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| ID | Type | Description | Link |
|---|---|---|---|
| R00HD093798 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Kenya Medical Research Institute | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental |
|
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| Control arm | No Intervention | Will not receive any training during the intervention period |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training | Behavioral | trainings to reduce conscious bias and stress |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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. | 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 | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 months |
| Change in Heart Rate Variability (HRV) Levels From Baseline to 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patience Afulani, PhD, MD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Migori County hospital and sub-county hospitals | Migori | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | WHO, UNICEF, UNFPA, The World Bank, United Nations Population Division. Trends in maternal mortality: 1990 to 2013 [Internet]. WHO. 2014 [cited 2014 Jul 17]. Available from: http://www.who.int/reproductivehealth/publications/monitoring/9789241503631/en/index.html | ||
| 19671156 | Background | Gabrysch S, Campbell OM. Still too far to walk: literature review of the determinants of delivery service use. BMC Pregnancy Childbirth. 2009 Aug 11;9:34. doi: 10.1186/1471-2393-9-34. | |
| 23962135 |
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Health facilities participating in the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm |
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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 28, 2020 |
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| 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 |
|
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 | 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 | 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 |
| Background |
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| 17892760 | Background | Sauve B, Koren G, Walsh G, Tokmakejian S, Van Uum SH. Measurement of cortisol in human hair as a biomarker of systemic exposure. Clin Invest Med. 2007;30(5):E183-91. doi: 10.25011/cim.v30i5.2894. |
| 28938885 | Background | Afulani PA, Diamond-Smith N, Golub G, Sudhinaraset M. Development of a tool to measure person-centered maternity care in developing settings: validation in a rural and urban Kenyan population. Reprod Health. 2017 Sep 22;14(1):118. doi: 10.1186/s12978-017-0381-7. |
| 32493424 | Background | Afulani PA, Buback L, Kelly AM, Kirumbi L, Cohen CR, Lyndon A. Providers' perceptions of communication and women's autonomy during childbirth: a mixed methods study in Kenya. Reprod Health. 2020 Jun 3;17(1):85. doi: 10.1186/s12978-020-0909-0. |
| Background | Lane, K. A., Banaji, M. R., Nosek, B. A. & Greenwald, A. G. Understanding and Using the Implicit Association Test: IV: What We Know (So Far) about the Method. in Implicit measures of attitudes (eds. Wittenbrink, B. & Schwarz, N.) 59-102 (Guilford Press, 2007). |
| Background | About the IAT. Available at: https://implicit.harvard.edu/implicit/iatdetails.html. |
| FG001 | Control Arm | Will not receive any training during the intervention period |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm |
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 |
| BG001 | Control Arm | Will not receive any training during the intervention period |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | health care providers | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months |
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| Primary | 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 | health care providers | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months |
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| Primary | 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. | health care providers | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months |
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| Primary | 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 | health care providers | Posted | Mean | Standard Error | score on a scale | Baseline and 6 months |
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| Secondary | 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. | health care providers | Posted | Mean | Standard Deviation | pg/mg | Baseline and 6 months |
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| Secondary | 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 | health care providers | Posted | Mean | Standard Deviation | ms | Baseline and 6 months |
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| Secondary | 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 | health care providers | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months |
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| Secondary | 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 | Health care providers | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months |
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Arm |
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 | 0 | 40 | 0 | 40 | 0 | 40 |
| EG001 | Control Arm | Will not receive any training during the intervention period | 0 | 43 | 0 | 43 | 0 | 43 |
Not provided
Not provided
Our initial plan was to use 14 and 17 items for assessing stress and bias knowledge and attitudes respectively, but the final analysis used 13 and 15 items- 3 questions did not perform well during pretesting. Change in Hair Cortisol Levels includes for analysis the total number of participants we were able to collect hair samples with- 15 and 7, for intervention and control, respecively. Change in Heart Rate Variability (HRV) Levels were limited to those who consented and provided HRV data.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Patience Afulani | University of California, San Francisco | (415) 476-1000 | Patience.Afulani@ucsf.edu |
| Apr 12, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 24, 2020 | Apr 18, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| D013315 | Stress, Psychological |
| D000077062 | Burnout, Psychological |
| D063508 | Social Discrimination |
| D000087302 | Bias, Implicit |
| D011287 | Prejudice |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
| D012919 | Social Behavior |
Not provided
Not provided
| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Will not receive any training during the intervention period
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| OG001 | Control Arm | Will not receive any training during the intervention period |
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| Control Arm |
Will not receive any training during the intervention period |
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Will not receive any training during the intervention period |
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Will not receive any training during the intervention period
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