Randomized Trial of an HIV Navigation Program for Early Palliative Care

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Case Western Reserve University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jacquelyn Slomka, PhD, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01884389
First received: June 14, 2013
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

With the advent of effective antiretroviral treatment for HIV has come a marked increase in the number of persons living with HIV/AIDS (PLWHA), with the highest prevalence since the epidemic began of more than 1.2 million. While PLWHA survive longer, they also experience increased burdens of chronic conditions related to lifestyle factors, treatment side effects, and age. PLWHA are a population at great risk for high symptom burden, impaired coping and social functioning, decreased quality of life, and inadequate end-of-life care. The remarkable shift in attitudes towards HIV, from an inevitably fatal disease to a chronic condition, has been accompanied by a lessening emphasis on symptom management and end-of-life planning. However, while mortality from AIDS-defining conditions has decreased, PLWHA continue to have unaddressed needs for coordinated care, symptom management and proactive advance care planning. Palliative care, focused on comprehensive management of physical, psychological, social, and spiritual needs of persons with incurable, progressive illnesses, is a health service uniquely designed to meet these needs. This research project will test a model of early palliative care for PLWHA at high risk of mortality and morbidity. First, focus group methods will be used to explore views of PLWHA regarding their needs for symptom management and social support, and attitudes towards advance care planning and end-of-life concerns. We will then conduct a randomized trial of a novel HIV Navigation Program, which will be a modification of an existing navigation program that uses trained and experienced volunteers as a core component, offered by a large, comprehensive hospice and palliative care organization. The specific aims of this study are 1) to identify needs and preferences for palliative care and advance care planning of PLWHA, in order to tailor an existing Patient Navigation Program to the specific needs of PLWHA with chronic conditions; and 2) to test the effect of an HIV Patient Navigation Program intervention on outcomes of quality of life, symptom burden, coping ability, and advance care planning; and 3) to determine if effectiveness of the HIV Navigation Program intervention differs by age, gender, ethnicity, education, income level, and level of palliative care service need. Because of the increasing prevalence of HIV coexisting with chronic conditions, there is an urgent need to assess palliative care needs and preferences of PLWHA and design effective interventions. This interdisciplinary study will test, at the community level, a novel health service designed to meet the unique needs of chronically ill PLWHA, and improve and support advance care planning. Results from this study will increase understanding of who are PLWHA at highest risk for need of palliative services and provide a model for providing early palliative care support for PLWHA.


Condition Intervention Phase
HIV
Chronic Disease
Other: Patient Navigation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Randomized Trial of an HIV Navigation Program for Early Palliative Care

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: Participants will be followed for 36 months, with quality of life measured at baseline and change from baseline at 9mo, 18mo, 27mo, 36mo ] [ Designated as safety issue: No ]
    Using HIV/AIDS Targeted Quality of Life (HAT_QoL) Instrument. It has 34 items measuring 9 dimensions of quality of life on a continuous scale of 0 (worst) to 10 (best).

  • Symptom burden [ Time Frame: Participants will be followed for 36 months with symptom burden measured at baseline and change from baseline at 9mo, 18mo, 27mo, 36mo ] [ Designated as safety issue: No ]
    Symptom burden (type and intensity of symptoms) using the Edmonton Symptom Assessment Scale, which has 10 items to measure a total of 10 symptoms on a continuous scale of 0 (no symptom present) to 10 (most severe level).

  • Coping ability [ Time Frame: Participants will be followed for 36 months with coping ability measured at baseline and change from baseline at 9mo, 18mo, 27mo, 36mo ] [ Designated as safety issue: No ]
    The Brief COPE will be used to measure illness coping ability. It measures 14 different coping constructs on a scale of 1 (I haven't been doing this at all) to 4 (I've been doing this a lot).

  • Advance Care Planning [ Time Frame: Participants will be assessed at baseline and up to every 6 months over a 36-month period for evidence of completion of advance care planning (yes/no) ] [ Designated as safety issue: No ]
    Advance care planning evidenced by number of participants completing an advance directive (living will and/or health proxy/health care power of attorney), or other documentation of initiation and/or implementation of advance care planning.


Estimated Enrollment: 180
Study Start Date: June 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patient Navigation

Subjects randomized to the intervention / patient navigation arm will be formally "admitted" to the navigation program, provided through a local community partner agency. Each of these subjects will be assigned an advanced practice registered nurse (APRN) and licensed social worker (LSW) as co-case managers, with their relative contributions depending on the nature of the subject's needs. Level of need will be confirmed for each patient. Depending on the level of need (1,2 or 3) a varying amount of in-person and phone call contacts will be made to provide on-going support and monitoring of patients.

Additionally, this group will meet with the research team for data collection at enrollment and at four 9-month intervals for a total of 5 time points.

Other: Patient Navigation
No Intervention: Usual Care

The control group will receive "usual care" - medical care and support provided by their primary care provider. They will not be exposed to any of the navigation program services. To provide control for the effects of attention, we will contact these subjects at baseline, one week after enrollment, and every other month thereafter, either by phone or during their regularly scheduled appointments with the primary care provider. During these contacts, we will ask about resource use (hospitalizations, clinic and emergency department visits) and medication adherence and ask a scripted "social" query (e.g. "How are things going for you?"). A subject who raises any health issues or need for specific information will be referred to the primary care provider.

Additionally, this group will meet with the research team for data collection at enrollment and at four 9-month intervals for a total of 5 time points.


  Eligibility

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

Inclusion Criteria:

  • HIV dx for 2+ years
  • English speaking
  • lives within 30miles of study headquarters
  • at least one co-morbid condition
  • receiving primary care at Institutional Review Board (IRB) approved clinic recruitment site

Exclusion Criteria:

  • currently enrolled in hospice care
  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: NCT01884389

Contacts
Contact: Jacquelyn Slomka, PhD RN 216-368-5990 jxs80@case.edu
Contact: Evelina DiFranco, MPH 216-368-8848 exd138@case.edu

Locations
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Jacquelyn Slomka, PhD, RN    216-368-5990    jxs80@case.edu   
Contact: Evelina DiFranco, MPH    216-368-8848    exd138@case.edu   
Principal Investigator: Jacquelyn Slomka, PhD RN         
Sub-Investigator: Barbara J Daly, PhD RN         
Sub-Investigator: Allison R Webel, PhD RN         
Sub-Investigator: Maryjo Prince-Paul, PhD APRN         
Sub-Investigator: Benigno Rodriguez, MD         
Sub-Investigator: Mendel E Singer, PhD         
Sub-Investigator: Charles V Wellman, MD         
Sub-Investigator: Nahida H Gordon, PhD         
Sponsors and Collaborators
Case Western Reserve University
Investigators
Principal Investigator: Jacquelyn Slomka, PhD RN Case Western Reserve University
  More Information

Additional Information:
Publications:
Responsible Party: Jacquelyn Slomka, PhD, Assistant Professor, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01884389     History of Changes
Other Study ID Numbers: RES121956, R01NR014059
Study First Received: June 14, 2013
Last Updated: June 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Case Western Reserve University:
HIV
Chronic disease
Early palliative care
Patient navigation

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 18, 2014