Organ FailureNCT03793803
Trial of Mount Sinai Palliative Care at Home
A study testing Home Palliative Care in people with Organ Failure, run by Icahn School of Medicine at Mount Sinai at 4 sites in United States.
Trial summary
The proposed project is a randomized controlled trial of a new home-based palliative care program for adults with serious illness and their caregivers within the Mount Sinai Health System. Potential subjects will be identified from Mount Sinai records or referred by a Mount Sinai healthcare provider. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Organ Failure
- What is being tested?
- Home Palliative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Oct 2018to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of a "serious medical illness" - according to pre-specified diagnostic code-based criteria
- Subject has a Mount Sinai physician who authorizes their participation in the study and receipt of the program
- Subject is resident in Manhattan outside of a long term care facility and is not receiving hospice 5.
- Subject has evidence of capacity to benefit from enrollment in palliative care program
- Subject is conversant in English or Spanish
- Subject has capacity to consent
Who cannot join
- Subject has no usual physician within Mount Sinai
- Subject's usual physician doesn't provide authorization to patient participation
- Subject resident outside of Manhattan or in long term care facility or receiving hospice
- Subject is not conversant in English or Spanish
- Subject cannot provide informed consent to participation
- Dementia (where the subject does not have the capacity to consent)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Mount Sinai Beth Israel
New York, New York, 10003
Mount Sinai West
New York, New York, 10019
Mount Sinai St Luke's
New York, New York, 10025
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Clinical Trial of Home Palliative Care for Seriously Ill Adults
The proposed project is a randomized controlled trial of a new home-based palliative care program for adults with serious illness and their caregivers within the Mount Sinai Health System. Potential subjects will be identified from Mount Sinai records or referred by a Mount Sinai healthcare provider. Patients will only be approached after authorization by their Mount Sinai physician. Participants who consent to enrollment will be randomized to receive the intervention (home-based palliative care program) or usual care (with their nominated Mount Sinai physician). Patients will be enrolled in the study for a minimum of 6 months.
After 6 months, patients can remain in the program if there is ongoing clinical need; data collection beyond 6 months will be done on all patients through chart abstraction/ administrative claims only.
Effectiveness of the intervention will be determined through assessment of patient and caregiver reported outcomes and abstraction of data from medical records and administrative claims. Impact on the following parameters will be measured: (i) Patient symptoms, quality of life, satisfaction with care, documentation of advanced directives, receipt of care consistent with preferences (ii) Caregiver burden, satisfaction with care, and depression (iii) Healthcare utilization and costs of care.
Read the detailed description
The objective of this randomized controlled trial is to study the impact of a new home based palliative care program on patients' symptoms, quality of life, satisfaction with care, completion of advance care planning documentation and receipt of care consistent with preferences. In addition, the study will examine the impact of this model of care on patient healthcare utilization, including hospitalization, emergency department utilization, and hospice use prior to death. The trial will also include patients' caregivers, in order to examine the impact of the intervention on caregiver burden and prevalence of depression.
Patients randomized to the intervention will be scheduled for an intake visit. This visit will be undertaken by the team's registered nurse and/or social worker, together with a community health worker, and other team members (advanced practice nurse, MD), depending on patients' needs. Following this visit, and in conjunction with the nurse practitioner and/or MD, a care plan will be developed to address areas of clinical need highlighted during the intake visit.
Patients in the intervention arm will receive ongoing monitoring and input (telephone-based and in-person) from members of the clinical team, dependent on their identified needs. Patients' cases will be discussed at the weekly IDT meeting, as appropriate to the level of clinical need. Patients and caregivers will be provided with access to a 24 hour telephone line, staffed by a Mount Sinai based physician, which acts as an advice line out of hours. These physicians will be able to provide advice to patients and caregivers.
- Conditions
- Organ Failure
- Being tested
- Home Palliative Care
- Keywords
- Palliative Care, Home-Based Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Palliative CareBehavioural
Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
| Study group | Role | What they receive |
|---|---|---|
| Home Palliative Care | Experimental | Randomized to Intervention Arm Receives: Behavioral: Home Palliative Care |
| Control Arm | No intervention | Usual Care - Patients will be cared for by the physician who treats their primary illness(es). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrated Palliative Outcomes Scale
Patient symptoms determined by the Integrated Palliative Outcomes Scale, a validated structured questionnaire administered to patient-subjects via telephone interview or in person by the trained research coordinator. The Integrated Palliative Outcomes Scale is scored on a likert scale from 0-4, with higher score indicating worse symptoms.
Measured: 6 months
Secondary outcomes (10)
McGill quality of life-revised
McGill quality of life-revised is a 14 item instrument administered to patient-subjects via telephone interview or in person by the trained research coordinator. Each item score on likert scale from 0-10, full scale from 0-140 with higher score indicating better quality of life.
Measured: 6 months
Family Satisfaction with End-of-Life Care (FAMCARE-10)
FAMCARE-10 to assess patient satisfaction by using a validated 10-item structured questionnaire administered to patient-subjects via telephone interview or in person by the trained research coordinator. FamCare each item score on likert scale 0-3, total scale from 0-30, with higher score indicating higher satisfaction
Measured: 6 months
Number of Completion of Advance Directives
Study team will examine the patient's chart for completion of advanced directives.
Measured: 6 months
Number of Preference Consistent Care
Study team will examine if the care patients receive is concordant with the care they wanted to receive. simple chart review of whether care received matches stated preferences (yes/no).
Measured: 6 months
Zarit Burden Inventory
Zarit Burden Inventory to determine caregiver burden by using a validated structured 22-item questionnaire administered to caregiver-subjects via telephone interview or in person by the trained research coordinator. Each item is on a 5-point score range from 0 (never) to 4 (always). Full scale from 0 to 88, with higher score indicating more burden.
Measured: 6 months
FAMCARE-10
FAMCARE-10 to assess caregiver satisfaction by using a validated 10-item structured questionnaire administered to patient-subjects via telephone interview or in person by the trained research coordinator. FamCare each item score on likert scale 0-3, total scale from 0-30, with higher score indicating higher satisfaction.
Measured: 6 months
The Patient Health Questionnaire (PHQ-9)
PHQ-9 to assess Caregiver Depression by using a validated structured 9 item questionnaire administered to caregiver-subjects via telephone interview or in person by the trained research coordinator. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Full scale from 0-27, with higher score indicating worse depression.
Measured: 6 months
Number of inpatient admissions
Number of inpatient admissions to measure healthcare utilization
Measured: 6 months
Number of emergency department visits
Number of emergency department visits to measure healthcare utilization
Measured: 6 months
Number of outpatient appointments
Number of outpatient appointments to measure healthcare utilization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start1 Oct 2018
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ FailureStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients and caregivers are randomized to receive care from the home-based palliative care team or will receive usual care from their primary physician
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathan Goldstein, Icahn School of Medicine at Mount Sinai
- Investigators
- Nathan Goldstein, MD, Study director, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793803
- Sponsor's protocol ID
- GCO 15-2215
- Status last verified
- Apr 2022
- First submitted
- 24 Dec 2018
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Home Palliative Care for Seriously Ill Adults
- ClinicalTrials.gov ID
- NCT03793803
- Acronym / sponsor ID
- GCO 15-2215
- Conditions
- Organ Failure
- Keywords
- Palliative Care, Home-Based Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 4 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed project is a randomized controlled trial of a new home-based palliative care program for adults with serious illness and their caregivers within the Mount Sinai Health System. Potential subjects will be identified from Mount Sinai records or referred by a Mount Sinai healthcare provider. Patients will only be approached after authorization by their Mount Sinai physician. Participants who consent to enrollment will be randomized to receive the intervention (home-based palliative care program) or usual care (with their nominated Mount Sinai physician). Patients will be enrolled in the study for a minimum of 6 months.
After 6 months, patients can remain in the program if there is ongoing clinical need; data collection beyond 6 months will be done on all patients through chart abstraction/ administrative claims only.
Effectiveness of the intervention will be determined through assessment of patient and caregiver reported outcomes and abstraction of data from medical records and administrative claims. Impact on the following parameters will be measured: (i) Patient symptoms, quality of life, satisfaction with care, documentation of advanced directives, receipt of care consistent with preferences (ii) Caregiver burden, satisfaction with care, and depression (iii) Healthcare utilization and costs of care.
