African Americans (AA) Communities Speak

NCT ID: NCT05908487

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-27
• Study Completion Date: 2028-07-31

Brief Summary

African Americans are less likely to receive quality end-of-life (EoL) care. Addressing disparities in EoL care will need efforts to support a better understanding of African American patients' EoL cultural values and preferences for EoL communication and the impact of historical and ongoing care delivery inequities in healthcare settings.

Our proposed "Caring for Older African Americans" training program is designed to empower clinicians to improve goal-concordant EoL care delivery by using community-developed storytelling videos to create empathy with experiences of racism in EoL care, guidelines for culturally concordant EoL care delivery, and an implicit bias recognition and management training to mitigate bias in goals of care communication.

Detailed Description

African Americans (AA) are less likely to receive quality end-of-life (EoL) care. For example, goals of care conversations, which are critical discussions between clinicians, patients, and families near the end of life, are less likely to occur for AAs than for Whites, and preferences are less likely to be followed when they do occur. Instead, families are more likely to be labeled as "difficult" if their decisions are incongruent with clinicians' recommendations. EoL decisions for many AA persons are rooted in both culture and a lifetime of experiences of structural racism. Efforts to address disparities need to address multiple factors such as patient-level cultural identity and EoL care values, interpersonal- and community-level norms for EoL communication and treatment, and healthcare institutional contexts for delivering EoL care in a setting affected by institutional racism.

Our research group began to address this need with 'African American Community Speaks', a proof-of-concept prototype of a community-developed training program for clinicians caring for AA older adults with serious illnesses. The program originally focused on rural Southern older AAs and is not broadly generalizable across the US due to geographic differences in culture, attitudes, and communication preferences among AA persons in the US. Thus, we propose to adapt our prototype program to urban-dwelling Southern and Northern older AA adults using our established platform of Community-Based Participatory Research (CBPR) in two geographically diverse regions: Birmingham, Alabama, and the Bronx, New York. To create the new training program called 'Caring for Older African Americans', our team of experts in CBPR, medical sociology, and clinical trials will work with local Community Advisory Boards to: 1. Conduct a comparative ethnographic study of urban dwelling AAs in the North and South to describe AA community values and preferences related to EoL care; 2. Adaptation of our prior community-developed training program by integrating community-developed storytelling videos for empathizing with experiences of racism in EoL care, guidelines for culturally concordant EoL care delivery, and adapting an existing implicit bias management program to goals of care communication; and 3. Conduct a cluster randomized trial in which we will randomize training times to 1 of 4 start dates using a stepped wedge design to accommodate the training of all clinicians and to mitigate the effect of secular trends.

Patients' personal experience of racism will be measured using the discrimination subscale of the Group Based Mistrust Scale. The primary outcome will be patient/family's perception of therapeutic alliance using The Human Connection Scale. Secondary outcomes will be family-reported goal-concordant care, and clinicians' knowledge of cultural values, awareness of implicit bias, and confidence to change practice. This innovative effort will be the first training program that: 1. addresses culturally concordant care, systemic racism, and implicit bias management, the three key elements in enhancing the provision of equitable care; and 2. is designed and implemented in full partnership with two distinct AA communities in the South and the North of the US.

Conditions

Healthy Aging; Health Knowledge, Attitudes, Practice; Social Responsibility; Care Eliciting Behavior; Racism, Systemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Clinician Trainees- Cluster 1

Within each participating institution, clinician clusters are randomized to 1 of 4 start date training times for the African American Communities Speak (AACS) Education Intervention. Each arm has a pre-intervention (control) period and a post-intervention (exposure) period.

Group Type: OTHER

AA Communities Speak to Healthcare Professionals

Intervention Type: BEHAVIORAL

The training program is designed to empower clinicians to improve goal-concordant EoL care delivery by using community-developed storytelling videos to create empathy with experiences of racism in EoL care, guidelines for culturally concordant EoL care delivery, and implicit bias recognition and management training to mitigate bias in goals of care communication.

Clinician Trainees- Cluster 2

Within each participating institution, clinician clusters are randomized to 1 of 4 start date training times for the African American Communities Speak (AACS) Education Intervention. Each arm has a pre-intervention (control) period and a post-intervention (exposure) period

Group Type: OTHER

AA Communities Speak to Healthcare Professionals

Intervention Type: BEHAVIORAL

The training program is designed to empower clinicians to improve goal-concordant EoL care delivery by using community-developed storytelling videos to create empathy with experiences of racism in EoL care, guidelines for culturally concordant EoL care delivery, and implicit bias recognition and management training to mitigate bias in goals of care communication.

Clinician Trainees- Cluster 3

Within each participating institution, clinician clusters are randomized to 1 of 4 start date training times for the African American Communities Speak (AACS) Education Intervention. Each arm has a pre-intervention (control) period and a post-intervention (exposure) period

Group Type: OTHER

AA Communities Speak to Healthcare Professionals

Intervention Type: BEHAVIORAL

The training program is designed to empower clinicians to improve goal-concordant EoL care delivery by using community-developed storytelling videos to create empathy with experiences of racism in EoL care, guidelines for culturally concordant EoL care delivery, and implicit bias recognition and management training to mitigate bias in goals of care communication.

