Quality Improvement Project for Maternal Health and Family Planning Services in Kenya (SPARQ_QIK)

December 19, 2019 updated by: University of California, San Francisco

Strengthening People-centered Accessibility, Respect, and Quality for Maternal Health and Family Planning Services in Nairobi, Kenya

Evaluation of a quality improvement (QI) collaborative aimed at improving person-centered care (PCC) for maternal health (MH) and family planning (FP) services

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Evaluation of a quality improvement (QI) collaborative in public facilities in Nairobi and Kiambu Counties in Kenya aimed at improving person-centered care (PCC) for maternal health (MH) and family planning (FP) services.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3354

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Nairobi, Kenya
        • Innovations for Poverty Action

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria for Women:

  • Women aged 15-49 years old
  • Agreed/consented to participate
  • Delivered at the facility within the last 7 days OR adopted a family planning method at their visit on day of survey
  • Has a working mobile phone and specified service provider (airtel/safaricom)

Exclusion Criteria for Women:

  • Not a women aged 15-49 years old
  • Did no agreed/consented to participate
  • Did not deliver at the facility within the last 7 days OR adopted a family planning method at their visit on day of survey
  • Does not have a working mobile phone or specified service provider (airtel/safaricom)

Inclusion Criteria for Providers:

  • Agreed/consented to participate
  • Staff at facility

Exclusion Criteria for Providers

  • Did no agreed/consent to participate
  • Not staff at facility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control - Women
Participants who delivered or received family planning services at a facility that was not implementing a QI project on PCC
Experimental: Intervention - Women
Participants who delivered or received family planning services at a facility that was implementing a QI project on PCC
Behavioral: Quality Improvement Collaborative
Facilities that participated in a QI collaborative to improve PCC for MH and FP services
No Intervention: Control - Provider
Provider working in a facility that is not implementing a QI project on PCC
Experimental: Intervention - Provider
Provider working in a facility that is implementing a QI project on PCC
Behavioral: Quality Improvement Collaborative
Facilities that participated in a QI collaborative to improve PCC for MH and FP services

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Person Centered Maternal Health Scale Score
Time Frame: Baseline
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
Time Frame: 2-weeks post baseline
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 baseline
Person Centered Maternal Health Scale Score
Time Frame: 4-weeks post baseline
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
Time Frame: 6-weeks post baseline
Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care
6-weeks post baseline
Person Centered Maternal Health Scale Score
Time Frame: 10-weeks post baseline
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
Time Frame: About 24 months post baseline
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 post baseline
Person Centered Maternal Health Scale Score
Time Frame: About 26 months post baseline
Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care
About 26 months post baseline
Person Centered Maternal Health Scale Score
Time Frame: About 30 months post baseline
Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care
About 30 months post baseline
Person Centered Maternal Health Scale Score
Time Frame: About 30.5 months post baseline
Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care
About 30.5 months post baseline
Person Centered Maternal Health Scale Score
Time Frame: about 31 months post baseline
Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care
about 31 months post baseline
Person Centered Maternal Health Scale Score
Time Frame: 31.5 months post baseline
Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care
31.5 months post baseline
Person Centered Maternal Health Scale Score
Time Frame: 32 months post baseline
Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care
32 months post baseline
Person Centered Maternal Health Scale Score
Time Frame: 32.5 months post baseline
Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care
32.5 months post baseline
Person Centered Family Planning Scale Score
Time Frame: Baseline
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
Time Frame: 4 weeks post baseline
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
Time Frame: 6 weeks post baseline
Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care
6 weeks post baseline
Person Centered Family Planning Scale Score
Time Frame: 8 weeks post baseline
Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care
8 weeks post baseline
Person Centered Family Planning Scale Score
Time Frame: 10 weeks post baseline
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
Person Centered Family Planning Scale Score
Time Frame: About 24 months post baseline
Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care
About 24 months post baseline
Person Centered Family Planning Scale Score
Time Frame: About 26 months post baseline
Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care
About 26 months post baseline
Person Centered Family Planning Scale Score
Time Frame: About 30 months post baseline
Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care
About 30 months post baseline
Person Centered Family Planning Scale Score
Time Frame: About 31 months post baseline
Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care
About 31 months post baseline
Person Centered Family Planning Scale Score
Time Frame: About 31.5 months post baseline
Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care
About 31.5 months post baseline
Person Centered Family Planning Scale Score
Time Frame: About 32 months post baseline
Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care
About 32 months post baseline
Person Centered Family Planning Scale Score
Time Frame: About 32.5 months post baseline
Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care
About 32.5 months post baseline
Attitudes toward Person-Centered Care
Time Frame: Baseline
Survey and In-depth interviews conducted with providers; perceptions of person-centered care
Baseline
Attitudes toward Person-Centered Care
Time Frame: About 24 months post baseline
Survey conducted with providers; perceptions of person-centered care
About 24 months post baseline
Attitudes toward Person-Centered Care
Time Frame: About 26 months post baseline
Survey conducted with providers; perceptions of person-centered care
About 26 months post baseline
Attitudes toward Person-Centered Care
Time Frame: About 30 months post baseline
Survey and In-depth interviews conducted with providers; perceptions of person-centered care
About 30 months post baseline
The Model for Understanding Success in Quality Survey
Time Frame: About 30 months post baseline
Survey conducted with intervention providers on facility readiness to implement QI; Possible range 0-154; higher the score the more ready facility is to participate in QI activities
About 30 months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Innovations for Poverty Action

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dominic Montagu, DrPH, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 8, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15-18008_KenyaQI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings