Randomized Trial of an HIV Navigation Program for Early Palliative Care

NCT01884389 | Completed Phase 2 DMC

• 2 other identifiers: RES121956R01NR014059
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV; Chronic Disease

Keywords

HIV; Chronic disease; Early palliative care; Patient navigation

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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)

Study Arms (2)

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.

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.

Interventions

Patient Navigation OTHER

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.

Patient Navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• currently enrolled in hospice care

Sponsors & Collaborators

• Case Western Reserve University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related 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.

  BACKGROUND

• 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.

  PMID: 22115794 BACKGROUND

• 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.

  PMID: 21628041 BACKGROUND

• 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. doi: 10.1016/j.jpainsymman.2005.04.011.

  PMID: 16310615 BACKGROUND

MeSH Terms

Conditions

Chronic Disease

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Jacquelyn Slomka, PhD RN

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: June 24, 2013
• Study Start: June 1, 2013
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: January 29, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)