Acquired Immunodeficiency Syndrome (AIDS)
Conditions
Keywords
Early Palliative Care, Motivational Interviewing, Persons Living With Human immunodeficiency virus(HIV), Acquired Immunodeficiency Syndrome (AIDS)
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAIDS 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.
OTHERStandard 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.
Sponsors
Grady Health System
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Indicator: Change in Mortality at 12 Months Post-baseline | Baseline, up to 12 months post- baseline | Number of deaths at 12 months post baseline |
| Clinical Indicator: Change in Self-report Hospitalizations | 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. |
| Change in Self-reported Completion of Advanced Care Planning Activities: Health Care Decision Maker | 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. |
| Change in Self-reported Completion of Advanced Care Planning Activities: Living Will | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment started in June 2014 at Emory University
Participants by arm
| Arm | Count |
|---|---|
| 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. | 61 |
| Standard of Care (SOC) Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment | 60 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | Incarceration | 2 | 2 |
| Overall Study | Lost to Follow-up | 6 | 8 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | AIDS EPC Package Plus MI | Standard of Care (SOC) | Total |
|---|---|---|---|
| Age, Continuous | 43.0 years STANDARD_DEVIATION 11.2 | 42.3 years STANDARD_DEVIATION 10.3 | 42.6 years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants | 56 Participants | 114 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 56 Participants | 50 Participants | 106 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) White | 3 Participants | 5 Participants | 8 Participants |
| Region of Enrollment United States | 61 participants | 60 participants | 121 participants |
| Sex/Gender, Customized Female | 13 participants | 13 participants | 26 participants |
| Sex/Gender, Customized Male | 46 participants | 44 participants | 90 participants |
| Sex/Gender, Customized Transgender | 2 participants | 3 participants | 5 participants |
| Sexual Orientation Bisexual | 6 Participants | 6 Participants | 12 Participants |
| Sexual Orientation Gay/homosexual | 25 Participants | 21 Participants | 46 Participants |
| Sexual Orientation None of de above/unsure | 6 Participants | 5 Participants | 11 Participants |
| Sexual Orientation Straight/heterosexual | 24 Participants | 28 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 61 | 1 / 60 |
| other Total, other adverse events | 0 / 61 | 0 / 60 |
| serious Total, serious adverse events | 0 / 61 | 0 / 60 |
Outcome results
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.
Time frame: Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline
Population: Only included participants that were able to complete the McGill Quality of Life Questionnaire at each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIDS EPC Package Plus MI | Change in Quality of Life | Baseline | 5.87 score on a scale | Standard Deviation 1.62 |
| AIDS EPC Package Plus MI | Change in Quality of Life | 3 months post-baseline | 5.68 score on a scale | Standard Deviation 1.73 |
| AIDS EPC Package Plus MI | Change in Quality of Life | 6 months post-baseline | 5.73 score on a scale | Standard Deviation 1.9 |
| AIDS EPC Package Plus MI | Change in Quality of Life | 12 months post-baseline | 6.15 score on a scale | Standard Deviation 1.73 |
| Standard of Care (SOC) | Change in Quality of Life | 12 months post-baseline | 5.30 score on a scale | Standard Deviation 1.78 |
| Standard of Care (SOC) | Change in Quality of Life | Baseline | 5.17 score on a scale | Standard Deviation 1.43 |
| Standard of Care (SOC) | Change in Quality of Life | 6 months post-baseline | 5.09 score on a scale | Standard Deviation 1.74 |
| Standard of Care (SOC) | Change in Quality of Life | 3 months post-baseline | 5.06 score on a scale | Standard Deviation 1.63 |
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.
Time frame: Baseline, 6 months post-baseline, and 12-months post baseline
Population: Participants analyzed in each time point include the ones that were able to complete the questionnaire.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AIDS EPC Package Plus MI | Change in Self-reported Completion of Advanced Care Planning Activities: Health Care Decision Maker | Baseline | 13 Participants |
| AIDS EPC Package Plus MI | Change in Self-reported Completion of Advanced Care Planning Activities: Health Care Decision Maker | 6 months post-baseline | 21 Participants |
| AIDS EPC Package Plus MI | Change in Self-reported Completion of Advanced Care Planning Activities: Health Care Decision Maker | 12 months post-baseline | 22 Participants |
| Standard of Care (SOC) | Change in Self-reported Completion of Advanced Care Planning Activities: Health Care Decision Maker | Baseline | 12 Participants |
| Standard of Care (SOC) | Change in Self-reported Completion of Advanced Care Planning Activities: Health Care Decision Maker | 6 months post-baseline | 11 Participants |
| Standard of Care (SOC) | Change in Self-reported Completion of Advanced Care Planning Activities: Health Care Decision Maker | 12 months post-baseline | 16 Participants |
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.
