Clinical trial NCT01848483: Living Well Project for Persons With AIDS
Official title: The Living Well Project: Early Palliative Care and Motivational Interviewing (MI) for Persons With AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Immunodeficiency Syndrome (AIDS)
Keywords: Early Palliative Care
Motivational Interviewing
Persons Living With Human immunodeficiency virus(HIV)
Acquired Immunodeficiency Syndrome (AIDS)
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Grady Health System
First posted: 2013-05-07
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline
Secondary outcomes:
measure: Clinical Indicator: Change in Mortality at 12 Months Post-baseline
timeFrame: Baseline, up to 12 months post- baseline
measure: Clinical Indicator: Change in Self-report Hospitalizations
timeFrame: Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline
measure: Change in Self-reported Completion of Advanced Care Planning Activities: Health Care Decision Maker
timeFrame: Baseline, 6 months post-baseline, and 12-months post baseline
measure: Change in Self-reported Completion of Advanced Care Planning Activities: Living Will
timeFrame: Baseline, 6 months post-baseline, and 12-months post baseline
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University, Nell Hodgson Woodruff School of Nursing
state: Georgia
Study officials:
affiliation: Emory University
name: Marcia McDonnell Holstad, phD
role: PRINCIPAL_INVESTIGATOR
References: