HIVPhase 2NCT01884389
Randomized Trial of an HIV Navigation Program for Early Palliative Care
A Phase 2 study testing Patient Navigation in people with HIV and Chronic Disease, run by Case Western Reserve University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Chronic Disease
- What is being tested?
- Patient Navigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 31 Jul 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- currently enrolled in hospice care
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44106
About this study
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.
Read the detailed 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.
- Conditions
- HIV, Chronic Disease
- Being tested
- Patient Navigation
- Keywords
- HIV, Chronic disease, Early palliative care, Patient navigation
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient Navigation | Experimental | Patients are "admitted" to the navigation program, provided through a local community partner agency. Each of these subjects will be assigned an advanced practice nurse (APN) 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 (1, 2 or 3) will be confirmed for each patient, and the level will inform the amount of in-person and phone call contacts 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. Receives: Other: Patient Navigation |
| Usual Care | No intervention | The control group will receive "usual care" - medical care and support provided by their primary care provider. They will not receive any of the navigation program services. To provide control for the effects of attention, we will contact these subjects at baseline and every other month thereafter by phone. During these contacts, we will 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Participants will be followed for 36 months, with quality of life measured at baseline and change from baseline at 9mo, 18mo, 27mo, 36mo
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).
Measured: Participants will be followed for 36 months with symptom burden measured at baseline and change from baseline at 9mo, 18mo, 27mo, 36mo
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).
Measured: Participants will be followed for 36 months with coping ability measured at baseline and change from baseline at 9mo, 18mo, 27mo, 36mo
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startJun 2013
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Jacquelyn Slomka, Case Western Reserve University
- Investigators
- Jacquelyn Slomka, PhD RN, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884389
- Sponsor's protocol ID
- RES121956
- Other IDs
- R01NR014059
- Status last verified
- Jan 2018
- First submitted
- 14 Jun 2013
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: A goal of this project is to test a novel health service model that could be replicated in other sites and with other hospice organizations. Therefore, we will share results with HIV clinicians and researchers, and palliative care and hospice clinicians and researchers. For clinical audiences, we will to target national meetings, including the American Academy of Hospice and Palliative Medicine and Hospice and Palliative Nurses Association annual symposium. The National Hospice and Palliative Care Organization is another avenue for dissemination of this model of care. We also expect to use the Center for AIDS Research, where several of the study team members participate, as an opportunity for reaching researchers. Because previous research shows that specific palliative care needs vary among populations, we will make the de-identified data available so that other centers can evaluate similarities and differences from our population in order to apply our findings.
Publications
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.
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.
PubMed 22115794Fausto 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.
PubMed 21628041Karus 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. doi: 10.1016/j.jpainsymman.2005.04.011.
PubMed 16310615
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of an HIV Navigation Program for Early Palliative Care
- ClinicalTrials.gov ID
- NCT01884389
- Acronym / sponsor ID
- RES121956
- Conditions
- HIV, Chronic Disease
- Keywords
- HIV, Chronic disease, Early palliative care, Patient navigation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jun 2013
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 24 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Navigation | Experimental | Other: Patient NavigationPatients are "admitted" to the navigation program, provided through a local community partner agency. Each of these subjects will be assigned an advanced practice nurse (APN) 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 (1, 2 or 3) will be confirmed for each patient, and the level will inform the amount of in-person and phone call contacts 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. |
| Usual Care | No intervention | –The control group will receive "usual care" - medical care and support provided by their primary care provider. They will not receive any of the navigation program services. To provide control for the effects of attention, we will contact these subjects at baseline and every other month thereafter by phone. During these contacts, we will 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- currently enrolled in hospice care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient NavigationHome-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. | Other | Patient Navigation |
Primary outcome
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
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
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
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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- BackgroundCenters for Disease Control and Prevention. HIV/AIDS Surveillance Report. US Department of Health and Human Services, Centers for Disease Control and Prevention, 2007, 2009.
- Background: PubMed 22115794Merlin 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.
- Background: PubMed 21628041Fausto 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.
- Background: PubMed 16310615Karus 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. doi: 10.1016/j.jpainsymman.2005.04.011.
- Individual participant dataSharing planned: Yes. A goal of this project is to test a novel health service model that could be replicated in other sites and with other hospice organizations. Therefore, we will share results with HIV clinicians and researchers, and palliative care and hospice clinicians and researchers. For clinical audiences, we will to target national meetings, including the American Academy of Hospice and Palliative Medicine and Hospice and Palliative Nurses Association annual symposium. The National Hospice and Palliative Care Organization is another avenue for dissemination of this model of care. We also expect to use the Center for AIDS Research, where several of the study team members participate, as an opportunity for reaching researchers. Because previous research shows that specific palliative care needs vary among populations, we will make the de-identified data available so that other centers can evaluate similarities and differences from our population in order to apply our findings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacquelyn Slomka, PhD RN principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Patient Navigation in people with HIV and Chronic Disease, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01884389, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.