Living Well Project for Persons With AIDS

Not Applicable

Completed

• Conditions: Acquired Immunodeficiency Syndrome (AIDS)
• Interventions: Behavioral: AIDS EPC Package plus MI; Other: Standard of Care (SOC)

• Registration Number: NCT01848483
• Lead Sponsor: Emory University

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.

Study Timeline

• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-05-03
• Study First Posted: 2013-05-07
• Study Start: 2014-06
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2019-12
• Results First Submitted: 2019-12-06
• Results First Submitted QC: 2019-12-06
• Last Update Submitted: 2019-12-06
• Results First Posted: 2019-12-30
• Last Update Posted: 2019-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AIDS EPC Package plus MI	AIDS EPC Package plus MI	AIDS EPC Package plus MI: AIDS Early Palliative Care (EPC) Package and Motivational Interviewing (MI) At least one early Palliative Care visit plus four weekly MI sessions within a 3 month period of time.
Standard of Care (SOC)	Standard of Care (SOC)	Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment
AIDS EPC Package plus MI	Standard of Care (SOC)	AIDS EPC Package plus MI: AIDS Early Palliative Care (EPC) Package and Motivational Interviewing (MI) At least one early Palliative Care visit plus four weekly MI sessions within a 3 month period of time.

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Indicator: Change in Mortality at 12 Months Post-baseline	Baseline, up to 12 months post- baseline	Number of deaths at 12 months post baseline
Clinical Indicator: Change in Self-report Hospitalizations	Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline	Participants completed a survey asking about hospitalizations for HIV related problems and non-HIV related health problems in the past 3 months.Results are expressed in number of participants reporting a hospital stay in the previous 3 months.
Change in Self-reported Completion of Advanced Care Planning Activities: Health Care Decision Maker	Baseline, 6 months post-baseline, and 12-months post baseline	The Advanced Care Planning Questionnaire contained questions about 5 aspects of advanced care planning: 1) advanced care planning decisions made; 2) how well informed a participant feels about medical decision makers and making decisions; 3) how much a person has thought about medical decision making; 4) one's perceived confidence to make medical decisions; 5) one's readiness to make medical decisions. The results focus on decisions made regarding signing papers that name a health care decision maker (yes/no). Results are reported as the number of patients who report "yes".
Change in Self-reported Completion of Advanced Care Planning Activities: Living Will	Baseline, 6 months post-baseline, and 12-months post baseline	The Advanced Care Planning Questionnaire contained questions about 5 aspects of advanced care planning: 1) advanced care planning decisions made; 2) how well informed a participant feels about medical decision makers and making decisions; 3) how much a person has thought about medical decision making; 4) one's perceived confidence to make medical decisions; 5) one's readiness to make medical decisions. The results focus on decisions made regarding signing papers for either advance directives or living will (yes/no). Results are reported as the number of patients who report "yes".

Trial Locations

Locations (1)

Emory University, Nell Hodgson Woodruff School of Nursing; 🇺🇸 Atlanta, Georgia, United States