Detailed description
The objective of this randomized controlled trial is to study the impact of a new home based palliative care program on patients' symptoms, quality of life, satisfaction with care, completion of advance care planning documentation and receipt of care consistent with preferences. In addition, the study will examine the impact of this model of care on patient healthcare utilization, including hospitalization, emergency department utilization, and hospice use prior to death. The trial will also include patients' caregivers, in order to examine the impact of the intervention on caregiver burden and prevalence of depression.
Patients randomized to the intervention will be scheduled for an intake visit. This visit will be undertaken by the team's registered nurse and/or social worker, together with a community health worker, and other team members (advanced practice nurse, MD), depending on patients' needs. Following this visit, and in conjunction with the nurse practitioner and/or MD, a care plan will be developed to address areas of clinical need highlighted during the intake visit.
Patients in the intervention arm will receive ongoing monitoring and input (telephone-based and in-person) from members of the clinical team, dependent on their identified needs. Patients' cases will be discussed at the weekly IDT meeting, as appropriate to the level of clinical need. Patients and caregivers will be provided with access to a 24 hour telephone line, staffed by a Mount Sinai based physician, which acts as an advice line out of hours. These physicians will be able to provide advice to patients and caregivers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients and caregivers are randomized to receive care from the home-based palliative care team or will receive usual care from their primary physician
| Arm | Type | Receives |
|---|---|---|
| Home Palliative Care | Experimental | Behavioral: Home Palliative CareRandomized to Intervention Arm |
| Control Arm | No intervention | –Usual Care - Patients will be cared for by the physician who treats their primary illness(es). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Presence of a "serious medical illness" - according to pre-specified diagnostic code-based criteria
- Subject has a Mount Sinai physician who authorizes their participation in the study and receipt of the program
- Subject is resident in Manhattan outside of a long term care facility and is not receiving hospice 5.
- Subject has evidence of capacity to benefit from enrollment in palliative care program
- Subject is conversant in English or Spanish
Key exclusion criteria (6 listed)
- Subject has no usual physician within Mount Sinai
- Subject's usual physician doesn't provide authorization to patient participation
- Subject resident outside of Manhattan or in long term care facility or receiving hospice
- Subject is not conversant in English or Spanish
- Subject cannot provide informed consent to participation
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 |
|---|---|---|
| Home Palliative CarePatients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician. | Behavioural | Home Palliative Care |
Primary outcome
Integrated Palliative Outcomes Scale
Time frame: 6 months
Patient symptoms determined by the Integrated Palliative Outcomes Scale, a validated structured questionnaire administered to patient-subjects via telephone interview or in person by the trained research coordinator. The Integrated Palliative Outcomes Scale is scored on a likert scale from 0-4, with higher score indicating worse symptoms.
10 secondary outcomes
McGill quality of life-revised
Time frame: 6 months
Family Satisfaction with End-of-Life Care (FAMCARE-10)
Time frame: 6 months
Number of Completion of Advance Directives
Time frame: 6 months
Number of Preference Consistent Care
Time frame: 6 months
Zarit Burden Inventory
Time frame: 6 months
FAMCARE-10
Time frame: 6 months
The Patient Health Questionnaire (PHQ-9)
Time frame: 6 months
Number of inpatient admissions
Time frame: 6 months
Number of emergency department visits
Time frame: 6 months
Number of outpatient appointments
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Organ Failure
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
RecruitingObservational study
Metabolic and Functional Study of γδ T Cells in Critically Ill Patients
Sepsis, Critical Illness
Recruiting
Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury
Acute Kidney Injury
RecruitingPhase 3
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
Active, not recruiting
Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure
Multi Organ Failure, Exocrine Pancreatic Insufficiency
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.
Nathan Goldstein, MD study director
Icahn School of Medicine at Mount Sinai
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Palliative Care in people with Organ Failure, run by Icahn School of Medicine at Mount Sinai at 4 sites 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 6 inclusion and 6 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 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Integrated Palliative Outcomes Scale (time frame: 6 months). 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 29 Apr 2022.