Stress, PsychologicalCPIPENCT06085105
Caring for Providers to Improve Patient Experience (CPIPE) Trial
A study testing CPIPE Training, Peer support groups and Mentorship in people with Stress, Psychological and Maternal Health, run by University of California, San Francisco at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Stress, Psychological, Maternal Health, Healthcare Provider
- What is being tested?
- CPIPE Training, Peer support groups and Mentorship
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,379 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Mar 2024to 6 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Women who are too ill to participate or do not live within a feasible location if interviews are scheduled to be conducted in the community.
- Women who are younger than 15 years of age.
- Provider's cohort
- Eligibility criteria
- Healthcare providers working in maternal health units for at least 6 months at the time of data collection.
- Capable and willing to provide informed consent.
Show all 9Show fewer
- Able and committed to attending the intervention training and follow up activities.
- Age 18 or above.
- 1. Healthcare providers planning to no longer be working at the facilities in the next six months, at the time of enrollment.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Caring for Providers to Improve Patient Experience (CPIPE) Study: A Cluster Randomized-controlled Trial to Assess the Impact of the CPIPE Intervention on Person-centered Maternity Care
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) test the effectiveness of an intervention that targets provider stress and bias to improve PCMC; (2) assess the cost-effectiveness of CPIPE; (3) examine the mechanisms of impact of CPIPE on PCMC; and (3) assess impact of the CPIPE intervention on distal outcomes including maternal health seeking behavior and maternal and neonatal health.
Read the detailed description
Poor person-centered maternal care (PCMC) contributes to high maternal mortality and morbidity, directly and indirectly, through lack of, delayed, inadequate, unnecessary, or harmful care. The proposed R01 will test the effectiveness of an intervention that targets provider stress and bias to improve PCMC. The investigators will accomplish this through 3 aims. Aim 1: to assess the effectiveness of the CPIPE intervention on PCMC in Kenya and Ghana. The investigators hypothesize that CPIPE will improve PCMC for all women, and especially for low SES women. The primary outcome is PCMC measured with the PCMC scale through multiple cross-sectional surveys of mothers who gave birth in the preceding 12 weeks in study facilities at baseline (prior to intervention), midline (6 months post-baseline), and endline (12 months post-baseline) (N=2000 at each time point). A sub-aim 1 will assess the cost-effectiveness of CPIPE. Aim 2: to examine the mechanisms of impact of CPIPE on PCMC. The investigators will assess the effect of CPIPE on intermediate outcomes such as provider knowledge, self-efficacy, stress, burnout, and bias levels; and conduct mediation analysis to assess if changes in these outcomes account for the effect of CPIPE on PCMC. Aim 3: to assess impact of the CPIPE intervention on distal outcomes including maternal health seeking behavior and maternal and neonatal health; and examine if changes in PCMC account for these effects.
- Conditions
- Stress, Psychological, Maternal Health, Healthcare Provider, Adverse Outcomes, Stress, Emotional, Mental Health Issue
- Being tested
- CPIPE Training, Peer support groups, Mentorship, Leadership engagement, Embedded champions
- Keywords
- quality of care, Kenya, providers, mental health, burnout, stress, person-centered care, discrimination, prejudice, unconscious bias
- Medical subject headings
- Stress, Psychological, Burnout, Psychological, Social Discrimination, Psychological Well-Being, Prejudice, Bias, Implicit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPIPE TrainingBehavioural
A two day training covering the following topics: understanding stress \& burnout and developing positive coping mechanisms, bias awareness \& mitigation, person-centered maternity care mindfulness, dealing with difficult situations, emergency obstetric and neonatal care, teamwork and communication, mentorship and peer support.
Peer support groupsBehavioural
Groups for healthcare providers to meet with other healthcare providers of their cadre, and discuss issues they are facing, brainstorm solutions, and provide support to one another.
MentorshipBehavioural
Mentor-mentee relationships that provide the opportunity to coach junior healthcare providers on professional development, work-life balance, clinical skills, career advancement and other topics. Mentors develop their mentorship and leadership skills.
