Living Well Project for Persons With AIDS
The Living Well Project: Early Palliative Care and Motivational Interviewing (MI) for Persons With AIDS
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Georgia
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Atlanta、Georgia、アメリカ、30322
- Emory University, Nell Hodgson Woodruff School of Nursing
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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他の名前：
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.
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他の：Standard of Care (SOC)
Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Quality of Life
時間枠：Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline
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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.
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Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Clinical Indicator: Change in Mortality at 12 Months Post-baseline
時間枠：Baseline, up to 12 months post- baseline
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Number of deaths at 12 months post baseline
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Baseline, up to 12 months post- baseline
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Clinical Indicator: Change in Self-report Hospitalizations
時間枠：Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline
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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.
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Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline
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Change in Self-reported Completion of Advanced Care Planning Activities: Health Care Decision Maker
時間枠：Baseline, 6 months post-baseline, and 12-months post baseline
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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".
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Baseline, 6 months post-baseline, and 12-months post baseline
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Change in Self-reported Completion of Advanced Care Planning Activities: Living Will
時間枠：Baseline, 6 months post-baseline, and 12-months post baseline
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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".
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Baseline, 6 months post-baseline, and 12-months post baseline
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Marcia McDonnell Holstad, phD、Emory University
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB00059987
- NIH/NINR-1R01NR014054-01 (その他の識別子：Other)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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