Multiple Chronic ConditionsNCT05129709
Black Health Identification Program (B-HIP)
A study testing "My Health Priorities" Identification Program in people with Multiple Chronic Conditions and Family Members, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Nearly 69% of African American (AA) Medicare beneficiaries have multiple chronic conditions (MCCs) such as cancer and cardiopulmonary diseases. Older age and MCCs are guideline-recommended indications for referral to early palliative care to assist with effective communication and value-solicitation surrounding… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multiple Chronic Conditions, Family Members
- What is being tested?
- "My Health Priorities" Identification Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 14 Feb 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- African American (AA)
- ≥ 65 years
- has at least two of the following chronic conditions: cancer, heart disease, kidney disease, liver disease
- English-speaking
- cognitively able to participate in decision-making discussions
- reliable internet and telephone access
Show all 11Show fewer
- FCG willing to participate in study
- AA
- 18 years
- identified by patient as his/her primary FCG
- English-speaking; and 5) reliable internet and telephone access.
Who cannot join
- Axis I psychiatric disorder (schizophrenia, bipolar disorder), dementia
- active substance use disorder
- living in a nursing home or assisted living facility residence.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Whitaker Clinic at the University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Addressing Communication Challenges Confronting Older African Americans With Multiple Chronic Conditions and Their Family Caregivers
Nearly 69% of African American (AA) Medicare beneficiaries have multiple chronic conditions (MCCs) such as cancer and cardiopulmonary diseases. Older age and MCCs are guideline-recommended indications for referral to early palliative care to assist with effective communication and value-solicitation surrounding treatment decision-making. Studies have shown that early palliative care participation achieves beneficial goals of care communication, quality of life (QOL), symptom burden, and mood in older adults with cancer and heart failure as well as among their family caregivers. However, older AAs with MCCs, especially those living in the Deep South, are less likely to have access to early palliative care, even though they generally experience higher symptom burden, healthcare use, and poorer communication around goals of care. This disparity in palliative care use may be, in part, to a lack of culturally-responsive care practices that effectively activate AAs with MCCs to identify their own values and priorities for end-of-life care. While efficacious communication models exist, few have been tested in culturally-diverse samples. Guided by the theory of Social Cognitive Theory and Health Behavior Model, this study's purpose is to conduct a formative evaluation of a Self-directed "My Health Priorities" Identification Program to determine cultural acceptability and feasibility of use in among AAs with MCCs in a primary care setting. The 2-phase study specific aims are to:
Aim 1. (Phase 1) Conduct a single-arm formative evaluation trial of Self-directed "My Health Priorities" Identification Program to determine acceptability and feasibility with a sample of 20 AA patients with MCCs and FCGs and adapt for future efficacy testing.
Read more
Aim 2. (Phase 2) To examine the ability of the dyads to complete pre- and post-test measures of perception of care, treatment burden, shared decision-making, and communication exchange.
The findings from the research will directly inform a small-scale pilot grant that will assess acceptability, feasibility, and potential efficacy of a values solicitation and operationalization intervention for AAs with MCCs and caregivers.
- Conditions
- Multiple Chronic Conditions, Family Members
- Being tested
- "My Health Priorities" Identification Program
- Medical subject headings
- Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"My Health Priorities" Identification ProgramBehavioural
The web-based "My Health Priorities" Identification Program may improve values solicitation and operationalization skills in primary care, but has not been optimized for AAs with MCCs and their FCGs. The Program is a facilitator-led evidence- and values-based care communication model for patients, clinicians, and caregivers that has reduced patient-reported treatment burden by aligning value-based priorities with treatment. The web-based program assists patients in identifying their health priorities as they complete t four online modules that help them to identify specific and actionable health goals and preferences. The final result can be printed and brought to the clinic or uploaded to the Electronic Medical Record to inform subsequent healthcare decision making. Unrecognized cultural preferences of AAs, including the important role of R/S beliefs and family-centered values, can interfere with adequate healthcare communication resulting in healthcare disparities and inequities.
| Study group | Role | What they receive |
|---|---|---|
| "My Health Priorities" Identification Program | Experimental | The intervention, the "My Health Priorities" Identification Program consists of four self-directed, web-based modules intended to guide patients with MCCs in identifying their own health priorities. These priorities can then be used to guide discussions with family caregivers and clinicians regarding specific goals and preferences that they wish to guide future treatment decisions. Most models of palliative care have been developed based on white middle-class populations and may not apply to African Americans (AA) who have a very different cultural value set. Receives: Behavioral: "My Health Priorities" Identification Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
A single arm formative evaluation (qualitative interviews) exploring acceptability of the program
Semi-structured interview of patients with multiple chronic illness (MCC)
Measured: one-time interview six weeks following baseline questionnaires
A single arm formative evaluation (qualitative interviews) exploring acceptability of program
Semi-structured interview of family caregivers (FCG) of patients with MCC
Measured: one-time interview six weeks following baseline questionnaires
System Usability Scale (ISUS)
Measures usability of web-based applications and programs in both patients and FCG,. subscales evaluate how learnable and usable the tested program is; 10 items, 5 items are scored positively and 5 items are scored negatively using a 5 point likert scale with 5 indicating strongly agree and 1 indicating strongly disagree
Measured: one-time interview six weeks following baseline questionnaires
Program Completion Statistics
Usability statistics will be obtained about the length of time the participant engaged with the program, and module completion rates
Measured: one-time interview six weeks following baseline questionnaires
Older Patient Assessment of Chronic Illness Care (O-PACIC)
Questionnaire of perception of care among patients with MCC. The questionnaire consists of 10 items scored on a 5 point likert scale with 5 indicating "almost always" and 1 indicating "almost never". Higher scores thus reflect patients' perception of better care.
Measured: Baseline
Treatment Burden Questionnaire (TBQ)
Patients with MCC perception of QOL and treatment burden related to chronic illness; 15 items rated on a ten point scale with 0 indicating that the item "is not a problem" and 10 indicating that the item reflects a "big problem".
Measured: Baseline
Clinical Shared Decision Making Questionnaire (CollaboRATE)
Patients with MCC-reported measure of clinical shared decision-making; 3 items requiring open-ended responses (no scale)
Measured: Baseline
Bakas Caregiver Outcomes (BCOS)
Measures FCG social function, subjective well-being, and somatic health; 10 items rated on a 7 point likert scale with -3 reflecting "changed for the worst" and +3 indicating "changed for the better".
Measured: Baseline
Shared Care Instrument (SCI)
PT and FCG's perception of communication exchange regarding illness experience, subscales include communication, decision making, and reciprocity; 19 items divided into 3 summary scales, each item is scored in likert format from 0 to 5 with 0 indicating "completely disagree" and 5 indicating "completely agree". On the communication subscale a higher score indicates better communication. For the patient decision making subscale, higher scores indicate better patient decision making. For the patient reciprocity scale, higher scores indicate more reciprocity between patient and caregiver.
Measured: Baseline
Change in Older Patient Assessment of Chronic Illness Care (O-PACIC)
Measure of older patient perception of primary care delivery; 10 items scored on a 5 point likert scale with 1 indicating "almost never" and 5 indicating "almost always". Higher scores reflect that patients have a more positive feeling about their care.
Measured: 18 weeks post-baseline
Change in Treatment Burden Questionnaire (TBQ)
Patients with MCC perception of QOL and treatment burden related to chronic illness; 15 items rated on a ten point scale with 0 indicating that the item "is not a problem" and 10 indicating that the item reflects a "big problem".
Measured: 18 weeks post-baseline
Change in Clinical Shared Decision Making Questionnaire (CollaboRATE)
Patients with MCC-reported measure of clinical shared decision-making; 3 items requiring open-ended responses (no scale)
Measured: 18 weeks post-baseline
Change in Bakas Caregiver Outcomes (BCOS)
Measures FCG social function, subjective well-being, and somatic health; 10 items rated on a 7 point likert scale with -3 reflecting "changed for the worst" and +3 indicating "changed for the better".