Leadership engagementBehavioural
Engagement of County leadership at the onset of the project through a community advisory board, regular updates of the study and findings, and discussing systemic gaps that impact provider stress and bias.
Embedded championsBehavioural
To facilitate ongoing engagement and sustainability at the facility level, we identified facility champions who lead in organizing and facilitating peer support groups and refreshers at their facilities and serve as role models.
| Study group | Role | What they receive |
|---|---|---|
| CPIPE Intervention arm | Experimental | 1. Training: A two-day training that addresses the following topics: Stress \& positive coping mechanisms; Bias awareness and mitigation; Person-centered maternity care; Dealing with difficult situations; and Teamwork and communication. 2. Peer support: Groups for healthcare providers to meet with other healthcare providers of their cadre, to debrief, discuss issues they are facing, brainstorm solutions, and provide support to one another. 3. Leadership engagement: Engagement of County leadership at the onset of the project through a community advisory board to guide and help address sources of stress. 4. Mentorship: mentor-mentee relationships that provide the opportunity to coach less experienced healthcare providers on professional development, work-life balance, clinical skills, career advancement and other topics. 5. Embedded champions: facility champions to lead in organizing and facilitating peer support groups and refreshers at their facilities and serve as role models. Receives: Behavioral: CPIPE Training; Behavioral: Peer support groups; Behavioral: Mentorship; Behavioral: Leadership engagement; Behavioral: Embedded champions |
| CPIPE control arm | No intervention | The control group will not receive the CPIPE intervention during the 12-month data collection period but will maintain their usual facility level activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in person-centered maternity care (PCMC) score from baseline to 6 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
The PCMC scale is a 30-item scale with 3 sub-scales for dignity and respect, communication and autonomy, and supportive care. Items for each scale are summed to create a score, which is standardized to range from 0 to 100, where higher scores indicate more person-centered care.
Measured: Baseline and 6 months
Change in person-centered maternity care (PCMC) score from 6 months sustained at 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
The PCMC scale is a 30-item scale with 3 sub-scales for dignity and respect, communication and autonomy, and supportive care. Items for each scale are summed to create a score, which is standardized to range from 0 to 100, where higher scores indicate more person-centered care.
Measured: 6 months and 12 months
Change in person-centered maternity care (PCMC) score from baseline to 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
The PCMC scale is a 30-item scale with 3 sub-scales for dignity and respect, communication and autonomy, and supportive care. Items for each scale are summed to create a score, which is standardized to range from 0 to 100, where higher scores indicate more person-centered care.
Measured: Baseline and 12 months
Secondary outcomes (33)
Change in stress and stress management knowledge and attitude scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities.
The stress knowledge and attitudes score is measured by 10 survey questions with scores ranging from 0 to 10. Higher scores indicate higher knowledge and positive attitudes regarding stress and stress management.
Measured: Baseline and 6 months
Change in stress and stress management knowledge and attitude scores from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.
The stress knowledge and attitudes score is measured by 10 survey questions with scores ranging from 0 to 10. Higher scores indicate higher knowledge and positive attitudes regarding stress and stress management.
Measured: 6 months and 12 months
Change in stress and stress management knowledge and attitude scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
The stress knowledge and attitudes score is measured by 10 survey questions with scores ranging from 0 to 10. Higher scores indicate higher knowledge and positive attitudes regarding stress and stress management.
Measured: Baseline and 12 months
Change in unconscious bias knowledge and attitude scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities.
The unconscious bias knowledge and attitudes score is measured by 10 survey questions with scores ranging from 0 to 10. Higher scores indicate higher knowledge and positive attitudes regarding unconscious bias.
Measured: Baseline and 6 months
Change in unconscious bias knowledge and attitude scores from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.
The unconscious bias knowledge and attitudes score is measured by 10 survey questions with scores ranging from 0 to 10. Higher scores indicate higher knowledge and positive attitudes regarding unconscious bias.
