NCT04208867

Brief Summary

Evaluation of a quality improvement (QI) collaborative aimed at improving person-centered care (PCC) for reproductive health (RH) services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,989

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

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 16, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
Last Updated

December 23, 2019

Status Verified

December 1, 2019

Enrollment Period

2.2 years

First QC Date

December 18, 2019

Last Update Submit

December 19, 2019

Conditions

Keywords

Maternal HealthDeliveryPerson-centered CareIndiaFamily Planning

Outcome Measures

Primary Outcomes (15)

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    Baseline

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    2-weeks post basline

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    4 weeks post baseline

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    10 weeks post baseline

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    About 12 months post baseline

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    About 14 months post baseline

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    about 24 months after baseline

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    About 24.5 months post baseline

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    25 months post baseline

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    26.5 months past baseline

  • Person Centered Family Planning Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care

    Baseline

  • Person Centered Family Planning Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care

    4 weeks post baseline

  • Person Centered Family Planning Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care

    10 weeks post baseline

  • Attitude toward Person-Centered Care

    Survey and in-depth interviews conducted with providers; perceptions of person-centered care

    About 12 months post baseline

  • Attitude toward Person-Centered Care

    Survey and in-depth interviews conducted with providers; perceptions of person-centered care

    About 24 months post baseline

Study Arms (4)

Intervention - Women

EXPERIMENTAL

Women who receive MH services from a facility participating in the QI collaborative to improve PCC

Behavioral: QI Collaborative

Control - Women

NO INTERVENTION

Women who receive MH services from a facility not participating in the QI collaborative to improve PCC

Intervention - Provider

EXPERIMENTAL

Provider working at a facility participating in the QI collaborative to improve PCC

Behavioral: QI Collaborative

Control - Provider

NO INTERVENTION

Provider working at a facility not participating in the QI collaborative to improve PCC

Interventions

Facilities that participated in a QI collaborative to improve PCC for MH services

Intervention - ProviderIntervention - Women

Eligibility Criteria

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

You may qualify if:

  • Women aged 18-49
  • Agree/consent to participate
  • Delivered a baby at the facility within 7 days (or adopted a family planning method at time of visit (baseline only, not part of intervention))

You may not qualify if:

  • Not a women aged 18-49
  • Did not agree/consent to participate
  • Did not deliver a baby at the facility within 7 days (or adopted a family planning method at time of visit (baseline only, not part of intervention))
  • Agreed/consented to participate
  • Staff at facility
  • Did not agree/consent to participate
  • Not Staff at facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Population Services International

Lucknow, Uttar Pradesh, India

Location

Related Publications (1)

  • Montagu D, Giessler K, Nakphong MK, Green C, Roy KP, Sahu AB, Sharma K, Sudhinarset M. A comparison of intensive vs. light-touch quality improvement interventions for maternal health in Uttar Pradesh, India. BMC Health Serv Res. 2020 Dec 4;20(1):1121. doi: 10.1186/s12913-020-05960-6.

Study Officials

  • Dominic Montagu, DrPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2019

First Posted

December 23, 2019

Study Start

September 16, 2016

Primary Completion

December 6, 2018

Study Completion

December 6, 2018

Last Updated

December 23, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations