Caring for Providers to Improve Patient Experience Study Phase 2 in Migori County (CPIPE2)

May 5, 2025 updated by: University of California, San Francisco

Addressing Provider Stress and Unconscious Bias to Improve Quality of Maternal Health Care

The activities described in this proposal are aimed at addressing health care provider stress and unconscious bias to improve quality of maternal health care, particularly related to the person-centered dimensions of care-i.e. care that is respectful and responsive to women's needs, preferences, and values. The investigators focus on health provider stress and unconscious bias because they are key drivers of poor-quality care that are often not addressed in interventions designed to improve quality of maternal health care. The investigators plan to (1) design an intervention that enables providers to identify and manage their stress and unconscious bias; (2) pilot the intervention to assess its feasibility and acceptability; and (3) assess preliminary effect of the intervention on: (a) provider knowledge, attitudes, and behaviors related to stress and unconscious bias; and (b) provider stress levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Poor person-centered maternal health care (PCMHC) contributes to high maternal and neonatal mortality in sub-Saharan Africa (SSA), and disparities in PCMHC are driving disparities in use of maternal health services., However, little research exists on how to improve PCMHC and reduce disparities. The investigators seek to fill this gap with this project. They propose targeting health provider stress and unconscious bias as fundamental factors driving both poor PCMHC and disparities in PCMHC. Health care provider stress and unconscious bias are important to consider because: (1) providers in low-resource settings often work under very stressful conditions; (2) unconscious bias is prevalent in every society including SSA; and (3) these factors are mutually reinforcing drivers of poor quality care and disparities in person-centered care. In the first phase of the project (CPIPE1), they conducted research to examine (1) the factors associated with PCMHC and identified provider stress and unconscious bias as key contributing factors. They also examined the levels of provider stress and unconscious bias and the types of stressors and biases in Migori County, Kenya. The results of that research will be used to inform this phase (CPIPE2), the aims of which are to: (1) design a multicomponent theory and evidence-based intervention that enables providers to identify and manage their stress and unconscious bias; (2) pilot the intervention to assess its feasibility and acceptability; and (3) assess preliminary effect of the intervention on: (a) provider knowledge, attitudes, and behaviors related to stress and unconscious bias; and (b) provider stress levels using a pretest-posttest control group design. They will use the results of the pilot to refine the intervention and develop an R01 proposal for a multi-site evaluation with a larger sample and longer follow up to assess impact on PCMHC. This study will yield valuable information to inform quality improvement efforts for PCMHC.

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • 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
      • Migori, Kenya
        • Migori County hospital and sub-county hospitals

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Providers working in maternity units of the intervention facilities are all eligible.

Exclusion Criteria:

  • Inability to attend scheduled training.

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: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
  1. Training: The investigators will develop a training for providers that addresses the following topics: Stress & positive coping mechanisms; Unconscious bias awareness and mitigation; Person-centered maternity care; Dealing with difficult situations; and Teamwork and communication;
  2. Peer support and mentorship: The investigators will identify what works best for these groups in terms of group composition, size, and how the groups want to interact.
  3. Leadership engagement: To ensure leadership buy in, support and sustainability of the intervention, the investigators will engage leadership of the County.
  4. Embedded champions: To facilitate ongoing engagement, the investigators will identify local leaders, and invite them to training where they will be taught how to facilitate peer support groups and serve as champions.
Behavioral: Training
trainings to reduce conscious bias and stress
Behavioral: Peer support and mentorship
facilitated peer and mentorship opportunities
Behavioral: Leadership engagement
Engaged leadership at the county and facility levels
Behavioral: Embedded champions
Facilitate local champions to promote intervention
No Intervention: Control arm
Will not receive any training during the intervention period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Perceived Stress Scale (PSS) Score From Baseline to 6 Months
Time Frame: Baseline and 6 months
The Perceived Stress Scale (PSS) score ranges from 0 to 40 with higher scores indicating higher perceived stress.
Baseline and 6 months
Change in Shirom-Melamed Burnout Measure (SMBM) Score From Baseline to 6 Months
Time Frame: Baseline and 6 months
The Shirom-Melamed Burnout Measure range from 1 to 7 with higher scores indicating higher burnout
Baseline and 6 months
Change in Stress Knowledge and Attitudes Score From Baseline to 6 Months
Time Frame: Baseline and 6 months
The stress knowledge and attitudes score is measured by 14 survey questions with scores ranging from 0 to 14. Higher scores indicate higher knowledge and positive attitudes regarding stress and stress management. We used 13 of the items from the 14-item survey scale. The score range used is 0 to 13- as noted in the limitations section.
Baseline and 6 months
Change in Unconscious Bias Knowledge and Attitudes Score From Baseline to 6 Months
Time Frame: Baseline and 6 months
The unconscious bias knowledge and attitudes score is measured by 17 survey questions with scores ranging from 0 to 17. Higher scores indicate higher knowledge and positive attitudes regarding unconscious bias and unconscious bias mitigation
Baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hair Cortisol Levels From Baseline to 6 Months
Time Frame: Baseline and 6 months
There are no specified cut-offs for cortisol levels, but, on average, higher cortisol levels indicate higher stress.
Baseline and 6 months
Change in Heart Rate Variability (HRV) Levels From Baseline to 6 Months
Time Frame: Baseline and 6 months
There are no specified cut-offs for HRV but, on average, lower HRV scores indicate higher stress
Baseline and 6 months
Change in Socioeconomic Status-person Centered Maternity Care Implicit Association Test (IAT) Score
Time Frame: Baseline and 6 months
IAT scores vary between -2 and +2. For this study, higher positive scores indicates a stronger implicit association between high status with good patient and low status with difficult patient
Baseline and 6 months
Change in Explicit Bias Scores From Baseline to 6 Months
Time Frame: Baseline and 6 months
The explicit bias scores are from responses to a vignette and range from 4 to 28. Higher scores indicate more explicit bias
Baseline and 6 months

Collaborators and Investigators

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

Sponsor

University of California, San Francisco

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Kenya Medical Research Institute

Investigators

  • Principal Investigator: Patience Afulani, PhD, MD, MPH, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 16, 2021

Primary Completion (Actual)

June 24, 2022

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

August 18, 2021

First Submitted That Met QC Criteria

August 18, 2021

First Posted (Actual)

August 24, 2021

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A135552
  • R00HD093798 (U.S. NIH Grant/Contract)

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

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.

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