Palliative Care in People Living With HIV/AIDS: Integrating Into Standard of Care
FACE
1 other identifier
interventional
444
1 country
5
Brief Summary
Our goal is to advance palliative care with persons living with AIDS (PLWA) or life-limiting co-morbidities to decrease suffering and increase quality of life (QOL). Left without advance care planning (ACP) for end-of-life decision, miscommunication and disagreements may result in families being charged with neglect or court battles over treatment choices, unmet care or delivery of unnecessary or unwanted care, and non-relative caregivers being dismissed (e.g. gay partners). We hope to increase families' understandings of their family member's wishes for end-of-life care to decrease conflict through the FAmily-CEntered Advance (FACE) Care Planning intervention. We will also study communication, quality of life, and spiritual struggle. Families will be randomized into either the Control (N=96 families) or the FACE Intervention (n=192 dyads). FACE families will meet with a trained/certified researcher for two 60-minute sessions scheduled one week apart: Session 1: The Respecting Choices Interview®; and Session 2: Completion of The Five Wishes©. Control families will also meet with a researcher for two 60-minute sessions scheduled one week apart: Session 1: Developmental History; and Session 2: Nutrition and Exercise. Questionnaires will be administered five times, Baseline and at 3, 6, 12 and 18 month post-intervention, for an average of 2 years. AIM 1. To determine the efficacy of FACE on congruence in treatment preferences between PLWA and their surrogates over time, and the effect of the pattern of congruence development trajectory on healthcare utilization (i.e., distal outcomes: number of hospitalizations, dialysis, ER visits). Hypothesis A: Development of congruence may not be homogeneous and FACE may influence the pattern of congruence development. Hypothesis B: Different patterns of congruence development may have different effects on health care utilization. Hypothesis C: Compared to Controls, FACE participants will better maintain congruence over time. AIM 2. To determine the efficacy of FACE on key components of QOL for PLWA. Hypothesis: FACE participants will increase or better maintain psychosocial QOL compared to Controls. AIM 3. To minimize health disparities in ACP between Blacks and non Blacks and identify factors associated with disparities. Hypothesis: Blacks in the FACE intervention will complete advance directives at a rate comparable to non Blacks, and at significantly greater rates compared to Controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv
Started Oct 2013
Typical duration for not_applicable hiv
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2012
CompletedFirst Posted
Study publicly available on registry
January 25, 2013
CompletedStudy Start
First participant enrolled
October 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2017
CompletedJuly 15, 2020
March 1, 2019
3.5 years
December 20, 2012
July 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Statement of Treatment Preferences
Measured by the Statement of Treatment Preferences. This measure was adapted using experts and community advisory board. It is a tool to express values and goals related to future medical decisions regarding frequently occurring situations specific to HIV/AIDS.Multiple Time Frames are needed as the Primary Outcome measure is going to report a change over time, per Aim 1: "to sustain congruence in treatment preferences between PLWA and their surrogate over time" compared to controls.
Baseline and 3, 6, 12, 18 month post-intervention
Secondary Outcomes (3)
Lyon Advance Care Planning Survey (Patient and Surrogate Version)
at baseline
Palliative Care Outcome Scale (POS)
Baseline, and 3, 6, 12 and 18 month post-intervention
Medical Outcomes Study-HIV (MOS-HIV)
Baseline, and 3, 6, 12 and 18 month post-intervention
Other Outcomes (10)
HIV Dementia Scale
Screen for eligibility at Baseline, 3, 6, 12 and 18 months post intervention
Psychological Interview
Baseline to screen to determine eligibility
Patient Health Questionnaire (PHQ-9)
Baseline screening to determine if eligible for participation, then at 3, 6, 12 and 18 month post-intervention follow-up
- +7 more other outcomes
Study Arms (2)
Healthy Living Control
ACTIVE COMPARATORTwo-60 to 90 minute sessions scheduled one week apart. Session 1: Developmental History: Goal: To take a non-medical developmental history. The Research Assistant (RA)-Control will conduct the session in a structured interview format. Administered with all medical questions removed to prevent any risk of contamination with the experimental condition. Session 2: Nutrition and Exercise: Assess nutritional status and provide advice for maintaining optimal nutrition to boost immune functioning. Administered by the RA Control and will be videotaped to control for what occurs in the FACE intervention.
FAmily-CEntered Advance Care Planning
EXPERIMENTALTwo-60 to 90 minute sessions scheduled one week apart. Session 1: Respecting Choices Interview (R)to facilitate conversations and shared decision-making between the patient and surrogate about palliative care \& prepare the surrogate to be able to fully represent the patient's wishes. Session 2: Five Wishes (C). Patient selects which person the patient wants to make health care decisions for him/her; the kind of medical treatment the patient wants; how comfortable the patient wants to be; how the patient wants people to treat him/her; what patient wants loved ones to know; and any spiritual or religious concerns the patient may have.
Interventions
Two-60 to 90 minute sessions scheduled one week apart. Session 1: Respecting Choices Interview (R)to facilitate conversations and shared decision-making between the patient and surrogate about palliative care \& prepare the surrogate to be able to fully represent the patient's wishes. Session 2: Five Wishes (C). Patient selects which person the patient wants to make health care decisions for him/her; the kind of medical treatment the patient wants; how comfortable the patient wants to be; how the patient wants people to treat him/her; what patient wants loved ones to know; and any spiritual or religious concerns the patient may have.
Session 1: Developmental History: Goal: To take a non-medical developmental history. The RA-Control will conduct the session in a structured interview format. Administered with all medical questions removed to prevent any risk of contamination with the experimental condition. Session 2: Nutrition and Exercise: Assess nutritional status and provide advice for maintaining optimal nutrition to boost immune functioning. Administered by the RA Control and will be videotaped to control for what occurs in the FACE intervention.
Eligibility Criteria
You may qualify if:
- HIV positive outpatients or inpatients with detectable viral load (\>200 copies) twice in the past 1 year period OR CD4 count \<200 OR with a co-morbidity that may significantly limit life expectancy, including malignancy, cirrhosis, cardiomyopathy, etc.
- Patients with AIDS receiving dialysis, inpatients or outpatients
- Patients not in the Intensive Care Unit (ICU)
- Age 21 years or older
- All ethnic groups
- Male or female
- Knows his/her HIV status
- English speaking
- Absence of active psychosis or homicidal or suicidal ideation, determined at baseline screening by a trained research assistant as assessed by questions from a structured questionnaire
- Absence of HIV dementia, determined at screening using the HIV Dementia Scale cut off score of \<10
- No evidence of developmental delay
- Consent from surrogate
- Consent from persons living with AIDS (PLWA) aged 21 or older
- Selected by patient
- Age 18 or older
- +6 more criteria
You may not qualify if:
- Patients in the ICU
- Age under 21 years old
- Patient unaware of HIV status
- Active psychosis or homicidal or suicidal ideation, determined at baseline screening by a trained research assistant as assessed by questions from a structured questionnaire
- Presence fo HIV Dementia at baseline
- Developmental delay
- Unable to find willing consented surrogate
- Surrogate under age of 18 years old
- Unwilling to discuss problems related to HIV and EOL
- Active psychosis or homicidal or suicidal ideation, determined at baseline screening by a trained research assistant as assessed by questions from a structured questionnaire
- Not an English speaker
- Unwilling to consent to participate and does not know HIV status of patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's National Research Institutelead
- Georgetown Universitycollaborator
- George Washington Universitycollaborator
- VA Medical Centercollaborator
- Medstar Health Research Institutecollaborator
Study Sites (5)
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Institute for Clinical Research, Inc. (Affiliated with Department of Veterans Affairs Medical Center of Washington, DC)
Washington D.C., District of Columbia, 20010, United States
MedStar Health Research Institute/Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
George Washington University
Washington D.C., District of Columbia, 20037, United States
Related Publications (5)
Kimmel AL, Wang J, Scott RK, Briggs L, Lyon ME. FAmily CEntered (FACE) advance care planning: Study design and methods for a patient-centered communication and decision-making intervention for patients with HIV/AIDS and their surrogate decision-makers. Contemp Clin Trials. 2015 Jul;43:172-8. doi: 10.1016/j.cct.2015.06.003. Epub 2015 Jun 2.
PMID: 26044463RESULTLyon ME, Squires L, D'Angelo LJ, Benator D, Scott RK, Greenberg IH, Tanjutco P, Turner MM, Weixel TE, Cheng YI, Wang J. FAmily-CEntered (FACE) Advance Care Planning Among African-American and Non-African-American Adults Living With HIV in Washington, DC: A Randomized Controlled Trial to Increase Documentation and Health Equity. J Pain Symptom Manage. 2019 Mar;57(3):607-616. doi: 10.1016/j.jpainsymman.2018.11.014. Epub 2018 Nov 23.
PMID: 30472318RESULTCurtin KB, Cheng YI, Wang J, Scott RK, Squires L, Benator DA, Lyon ME; Palliative Care Consortiums. Quality of life of persons living with HIV and congruence with surrogate decision-makers. Qual Life Res. 2019 Jan;28(1):47-56. doi: 10.1007/s11136-018-2002-5. Epub 2018 Sep 15.
PMID: 30219937RESULTLyon ME, Squires L, Scott RK, Benator D, Briggs L, Greenberg I, D'Angelo LJ, Cheng YI, Wang J. Effect of FAmily CEntered (FACE(R)) Advance Care Planning on Longitudinal Congruence in End-of-Life Treatment Preferences: A Randomized Clinical Trial. AIDS Behav. 2020 Dec;24(12):3359-3375. doi: 10.1007/s10461-020-02909-y.
PMID: 32399799RESULTGrill KB, Wang J, Cheng YI, Lyon ME. The Role of Religiousness and Spirituality in Health-related Quality of Life of Persons Living with HIV: A Latent Class Analysis. Psycholog Relig Spiritual. 2020 Nov;12(4):494-504. doi: 10.1037/rel0000301. Epub 2020 Jan 30.
PMID: 33777311RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maureen E Lyon, PhD
Children's National Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Assessor did not know which study arm the participant was randomized to.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 20, 2012
First Posted
January 25, 2013
Study Start
October 13, 2013
Primary Completion
March 28, 2017
Study Completion
March 28, 2017
Last Updated
July 15, 2020
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will become available on June 30, 2018 and for a period of two years.
- Access Criteria
- Researchers or graduate students in need of a master's theses or dissertation project from academic settings, e.g. university or academic/research hospital will be allowed to have access to de-identified data. Contact the PI Dr. Lyon at mlyon@childrensnational.org.
There is a plan to make de-identified individual participant data (IPD) collected in this study, which are not part of the specific aims, available for secondary analysis, to be shared with other researchers by submitting a request to the PI, Dr. Lyon.