Palliative CareNCT03520023
Critical Care and Palliative Care Medicine Together in the ICU
A study testing Palliative Care Consult in people with Palliative Care and Intensive Care Unit, run by Mayo Clinic at 1 site in United States.
Trial summary
Will earlier palliative care medicine consultation in the ICU result in decreased length of stay in the ICU and hospital, as well as, increased patient and family satisfaction. Secondary questions to be answered is if this early consultation changes ICU and hospital death, discharge destinations, hospice admissions… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Intensive Care Unit, Hospice
- What is being tested?
- Palliative Care Consult
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2018to 1 Mar 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Age >80 years
- Apache II score >14
- SOFA score > 9
- Pre-existing functional dependency (admitted from ALF, SNF, LTAC, etc.)
- Late stage dementia (bed-bound, nonverbal, incontinent, or unable to self-nourish/tube feed)
- Stage 4 metastatic disease
- Consideration to place permanent feeding tube or trach
- Recurrent ICU admissions in the past year
- Post-cardiac arrest
- End-stage disease (lung, ESRD, ESLD)
- ICU perceived need
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Early vs Usual Palliative Care Consultation Augment the Critical Care Physician to Decrease Healthcare Utilization and Increase Caregiver Satisfaction
Will earlier palliative care medicine consultation in the ICU result in decreased length of stay in the ICU and hospital, as well as, increased patient and family satisfaction. Secondary questions to be answered is if this early consultation changes ICU and hospital death, discharge destinations, hospice admissions, code status changes, and withdrawal of life sustaining interventions.
- Conditions
- Palliative Care, Intensive Care Unit, Hospice
- Being tested
- Palliative Care Consult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative Care ConsultOther
Consult of hospital palliative care service for those meeting study inclusion criteria
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Standard care with consultant discretion regarding consult of palliative care medicine |
| Experimental | Experimental | Early palliative care consult based upon meeting study inclusion criteria Receives: Other: Palliative Care Consult |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Measure will assessed by using the family satisfaction with care in the intensive care unit form (FS-ICU 24)
Measured: 1 year
Secondary outcomes (3)
ICU length of stay
Measured: 1 year
Ventilator Days
Measured: 1 year
Percentage admission to hospice
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start4 Sep 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John E. Moss, Mayo Clinic
- Investigators
- John E Moss, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520023
- Sponsor's protocol ID
- 18-001107
- Status last verified
- Oct 2020
- First submitted
- 23 Apr 2018
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Early vs Usual Palliative Care Consultation Augment the Critical Care Physician to Decrease Healthcare Utilization and Increase Caregiver Satisfaction
- ClinicalTrials.gov ID
- NCT03520023
- Acronym / sponsor ID
- 18-001107
- Conditions
- Palliative Care, Intensive Care Unit, Hospice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 9 May 2018 (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.
Will earlier palliative care medicine consultation in the ICU result in decreased length of stay in the ICU and hospital, as well as, increased patient and family satisfaction. Secondary questions to be answered is if this early consultation changes ICU and hospital death, discharge destinations, hospice admissions, code status changes, and withdrawal of life sustaining interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Standard care with consultant discretion regarding consult of palliative care medicine |
| Experimental | Experimental | Other: Palliative Care ConsultEarly palliative care consult based upon meeting study inclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 ConsultConsult of hospital palliative care service for those meeting study inclusion criteria | Other | Experimental |
Primary outcome
Patient satisfaction
Time frame: 1 year
Measure will assessed by using the family satisfaction with care in the intensive care unit form (FS-ICU 24)
3 secondary outcomes
ICU length of stay
Time frame: 1 year
Ventilator Days
Time frame: 1 year
Percentage admission to hospice
Time frame: 1 year
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 20 Oct 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Palliative Care
Not yet recruitingObservational study
IN-TALK: Co-producing a Hospice Intimacy Support Toolkit in England
Communication About Intimacy Needs in Hospice and Palliative Care
Not yet recruitingPhase 2
Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 1/2
Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction
Malignant Solid Neoplasm
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
Not yet recruiting
Comparing Radiotherapy Dose Strategies for Symptom Relief in Large Solid Tumors
Solid Tumor
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.
John E Moss principal investigator
Mayo Clinic
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 Consult in people with Palliative Care and Intensive Care Unit, run by Mayo Clinic 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?
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 20 Oct 2020. 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?
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?
Patient satisfaction (time frame: 1 year). 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 20 Oct 2020.