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Living Well Project for Persons With AIDS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01848483
Recruitment Status : Completed
First Posted : May 7, 2013
Results First Posted : December 30, 2019
Last Update Posted : December 30, 2019
Sponsor:
Collaborator:
Grady Health System
Information provided by (Responsible Party):
Marcia McDonnell Holstad, DSN, FNP-BC, 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.

Condition or disease Intervention/treatment Phase
Acquired Immunodeficiency Syndrome (AIDS) Behavioral: AIDS EPC Package plus MI Other: Standard of Care (SOC) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Living Well Project: Early Palliative Care and Motivational Interviewing (MI) for Persons With AIDS
Study Start Date : June 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: AIDS EPC Package plus MI
  1. Motivational Interviewing: In MI session #1, the nurse will set the agenda & ask the participant to discuss any adjustments to the AIDS diagnosis. In sessions #2 - 4, the participant will be asked to set the agenda related to current concerns. In sessions #3 & 4, the nurse will also introduce advance care planning.
  2. EPC Package: Participants will be seen by palliative care providers, for approximately 30 minutes each, in the following order: 1) Chaplain: introduces the concept of EPC clinic & conducts a spiritual evaluation/intervention as needed. 2) Social worker: conducts an evaluation/intervention as needed. 3) Psychologist: conducts an evaluation/intervention as needed. 4) Palliative Care Physician: conducts symptom management, medication reconciliation & coordination of care.
Other Names:
  • Motivational Interviewing
  • AIDS Early Palliative Care Package

Other: Standard of Care (SOC)
The routine standard of care provider visit occurs in the following order. The vital signs are taken and the participant sees the nurse to review medications. The provider visits are scheduled for approximately 30 minutes, except for a new patient or patient with complex medical needs. The provider conducts a history to elicit symptoms, health problems, concerns, and a physical exam, then orders labs or immunizations; and referrals to subspecialty clinics. Medications are prescribed or renewed. The patient then receives a follow-up appointment, typically every 3 months for a stable patient. If the patient starts Antiretroviral therapy (ART), an appointment to the nurse educator is required. Typically, the patient will have 1- 2 visits to the nurse educator to begin medications and follow-up for side-effects.

Standard of Care (SOC)
Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment
Other: Standard of Care (SOC)
The routine standard of care provider visit occurs in the following order. The vital signs are taken and the participant sees the nurse to review medications. The provider visits are scheduled for approximately 30 minutes, except for a new patient or patient with complex medical needs. The provider conducts a history to elicit symptoms, health problems, concerns, and a physical exam, then orders labs or immunizations; and referrals to subspecialty clinics. Medications are prescribed or renewed. The patient then receives a follow-up appointment, typically every 3 months for a stable patient. If the patient starts Antiretroviral therapy (ART), an appointment to the nurse educator is required. Typically, the patient will have 1- 2 visits to the nurse educator to begin medications and follow-up for side-effects.




Primary Outcome Measures :
  1. Change in Quality of Life [ Time Frame: 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 :
  1. Clinical Indicator: Change in Mortality at 12 Months Post-baseline [ Time Frame: Baseline, up to 12 months post- baseline ]
    Number of deaths at 12 months post baseline

  2. Clinical Indicator: Change in Self-report Hospitalizations [ Time Frame: 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.

  3. Change in Self-reported Completion of Advanced Care Planning Activities: Health Care Decision Maker [ Time Frame: 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".

  4. Change in Self-reported Completion of Advanced Care Planning Activities: Living Will [ Time Frame: 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".



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848483


Locations
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United States, Georgia
Emory University, Nell Hodgson Woodruff School of Nursing
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Grady Health System
Investigators
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Principal Investigator: Marcia McDonnell Holstad, phD Emory University
  Study Documents (Full-Text)

Documents provided by Marcia McDonnell Holstad, DSN, FNP-BC, Emory University:

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Responsible Party: Marcia McDonnell Holstad, DSN, FNP-BC, Principal Investigator, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01848483    
Other Study ID Numbers: IRB00059987
NIH/NINR-1R01NR014054-01 ( Other Identifier: Other )
First Posted: May 7, 2013    Key Record Dates
Results First Posted: December 30, 2019
Last Update Posted: December 30, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Marcia McDonnell Holstad, DSN, FNP-BC, Emory University:
Early Palliative Care
Motivational Interviewing
Persons Living With Human immunodeficiency virus(HIV)
Acquired Immunodeficiency Syndrome (AIDS)
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases