NCT04208841

Brief Summary

Evaluating the spread of a quality improvement (QI) change package working to improve person-centered care (PCC) for maternal health (MH) services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,971

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

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

May 14, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2019

Completed
6 months 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

1.1 years

First QC Date

December 18, 2019

Last Update Submit

December 19, 2019

Conditions

Keywords

Maternal HealthIndiaPerson-Centered CareQuality Improvement

Outcome Measures

Primary Outcomes (4)

  • 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

    About 12 month post baseline

  • Person-Centered Scale Score

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

    baseline

  • Person-Centered Scale Score

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

    About 12 months post baseline

Study Arms (6)

Control - Patient

NO INTERVENTION

Participants who receive maternal health services at a facility not participating in the Quality Improvement Intervention or implementing the change package

Sustaining - Patients

EXPERIMENTAL

Participants who received maternal health services at a facility where a quality improvement collaborative had been implemented

Behavioral: Person-Centered Care Quality Improvement Collaborative Sustain

Spread - Patients

EXPERIMENTAL

Participants who received maternal health services at a facility that was provided a change package of ideas developed during the quality improvement collaborative (in phase 1) and used to make improvements on person-centered care

Behavioral: Person-Centered Care Quality Improvement Collaborative Spread

Control - Providers

NO INTERVENTION

Providers who work at a facility not participating in the Quality Improvement Intervention or implementing the change package

Sustaining - Providers

EXPERIMENTAL

Providers who work at a facility where a quality improvement collaborative had been implemented

Behavioral: Person-Centered Care Quality Improvement Collaborative Sustain

Spread - Providers

EXPERIMENTAL

Participants who work at a facility that was provided a change package of ideas developed during the quality improvement collaborative (in phase 1) and used to make improvements on person-centered care

Behavioral: Person-Centered Care Quality Improvement Collaborative Spread

Interventions

Sustain improvements during QI collaborative focused on PCC

Sustaining - PatientsSustaining - Providers

Implement change package developed during QI Collaborative

Spread - PatientsSpread - Providers

Eligibility Criteria

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

You may qualify if:

  • Women aged 18-49 years old
  • Who agreed to participate
  • Who delivered a baby at the facility where data collection is taking place within the last 7 days

You may not qualify if:

  • Not a women aged 18-49
  • Did not agree to participate
  • Did not deliver a baby at the facility where data collection is taking place within the last 7 days
  • Agreed to participate
  • Purposive sampling
  • Permanent staff at the facility
  • Did not agree to participate
  • Not permanent staff at the facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Population Services International

Lucknow, Uttar Pradesh, India

Location

Related Publications (2)

  • Sudhinaraset M, Giessler K, Nakphong MK, Roy KP, Sahu AB, Sharma K, Montagu D, Green C. Can changes to improve person-centred maternity care be spread across public health facilities in Uttar Pradesh, India? Sex Reprod Health Matters. 2021 Dec;29(1):1-15. doi: 10.1080/26410397.2021.1892570.

  • 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 Monatgu, 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

May 14, 2018

Primary Completion

June 29, 2019

Study Completion

June 29, 2019

Last Updated

December 23, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations