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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05019131

Acronym

CPIPE2

Enrollment

Registered

2021-08-24

Start date

2021-08-16

Completion date

2023-08-31

Last updated

2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Outcomes, Burnout, Discrimination, Social, Healthcare Provider, Maternal Health, Mental Health, Quality of Care, Stress, Stress, Emotional, Stress, Psychological

Keywords

providers, mental health, unconscious bias, prejudice, Kenya, stress, burnout, person-centered care, quality of care, discrimination

Brief summary

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.

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.

Interventions

BEHAVIORALPeer support and mentorship

facilitated peer and mentorship opportunities

BEHAVIORALLeadership engagement

Engaged leadership at the county and facility levels

BEHAVIORALEmbedded champions

Facilitate local champions to promote intervention

BEHAVIORALTraining

trainings to reduce conscious bias and stress

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Inability to attend scheduled training.

Design outcomes

Primary

Measure	Time frame	Description
Change in Unconscious Bias Knowledge and Attitudes Score From Baseline to 6 Months	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
Change in Perceived Stress Scale (PSS) Score From Baseline to 6 Months	Baseline and 6 months	The Perceived Stress Scale (PSS) score ranges from 0 to 40 with higher scores indicating higher perceived stress.
Change in Shirom-Melamed Burnout Measure (SMBM) Score From Baseline to 6 Months	Baseline and 6 months	The Shirom-Melamed Burnout Measure range from 1 to 7 with higher scores indicating higher burnout
Change in Stress Knowledge and Attitudes Score From Baseline to 6 Months	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.

Secondary

Measure	Time frame	Description
Change in Hair Cortisol Levels From Baseline to 6 Months	Baseline and 6 months	There are no specified cut-offs for cortisol levels, but, on average, higher cortisol levels indicate higher stress.
Change in Heart Rate Variability (HRV) Levels From Baseline to 6 Months	Baseline and 6 months	There are no specified cut-offs for HRV but, on average, lower HRV scores indicate higher stress
Change in Socioeconomic Status-person Centered Maternity Care Implicit Association Test (IAT) Score	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
Change in Explicit Bias Scores From Baseline to 6 Months	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

Countries

Kenya

Participant flow

Recruitment details

Health facilities participating in the study

Participants by arm

Arm	Count
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. Training: trainings to reduce conscious bias and stress Peer support and mentorship: facilitated peer and mentorship opportunities Leadership engagement: Engaged leadership at the county and facility levels Embedded champions: Facilitate local champions to promote intervention	40
Control Arm Will not receive any training during the intervention period	43
Total	83

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	0	3

Baseline characteristics

Characteristic	Intervention Arm	Control Arm	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	40 Participants	43 Participants	83 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	40 Participants	43 Participants	83 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants
Region of Enrollment Kenya	40 Participants	43 Participants	83 Participants
Sex: Female, Male Female	32 Participants	29 Participants	61 Participants
Sex: Female, Male Male	8 Participants	14 Participants	22 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 40	0 / 43
other Total, other adverse events	0 / 40	0 / 43
serious Total, serious adverse events	0 / 40	0 / 43

Outcome results

Primary

Change in Perceived Stress Scale (PSS) Score From Baseline to 6 Months

The Perceived Stress Scale (PSS) score ranges from 0 to 40 with higher scores indicating higher perceived stress.