The Living Well Project: Early Palliative Care and Motivational Interviewing (MI) for Persons With AIDS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Change in Quality of Life
研究概览
简要总结
The overall goal of this project is to implement and test the efficacy of an enhanced comprehensive multidisciplinary early palliative care (EPC) package that includes four motivational interviewing sessions (MI) for persons diagnosed with AIDS. We posit that the innovative EPC will improve quality of life, clinical and psychosocial outcomes and advance care planning in a cost effective manner and could promote engagement and retention in HIV care. If successful, it could serve as a model of early palliative care for persons with AIDS in the US.
详细描述
The overall goal of this project is to improve the health and quality of life of persons living with HIV/AIDS (PLWH). To this end, we will implement an innovative model of enhanced early integrative palliative care services (EPC) for persons diagnosed with AIDS. Patients will be recruited from either the inpatient service or outpatient infectious disease program (IDP) at the Grady Health System (GHS) in Atlanta, Georgia. The AIDS EPC Package includes use of motivational interviewing (MI) to facilitate adjustment to disease and advance care planning decision making. The project has three specific aims:
Aim 1. Conduct a research clinical trial (RCT) to examine the efficacy of the AIDS EPC Package intervention vs. standard HIV care (SOC) and compare outcomes at 12 months post baseline. Our hypothesis is that those in the AIDS EPC group will have:
i. Better clinical outcomes: a lower one year mortality, higher proportion who initiate antiretroviral therapy (ART), higher proportion with virologic suppression, higher CD4 gain, fewer opportunistic infections (OI), fewer hospitalizations, lower depression scores, and better symptom management (including cognitive dysfunction).
ii. Better psychosocial outcomes: Better coping skills, higher perceived social support, higher spirituality, higher levels of self-advocacy, lower proportion who report substance use.
iii. Better Quality of Life (QOL) and a higher proportion who report advance care planning activities: named a surrogate; set personal goals regarding life saving measures; and discussed these goals with a surrogate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of AIDS (using current Centers for Disease Control and Prevention criteria)
- •Detectable viral load (>1.6 log or > 40 copies per ml)
- •Not currently on ART
- •Age ≥18 years
- •Able to speak and write English
- •Able to give and understand consent
- •Willing to participate in study activities.
排除标准
- •Participants who have a Karnofsky score of 30 or less and are impaired in 5 activities of daily living (ADL) from this list: Bathing, dressing, transferring from bed or chair, walking, eating, toilet use, or grooming
- •Those not HIV infected
- •Minors under 18 years of age
- •Unable to read or understand English
- •Cognitive impairment
- •Actively psychotic
- •Severely depressed/suicidal
- •Pose a risk of harm to themselves or others
结局指标
主要结局
Change in Quality of Life
时间窗: Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline
Change in Quality of Life (QOL) as measured by the McGill Quality of Life Questionnaire (MQOL) The MQOL has been widely used with persons with a life-threatening illness, including HIV/AIDS. It contains questions about physical wellbeing, physical symptoms, psychological symptoms, existential wellbeing and support in the past 2 days.A total score was computed.Scores range from 0 to 10 with higher scores indicating better perceived quality of life.
次要结局
- Clinical Indicator: Change in Mortality at 12 Months Post-baseline(Baseline, up to 12 months post- baseline)
- Clinical Indicator: Change in Self-report Hospitalizations(Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline)
- Change in Self-reported Completion of Advanced Care Planning Activities: Health Care Decision Maker(Baseline, 6 months post-baseline, and 12-months post baseline)
- Change in Self-reported Completion of Advanced Care Planning Activities: Living Will(Baseline, 6 months post-baseline, and 12-months post baseline)
研究者
Marcia McDonnell Holstad, DSN, FNP-BC
Principal Investigator, Professor
Emory University