Trial Outcomes & Findings for Caring for Providers to Improve Patient Experience Study Phase 2 in Migori County (NCT NCT05019131)
NCT ID: NCT05019131
Last Updated: 2025-05-07
Results Overview
The Perceived Stress Scale (PSS) score ranges from 0 to 40 with higher scores indicating higher perceived stress.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
83 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2025-05-07
Participant Flow
Health facilities participating in the study
Participant milestones
| Measure |
Intervention Arm
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.
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
|
Control Arm
Will not receive any training during the intervention period
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
43
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Intervention Arm
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.
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
|
Control Arm
Will not receive any training during the intervention period
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
Baseline Characteristics
Caring for Providers to Improve Patient Experience Study Phase 2 in Migori County
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=40 Participants
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.
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
|
Control Arm
n=43 Participants
Will not receive any training during the intervention period
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
40 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Kenya
|
40 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: health care providers
The Perceived Stress Scale (PSS) score ranges from 0 to 40 with higher scores indicating higher perceived stress.
Outcome measures
| Measure |
Intervention Arm
n=40 Participants
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.
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
|
Control Arm
n=40 Participants
Will not receive any training during the intervention period
|
|---|---|---|
|
Change in Perceived Stress Scale (PSS) Score From Baseline to 6 Months
Baseline
|
20.89 score on a scale
Standard Deviation 3.86
|
20.58 score on a scale
Standard Deviation 4.51
|
|
Change in Perceived Stress Scale (PSS) Score From Baseline to 6 Months
End line
|
18.63 score on a scale
Standard Deviation 5.34
|
20.05 score on a scale
Standard Deviation 5.57
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: health care providers
The Shirom-Melamed Burnout Measure range from 1 to 7 with higher scores indicating higher burnout
Outcome measures
| Measure |
Intervention Arm
n=40 Participants
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.
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
|
Control Arm
n=40 Participants
Will not receive any training during the intervention period
|
|---|---|---|
|
Change in Shirom-Melamed Burnout Measure (SMBM) Score From Baseline to 6 Months
Baseline
|
3.64 score on a scale
Standard Deviation 1.05
|
3.70 score on a scale
Standard Deviation 1.10
|
|
Change in Shirom-Melamed Burnout Measure (SMBM) Score From Baseline to 6 Months
End line
|
2.95 score on a scale
Standard Deviation 0.97
|
3.42 score on a scale
Standard Deviation 1.08
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: health care providers
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.
Outcome measures
| Measure |
Intervention Arm
n=40 Participants
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.
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
|
Control Arm
n=40 Participants
Will not receive any training during the intervention period
|
|---|---|---|
|
Change in Stress Knowledge and Attitudes Score From Baseline to 6 Months
Baseline
|
7.78 score on a scale
Standard Deviation 2.41
|
7.95 score on a scale
Standard Deviation 2.77
|
|
Change in Stress Knowledge and Attitudes Score From Baseline to 6 Months
End line
|
9.50 score on a scale
Standard Deviation 1.80
|
8.53 score on a scale
Standard Deviation 2.01
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: health care providers
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
Outcome measures
| Measure |
Intervention Arm
n=40 Participants
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.
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
|
Control Arm
n=40 Participants
Will not receive any training during the intervention period
|
|---|---|---|
|
Change in Unconscious Bias Knowledge and Attitudes Score From Baseline to 6 Months
Baseline
|
8.93 score on a scale
Standard Error 1.94
|
9.13 score on a scale
Standard Error 2.14
|
|
Change in Unconscious Bias Knowledge and Attitudes Score From Baseline to 6 Months
End line
|
10.70 score on a scale
Standard Error 1.73
|
9.45 score on a scale
Standard Error 2.16
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: health care providers
There are no specified cut-offs for cortisol levels, but, on average, higher cortisol levels indicate higher stress.
Outcome measures
| Measure |
Intervention Arm
n=15 Participants
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.
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
|
Control Arm
n=7 Participants
Will not receive any training during the intervention period
|
|---|---|---|
|
Change in Hair Cortisol Levels From Baseline to 6 Months
Baseline
|
74.13 pg/mg
Standard Deviation 147.38
|
8.43 pg/mg
Standard Deviation 3.03
|
|
Change in Hair Cortisol Levels From Baseline to 6 Months
End line
|
41.50 pg/mg
Standard Deviation 72.19
|
36.05 pg/mg
Standard Deviation 58.29
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: health care providers
There are no specified cut-offs for HRV but, on average, lower HRV scores indicate higher stress
Outcome measures
| Measure |
Intervention Arm
n=34 Participants
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.
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
|
Control Arm
n=32 Participants
Will not receive any training during the intervention period
|
|---|---|---|
|
Change in Heart Rate Variability (HRV) Levels From Baseline to 6 Months
Baseline
|
3.70 ms
Standard Deviation 0.59
|
3.71 ms
Standard Deviation 0.61
|
|
Change in Heart Rate Variability (HRV) Levels From Baseline to 6 Months
End line
|
3.71 ms
Standard Deviation 0.43
|
3.84 ms
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: health care providers
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
Outcome measures
| Measure |
Intervention Arm
n=34 Participants
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.
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
|
Control Arm
n=34 Participants
Will not receive any training during the intervention period
|
|---|---|---|
|
Change in Socioeconomic Status-person Centered Maternity Care Implicit Association Test (IAT) Score
Baseline
|
0.75 score on a scale
Standard Deviation 0.37
|
0.67 score on a scale
Standard Deviation 0.46
|
|
Change in Socioeconomic Status-person Centered Maternity Care Implicit Association Test (IAT) Score
End line
|
0.62 score on a scale
Standard Deviation 0.52
|
0.43 score on a scale
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Health care providers
The explicit bias scores are from responses to a vignette and range from 4 to 28. Higher scores indicate more explicit bias
Outcome measures
| Measure |
Intervention Arm
n=40 Participants
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.
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
|
Control Arm
n=40 Participants
Will not receive any training during the intervention period
|
|---|---|---|
|
Change in Explicit Bias Scores From Baseline to 6 Months
End line
|
15.65 score on a scale
Standard Deviation 3.76
|
14.91 score on a scale
Standard Deviation 3.12
|
|
Change in Explicit Bias Scores From Baseline to 6 Months
Baseline
|
17.38 score on a scale
Standard Deviation 3.06
|
16.30 score on a scale
Standard Deviation 3.27
|
Adverse Events
Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Patience Afulani
University of California, San Francisco
Phone: (415) 476-1000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place