Living Well Project for Persons With AIDS

NCT01848483 | Completed Results DMC

• 2 other identifiers: IRB00059987NIH/NINR-1R01NR014054-01
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Immunodeficiency Syndrome (AIDS)

Keywords

Early Palliative Care; Motivational Interviewing; Persons Living With Human immunodeficiency virus(HIV); Acquired Immunodeficiency Syndrome (AIDS)

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life

  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.

  Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline

Secondary Outcomes (4)

• 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

Study Arms (2)

AIDS EPC Package plus MI

EXPERIMENTAL

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; Other: Standard of Care (SOC)

Standard of Care (SOC)

OTHER

Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment

Other: Standard of Care (SOC)

Interventions

AIDS EPC Package plus MI BEHAVIORAL

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.

Also known as: Motivational Interviewing, AIDS Early Palliative Care Package

AIDS EPC Package plus MI

Standard of Care (SOC) OTHER

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.

AIDS EPC Package plus MI; Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Grady Health System: collaborator

Study Sites (1)

Emory University, Nell Hodgson Woodruff School of Nursing

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Motivational Interviewing; Standard of Care

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Marcia McDonnell Holstad
• Organization: Emory University

nurmmcd@emory.edu

404-727-1307

Study Officials

• Marcia McDonnell Holstad, phD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: May 7, 2013
• Study Start: June 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 30, 2019
• Results First Posted: December 30, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)