Measured: 6 months and 12 months
Change in unconscious bias knowledge and attitude scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
The unconscious bias knowledge and attitudes score is measured by 10 survey questions with scores ranging from 0 to 10. Higher scores indicate higher knowledge and positive attitudes regarding unconscious bias.
Measured: Baseline and 12 months
Change in Perceived Stress Scale (PSS) score from baseline to 6 Months, among providers in intervention facilities compared to those in control facilities.
Perceived Stress is measured by the 10-item Cohen Perceived Stress Scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: Baseline and 6 months
Change in Perceived Stress Scale (PSS) score from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.
Perceived Stress is measured by the 10-item Cohen Perceived Stress Scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: 6 months and 12 months
Change in Perceived Stress Scale (PSS) score from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
Perceived Stress is measured by the 10-item Cohen Perceived Stress Scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: Baseline and 12 months
Change in Shirom-Melamed Burnout Measure (SMBM) score from baseline to 6 months among providers in intervention facilities compared to those in control facilities.
The Shirom-Melamed Burnout Measure is a 14-item scale. Scores range from 1 to 7 with higher scores indicating higher burnout.
Measured: Baseline and 6 months
Change in Shirom-Melamed Burnout Measure (SMBM) score from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.
The Shirom-Melamed Burnout Measure is a 14-item scale. Scores range from 1 to 7 with higher scores indicating higher burnout.
Measured: 6 months and 12 months
Change in Shirom-Melamed Burnout Measure (SMBM) score from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
The Shirom-Melamed Burnout Measure is a 14-item scale. Scores range from 1 to 7 with higher scores indicating higher burnout.
Measured: Baseline and 12 months
Change in bias awareness and mitigation scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities.
The scale is composed of the following 3 subscales: a 9-item Bias Awareness subscale; and a 7-item Bias Mitigation Self-Efficacy sub-scale; and 7-item Bias mitigation subscale.
Measured: Baseline and 6 months
Change in bias awareness and mitigation scores from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.
The scale is composed of the following 3 subscales: a 9-item Bias Awareness subscale; and a 7-item Bias Mitigation Self-Efficacy sub-scale; and 7-item Bias mitigation subscale.
Measured: 6 months and 12 months
Change in bias awareness and mitigation scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
The scale is composed of the following 3 subscales: a 9-item Bias Awareness subscale; and a 7-item Bias Mitigation Self-Efficacy sub-scale; and 7-item Bias mitigation subscale.
Measured: Baseline and 12 months
Change in explicit bias scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities.
The explicit bias scores are from responses to a vignette and range from 4 to 28. Higher scores indicate more explicit bias.
Measured: Baseline and 6 months
Change in explicit bias scores from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.
The explicit bias scores are from responses to a vignette and range from 4 to 28. Higher scores indicate more explicit bias.
Measured: 6 months and 12 months
Change in explicit bias scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
The explicit bias scores are from responses to a vignette and range from 4 to 28. Higher scores indicate more explicit bias.
Measured: Baseline and 12 months
Change in supportive environment score from baseline to 6 months among providers in intervention facilities compared to those in control facilities.
Survey questions to assess support from leadership, superiors and colleagues, indicating a more supportive and enabling environment.
Measured: Baseline and 6 months
Change in supportive environment score from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.
Survey questions to assess support from leadership, superiors and colleagues, indicating a more supportive and enabling environment.
Measured: 6 months and 12 months
Change in supportive environment score from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
Survey questions to assess support from leadership, superiors and colleagues, indicating a more supportive and enabling environment.
Measured: Baseline and 12 months
Change in self-reported PCMC provision scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities.
The 9-item provider reported PCMC scale ranges from 0 to 27 with higher scores indicating higher PCMC provision.
Measured: Baseline and 6 months
Change in self-reported PCMC provision scores from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.
The 9-item provider reported PCMC scale ranges from 0 to 27 with higher scores indicating higher PCMC provision.
Measured: 6 months and 12 months
Change in self-reported PCMC provision scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
The 9-item provider reported PCMC scale ranges from 0 to 27 with higher scores indicating higher PCMC provision.
Measured: Baseline and 12 months
Change in postnatal care utilization from baseline to 6 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
Survey questions on receipt and timing of postnatal care
Measured: Baseline and 6 months
Change in postnatal care utilization from 6 months sustained at 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
Survey questions on receipt and timing of postnatal care
Measured: 6 months and 12 months
Change in postnatal care utilization from baseline to 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
Survey questions on receipt and timing of postnatal care
Measured: Baseline and 12 months
Change in breastfeeding rates from baseline to 6 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
Survey questions on breastfeeding initiation, exclusive breastfeeding, and duration of breastfeeding
Measured: Baseline and 6 months
Change in breastfeeding rates from 6 months sustained at 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
Survey questions on breastfeeding initiation, exclusive breastfeeding, and duration of breastfeeding
Measured: 6 months and 12 months
Change in breastfeeding rates from baseline to 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
Survey questions on breastfeeding initiation, exclusive breastfeeding, and duration of breastfeeding
Measured: Baseline and 12 months
Change in post-partum depression rates from baseline to 6 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
10-item Edinburgh Perinatal/Postnatal Depression Scale (EPDS). Scores range from 0 to 30 with higher scores indicating more severe depression
Measured: Baseline and 6 months
Change in post-partum depression rates from 6 months sustained at 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
10-item Edinburgh Perinatal/Postnatal Depression Scale (EPDS). Scores range from 0 to 30 with higher scores indicating more severe depression
Measured: 6 months and 12 months
Change in post-partum depression rates from baseline to 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
10-item Edinburgh Perinatal/Postnatal Depression Scale (EPDS). Scores range from 0 to 30 with higher scores indicating more severe depression
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start1 Mar 2024
- Primary completion6 May 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (132)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,379 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kenya Medical Research Institute, Navrongo Health Research Centre, Ghana
- Responsible party
- Sponsor
- Investigators
- Patience Afulani, PhD, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085105
- Sponsor's protocol ID
- 23-38843
- Other IDs
- R01HD110370
- Acronym
- CPIPE
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28938885Alkema L, Chou D, Hogan D, Zhang S, Moller AB, Gemmill A, Fat DM, Boerma T, Temmerman M, Mathers C, Say L; United Nations Maternal Mortality Estimation Inter-Agency Group collaborators and technical advisory group. Global, regional, and national levels and trends in maternal mortality between 1990 and 2015, with scenario-based projections to 2030: a systematic analysis by the UN Maternal Mortality Estimation Inter-Agency Group. Lancet. 2016 Jan 30;387(10017):462-74. doi: 10.1016/S0140-6736(15)00838-7. Epub 2015 Nov 13.
PubMed 26584737Friberg IK, Kinney MV, Lawn JE, Kerber KJ, Odubanjo MO, Bergh AM, Walker N, Weissman E, Chopra M, Black RE; Science in Action: Saving the lives of Africa's Mothers, Newborns, and Children working group; Axelson H, Cohen B, Coovadia H, Diab R, Nkrumah F. Sub-Saharan Africa's mothers, newborns, and children: how many lives could be saved with targeted health interventions? PLoS Med. 2010 Jun 21;7(6):e1000295. doi: 10.1371/journal.pmed.1000295.
PubMed 20574515Khan KS, Wojdyla D, Say L, Gulmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr 1;367(9516):1066-1074. doi: 10.1016/S0140-6736(06)68397-9.
PubMed 16581405Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.
PubMed 25103301Gabrysch 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.
PubMed 19671156Moyer CA, Mustafa A. Drivers and deterrents of facility delivery in sub-Saharan Africa: a systematic review. Reprod Health. 2013 Aug 20;10:40. doi: 10.1186/1742-4755-10-40.
PubMed 23962135van den Broek NR, Graham WJ. Quality of care for maternal and newborn health: the neglected agenda. BJOG. 2009 Oct;116(Suppl 1):18-21. doi: 10.1111/j.1471-0528.2009.02333.x.
