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Completed

NCT Number: NCT05019131

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

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.

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Key information

Conditions

Maternal Health Adverse Outcomes Behavior Behavioral Symptoms Bias, Implicit Burnout Burnout, Psychological Discrimination, Social Healthcare Provider Mental Health Personal Satisfaction Prejudice Psychological Well-Being Quality Of Care Social Behavior Social Discrimination Stress Stress, Emotional Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Migori County hospital and sub-county hospitals

Migori, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Inability to attend scheduled training.

Treatment and study plan

Training

Behavioral

trainings to reduce conscious bias and stress

Peer support and mentorship

Behavioral

facilitated peer and mentorship opportunities

Leadership engagement

Behavioral

Engaged leadership at the county and facility levels

Embedded champions

Behavioral

Facilitate local champions to promote intervention

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

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

Registry information

Official study title

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

Acronym: CPIPE2

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 24, 2021
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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