Advance Care PlanningNCT05308004
Palliative Care for Persons With ADRD and CI in SNF
A study testing Palliative Care Consultation in people with Advance Care Planning and Palliative Care, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Alzheimer's disease and related dementias (ADRD) are serious, life limiting illnesses with no known cure. Dementia is the fifth-leading cause of death in older adults and the majority of people with advanced dementia die in nursing homes (NHs). Miller et al reported that 40% of U.S. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Advance Care Planning, Palliative Care, Skilled Nursing Facility
- What is being tested?
- Palliative Care Consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 14 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients:
- Admitted for SNF post-acute care at a participating NHs following a recent hospitalization
- Age ≥ 60 years old
- Speaks English (if verbal)
- If non-verbal/unable to participate in a conversation and/or unable to make decisions, a legally authorized representative (LAR)/surrogate decision maker who can make decisions for the patient as determined by ACTs staff
- Documented ADRD diagnosis in the medical record or history of cognitive impairment (defined as BIMS score ≤ 12)
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- At least one global indicator for PC at SNF admission (provider would not be surprised if patient died within 1 year, believes the patient would benefit from advance care planning or symptom management; frequent hospital or NH SNF admissions; complex care requirements; decline in function; feeding intolerance; unintended decline in weight; or previous hospice assessment or enrollment and subsequent discharge)
- Surrogate/LAR:
- ≥18 years old
- Family member or friend of an eligible patient as determined by ACTs staff
- Speaks English
Who cannot join
- Patients:
- Who have previously received or are referred for PC by their primary care team
- With a discharge plan within 48 hours of screening
- Currently receiving hospice care
- Who do not have one global indicator of need
- No documented ADRD diagnosis or history of cognitive impairment in the medical record
Show all 12Show fewer
- That are non-English speaking, (if verbal)
- If unable to make decisions, do not have an LAR/surrogate decision maker.
- Surrogate/LAR:
- < 18 years of age
- Not a family Member or friend of an eligible patient
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Acts Continuing Care Retirement Communities
Philadelphia, Pennsylvania, 19014
About this study
Official title: Palliative Care Consultations for Persons With Alzheimer's Disease and Related Dementia and Cognitive Impairment in the Medicare Skilled Nursing Facility (SNF) Setting
Alzheimer's disease and related dementias (ADRD) are serious, life limiting illnesses with no known cure. Dementia is the fifth-leading cause of death in older adults and the majority of people with advanced dementia die in nursing homes (NHs). Miller et al reported that 40% of U.S. NH residents dying with advanced dementia received Skilled Nursing Facility (SNF) care in the last 90 days of life, and receipt of this care was associated significantly with poorer end-of-life outcomes, including a higher risk of dying in a hospital, compared to decedents with no SNF care. SNF care is a Medicare post-acute rehabilitation service delivered in NHs focused on intense rehabilitation and/or aggressive, disease-modifying therapies. Regardless of life expectancy, use of SNF care precludes access to Hospice services. Palliative care (PC) offers an evidence-based alternative.
Read the detailed description
In this pragmatic clinical trial, broadcast notification will be utilized to inform all newly admitted patients at each study site of their participation in this trial. During the admission process, potential subjects will be provided with a 1-page summary sheet (Broadcast notification) detailing their participation in this study that will include contact information for the study team, should the subject or their LAR/surrogate decision maker elect to opt-out of participating.
Baseline data will be collected virtually via telephone by asking each subject or if unable to respond their surrogate decision maker to complete the Patient Outcomes Scale (POSv2), the Satisfaction With Care at the End of Life in Dementia (SWC-EOLD), and the Symptom Management at the End of Life in Dementia (SM-EOLD).
Between 14 days and 21 days after the baseline POSv2, SW-EOLD, and the SM-EOLD are administered, all subjects or if unable to respond their surrogate decision maker will be asked to complete the POSv2, SW-EOLD, and the SM-EOLD again virtually via telephone. The POSv2, SW-EOLD, and the SM-EOLD will be given a total of two times to those in the INTERVENTION and CONTROL groups; at baseline and follow up (14-21 days later).