PubMed 19740165Graham WJ, McCaw-Binns A, Munjanja S. Translating coverage gains into health gains for all women and children: the quality care opportunity. PLoS Med. 2013;10(1):e1001368. doi: 10.1371/journal.pmed.1001368. Epub 2013 Jan 15.
PubMed 23335862Koblinsky M, Moyer CA, Calvert C, Campbell J, Campbell OM, Feigl AB, Graham WJ, Hatt L, Hodgins S, Matthews Z, McDougall L, Moran AC, Nandakumar AK, Langer A. Quality maternity care for every woman, everywhere: a call to action. Lancet. 2016 Nov 5;388(10057):2307-2320. doi: 10.1016/S0140-6736(16)31333-2. Epub 2016 Sep 16.
PubMed 27642018Anwar I, Kalim N, Koblinsky M. Quality of obstetric care in public-sector facilities and constraints to implementing emergency obstetric care services: evidence from high- and low-performing districts of Bangladesh. J Health Popul Nutr. 2009 Apr;27(2):139-55. doi: 10.3329/jhpn.v27i2.3327.
PubMed 19489412Donabedian A. The quality of care. How can it be assessed? JAMA. 1988 Sep 23-30;260(12):1743-8. doi: 10.1001/jama.260.12.1743.
PubMed 3045356Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK222274/
PubMed 25057539Bohren MA, Hunter EC, Munthe-Kaas HM, Souza JP, Vogel JP, Gulmezoglu AM. Facilitators and barriers to facility-based delivery in low- and middle-income countries: a qualitative evidence synthesis. Reprod Health. 2014 Sep 19;11(1):71. doi: 10.1186/1742-4755-11-71.
PubMed 25238684Bohren MA, Vogel JP, Hunter EC, Lutsiv O, Makh SK, Souza JP, Aguiar C, Saraiva Coneglian F, Diniz AL, Tuncalp O, Javadi D, Oladapo OT, Khosla R, Hindin MJ, Gulmezoglu AM. The Mistreatment of Women during Childbirth in Health Facilities Globally: A Mixed-Methods Systematic Review. PLoS Med. 2015 Jun 30;12(6):e1001847; discussion e1001847. doi: 10.1371/journal.pmed.1001847. eCollection 2015 Jun.
PubMed 26126110
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caring for Providers to Improve Patient Experience (CPIPE) Study: A Cluster Randomized-controlled Trial to Assess the Impact of the CPIPE Intervention on Person-centered Maternity Care
- ClinicalTrials.gov ID
- NCT06085105
- Acronym / sponsor ID
- CPIPE / 23-38843
- Conditions
- Stress, Psychological, Maternal Health, Healthcare Provider, Adverse Outcomes, Stress, Emotional, Mental Health Issue
- Keywords
- quality of care, Kenya, providers, mental health, burnout, stress, person-centered care, discrimination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,379 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kenya Medical Research Institute, Navrongo Health Research Centre, Ghana
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) test the effectiveness of an intervention that targets provider stress and bias to improve PCMC; (2) assess the cost-effectiveness of CPIPE; (3) examine the mechanisms of impact of CPIPE on PCMC; and (3) assess impact of the CPIPE intervention on distal outcomes including maternal health seeking behavior and maternal and neonatal health.
