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Living Well Project for Persons With AIDS

6 de diciembre de 2019 actualizado por: Marcia McDonnell Holstad, DSN, FNP-BC, Emory University

The Living Well Project: Early Palliative Care and Motivational Interviewing (MI) for Persons With AIDS

The overall goal of this project is to implement and test the efficacy of an enhanced comprehensive multidisciplinary early palliative care (EPC) package that includes four motivational interviewing sessions (MI) for persons diagnosed with AIDS. We posit that the innovative EPC will improve quality of life, clinical and psychosocial outcomes and advance care planning in a cost effective manner and could promote engagement and retention in HIV care. If successful, it could serve as a model of early palliative care for persons with AIDS in the US.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The overall goal of this project is to improve the health and quality of life of persons living with HIV/AIDS (PLWH). To this end, we will implement an innovative model of enhanced early integrative palliative care services (EPC) for persons diagnosed with AIDS. Patients will be recruited from either the inpatient service or outpatient infectious disease program (IDP) at the Grady Health System (GHS) in Atlanta, Georgia. The AIDS EPC Package includes use of motivational interviewing (MI) to facilitate adjustment to disease and advance care planning decision making. The project has three specific aims:

Aim 1. Conduct a research clinical trial (RCT) to examine the efficacy of the AIDS EPC Package intervention vs. standard HIV care (SOC) and compare outcomes at 12 months post baseline. Our hypothesis is that those in the AIDS EPC group will have:

i. Better clinical outcomes: a lower one year mortality, higher proportion who initiate antiretroviral therapy (ART), higher proportion with virologic suppression, higher CD4 gain, fewer opportunistic infections (OI), fewer hospitalizations, lower depression scores, and better symptom management (including cognitive dysfunction).

ii. Better psychosocial outcomes: Better coping skills, higher perceived social support, higher spirituality, higher levels of self-advocacy, lower proportion who report substance use.

iii. Better Quality of Life (QOL) and a higher proportion who report advance care planning activities: named a surrogate; set personal goals regarding life saving measures; and discussed these goals with a surrogate.

SECONDARY OUTCOMES:

Aim 2. Evaluate the cost effectiveness and cost utility of the AIDS EPC Package compared to SOC where the outcomes are valued as survival and quality-adjusted life years (QALYs) respectively.

Aim 3. Promote engagement and retention in HIV care as evidenced by attending a greater proportion of scheduled appointments and reporting higher satisfaction with care compared to SOC.

Tipo de estudio

Intervencionista

Inscripción (Actual)

121

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Emory University, Nell Hodgson Woodruff School of Nursing

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Diagnosis of AIDS (using current Centers for Disease Control and Prevention criteria)
  • Detectable viral load (>1.6 log or > 40 copies per ml)
  • Not currently on ART
  • Age ≥18 years
  • Able to speak and write English
  • Able to give and understand consent
  • Willing to participate in study activities.

Exclusion Criteria:

  • Participants who have a Karnofsky score of 30 or less and are impaired in 5 activities of daily living (ADL) from this list: Bathing, dressing, transferring from bed or chair, walking, eating, toilet use, or grooming
  • Those not HIV infected
  • Minors under 18 years of age
  • Unable to read or understand English
  • Cognitive impairment
  • Actively psychotic
  • Severely depressed/suicidal
  • Pose a risk of harm to themselves or others

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: AIDS EPC Package plus MI
AIDS EPC Package plus MI: AIDS Early Palliative Care (EPC) Package and Motivational Interviewing (MI) At least one early Palliative Care visit plus four weekly MI sessions within a 3 month period of time.
Conductual: AIDS EPC Package plus MI
  1. Motivational Interviewing: In MI session #1, the nurse will set the agenda & ask the participant to discuss any adjustments to the AIDS diagnosis. In sessions #2 - 4, the participant will be asked to set the agenda related to current concerns. In sessions #3 & 4, the nurse will also introduce advance care planning.
  2. EPC Package: Participants will be seen by palliative care providers, for approximately 30 minutes each, in the following order: 1) Chaplain: introduces the concept of EPC clinic & conducts a spiritual evaluation/intervention as needed. 2) Social worker: conducts an evaluation/intervention as needed. 3) Psychologist: conducts an evaluation/intervention as needed. 4) Palliative Care Physician: conducts symptom management, medication reconciliation & coordination of care.
Otros nombres:
  • Entrevista motivacional
  • AIDS Early Palliative Care Package
Otro: Standard of Care (SOC)
The routine standard of care provider visit occurs in the following order. The vital signs are taken and the participant sees the nurse to review medications. The provider visits are scheduled for approximately 30 minutes, except for a new patient or patient with complex medical needs. The provider conducts a history to elicit symptoms, health problems, concerns, and a physical exam, then orders labs or immunizations; and referrals to subspecialty clinics. Medications are prescribed or renewed. The patient then receives a follow-up appointment, typically every 3 months for a stable patient. If the patient starts Antiretroviral therapy (ART), an appointment to the nurse educator is required. Typically, the patient will have 1- 2 visits to the nurse educator to begin medications and follow-up for side-effects.
Otro: Standard of Care (SOC)
Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment
Otro: Standard of Care (SOC)
The routine standard of care provider visit occurs in the following order. The vital signs are taken and the participant sees the nurse to review medications. The provider visits are scheduled for approximately 30 minutes, except for a new patient or patient with complex medical needs. The provider conducts a history to elicit symptoms, health problems, concerns, and a physical exam, then orders labs or immunizations; and referrals to subspecialty clinics. Medications are prescribed or renewed. The patient then receives a follow-up appointment, typically every 3 months for a stable patient. If the patient starts Antiretroviral therapy (ART), an appointment to the nurse educator is required. Typically, the patient will have 1- 2 visits to the nurse educator to begin medications and follow-up for side-effects.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Quality of Life
Periodo de tiempo: Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline
Change in Quality of Life (QOL) as measured by the McGill Quality of Life Questionnaire (MQOL) The MQOL has been widely used with persons with a life-threatening illness, including HIV/AIDS. It contains questions about physical wellbeing, physical symptoms, psychological symptoms, existential wellbeing and support in the past 2 days.A total score was computed.Scores range from 0 to 10 with higher scores indicating better perceived quality of life.
Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Clinical Indicator: Change in Mortality at 12 Months Post-baseline
Periodo de tiempo: Baseline, up to 12 months post- baseline
Number of deaths at 12 months post baseline
Baseline, up to 12 months post- baseline
Clinical Indicator: Change in Self-report Hospitalizations
Periodo de tiempo: Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline
Participants completed a survey asking about hospitalizations for HIV related problems and non-HIV related health problems in the past 3 months.Results are expressed in number of participants reporting a hospital stay in the previous 3 months.
Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline
Change in Self-reported Completion of Advanced Care Planning Activities: Health Care Decision Maker
Periodo de tiempo: Baseline, 6 months post-baseline, and 12-months post baseline
The Advanced Care Planning Questionnaire contained questions about 5 aspects of advanced care planning: 1) advanced care planning decisions made; 2) how well informed a participant feels about medical decision makers and making decisions; 3) how much a person has thought about medical decision making; 4) one's perceived confidence to make medical decisions; 5) one's readiness to make medical decisions. The results focus on decisions made regarding signing papers that name a health care decision maker (yes/no). Results are reported as the number of patients who report "yes".
Baseline, 6 months post-baseline, and 12-months post baseline
Change in Self-reported Completion of Advanced Care Planning Activities: Living Will
Periodo de tiempo: Baseline, 6 months post-baseline, and 12-months post baseline
The Advanced Care Planning Questionnaire contained questions about 5 aspects of advanced care planning: 1) advanced care planning decisions made; 2) how well informed a participant feels about medical decision makers and making decisions; 3) how much a person has thought about medical decision making; 4) one's perceived confidence to make medical decisions; 5) one's readiness to make medical decisions. The results focus on decisions made regarding signing papers for either advance directives or living will (yes/no). Results are reported as the number of patients who report "yes".
Baseline, 6 months post-baseline, and 12-months post baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Emory University

Colaboradores

Grady Health System

Investigadores

  • Investigador principal: Marcia McDonnell Holstad, phD, Emory University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de junio de 2014

Finalización primaria (Actual)

1 de junio de 2017

Finalización del estudio (Actual)

1 de junio de 2017

Fechas de registro del estudio

Enviado por primera vez

5 de febrero de 2013

Primero enviado que cumplió con los criterios de control de calidad

3 de mayo de 2013

Publicado por primera vez (Estimar)

7 de mayo de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de diciembre de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

6 de diciembre de 2019

Última verificación

1 de diciembre de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • IRB00059987
  • NIH/NINR-1R01NR014054-01 (Otro identificador: Other)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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