Time frame: Baseline, 6 months post-baseline, and 12-months post baseline
Population: Participants analyzed in each time point include the ones that were able to complete the questionnaire.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AIDS EPC Package Plus MI | Change in Self-reported Completion of Advanced Care Planning Activities: Living Will | Baseline | 12 Participants |
| AIDS EPC Package Plus MI | Change in Self-reported Completion of Advanced Care Planning Activities: Living Will | 6 months post-baseline | 14 Participants |
| AIDS EPC Package Plus MI | Change in Self-reported Completion of Advanced Care Planning Activities: Living Will | 12 months post-baseline | 19 Participants |
| Standard of Care (SOC) | Change in Self-reported Completion of Advanced Care Planning Activities: Living Will | Baseline | 8 Participants |
| Standard of Care (SOC) | Change in Self-reported Completion of Advanced Care Planning Activities: Living Will | 6 months post-baseline | 8 Participants |
| Standard of Care (SOC) | Change in Self-reported Completion of Advanced Care Planning Activities: Living Will | 12 months post-baseline | 11 Participants |
Secondary
Clinical Indicator: Change in Mortality at 12 Months Post-baseline
Number of deaths at 12 months post baseline
Time frame: Baseline, up to 12 months post- baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AIDS EPC Package Plus MI | Clinical Indicator: Change in Mortality at 12 Months Post-baseline | 2 Participants |
| Standard of Care (SOC) | Clinical Indicator: Change in Mortality at 12 Months Post-baseline | 1 Participants |
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.
Time frame: Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline
Population: Participants analyzed in each time point include the ones that were able to complete the survey.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AIDS EPC Package Plus MI | Clinical Indicator: Change in Self-report Hospitalizations | Baseline HIV related | 24 Participants |
| AIDS EPC Package Plus MI | Clinical Indicator: Change in Self-report Hospitalizations | Baseline non-HIV related | 22 Participants |
| AIDS EPC Package Plus MI | Clinical Indicator: Change in Self-report Hospitalizations | 6 months post-baseline HIV related | 5 Participants |
| AIDS EPC Package Plus MI | Clinical Indicator: Change in Self-report Hospitalizations | 3 months post-baseline non-HIV related | 15 Participants |
| AIDS EPC Package Plus MI | Clinical Indicator: Change in Self-report Hospitalizations | 3 months post-baseline HIV related | 11 Participants |
| AIDS EPC Package Plus MI | Clinical Indicator: Change in Self-report Hospitalizations | 6 months post-baseline non-HIV related | 7 Participants |
| AIDS EPC Package Plus MI | Clinical Indicator: Change in Self-report Hospitalizations | 12 months post-baseline HIV related | 6 Participants |
| AIDS EPC Package Plus MI | Clinical Indicator: Change in Self-report Hospitalizations | 12 months post0baseline non-HIV related | 10 Participants |
| Standard of Care (SOC) | Clinical Indicator: Change in Self-report Hospitalizations | 12 months post0baseline non-HIV related | 12 Participants |
| Standard of Care (SOC) | Clinical Indicator: Change in Self-report Hospitalizations | Baseline HIV related | 27 Participants |
| Standard of Care (SOC) | Clinical Indicator: Change in Self-report Hospitalizations | 3 months post-baseline HIV related | 12 Participants |
| Standard of Care (SOC) | Clinical Indicator: Change in Self-report Hospitalizations | 6 months post-baseline HIV related | 10 Participants |
| Standard of Care (SOC) | Clinical Indicator: Change in Self-report Hospitalizations | 12 months post-baseline HIV related | 7 Participants |
| Standard of Care (SOC) | Clinical Indicator: Change in Self-report Hospitalizations | Baseline non-HIV related | 23 Participants |
| Standard of Care (SOC) | Clinical Indicator: Change in Self-report Hospitalizations | 3 months post-baseline non-HIV related | 15 Participants |
| Standard of Care (SOC) | Clinical Indicator: Change in Self-report Hospitalizations | 6 months post-baseline non-HIV related | 17 Participants |