Detailed description
Poor person-centered maternal care (PCMC) contributes to high maternal mortality and morbidity, directly and indirectly, through lack of, delayed, inadequate, unnecessary, or harmful care. The proposed R01 will test the effectiveness of an intervention that targets provider stress and bias to improve PCMC. The investigators will accomplish this through 3 aims. Aim 1: to assess the effectiveness of the CPIPE intervention on PCMC in Kenya and Ghana. The investigators hypothesize that CPIPE will improve PCMC for all women, and especially for low SES women. The primary outcome is PCMC measured with the PCMC scale through multiple cross-sectional surveys of mothers who gave birth in the preceding 12 weeks in study facilities at baseline (prior to intervention), midline (6 months post-baseline), and endline (12 months post-baseline) (N=2000 at each time point). A sub-aim 1 will assess the cost-effectiveness of CPIPE. Aim 2: to examine the mechanisms of impact of CPIPE on PCMC. The investigators will assess the effect of CPIPE on intermediate outcomes such as provider knowledge, self-efficacy, stress, burnout, and bias levels; and conduct mediation analysis to assess if changes in these outcomes account for the effect of CPIPE on PCMC. Aim 3: to assess impact of the CPIPE intervention on distal outcomes including maternal health seeking behavior and maternal and neonatal health; and examine if changes in PCMC account for these effects.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPIPE Intervention arm | Experimental | Behavioral: CPIPE Training, Behavioral: Peer support groups, Behavioral: Mentorship, Behavioral: Leadership engagement, Behavioral: Embedded champions1. Training: A two-day training that addresses the following topics: Stress \& positive coping mechanisms; Bias awareness and mitigation; Person-centered maternity care; Dealing with difficult situations; and Teamwork and communication. 2. Peer support: Groups for healthcare providers to meet with other healthcare providers of their cadre, to debrief, discuss issues they are facing, brainstorm solutions, and provide support to one another. 3. Leadership engagement: Engagement of County leadership at the onset of the project through a community advisory board to guide and help address sources of stress. 4. Mentorship: mentor-mentee relationships that provide the opportunity to coach less experienced healthcare providers on professional development, work-life balance, clinical skills, career advancement and other topics. 5. Embedded champions: facility champions to lead in organizing and facilitating peer support groups and refreshers at their facilities and serve as role models. |
| CPIPE control arm | No intervention | –The control group will not receive the CPIPE intervention during the 12-month data collection period but will maintain their usual facility level activities. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Women who are too ill to participate or do not live within a feasible location if interviews are scheduled to be conducted in the community.
- Women who are younger than 15 years of age.
- Provider's cohort
- Eligibility criteria
- Healthcare providers working in maternal health units for at least 6 months at the time of data collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPIPE TrainingA two day training covering the following topics: understanding stress \& burnout and developing positive coping mechanisms, bias awareness \& mitigation, person-centered maternity care mindfulness, dealing with difficult situations, emergency obstetric and neonatal care, teamwork and communication, mentorship and peer support. | Behavioural | CPIPE Intervention arm |
| Peer support groupsGroups for healthcare providers to meet with other healthcare providers of their cadre, and discuss issues they are facing, brainstorm solutions, and provide support to one another. | Behavioural | CPIPE Intervention arm |
| MentorshipMentor-mentee relationships that provide the opportunity to coach junior healthcare providers on professional development, work-life balance, clinical skills, career advancement and other topics. Mentors develop their mentorship and leadership skills. | Behavioural | CPIPE Intervention arm |
| Leadership engagementEngagement of County leadership at the onset of the project through a community advisory board, regular updates of the study and findings, and discussing systemic gaps that impact provider stress and bias. | Behavioural | CPIPE Intervention arm |
| Embedded championsTo facilitate ongoing engagement and sustainability at the facility level, we identified facility champions who lead in organizing and facilitating peer support groups and refreshers at their facilities and serve as role models. | Behavioural | CPIPE Intervention arm |
Primary outcome
Change in person-centered maternity care (PCMC) score from baseline to 6 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
Time frame: Baseline and 6 months
The PCMC scale is a 30-item scale with 3 sub-scales for dignity and respect, communication and autonomy, and supportive care. Items for each scale are summed to create a score, which is standardized to range from 0 to 100, where higher scores indicate more person-centered care.
Change in person-centered maternity care (PCMC) score from 6 months sustained at 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
Time frame: 6 months and 12 months
The PCMC scale is a 30-item scale with 3 sub-scales for dignity and respect, communication and autonomy, and supportive care. Items for each scale are summed to create a score, which is standardized to range from 0 to 100, where higher scores indicate more person-centered care.
