Randomized Trial of an HIV Navigation Program for Early Palliative Care

HIV Clinical Trial

Official title:

Randomized Trial of an HIV Navigation Program for Early Palliative Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884389
• Other study ID #: RES121956
• Secondary ID: R01NR014059
• Status: Completed
• Phase: Phase 2
• First received: June 14, 2013
• Last updated: January 25, 2018
• Start date: June 2013
• Est. completion date: July 31, 2017

Study information

• Verified date: January 2018
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is testing a navigation program for early palliative care provided in tandem with HIV primary care for persons living with HIV (PLWH) who are at high risk or mortality and morbidity related to their co-morbid chronic conditions. Participants are enrolled for a period of 36 months, with data collection at enrollment and every 9 months after, for a total of 5 data collection time points. Study participants enrolled will be randomized into one of two groups: control or intervention. Control group participants will receive control calls in between survey data collection time points. Intervention group participants will participate in a Navigation Program which includes home visits and phone calls with an advanced practice nurse (APN) and licensed social worker (LSW), as well as visits / calls by a volunteer if desired. The frequency of visits / calls will be determined based on level of need (high, medium or low).

The specific aims of the study are to: 1) identify needs and preferences for palliative care and advance care planning for PLWH, in order to tailor an existing Navigation Program for this study; 2) test the effectiveness of an HIV Navigation Program intervention on outcomes of quality of life, symptom burden, coping ability, and advance care planning; and 3) determine if effectiveness of the HIV Navigation Program intervention differs by age, gender, ethnicity, education, income level, and level of palliative care service need.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV dx for 2+ years

• English speaking

• lives within 50 miles of study headquarters

• at least one physical co-morbid condition

• receiving primary care at Institutional Review Board (IRB) approved clinic recruitment site

Exclusion Criteria:

• currently enrolled in hospice care

Related Conditions & MeSH terms

• Chronic Disease
• HIV

Intervention

Other:
• Patient Navigation
Home-based medical and social support services, as an extension of and collaboration with primary care services provided. Phone calls and visits scheduled based on patient's level of need. Communication with primary care team via navigation plan faxed / emailed as needed. Volunteers will also be matched with intervention patients to provide additional support services by phone / in-person visits.

Locations

Country	Name	City	State
United States	Case Western Reserve University	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Centers for Disease Control and Prevention. HIV/AIDS Surveillance Report. US Department of Health and Human Services, Centers for Disease Control and Prevention, 2007, 2009.

Fausto JA Jr, Selwyn PA. Palliative care in the management of advanced HIV/AIDS. Prim Care. 2011 Jun;38(2):311-26, ix. doi: 10.1016/j.pop.2011.03.010. Review. — View Citation

Karus D, Raveis VH, Alexander C, Hanna B, Selwyn P, Marconi K, Higginson I. Patient reports of symptoms and their treatment at three palliative care projects servicing individuals with HIV/AIDS. J Pain Symptom Manage. 2005 Nov;30(5):408-17. — View Citation

Merlin JS, Cen L, Praestgaard A, Turner M, Obando A, Alpert C, Woolston S, Casarett D, Kostman J, Gross R, Frank I. Pain and physical and psychological symptoms in ambulatory HIV patients in the current treatment era. J Pain Symptom Manage. 2012 Mar;43(3):638-45. doi: 10.1016/j.jpainsymman.2011.04.019. Epub 2011 Nov 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life	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).	Participants will be followed for 36 months, with quality of life measured at baseline and change from baseline at 9mo, 18mo, 27mo, 36mo
Primary	Symptom burden	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).	Participants will be followed for 36 months with symptom burden measured at baseline and change from baseline at 9mo, 18mo, 27mo, 36mo
Primary	Coping ability	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).	Participants will be followed for 36 months with coping ability measured at baseline and change from baseline at 9mo, 18mo, 27mo, 36mo
Primary	Advance Care Planning	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.	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)

External Links

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