Organ Failure Clinical Trial
Official title:
Clinical Trial of Home Palliative Care for Seriously Ill Adults
Verified date | April 2022 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 193 |
Est. completion date | November 1, 2021 |
Est. primary completion date | November 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
United States | Mount Sinai Beth Israel | New York | New York |
United States | Mount Sinai St Luke's | New York | New York |
United States | Mount Sinai West | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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 | 6 months | |
Secondary | Number of Completion of Advance Directives | Study team will examine the patient's chart for completion of advanced directives. | 6 months | |
Secondary | 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). | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | 6 months | |
Secondary | Number of inpatient admissions | Number of inpatient admissions to measure healthcare utilization | 6 months | |
Secondary | Number of emergency department visits | Number of emergency department visits to measure healthcare utilization | 6 months | |
Secondary | Number of outpatient appointments | Number of outpatient appointments to measure healthcare utilization | 6 months |
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