Change in person-centered maternity care (PCMC) score from baseline to 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
Time frame: Baseline and 12 months
The PCMC scale is a 30-item scale with 3 sub-scales for dignity and respect, communication and autonomy, and supportive care. Items for each scale are summed to create a score, which is standardized to range from 0 to 100, where higher scores indicate more person-centered care.
33 secondary outcomes
Change in stress and stress management knowledge and attitude scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities.
Time frame: Baseline and 6 months
Change in stress and stress management knowledge and attitude scores from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.
Time frame: 6 months and 12 months
Change in stress and stress management knowledge and attitude scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
Time frame: Baseline and 12 months
Change in unconscious bias knowledge and attitude scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities.
Time frame: Baseline and 6 months
Change in unconscious bias knowledge and attitude scores from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.
Time frame: 6 months and 12 months
Change in unconscious bias knowledge and attitude scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
Time frame: Baseline and 12 months
Change in Perceived Stress Scale (PSS) score from baseline to 6 Months, among providers in intervention facilities compared to those in control facilities.
Time frame: Baseline and 6 months
Change in Perceived Stress Scale (PSS) score from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.
Time frame: 6 months and 12 months
Change in Perceived Stress Scale (PSS) score from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
Time frame: Baseline and 12 months
Change in Shirom-Melamed Burnout Measure (SMBM) score from baseline to 6 months among providers in intervention facilities compared to those in control facilities.
Time frame: Baseline and 6 months
Change in Shirom-Melamed Burnout Measure (SMBM) score from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.
Time frame: 6 months and 12 months
Change in Shirom-Melamed Burnout Measure (SMBM) score from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
Time frame: Baseline and 12 months
Change in bias awareness and mitigation scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities.
Time frame: Baseline and 6 months
Change in bias awareness and mitigation scores from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.
Time frame: 6 months and 12 months
Change in bias awareness and mitigation scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
Time frame: Baseline and 12 months
Change in explicit bias scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities.
Time frame: Baseline and 6 months
Change in explicit bias scores from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.
Time frame: 6 months and 12 months
Change in explicit bias scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
Time frame: Baseline and 12 months
Change in supportive environment score from baseline to 6 months among providers in intervention facilities compared to those in control facilities.
Time frame: Baseline and 6 months
Change in supportive environment score from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.
Time frame: 6 months and 12 months
Change in supportive environment score from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
Time frame: Baseline and 12 months
Change in self-reported PCMC provision scores from baseline to 6 months among providers in intervention facilities compared to those in control facilities.
Time frame: Baseline and 6 months
Change in self-reported PCMC provision scores from 6 months sustained at 12 months among providers in intervention facilities compared to those in control facilities.
Time frame: 6 months and 12 months
Change in self-reported PCMC provision scores from baseline to 12 months among providers in intervention facilities compared to those in control facilities.
Time frame: Baseline and 12 months
Change in postnatal care utilization from baseline to 6 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
Time frame: Baseline and 6 months
Change in postnatal care utilization from 6 months sustained at 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
Time frame: 6 months and 12 months
Change in postnatal care utilization from baseline to 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
Time frame: Baseline and 12 months
Change in breastfeeding rates from baseline to 6 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
Time frame: Baseline and 6 months
Change in breastfeeding rates from 6 months sustained at 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
Time frame: 6 months and 12 months
Change in breastfeeding rates from baseline to 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
Time frame: Baseline and 12 months
Change in post-partum depression rates from baseline to 6 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
Time frame: Baseline and 6 months
Change in post-partum depression rates from 6 months sustained at 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
Time frame: 6 months and 12 months
Change in post-partum depression rates from baseline to 12 months among women who give birth in intervention facilities compared to those who give birth in control facilities.
Time frame: Baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: PubMed 28938885Afulani 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.
- Background: PubMed 26584737Alkema L, Chou D, Hogan D, Zhang S, Moller AB, Gemmill A, Fat DM, Boerma T, Temmerman M, Mathers C, Say L; United Nations Maternal Mortality Estimation Inter-Agency Group collaborators and technical advisory group. Global, regional, and national levels and trends in maternal mortality between 1990 and 2015, with scenario-based projections to 2030: a systematic analysis by the UN Maternal Mortality Estimation Inter-Agency Group. Lancet. 2016 Jan 30;387(10017):462-74. doi: 10.1016/S0140-6736(15)00838-7. Epub 2015 Nov 13.
