Trial record 10 of 45 for:    " January 13, 2013":" February 12, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Living Well Project

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Emory University
Sponsor:
Collaborator:
Grady Health System
Information provided by (Responsible Party):
Marcia McDonnell Holstad, DSN, FNP-BC, Emory University
ClinicalTrials.gov Identifier:
NCT01848483
First received: February 5, 2013
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

The overall goal of this project is to implement and test the efficacy of an enhanced comprehensive multidisciplinary early palliative care package that includes four motivational interviewing sessions (EPC) for persons newly 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 Intervention
Acquired Immunodeficiency Syndrome (AIDS)
Behavioral: AIDS EPC Package plus MI
Other: Standard of Care (SOC)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: The Living Well Project: Early Palliative Care and Motivational Interviewing (MI) for Persons With AIDS

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Change in Quality of Life [ Time Frame: Baseline and up to 12 months ] [ Designated as safety issue: No ]
    Change in Quality of Life (QOL) as measured by the McGill Quality of Life Questionnaire (MQOL)


Secondary Outcome Measures:
  • Change in Clinical Indicators [ Time Frame: 3, 6, and 12 months post- baseline ] [ Designated as safety issue: No ]
    Change in clinical indicators: 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, all as measured by medical record review. Lower depression scores will be assessed using Center for Epidemiologic Studies Depression Scale (CES-D). Symptom management will be assessed using the Edmonton Symptom Assessment Scale (ESAS). Cognitive dysfunction will be measured using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).


Other Outcome Measures:
  • Change in Psychosocial outcomes [ Time Frame: 3, 6, and 12 months post-baseline ] [ Designated as safety issue: No ]
    Change in coping skills using the Brief Cope Scale, higher perceived social support using the Medical Outcomes Study Social Support Survey (MOS-SSS), higher spirituality using the Spiritual Well-being Scale (SWB), higher levels of self-advocacy using the Patient Self-Advocacy Scale (PSAS), lower proportion who report substance use using the Substance Abuse Module of the Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-IV Axis I diagnoses (SCID).

  • Change in engagement and retention in HIV care [ Time Frame: 3, 6, and 12-months post baseline ] [ Designated as safety issue: No ]
    Change in engagement and retention in HIV care will be measured by recording appointments for HIV care and study appointment and whether these were kept, cancelled, rescheduled, or not kept. These data are available from the electronic medical record and study tracking records. The Patient Satisfaction Questionnaire (PSQ-18) will be used to document satisfaction with health care.


Estimated Enrollment: 240
Study Start Date: June 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIDS EPC Package plus MI
AIDS EPC Package plus MI - AIDS Early Palliative Care (EPC)Package and Motivational Interviewing (MI) Three Early Palliative Care visits plus four weekly MI sessions within a 3 month period of time.
Behavioral: AIDS EPC Package plus MI
In the first MI session, the nurse will set the agenda and ask the participant to discuss any adjustments to the AIDS diagnosis. The next three sessions, the participant will be asked to set the agenda related to current concerns. In the third and fourth sessions, the nurse will also introduce advance care planning. The standardized AIDS EPC Package consultation will last approximately 30 minutes in the following order: 1) Chaplain: introduces the concept of EPC clinic and conducts a spiritual evaluation/intervention as needed. 2) Social worker: conducts an evaluation/intervention as needed. 3) Psychologist: conducts an evaluation and intervention as needed. 4) Palliative Care Physician: conducts symptom management, medication reconciliation and coordination of care.
Other Names:
  • Motivational Interviewing
  • AIDS Early Palliative Care Package
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 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.

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 newly 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • new diagnosis of AIDS (using current Centers for Disease Control and Prevention criteria) within 6 months
  • Age ≥18 years
  • Able to speak and write English
  • not currently on ART
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01848483

Contacts
Contact: Amy Lovvorn, MPH 404-727-8323 amy.lovvorn@emory.edu
Contact: Marcia McDonnell Holstad, DSN 404-727-1307 nurmmcd@emory.edu

Locations
United States, Georgia
Emory University, Nell Hodgson Woodruff School of Nursing Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Amy Lovvorn, MPH    404-727-8323    amy.lovvorn@emory.edu   
Contact: Marcia McDonnell Holstad, DSN    404-727-1307    nurmmcd@emory.edu   
Principal Investigator: Marcia McDonnell Holstad, DSN         
Sponsors and Collaborators
Emory University
Grady Health System
Investigators
Principal Investigator: Marcia McDonnell Holstad, DSN Emory University
  More Information

No publications provided

Responsible Party: Marcia McDonnell Holstad, DSN, FNP-BC, Principal Investigator, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT01848483     History of Changes
Other Study ID Numbers: IRB00059987, NIH/NINR-1R01NR014054-01
Study First Received: February 5, 2013
Last Updated: April 30, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by Emory University:
Early Palliative Care
Motivational Interviewing
Persons Living With Human immunodeficiency virus(HIV)
Acquired Immunodeficiency Syndrome (AIDS)

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014