Living Well Project for Persons With AIDS
This trial is active, not recruiting.
|Condition||acquired immunodeficiency syndrome (aids)|
|Treatments||aids epc package plus mi, standard of care (soc)|
|Collaborator||Grady Health System|
|Start date||June 2014|
|End date||June 2017|
|Trial size||121 participants|
|Trial identifier||NCT01848483, IRB00059987, NIH/NINR-1R01NR014054-01|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Primary purpose||supportive care|
Change in Quality of Life
time frame: Baseline and up to 12 months
Change in Clinical Indicators
time frame: 3, 6, and 12 months post- baseline
Male or female participants at least 18 years old.
Inclusion Criteria: - 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. Exclusion Criteria: - 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
|Official title||The Living Well Project: Early Palliative Care and Motivational Interviewing (MI) for Persons With AIDS|
|Principal investigator||Marcia McDonnell Holstad, DSN|
|Description||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. SECONDARY OUTCOMES: Aim 2. Evaluate the cost effectiveness and cost utility of the AIDS EPC Package compared to SOC where the outcomes are valued as survival and quality-adjusted life years (QALYs) respectively. Aim 3. Promote engagement and retention in HIV care as evidenced by attending a greater proportion of scheduled appointments and reporting higher satisfaction with care compared to SOC.|
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