- Background: PubMed 20574515Friberg IK, Kinney MV, Lawn JE, Kerber KJ, Odubanjo MO, Bergh AM, Walker N, Weissman E, Chopra M, Black RE; Science in Action: Saving the lives of Africa's Mothers, Newborns, and Children working group; Axelson H, Cohen B, Coovadia H, Diab R, Nkrumah F. Sub-Saharan Africa's mothers, newborns, and children: how many lives could be saved with targeted health interventions? PLoS Med. 2010 Jun 21;7(6):e1000295. doi: 10.1371/journal.pmed.1000295.
- Background: PubMed 16581405Khan KS, Wojdyla D, Say L, Gulmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr 1;367(9516):1066-1074. doi: 10.1016/S0140-6736(06)68397-9.
- Background: PubMed 25103301Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.
- Background: PubMed 19671156Gabrysch 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.
- Background: PubMed 23962135Moyer CA, Mustafa A. Drivers and deterrents of facility delivery in sub-Saharan Africa: a systematic review. Reprod Health. 2013 Aug 20;10:40. doi: 10.1186/1742-4755-10-40.
- Background: PubMed 19740165van den Broek NR, Graham WJ. Quality of care for maternal and newborn health: the neglected agenda. BJOG. 2009 Oct;116(Suppl 1):18-21. doi: 10.1111/j.1471-0528.2009.02333.x.
- Background: PubMed 23335862Graham WJ, McCaw-Binns A, Munjanja S. Translating coverage gains into health gains for all women and children: the quality care opportunity. PLoS Med. 2013;10(1):e1001368. doi: 10.1371/journal.pmed.1001368. Epub 2013 Jan 15.
- Background: PubMed 27642018Koblinsky M, Moyer CA, Calvert C, Campbell J, Campbell OM, Feigl AB, Graham WJ, Hatt L, Hodgins S, Matthews Z, McDougall L, Moran AC, Nandakumar AK, Langer A. Quality maternity care for every woman, everywhere: a call to action. Lancet. 2016 Nov 5;388(10057):2307-2320. doi: 10.1016/S0140-6736(16)31333-2. Epub 2016 Sep 16.
- Background: PubMed 19489412Anwar I, Kalim N, Koblinsky M. Quality of obstetric care in public-sector facilities and constraints to implementing emergency obstetric care services: evidence from high- and low-performing districts of Bangladesh. J Health Popul Nutr. 2009 Apr;27(2):139-55. doi: 10.3329/jhpn.v27i2.3327.
- Background: PubMed 3045356Donabedian A. The quality of care. How can it be assessed? JAMA. 1988 Sep 23-30;260(12):1743-8. doi: 10.1001/jama.260.12.1743.
- Project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Stress, Psychological
Active, not recruitingObservational study
Evaluating the Effects of Genetic Testing on Patients' Stress Levels
Breast Cancer
Not yet recruiting
Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health
Inflammation, Depression Disorder
Active, not recruiting
Resilient Students Training (ReST) : A Pilot RCT
Psychological Wellness
Not yet recruitingObservational study
Relationship of Forward Head Posture With Burnout and Quality of Life
Forward Head Posture
Not yet recruiting
Feasibility Pilot of Remote Mindfulness Training Across Multiple Sites (REFORM Pilot)
Psychological Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patience Afulani, PhD, MD, MPH principal investigator
University of California, San Francisco
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPIPE Training, Peer support groups and Mentorship in people with Stress, Psychological and Maternal Health, run by University of California, San Francisco at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ghana, Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in person-centered maternity care (PCMC) score from baseline to 6 months among women who give birth in intervention facilities compared to those who give birth in control facilities. (time frame: Baseline and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06085105, which also lists 132 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.