Addressing Communication Challenges Confronting Older African Americans With Multiple Chronic Conditions and Their Family Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- A single arm formative evaluation (qualitative interviews) exploring acceptability of program
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Patients
- •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
- •FCG willing to participate in study
- •Inclusion Criteria for FCG
- •identified by patient as his/her primary FCG
- •English-speaking; and 5) reliable internet and telephone access.
排除标准
- •for Patients and FCG
- •Axis I psychiatric disorder (schizophrenia, bipolar disorder), dementia
- •active substance use disorder
- •living in a nursing home or assisted living facility residence.
研究组 & 干预措施
"My Health Priorities" Identification Program
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.
干预措施: "My Health Priorities" Identification Program (Behavioral)
结局指标
主要结局
A single arm formative evaluation (qualitative interviews) exploring acceptability of program
时间窗: one-time interview six weeks following baseline questionnaires
Semi-structured interview of family caregivers (FCG) of patients with MCC
Change in Older Patient Assessment of Chronic Illness Care (O-PACIC)
时间窗: 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.
A single arm formative evaluation (qualitative interviews) exploring acceptability of the program
时间窗: one-time interview six weeks following baseline questionnaires
Semi-structured interview of patients with multiple chronic illness (MCC)
Program Completion Statistics
时间窗: 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
Clinical Shared Decision Making Questionnaire (CollaboRATE)
时间窗: Baseline
Patients with MCC-reported measure of clinical shared decision-making; 3 items requiring open-ended responses (no scale)
Older Patient Assessment of Chronic Illness Care (O-PACIC)
时间窗: 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)
时间窗: 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".
Bakas Caregiver Outcomes (BCOS)
时间窗: 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 Bakas Caregiver Outcomes (BCOS)
时间窗: 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".
Shared Care Instrument (SCI)
时间窗: 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.
System Usability Scale (ISUS)
时间窗: 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
Change in Treatment Burden Questionnaire (TBQ)
时间窗: 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)
时间窗: 18 weeks post-baseline
Patients with MCC-reported measure of clinical shared decision-making; 3 items requiring open-ended responses (no scale)
Change in Shared Care Instrument (SCI)
时间窗: 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.
次要结局
未报告次要终点
研究者
Deborah Ejem
Assistant Professor
University of Alabama at Birmingham