Deidentified subject demographics will be collected on all participants in the following way: Study team members will review subject's medical records and enter de-identified data into a Research Electronic Data Capture (REDCap) database (Acts staff assists with the study team's access to subject's medical record).
Palliative Care Encounter Trained provider will discuss illness trajectories, establish and communicate patient-directed goals that guide health care decisions, identify and treat illness-related symptoms, and identify psycho-spiritual needs and approaches to mitigate suffering.
- Being tested
- Palliative Care Consultation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative Care ConsultationOther
Trained provider will discuss illness trajectories, establish and communicate patient-directed goals that guide health care decisions, identify and treat illness-related symptoms, and identify psycho-spiritual needs and approaches to mitigate suffering
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Participants will receive the standard Medicare Skilled Nursing Facility care. |
| Palliative Care Consult | Experimental | Participants will receive the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider. Receives: Other: Palliative Care Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Completed Patient Quality of Life Survey
12-item survey that measures quality of life in five dimensions: 1) physical; 2) emotional; 3) psychological; 4) spiritual needs, and 5) provision of information and support. Items scored on a 5 point Likert Scale (0=not at all, 4= overwhelmingly) based on symptom/need in the past week. Overall profile score is calculated by summing responses (range 0-40). Source: patient or family caregiver; Time to complete: 5-7 minutes
Measured: Collected upon admission to the nursing home (Baseline) and again 21 days post-admission to the nursing home (Follow up)
Secondary outcomes (2)
Number of Participants That Completed Satisfaction With Care Survey (SWC-EOLD)
10-item scale that measures caregiver satisfaction with care for persons with dementia. Each item is measured on a 4-point Likert scale ranging from 1 ("strongly disagree") to 4 ("strongly agree"). Specific elements include satisfaction with medical and nursing care, decision-making, and their understanding of the persons with dementia illness. All items are summed, yielding a range of scores of 10-40. Higher scores indicate greater satisfaction.
Measured: Collected upon admission to the nursing home and again 21 days post-admission to the nursing home
Number of Participants That Completed the Symptom Management Survey (SM-EOLD)
9-item scale administered to a caregiver that measures persons with dementia physical and psychological symptoms. Each item is rated on a 6-point Likert scale ranging from 0 to 5 (0 = "daily", 1 = "several days a week", 2 = "once per week", 3 = "2 or 3 days a month", 4 = "once a month", 5 = "never"). Scores are summed and range from 0 to 45. Higher scores indicate better symptom management.
Measured: Collected upon admission to the nursing home and again 21 days post-admission to the nursing home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start15 Jun 2022
- Primary completion24 Apr 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advance Care PlanningStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pre-post design where control data will be collected prior to intervention being implemented
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Joan Carpenter, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308004
- Sponsor's protocol ID
- HP-00100348
- Other IDs
- 3K23NR017663-02S1, 1K23NR017663-01A1
- Status last verified
- Dec 2024
- First submitted
- 24 Mar 2022
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Care Consultations for Persons With Alzheimer's Disease and Related Dementia and Cognitive Impairment in the Medicare Skilled Nursing Facility (SNF) Setting
- ClinicalTrials.gov ID
- NCT05308004
- Acronym / sponsor ID
- HP-00100348
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institute of Nursing Research (NINR)
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Posted 14 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alzheimer's disease and related dementias (ADRD) are serious, life limiting illnesses with no known cure. Dementia is the fifth-leading cause of death in older adults and the majority of people with advanced dementia die in nursing homes (NHs). Miller et al reported that 40% of U.S. NH residents dying with advanced dementia received Skilled Nursing Facility (SNF) care in the last 90 days of life, and receipt of this care was associated significantly with poorer end-of-life outcomes, including a higher risk of dying in a hospital, compared to decedents with no SNF care. SNF care is a Medicare post-acute rehabilitation service delivered in NHs focused on intense rehabilitation and/or aggressive, disease-modifying therapies. Regardless of life expectancy, use of SNF care precludes access to Hospice services. Palliative care (PC) offers an evidence-based alternative.
