- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01775436
Palliative Care in People Living With HIV/AIDS: Integrating Into Standard of Care (FACE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Children's National Medical Center
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Washington, District of Columbia, United States, 20037
- George Washington University
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Washington, District of Columbia, United States, 20007
- Georgetown University Hospital
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Washington, District of Columbia, United States, 20010
- Institute for Clinical Research, Inc. (Affiliated with Department of Veterans Affairs Medical Center of Washington, DC)
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Washington, District of Columbia, United States, 20010
- MedStar Health Research Institute/Washington Hospital Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Patient Inclusion Criteria:
- 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
Surrogate Decision-maker inclusion criteria:
- Selected by patient
- Age 18 or older
- Willingness to discuss problems related to HIV and End Of Life (EOL)
- Absence of active psychosis, homicidal ideation, or suicidal ideation determined at baseline screening by trained RA
- Absence of HIV dementia, determined at screening using the HIV Dementia Scale cut off score of <10
- English speaking
- Consent to participate
- Knows HIV status of patient
Patient Exclusion Criteria:
- 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 Decision-maker Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Healthy Living Control
Two-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. |
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.
Other Names:
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.
Other Names:
|
Experimental: FAmily-CEntered Advance Care Planning
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. |
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.
Other Names:
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Statement of Treatment Preferences
Time Frame: Baseline and 3, 6, 12, 18 month post-intervention
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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.
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Baseline and 3, 6, 12, 18 month post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lyon Advance Care Planning Survey (Patient and Surrogate Version)
Time Frame: at baseline
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A 31-item instrument that assesses palliative care needs of PLWA of Black and non Black PLWA in DC metropolitan area
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at baseline
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Palliative Care Outcome Scale (POS)
Time Frame: Baseline, and 3, 6, 12 and 18 month post-intervention
|
This scale is a valid and reliable measure of patient's current health, social and psychological status.We are conducting a longitudinal study and therefore looking at multiple time frames for change in palliative care over time.
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Baseline, and 3, 6, 12 and 18 month post-intervention
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Medical Outcomes Study-HIV (MOS-HIV)
Time Frame: Baseline, and 3, 6, 12 and 18 month post-intervention
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Measures HIV specific Health Related Quality of Life; general health perceptions; pain; physical, role, cognitive and social functioning; mental health; energy/fatigue; health distress and quality of life.
This is a longitudinal study requiring multiple time frames so we can report change in quality of life over time, related to HIV specific symptoms.
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Baseline, and 3, 6, 12 and 18 month post-intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV Dementia Scale
Time Frame: Screen for eligibility at Baseline, 3, 6, 12 and 18 months post intervention
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Rapid screener to identify HIV dementia, which is an exclusion criteria.
However, once enrolled in the study we will track changes in status over time, per the longitudinal nature of this study.
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Screen for eligibility at Baseline, 3, 6, 12 and 18 months post intervention
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Psychological Interview
Time Frame: Baseline to screen to determine eligibility
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Questions to screen for homicidality and psychosis
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Baseline to screen to determine eligibility
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Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline screening to determine if eligible for participation, then at 3, 6, 12 and 18 month post-intervention follow-up
|
Patients or surrogates who present with severe depression or suicidality are excluded from this study.
However, once enrolled levels of depressive symptoms will be monitored over the course of this longitudinal study.
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Baseline screening to determine if eligible for participation, then at 3, 6, 12 and 18 month post-intervention follow-up
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Medication Adherence Self Report Inventory (MASRI)
Time Frame: Baseline and 3, 6, 12 and 18 month follow-up
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Validated self-report measure of medication adherence, using the Visual Analogue Scale for estimated adherence in the past month.
Measured multiple times as part of this longitudinal study.
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Baseline and 3, 6, 12 and 18 month follow-up
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Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted)
Time Frame: Baseline and 3, 6, 12 and 18-month post intervention
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Assesses the construct of spiritual functioning, specifically subscales for Forgiveness, Values and Believes will be used for study purposes.
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Baseline and 3, 6, 12 and 18-month post intervention
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Brief Religious Coping Questionnaire (Brief RCOPE)
Time Frame: Baseline and 3, 6, 12 and 18-month post-intervention
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Assesses positive and negative religious coping methods.
Study will use 14-item version.
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Baseline and 3, 6, 12 and 18-month post-intervention
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Satisfaction Scale
Time Frame: Immediately following Session 1 and Session 2, week 2 and week 3 of the study
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Process measure developed in pilot study to assess satisfaction.
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Immediately following Session 1 and Session 2, week 2 and week 3 of the study
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Longitudinal Satisfaction Questionnaire
Time Frame: 3, 6, 12 and 18 month post-intervention
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Process measure to assess longitudinal satisfaction with future decision making.
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3, 6, 12 and 18 month post-intervention
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Medical Chart Abstraction
Time Frame: Baseline and 3, 6, 12 and 18 month post intervention
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Mode of transmission, Cluster of Differentiation 4 (CD4) count, viral load, hospitalization, emergency room visit or dialysis since last study visit.
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Baseline and 3, 6, 12 and 18 month post intervention
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Threat Appraisal Scale (TAS)
Time Frame: Baseline, 3, 6, 12 and 18 month post-intervention
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Threat Appraisal Scale (TAS)is a questionnaire administered to the adolescent during baseline assessment only.
This measure will retrospectively estimate the adolescent's threat appraisal of cancer when adolescent learned of cancer diagnosis.
Test-retest reliability for this measure ranges from .68 in younger children to .93 in older children.
TAS scores are found to demonstrate a high degree of agreement with children's open-ended descriptions of negative life events, indicating adequate convergent validity of this measure.
Theoretically, threat appraisal is related to Lazarus' concept of primary appraisal, particularly to the way in which the event threatens the child's commitments, goals, or values.
Higher threat appraisals should lead to negative arousal and coping and to increased psychological symptoms.
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Baseline, 3, 6, 12 and 18 month post-intervention
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Maureen E Lyon, PhD, Children's National Research Institute
Publications and helpful links
General Publications
- 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.
- Lyon 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.
- Curtin 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.
- Lyon 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.
- Grill 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 1R01NR01405201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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