Clinician Trainees- Cluster 4

Within each participating institution, clinician clusters are randomized to 1 of 4 start date training times for the African American Communities Speak (AACS) Education Intervention. Each arm has a pre-intervention (control) period and a post-intervention (exposure) period

Group Type: OTHER

AA Communities Speak to Healthcare Professionals

Intervention Type: BEHAVIORAL

The training program is designed to empower clinicians to improve goal-concordant EoL care delivery by using community-developed storytelling videos to create empathy with experiences of racism in EoL care, guidelines for culturally concordant EoL care delivery, and implicit bias recognition and management training to mitigate bias in goals of care communication.

Interventions

AA Communities Speak to Healthcare Professionals

The training program is designed to empower clinicians to improve goal-concordant EoL care delivery by using community-developed storytelling videos to create empathy with experiences of racism in EoL care, guidelines for culturally concordant EoL care delivery, and implicit bias recognition and management training to mitigate bias in goals of care communication.

Intervention Type: BEHAVIORAL

Other Intervention Names

Clinician Training

Eligibility Criteria

Inclusion Criteria

Person with serious Illness:

• Self-identified as African American (i.e., born, raised, and lived primarily in the US)
• Non-Hispanic or Latino
• Age ≥60 years
• English-speaking
• Has been diagnosed with a condition that fits into one of 3 illness paradigms including cancer, cardiac disease, pulmonary disease, neuro-degenerative disease, renal disease, stroke, sepsis, hepatic disease)
• Callahan Six-Item Screener score ≥4
• Able to complete baseline surveys.

Bereaved family member:

• Self-identified as African American (i.e., born, raised, and lived primarily in the US)
• Non-Hispanic or Latino
• Age ≥60 years
• English-speaking
• Loved one dies in the last 12 months and was diagnosed with a condition that fits into one of 3 illness paradigms including cancer, cardiac disease, pulmonary disease, neuro- degenerative disease, renal disease, stroke, sepsis, hepatic disease)
• Callahan Six-Item Screener score ≥4
• Able to complete baseline surveys.

Bereaved Family member:

• Self-identified as African American (i.e., born, raised, and lived primarily in the US)
• Non-Hispanic or Latino
• Age ≥60 years
• English-speaking
• Loved one dies in the last 12 months and was diagnosed with a condition that fits into one of 3 illness paradigms including cancer, cardiac disease, pulmonary disease, neuro- degenerative disease, renal disease, stroke, sepsis, hepatic disease)
• Callahan Six-Item Screener score ≥4
• Able to complete baseline surveys

Pastors:

• Self-identifying as African American
• White, Non-Hispanic or Latino
• Sged ≥18 years old.

Clinician eligibility:

• Practice at a University of Alabama at Birmingham (UAB) or Montefiore/Einstein site that provides care to patients eligible for outcomes surveys
• At least 3 months of clinical practice at the study site prior to the intervention training to measure pre-intervention patient surveys

Exclusion Criteria

Person with serious illness:

-Cannot be receiving hospice care

Bereaved Family Member:

-Cannot be a paid "sitter"

-Lack of at least 3 months of clinical practice at the study site prior to the intervention training.

Patient eligibility:

• Self-identified as African American (i.e., born, raised, and lived primarily in the US)
• Non-Hispanic or Latino, 3. age ≥60 years
• English-speaking
• Has been diagnosed with a condition that fits into one of 3 illness paradigms including cancer, cardiac disease, pulmonary disease, neuro-degenerative disease, renal disease, stroke, sepsis, hepatic disease)
• Callahan Six-Item Screener score ≥4
• Able to complete baseline surveys.

-Currently receiving hospice care.

Family member eligibility:

• Age ≥ 18 years
• English-speaking
• Community-dwelling
• Unpaid care provider of a person with a serious illness.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Ronit Elk

Associate Director, Center of Palliative and Supportive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Tjia, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

UAB

Birmingham, Alabama, United States

Site Status: RECRUITING

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Albert Einstein/Montefiore

The Bronx, New York, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Ronit Elk, PhD

Role: CONTACT

relk@uabmc.edu

205.996.1702

Tametria V Heard, PhD

Role: CONTACT

tvheard@uabmc.edu

205.934.7905

Facility Contacts

Ronit Elk, PhD

Role: primary

relk@uabmc.edu

205.996.1702

Tametria Heard, PhD

Role: backup

tvheard@uabmc.edu

205.934.7905

Tametria Heard, PhD

Role: primary

tvheard@uabmc.edu

2050347905

Elizabeth Chuang, MD

Role: primary

Echuang@montefiore.org

718-920-4630

Other Identifiers

IRB300007677

Identifier Type: -

Identifier Source: org_study_id