NCT02004912

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
295

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

3 years

First QC Date

November 27, 2013

Last Update Submit

November 25, 2016

Conditions

Maternal-child Health Services

Keywords

maternalneonatalchildhealth serviceshealth careKarnatakaIndia

Outcome Measures

Primary Outcomes (1)

  • Changes in provider knowledge and performance from baseline on intrapartum, postpartum and newborn care

    Outcome measures with respect to knowledge of intrapartum care include, among others: % providers who know how to do AMTSL; % providers who know how to use a partograph; % providers who know what are danger signs needing referral; % providers who know to identify and manage PPH; % providers who know to identify and manage obstructed labour; % providers who know to identify and manage fetal distress. There are also several indicators that will be measured with respect to provider performance during labour, such as % labours with fully completed essential general history taking documentation. Outcome measures with respect to knowledge of and performance in postpartum and newborn care include, among others: % providers who know what to monitor in the mother in the immediate PP period; % postpartum women staying in the facility for at least 12 hours and for 2 days or more; % postpartum women properly monitored 2 and 4 hourly; % PHC clients who were given FP counselling.

    12-24 months

Secondary Outcomes (1)

  • Change from baseline in quality of care provided at primary health care centres

    12-24 months

Study Arms (2)

Mentoring intervention

EXPERIMENTAL

The mentoring intervention involves periodic supportive visits and education to health center staff by nurse mentors.

Other: Mentoring intervention

No mentoring intervention

NO INTERVENTION

The no mentoring intervention arm does not have supportive visits and education to health center staff by nurse mentors.

Interventions

Mentoring interventionOTHER

The mentoring intervention involves periodic supportive visits and education to health center staff by nurse mentors.

Mentoring intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All physicians and staff nurses in PHCs in the two districts.

You may not qualify if:

  • Physicians and staff nurses in PHCs who do not consent to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bellary and Gulbarga districts

Bangalore, Karnataka, India

Location

Related Publications (2)

  • Bradley J, Jayanna K, Shaw S, Cunningham T, Fischer E, Mony P, Ramesh BM, Moses S, Avery L, Crockett M, Blanchard JF. Improving the knowledge of labour and delivery nurses in India: a randomized controlled trial of mentoring and case sheets in primary care centres. BMC Health Serv Res. 2017 Jan 7;17(1):14. doi: 10.1186/s12913-016-1933-1.

    PMID: 28061783DERIVED

  • Jayanna K, Bradley J, Mony P, Cunningham T, Washington M, Bhat S, Rao S, Thomas A, S R, Kar A, N S, B M R, H L M, Fischer E, Crockett M, Blanchard J, Moses S, Avery L. Effectiveness of Onsite Nurse Mentoring in Improving Quality of Institutional Births in the Primary Health Centres of High Priority Districts of Karnataka, South India: A Cluster Randomized Trial. PLoS One. 2016 Sep 22;11(9):e0161957. doi: 10.1371/journal.pone.0161957. eCollection 2016.

    PMID: 27658215DERIVED

Related Links

Study Officials

  • Ramesh Banadakoppa, PhD

    Karnataka Health Promotion Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trustee

Study Record Dates

First Submitted

November 27, 2013

First Posted

December 9, 2013

Study Start

September 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 28, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

Peer-reviewed publications and end-of-project workshop held in February 2016

Locations

IN(1)