Detailed description
In this pragmatic clinical trial, broadcast notification will be utilized to inform all newly admitted patients at each study site of their participation in this trial. During the admission process, potential subjects will be provided with a 1-page summary sheet (Broadcast notification) detailing their participation in this study that will include contact information for the study team, should the subject or their LAR/surrogate decision maker elect to opt-out of participating.
Baseline data will be collected virtually via telephone by asking each subject or if unable to respond their surrogate decision maker to complete the Patient Outcomes Scale (POSv2), the Satisfaction With Care at the End of Life in Dementia (SWC-EOLD), and the Symptom Management at the End of Life in Dementia (SM-EOLD).
Between 14 days and 21 days after the baseline POSv2, SW-EOLD, and the SM-EOLD are administered, all subjects or if unable to respond their surrogate decision maker will be asked to complete the POSv2, SW-EOLD, and the SM-EOLD again virtually via telephone. The POSv2, SW-EOLD, and the SM-EOLD will be given a total of two times to those in the INTERVENTION and CONTROL groups; at baseline and follow up (14-21 days later).
Deidentified subject demographics will be collected on all participants in the following way: Study team members will review subject's medical records and enter de-identified data into a Research Electronic Data Capture (REDCap) database (Acts staff assists with the study team's access to subject's medical record).
Palliative Care Encounter Trained provider will discuss illness trajectories, establish and communicate patient-directed goals that guide health care decisions, identify and treat illness-related symptoms, and identify psycho-spiritual needs and approaches to mitigate suffering.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pre-post design where control data will be collected prior to intervention being implemented
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Participants will receive the standard Medicare Skilled Nursing Facility care. |
| Palliative Care Consult | Experimental | Other: Palliative Care ConsultationParticipants will receive the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Admitted for SNF post-acute care at a participating NHs following a recent hospitalization
- Age ≥ 60 years old
- Speaks English (if verbal)
- If non-verbal/unable to participate in a conversation and/or unable to make decisions, a legally authorized representative (LAR)/surrogate decision maker who can make decisions for the patient as determined by ACTs staff
- Documented ADRD diagnosis in the medical record or history of cognitive impairment (defined as BIMS score ≤ 12)
Key exclusion criteria (12 listed)
- Who have previously received or are referred for PC by their primary care team
- With a discharge plan within 48 hours of screening
- Currently receiving hospice care
- Who do not have one global indicator of need
- No documented ADRD diagnosis or history of cognitive impairment in the medical record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative Care ConsultationTrained provider will discuss illness trajectories, establish and communicate patient-directed goals that guide health care decisions, identify and treat illness-related symptoms, and identify psycho-spiritual needs and approaches to mitigate suffering | Other | Palliative Care Consult |
Primary outcome
Number of Participants That Completed Patient Quality of Life Survey
Time frame: Collected upon admission to the nursing home (Baseline) and again 21 days post-admission to the nursing home (Follow up)
12-item survey that measures quality of life in five dimensions: 1) physical; 2) emotional; 3) psychological; 4) spiritual needs, and 5) provision of information and support. Items scored on a 5 point Likert Scale (0=not at all, 4= overwhelmingly) based on symptom/need in the past week. Overall profile score is calculated by summing responses (range 0-40). Source: patient or family caregiver; Time to complete: 5-7 minutes
2 secondary outcomes
Number of Participants That Completed Satisfaction With Care Survey (SWC-EOLD)
Time frame: Collected upon admission to the nursing home and again 21 days post-admission to the nursing home
Number of Participants That Completed the Symptom Management Survey (SM-EOLD)
Time frame: Collected upon admission to the nursing home and again 21 days post-admission to the nursing home
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative Care Consultation in people with Advance Care Planning and Palliative Care, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Completed Patient Quality of Life Survey (time frame: Collected upon admission to the nursing home (Baseline) and again 21 days post-admission to the nursing home (Follow up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.