NCT05019131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
10 months until next milestone

Results Posted

Study results publicly available

June 12, 2024

Completed
Last Updated

May 7, 2025

Status Verified

May 1, 2025

Enrollment Period

10 months

First QC Date

August 18, 2021

Results QC Date

April 18, 2024

Last Update Submit

May 5, 2025

Conditions

Keywords

providersmental healthunconscious biasprejudiceKenyastressburnoutperson-centered carequality of carediscrimination

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (4)

  • Change in Hair Cortisol Levels From Baseline to 6 Months

    Baseline and 6 months

  • Change in Heart Rate Variability (HRV) Levels From Baseline to 6 Months

    Baseline and 6 months

  • Change in Socioeconomic Status-person Centered Maternity Care Implicit Association Test (IAT) Score

    Baseline and 6 months

  • Change in Explicit Bias Scores From Baseline to 6 Months

    Baseline and 6 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

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: TrainingBehavioral: Peer support and mentorshipBehavioral: Leadership engagementBehavioral: Embedded champions

Control arm

NO INTERVENTION

Will not receive any training during the intervention period

Interventions

TrainingBEHAVIORAL

trainings to reduce conscious bias and stress

Intervention arm

facilitated peer and mentorship opportunities

Intervention arm

Engaged leadership at the county and facility levels

Intervention arm

Facilitate local champions to promote intervention

Intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Inability to attend scheduled training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Migori County hospital and sub-county hospitals

Migori, Kenya

Location

Related Publications (84)

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    PMID: 17892760BACKGROUND
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  • 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.

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

    BACKGROUND

MeSH Terms

Conditions

Psychological Well-BeingStress, PsychologicalBurnout, PsychologicalSocial DiscriminationBias, ImplicitPrejudice

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorBehavioral SymptomsSocial Behavior

Limitations and Caveats

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.

Results Point of Contact

Title
Dr. Patience Afulani
Organization
University of California, San Francisco

Study Officials

  • Patience Afulani, PhD, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2021

First Posted

August 24, 2021

Study Start

August 16, 2021

Primary Completion

June 24, 2022

Study Completion

August 31, 2023

Last Updated

May 7, 2025

Results First Posted

June 12, 2024

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations