Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NIH/NINR-1R01NR014054-01 | Other Identifier | Other |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Grady Health System | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIDS EPC Package plus MI | Experimental | 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. |
|
| Standard of Care (SOC) | Other | Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIDS EPC Package plus MI | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Indicator: Change in Mortality at 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marcia McDonnell Holstad, phD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University, Nell Hodgson Woodruff School of Nursing | Atlanta | Georgia | 30322 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment started in June 2014 at Emory University
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Standard of Care (SOC) | Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment 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 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Standard of Care (SOC) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Quality of Life | 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. | Only included participants that were able to complete the McGill Quality of Life Questionnaire at each visit. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline |
|
12 months post baseline
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marcia McDonnell Holstad | Emory University | 404-727-1307 | nurmmcd@emory.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2016 | Dec 6, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Standard of Care (SOC) | Other | 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. |
|
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 | 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 | 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 |
| Withdrawal by Subject |
|
| Incarceration |
|
Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Sexual Orientation | Count of Participants | Participants |
|
| OG001 | Standard of Care (SOC) | Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment |
|
|
| Secondary | Clinical Indicator: Change in Mortality at 12 Months Post-baseline | Number of deaths at 12 months post baseline | Posted | Count of Participants | Participants | Baseline, up to 12 months post- baseline |
|
|
|
| Secondary | Clinical Indicator: Change in Self-report Hospitalizations | 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. | Participants analyzed in each time point include the ones that were able to complete the survey. | Posted | Count of Participants | Participants | Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline |
|
|
|
| Secondary | Change in Self-reported Completion of Advanced Care Planning Activities: Health Care Decision Maker | 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". | Participants analyzed in each time point include the ones that were able to complete the questionnaire. | Posted | Count of Participants | Participants | Baseline, 6 months post-baseline, and 12-months post baseline |
|
|
|
| Secondary | Change in Self-reported Completion of Advanced Care Planning Activities: Living Will | 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". | Participants analyzed in each time point include the ones that were able to complete the questionnaire. | Posted | Count of Participants | Participants | Baseline, 6 months post-baseline, and 12-months post baseline |
|
|
|
| 2 |
| 61 |
| 0 |
| 61 |
| 0 |
| 61 |
| EG001 | Standard of Care (SOC) | Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment 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 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. | 1 | 60 | 0 | 60 | 0 | 60 |
Not provided
Not provided
Not provided
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| 3 months post-baseline HIV related |
|
|
| 6 months post-baseline HIV related |
|
|
| 12 months post-baseline HIV related |
|
|
| Baseline non-HIV related |
|
|
| 3 months post-baseline non-HIV related |
|
|
| 6 months post-baseline non-HIV related |
|
|
| 12 months post0baseline non-HIV related |
|
|
| 6 months post-baseline |
|
|
| 12 months post-baseline |
|
|
| 6 months post-baseline |
|
|
| 12 months post-baseline |
|
|