abilities, and
experience/familiarity with government health systems. They will be guided by a Mentoring
Coordinator in each district who will support the mentors' activities and liaise between
them, the PHCs, district government staff and KHPT district staff. During the first year,
the mentors will be trained by the Project to (a) provide clinical mentoring in safe
delivery to staff nurses by hands-on coaching; (b) provide mentoring in how to improve the
quality of services by building teamwork and introducing problem solving initiatives to
address other aspects of service delivery (including especially referral processes); and in
year 2 to mentor ANMs who will come to the PHC during the MNCH mentor visits, in providing
antenatal, postpartum and newborn care, and referrals and follow up.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04100577 -
Today Not Tomorrow Pregnancy and Infant Support Program (TNT- PISP)
|
N/A | |
| Completed |
NCT02786225 -
Collaboration for Antepartum Risk Evaluation
|
N/A | |
| Recruiting |
NCT03773913 -
Integrated Community Based Health Systems Strengthening Preliminary Study in Kozah Togo
|