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Palliative Care in People Living With HIV/AIDS: Integrating Into Standard of Care (FACE)

13. července 2020 aktualizováno: Maureen Lyon, Children's National Research Institute

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Our goal is to advance palliative care with persons living with AIDS (PLWA) or life-limiting co-morbidities aimed at relieving suffering and maximizing quality of life. One objective is to identify variables which influence decision-making with respect to advance care planning (ACP) for PLWA, as well as to determine the unique person-centered needs of subgroups of PLWA, as these are unknown. The negative consequences of no ACP or poor ACP include: unmet care or delivery of unnecessary or unwanted care, conflict erupting in the ICU, or the importance of non-relative caregivers being dismissed, for example gay partners. A second objective is to identify a "best approach" for standard of care in ACP, a key component of palliative care, as an end of life support. This approach may minimize health disparities in the likelihood of both identifying a surrogate decision-maker and using advance directives. We propose building on our evidence based, theoretical model, FAmily-CEntered (FACE) Advance Care Planning intervention, an HIV specific ACP program for Black teens which gained acceptance and demonstrated efficacy through increased congruence in treatment preferences and universal complete of advance directives with a surrogate decision-maker. Given the demonstrated needs and benefits of ACP and the low utilization among adult Black PLWA, we propose meeting this need by building on our FACE model with adults living with advanced AIDS and/or life-limiting co-morbidities in Washington, District of Columbia (DC) a city with endemic HIV and significant health disparities in death rates by race in an adequately-powered, randomized, clinical, 2-arm, single-blinded, controlled trial. We will test the efficacy of the FACE intervention for increasing congruence in end-of-life treatment preferences between PLWA and their surrogate decision-maker, to determine if increased congruence can be maintained over time. We will also determine if FACE is acceptable to primarily Black inner city adult PLWA. We will recruit from four hospital-based clinics and randomize 288 patient/surrogate dyads (N=576 subjects) in a 2:1 ratio to either FACE Intervention (N=192 dyads) or Control (N=96 dyads). Participants with HIV dementia, suicidality, homicidality or psychosis will be excluded. Two 60-minuted sessions will be conducted with a trained/certified facilitator at weekly intervals: FACE Session 1: The Respecting Choices Interview (R); Session 2: Completion of The Five Wishes (c). Control will also be administered in a dyadic format: Session 1: Developmental History; Session 2: Nutrition and Exercise. Standardized self-report measures will be administered at baseline, 3 month post-intervention 6 month post-intervention, 12 month post-intervention, and 18 month post-intervention. Thus, participants will be followed for an average of 2 years. This will be the first study to test an ACP model, integrating person-centered (GMM) and variable-centered analysis (GEE) to assess study outcomes.

Typ studie

Intervenční

Zápis (Aktuální)

444

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • District of Columbia
      • Washington, District of Columbia, Spojené státy, 20010
        • Children's National Medical Center
      • Washington, District of Columbia, Spojené státy, 20037
        • George Washington University
      • Washington, District of Columbia, Spojené státy, 20007
        • Georgetown University Hospital
      • Washington, District of Columbia, Spojené státy, 20010
        • Institute for Clinical Research, Inc. (Affiliated with Department of Veterans Affairs Medical Center of Washington, DC)
      • Washington, District of Columbia, Spojené státy, 20010
        • MedStar Health Research Institute/Washington Hospital Center

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.
Behaviorální: 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.

Ostatní jména:
  • TVÁŘ
Behaviorální: Healthy Living Control

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.

Ostatní jména:
  • HLC
Experimentální: 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.
Behaviorální: 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.

Ostatní jména:
  • TVÁŘ
Behaviorální: Healthy Living Control

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.

Ostatní jména:
  • HLC

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Statement of Treatment Preferences
Časové okno: Baseline and 3, 6, 12, 18 month post-intervention
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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Lyon Advance Care Planning Survey (Patient and Surrogate Version)
Časové okno: at baseline
A 31-item instrument that assesses palliative care needs of PLWA of Black and non Black PLWA in DC metropolitan area
at baseline
Palliative Care Outcome Scale (POS)
Časové okno: 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.
Baseline, and 3, 6, 12 and 18 month post-intervention
Medical Outcomes Study-HIV (MOS-HIV)
Časové okno: Baseline, and 3, 6, 12 and 18 month post-intervention
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.
Baseline, and 3, 6, 12 and 18 month post-intervention

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
HIV Dementia Scale
Časové okno: Screen for eligibility at Baseline, 3, 6, 12 and 18 months post intervention
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.
Screen for eligibility at Baseline, 3, 6, 12 and 18 months post intervention
Psychological Interview
Časové okno: Baseline to screen to determine eligibility
Questions to screen for homicidality and psychosis
Baseline to screen to determine eligibility
Patient Health Questionnaire (PHQ-9)
Časové okno: 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.
Baseline screening to determine if eligible for participation, then at 3, 6, 12 and 18 month post-intervention follow-up
Medication Adherence Self Report Inventory (MASRI)
Časové okno: Baseline and 3, 6, 12 and 18 month follow-up
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.
Baseline and 3, 6, 12 and 18 month follow-up
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted)
Časové okno: Baseline and 3, 6, 12 and 18-month post intervention
Assesses the construct of spiritual functioning, specifically subscales for Forgiveness, Values and Believes will be used for study purposes.
Baseline and 3, 6, 12 and 18-month post intervention
Brief Religious Coping Questionnaire (Brief RCOPE)
Časové okno: Baseline and 3, 6, 12 and 18-month post-intervention
Assesses positive and negative religious coping methods. Study will use 14-item version.
Baseline and 3, 6, 12 and 18-month post-intervention
Satisfaction Scale
Časové okno: Immediately following Session 1 and Session 2, week 2 and week 3 of the study
Process measure developed in pilot study to assess satisfaction.
Immediately following Session 1 and Session 2, week 2 and week 3 of the study
Longitudinal Satisfaction Questionnaire
Časové okno: 3, 6, 12 and 18 month post-intervention
Process measure to assess longitudinal satisfaction with future decision making.
3, 6, 12 and 18 month post-intervention
Medical Chart Abstraction
Časové okno: Baseline and 3, 6, 12 and 18 month post intervention
Mode of transmission, Cluster of Differentiation 4 (CD4) count, viral load, hospitalization, emergency room visit or dialysis since last study visit.
Baseline and 3, 6, 12 and 18 month post intervention
Threat Appraisal Scale (TAS)
Časové okno: Baseline, 3, 6, 12 and 18 month post-intervention
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.
Baseline, 3, 6, 12 and 18 month post-intervention

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Children's National Research Institute

Spolupracovníci

Georgetown University
George Washington University
Medstar Health Research Institute
VA Medical Center

Vyšetřovatelé

  • Vrchní vyšetřovatel: Maureen E Lyon, PhD, Children's National Research Institute

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

13. října 2013

Primární dokončení (Aktuální)

28. března 2017

Dokončení studie (Aktuální)

28. března 2017

Termíny zápisu do studia

První předloženo

20. prosince 2012

První předloženo, které splnilo kritéria kontroly kvality

22. ledna 2013

První zveřejněno (Odhad)

25. ledna 2013

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

15. července 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

13. července 2020

Naposledy ověřeno

1. března 2019

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 1R01NR01405201

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.

Časový rámec sdílení IPD

Data will become available on June 30, 2018 and for a period of two years.

Kritéria přístupu pro sdílení IPD

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.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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