Living Well Project for Persons With AIDS

NCT ID: NCT01848483

Last Updated: 2019-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-06-30

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.

Conditions

Acquired Immunodeficiency Syndrome (AIDS)

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

AIDS EPC Package plus MI

Intervention Type: 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.

Standard of Care (SOC)

Intervention Type: 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.

Standard of Care (SOC)

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

Group Type: OTHER

Standard of Care (SOC)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

Motivational Interviewing; AIDS Early Palliative Care Package

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grady Health System

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Marcia McDonnell Holstad, DSN, FNP-BC

Principal Investigator, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcia McDonnell Holstad, phD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University, Nell Hodgson Woodruff School of Nursing

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NIH/NINR-1R01NR014054-01

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00059987

Identifier Type: -

Identifier Source: org_study_id