Measured: 18 weeks post-baseline
Change in Shared Care Instrument (SCI)
PT perception of communication exchange regarding illness experience, subscales include communication, decision making, and reciprocity; 19 items divided into 3 summary scales, each item is scored in likert format from 0 to 5 with 0 indicating "completely disagree" and 5 indicating "completely agree". On the communication subscale a higher score indicates better communication. For the patient decision making subscale, higher scores indicate better patient decision making. For the patient reciprocity scale, higher scores indicate more reciprocity between patient and caregiver.
Measured: 18 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start1 Feb 2022
- Primary completion14 Feb 2024
- Study completion14 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Chronic ConditionsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The Social Cognitive Theory (SCT) and the Health Belief Model (HBM) inform this proposal. The SCT posits that human behavior is determined by expectancies- of culture, potential outcomes, and self-efficacy- and incentives. The HBM holds that health-related behavior depends on motivation, the belief that one is susceptible to serious illness, and the belief that following provider advice will reduce the threat. Concepts of health beliefs, self-efficacy, and culture must be considered when developing effective interventions for value solicitations and behavior change. This is especially true for older AAs in the Deep South, who report different lived experiences and experiences with medical icare than Whites. Patient-centered care cannot be realized for AAs without reshaping interventions to consider factors important to seriously ill older AAs with MCCs. Reframing discussion in a culturally-responsive manner is necessary to establish patient and FCG preferences prior to a health crisis.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Ejem, University of Alabama at Birmingham
- Investigators
- Deborah Ejem, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129709
- Sponsor's protocol ID
- IRB-300007623
- Other IDs
- Kornfeld Scholar Award
- Status last verified
- Jun 2024
- First submitted
- 28 Jul 2021
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ejem D, Bakitas M, Durant RW, Parker TN, Oppong KD, Esterson J, Odom JN, Wells RD, Boockvar K, Tinetti ME. Exploring the Acceptability and Feasibility of a Self-directed Approach to Identifying Health Priorities in a Sample of Southern Older African American Adults with Multiple Chronic Conditions. J Racial Ethn Health Disparities. 2026 Aug;13(4):2940-2957. doi: 10.1007/s40615-025-02469-8. Epub 2025 May 23.
PubMed 40410637
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Communication Challenges Confronting Older African Americans With Multiple Chronic Conditions and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT05129709
- Acronym / sponsor ID
- IRB-300007623
- Conditions
- Multiple Chronic Conditions, Family Members
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 22 Nov 2021 (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.
Nearly 69% of African American (AA) Medicare beneficiaries have multiple chronic conditions (MCCs) such as cancer and cardiopulmonary diseases. Older age and MCCs are guideline-recommended indications for referral to early palliative care to assist with effective communication and value-solicitation surrounding treatment decision-making. Studies have shown that early palliative care participation achieves beneficial goals of care communication, quality of life (QOL), symptom burden, and mood in older adults with cancer and heart failure as well as among their family caregivers. However, older AAs with MCCs, especially those living in the Deep South, are less likely to have access to early palliative care, even though they generally experience higher symptom burden, healthcare use, and poorer communication around goals of care. This disparity in palliative care use may be, in part, to a lack of culturally-responsive care practices that effectively activate AAs with MCCs to identify their own values and priorities for end-of-life care. While efficacious communication models exist, few have been tested in culturally-diverse samples. Guided by the theory of Social Cognitive Theory and Health Behavior Model, this study's purpose is to conduct a formative evaluation of a Self-directed "My Health Priorities" Identification Program to determine cultural acceptability and feasibility of use in among AAs with MCCs in a primary care setting. The 2-phase study specific aims are to:
Aim 1. (Phase 1) Conduct a single-arm formative evaluation trial of Self-directed "My Health Priorities" Identification Program to determine acceptability and feasibility with a sample of 20 AA patients with MCCs and FCGs and adapt for future efficacy testing.
Aim 2. (Phase 2) To examine the ability of the dyads to complete pre- and post-test measures of perception of care, treatment burden, shared decision-making, and communication exchange.
The findings from the research will directly inform a small-scale pilot grant that will assess acceptability, feasibility, and potential efficacy of a values solicitation and operationalization intervention for AAs with MCCs and caregivers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The Social Cognitive Theory (SCT) and the Health Belief Model (HBM) inform this proposal. The SCT posits that human behavior is determined by expectancies- of culture, potential outcomes, and self-efficacy- and incentives. The HBM holds that health-related behavior depends on motivation, the belief that one is susceptible to serious illness, and the belief that following provider advice will reduce the threat. Concepts of health beliefs, self-efficacy, and culture must be considered when developing effective interventions for value solicitations and behavior change. This is especially true for older AAs in the Deep South, who report different lived experiences and experiences with medical icare than Whites. Patient-centered care cannot be realized for AAs without reshaping interventions to consider factors important to seriously ill older AAs with MCCs. Reframing discussion in a culturally-responsive manner is necessary to establish patient and FCG preferences prior to a health crisis.
| Arm | Type | Receives |
|---|---|---|
| "My Health Priorities" Identification Program | Experimental | Behavioral: "My Health Priorities" Identification ProgramThe intervention, the "My Health Priorities" Identification Program consists of four self-directed, web-based modules intended to guide patients with MCCs in identifying their own health priorities. These priorities can then be used to guide discussions with family caregivers and clinicians regarding specific goals and preferences that they wish to guide future treatment decisions. Most models of palliative care have been developed based on white middle-class populations and may not apply to African Americans (AA) who have a very different cultural value set. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- African American (AA)
- ≥ 65 years
- has at least two of the following chronic conditions: cancer, heart disease, kidney disease, liver disease
- English-speaking
- cognitively able to participate in decision-making discussions
Key exclusion criteria (3 listed)
- Axis I psychiatric disorder (schizophrenia, bipolar disorder), dementia
- active substance use disorder
- living in a nursing home or assisted living facility residence.
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 |
|---|---|---|
| "My Health Priorities" Identification ProgramThe web-based "My Health Priorities" Identification Program may improve values solicitation and operationalization skills in primary care, but has not been optimized for AAs with MCCs and their FCGs. The Program is a facilitator-led evidence- and values-based care communication model for patients, clinicians, and caregivers that has reduced patient-reported treatment burden by aligning value-based priorities with treatment. The web-based program assists patients in identifying their health priorities as they complete t four online modules that help them to identify specific and actionable health goals and preferences. The final result can be printed and brought to the clinic or uploaded to the Electronic Medical Record to inform subsequent healthcare decision making. Unrecognized cultural preferences of AAs, including the important role of R/S beliefs and family-centered values, can interfere with adequate healthcare communication resulting in healthcare disparities and inequities. | Behavioural | "My Health Priorities" Identification Program |
Primary outcome
A single arm formative evaluation (qualitative interviews) exploring acceptability of the program
Time frame: one-time interview six weeks following baseline questionnaires
Semi-structured interview of patients with multiple chronic illness (MCC)
A single arm formative evaluation (qualitative interviews) exploring acceptability of program
Time frame: one-time interview six weeks following baseline questionnaires
Semi-structured interview of family caregivers (FCG) of patients with MCC
System Usability Scale (ISUS)
Time frame: one-time interview six weeks following baseline questionnaires
Measures usability of web-based applications and programs in both patients and FCG,. subscales evaluate how learnable and usable the tested program is; 10 items, 5 items are scored positively and 5 items are scored negatively using a 5 point likert scale with 5 indicating strongly agree and 1 indicating strongly disagree
Program Completion Statistics
Time frame: one-time interview six weeks following baseline questionnaires
Usability statistics will be obtained about the length of time the participant engaged with the program, and module completion rates
Older Patient Assessment of Chronic Illness Care (O-PACIC)
Time frame: Baseline
Questionnaire of perception of care among patients with MCC. The questionnaire consists of 10 items scored on a 5 point likert scale with 5 indicating "almost always" and 1 indicating "almost never". Higher scores thus reflect patients' perception of better care.
Treatment Burden Questionnaire (TBQ)
Time frame: Baseline
Patients with MCC perception of QOL and treatment burden related to chronic illness; 15 items rated on a ten point scale with 0 indicating that the item "is not a problem" and 10 indicating that the item reflects a "big problem".
Clinical Shared Decision Making Questionnaire (CollaboRATE)
Time frame: Baseline
Patients with MCC-reported measure of clinical shared decision-making; 3 items requiring open-ended responses (no scale)
Bakas Caregiver Outcomes (BCOS)
Time frame: Baseline
Measures FCG social function, subjective well-being, and somatic health; 10 items rated on a 7 point likert scale with -3 reflecting "changed for the worst" and +3 indicating "changed for the better".
Shared Care Instrument (SCI)
Time frame: Baseline
PT and FCG's perception of communication exchange regarding illness experience, subscales include communication, decision making, and reciprocity; 19 items divided into 3 summary scales, each item is scored in likert format from 0 to 5 with 0 indicating "completely disagree" and 5 indicating "completely agree". On the communication subscale a higher score indicates better communication. For the patient decision making subscale, higher scores indicate better patient decision making. For the patient reciprocity scale, higher scores indicate more reciprocity between patient and caregiver.
Change in Older Patient Assessment of Chronic Illness Care (O-PACIC)
Time frame: 18 weeks post-baseline
Measure of older patient perception of primary care delivery; 10 items scored on a 5 point likert scale with 1 indicating "almost never" and 5 indicating "almost always". Higher scores reflect that patients have a more positive feeling about their care.
Change in Treatment Burden Questionnaire (TBQ)
Time frame: 18 weeks post-baseline
Patients with MCC perception of QOL and treatment burden related to chronic illness; 15 items rated on a ten point scale with 0 indicating that the item "is not a problem" and 10 indicating that the item reflects a "big problem".
Change in Clinical Shared Decision Making Questionnaire (CollaboRATE)
Time frame: 18 weeks post-baseline
Patients with MCC-reported measure of clinical shared decision-making; 3 items requiring open-ended responses (no scale)
Change in Bakas Caregiver Outcomes (BCOS)
Time frame: 18 weeks post-baseline
Measures FCG social function, subjective well-being, and somatic health; 10 items rated on a 7 point likert scale with -3 reflecting "changed for the worst" and +3 indicating "changed for the better".
Change in Shared Care Instrument (SCI)
Time frame: 18 weeks post-baseline
PT perception of communication exchange regarding illness experience, subscales include communication, decision making, and reciprocity; 19 items divided into 3 summary scales, each item is scored in likert format from 0 to 5 with 0 indicating "completely disagree" and 5 indicating "completely agree". On the communication subscale a higher score indicates better communication. For the patient decision making subscale, higher scores indicate better patient decision making. For the patient reciprocity scale, higher scores indicate more reciprocity between patient and caregiver.
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 1 Jul 2024.
- Derived from this study: PubMed 40410637Ejem D, Bakitas M, Durant RW, Parker TN, Oppong KD, Esterson J, Odom JN, Wells RD, Boockvar K, Tinetti ME. Exploring the Acceptability and Feasibility of a Self-directed Approach to Identifying Health Priorities in a Sample of Southern Older African American Adults with Multiple Chronic Conditions. J Racial Ethn Health Disparities. 2026 Aug;13(4):2940-2957. doi: 10.1007/s40615-025-02469-8. Epub 2025 May 23.
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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.
Deborah Ejem, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "My Health Priorities" Identification Program in people with Multiple Chronic Conditions and Family Members, run by University of Alabama at Birmingham at 1 site in United States.
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 11 inclusion and 3 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 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
A single arm formative evaluation (qualitative interviews) exploring acceptability of the program (time frame: one-time interview six weeks following baseline questionnaires). The study lists 14 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 NCT05129709, which also lists 1 linked publication.
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 1 Jul 2024.