An interventional study of Training and Peer support and mentorship in Maternal Health, Mental Health and Healthcare Provider, sponsored by University of California, San Francisco. Completed at 1 site in Kenya. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Health services research
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.
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.
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Exclusion Criteria:
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 · Behavioral: Peer support and mentorship · Behavioral: Leadership engagement · Behavioral: Embedded champions
Will not receive any training during the intervention period
trainings to reduce conscious bias and stress
facilitated peer and mentorship opportunities
Engaged leadership at the county and facility levels
Facilitate local champions to promote intervention
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.
Time frame: Baseline and 6 months
Change in Shirom-Melamed Burnout Measure (SMBM) Score From Baseline to 6 Months
The Shirom-Melamed Burnout Measure range from 1 to 7 with higher scores indicating higher burnout
Time frame: Baseline and 6 months
Change in Stress Knowledge and Attitudes Score From Baseline to 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.
Time frame: Baseline and 6 months
Change in Unconscious Bias Knowledge and Attitudes Score From Baseline to 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
Time frame: Baseline and 6 months
Change in Hair Cortisol Levels From Baseline to 6 Months
There are no specified cut-offs for cortisol levels, but, on average, higher cortisol levels indicate higher stress.
Time frame: Baseline and 6 months
Change in Heart Rate Variability (HRV) Levels From Baseline to 6 Months
There are no specified cut-offs for HRV but, on average, lower HRV scores indicate higher stress
Time frame: Baseline and 6 months
Change in Socioeconomic Status-person Centered Maternity Care Implicit Association Test (IAT) Score
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
Time frame: Baseline and 6 months
Change in Explicit Bias Scores From Baseline to 6 Months
The explicit bias scores are from responses to a vignette and range from 4 to 28. Higher scores indicate more explicit bias
Time frame: Baseline and 6 months
Health facilities participating in the study
| Milestone | Intervention Arm | Control Arm |
|---|---|---|
| Started | 40 | 43 |
| Completed | 40 | 40 |
| Not completed | 0 | 3 |
| Withdrew: Lost to follow-up | 0 | 3 |
The Perceived Stress Scale (PSS) score ranges from 0 to 40 with higher scores indicating higher perceived stress.
| score on a scale | Intervention Arm | Control Arm |
|---|---|---|
| Baseline | 20.89 ± 3.86 | 20.58 ± 4.51 |
| End line | 18.63 ± 5.34 | 20.05 ± 5.57 |
The Shirom-Melamed Burnout Measure range from 1 to 7 with higher scores indicating higher burnout
| score on a scale | Intervention Arm | Control Arm |
|---|---|---|
| Baseline | 3.64 ± 1.05 | 3.70 ± 1.10 |
| End line | 2.95 ± 0.97 | 3.42 ± 1.08 |
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.
| score on a scale | Intervention Arm | Control Arm |
|---|---|---|
| Baseline | 7.78 ± 2.41 | 7.95 ± 2.77 |
| End line | 9.50 ± 1.80 | 8.53 ± 2.01 |
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
| score on a scale | Intervention Arm | Control Arm |
|---|---|---|
| Baseline | 8.93 ± 1.94 | 9.13 ± 2.14 |
| End line | 10.70 ± 1.73 | 9.45 ± 2.16 |
There are no specified cut-offs for cortisol levels, but, on average, higher cortisol levels indicate higher stress.
| pg/mg | Intervention Arm | Control Arm |
|---|---|---|
| Baseline | 74.13 ± 147.38 | 8.43 ± 3.03 |
| End line | 41.50 ± 72.19 | 36.05 ± 58.29 |
There are no specified cut-offs for HRV but, on average, lower HRV scores indicate higher stress
| ms | Intervention Arm | Control Arm |
|---|---|---|
| Baseline | 3.70 ± 0.59 | 3.71 ± 0.61 |
| End line | 3.71 ± 0.43 | 3.84 ± 0.63 |
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
| score on a scale | Intervention Arm | Control Arm |
|---|---|---|
| Baseline | 0.75 ± 0.37 | 0.67 ± 0.46 |
| End line | 0.62 ± 0.52 | 0.43 ± 0.55 |
The explicit bias scores are from responses to a vignette and range from 4 to 28. Higher scores indicate more explicit bias
| score on a scale | Intervention Arm | Control Arm |
|---|---|---|
| Baseline | 17.38 ± 3.06 | 16.30 ± 3.27 |
| End line | 15.65 ± 3.76 | 14.91 ± 3.12 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Arm | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Control Arm | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Age, Categorical(Participants) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 40 | 43 | 83 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Female | 32 | 29 | 61 |
| Male | 8 | 14 | 22 |
| Race (NIH/OMB)(Participants) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 40 | 43 | 83 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Kenya | 40 | 43 | 83 |
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