Randomized Trial of an HIV Navigation Program for Early Palliative Care
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/31/2018 |
| Start Date: | June 2013 |
| End Date: | July 31, 2017 |
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.
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.
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.
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.
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
We found this trial at
1
site
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
Click here to add this to my saved trials
