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

Stress Clinical Trial

— CPIPE2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05019131
• Other study ID #: A135552
• Secondary ID: R00HD093798
• Status: Completed
• Phase: N/A
• Start date: August 16, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: November 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: August 31, 2023
• Est. primary completion date: June 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Inability to attend scheduled training.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Kenya	Migori County hospital and sub-county hospitals	Migori

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kenya Medical Research Institute

Country where clinical trial is conducted

Kenya, 

References & Publications (84)

About the IAT. Available at: https://implicit.harvard.edu/implicit/iatdetails.html.

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* Note: There are 84 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and 6 months
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	Baseline and 6 months
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	Baseline and 6 months
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	Baseline and 6 months
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	Baseline and 6 months
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	Baseline and 6 months
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	Baseline and 6 months
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	Baseline and 6 months