CPIPE2: Caring for Providers to Improve Patient Experience Study Phase 2 in Migori County

Sponsor

University of California, San Francisco (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05019131

Collaborator

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

Enrollment

Location

Arms

24.5

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Maternal Health Mental Health Healthcare Provider Adverse Outcomes Stress Stress, Psychological Stress, Emotional Quality of Care Burnout Discrimination, Social	Behavioral: Training Behavioral: Peer support and mentorship Behavioral: Leadership engagement Behavioral: Embedded champions	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Aug 16, 2021

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention arm 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; 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. Leadership engagement: To ensure leadership buy in, support and sustainability of the intervention, the investigators will engage leadership of the County. 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 trainings to reduce conscious bias and stress Behavioral: Peer support and mentorship facilitated peer and mentorship opportunities Behavioral: Leadership engagement Engaged leadership at the county and facility levels Behavioral: Embedded champions Facilitate local champions to promote intervention
No Intervention: Control arm Will not receive any training during the intervention period

Arm

Intervention/Treatment

Experimental: Intervention arm

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; 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. Leadership engagement: To ensure leadership buy in, support and sustainability of the intervention, the investigators will engage leadership of the County. 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

trainings to reduce conscious bias and stress

Behavioral: Peer support and mentorship

facilitated peer and mentorship opportunities

Behavioral: Leadership engagement

Engaged leadership at the county and facility levels

Behavioral: Embedded champions

Facilitate local champions to promote intervention

No Intervention: Control arm

Will not receive any training during the intervention period

Outcome Measures

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Inability to attend scheduled training.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Migori County hospital and sub-county hospitals	Migori		Kenya

Sponsors and Collaborators

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