Outcomes of Early Palliative Care Intervention for High-Risk Patients in the Intensive Care Unit-A Pilot Study

Palliative Care Clinical Trial

Official title:

Outcomes of Early Palliative Care Intervention for High-Risk Patients in the Intensive Care Unit- A Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04487054
• Other study ID #: 1711863473
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 16, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: July 2020
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators propose to conduct a feasibility study of identifying high-risk ICU patients using previously validated integrated prediction model and employing early palliative care intervention. The study will consist of two four-month time periods: usual care in time period one and usual care plus targeted pro-active palliative care intervention within 48 hours of ICU admission in time period two.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 104
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients greater than 18 years of age admitted to the medical ICU at West Virginia University Hospital.

• Patients with a predicted six-month mortality greater than 40% on the integrated prognostic model.

• Patients who live longer than 48 hours after medical ICU admission.

Exclusion Criteria:

• Patient who did not meet inclusion criteria will be excluded.

• Pregnant female/incarcerated patients will be excluded.

• Since this is a study in an adult patient population, children will be excluded.

Related Conditions & MeSH terms

• End-of-life Care
• Intensive Care Unit
• Palliative Care

Intervention

Other:
• Pro-active palliative care
Patient with high risk of mortality in ICU will be identified using our previously validated prognostic model. Intervention phase will employ pro-active palliative care on eligible patients after they survive 48 hours in ICU.

Locations

Country	Name	City	State
United States	West Virginia University Hospital	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length Of Stay (LOS) in the medical ICU		From enrollment to Discharge from the ICU, an average of 24 weeks
Primary	Length Of Stay in hospital		From enrollment to Discharge from the hospital, an average of 24 weeks
Primary	Medical ICU re-admission during the hospital stay		From enrollment to discharge from the hospital, up to 16 weeks
Primary	Treatment limitation orders (do-not-resuscitate, do-not-intubate, no vasopressors, etc) within 48 hours of admission		From enrollment to discharge from the hospital, an average of 24 weeks
Primary	Family satisfaction with care in ICU (modified from the FS-ICU 24 and Bereaved Family Survey (BFS) global performance measure #18)	Six-weeks post discharge, a telephone survey will be conducted with health care surrogate or medical power attorney to determine their satisfaction with the care received in ICU. The results will be compared between participants that received early palliative care intervention and those that did not.	From enrollment to six weeks post ICU discharge
Primary	Advance directive completion [a written statement of a person's wishes regarding medical treatment]	Difference in completion rate of the advance directive between the baseline period and following the intervention	From enrollment to hospital discharge, an average of 24 weeks
Primary	Physician Orders for Scope of Treatment (POST) form completion	Difference in completion rate of the Physician Orders for scope of Treatment (POST) form between the baseline period and following the intervention	From enrollment to hospital discharge, an average of 24 weeks
Primary	Discharge outcomes	Difference in discharge outcome (location) between the baseline period and following the intervention	From enrollment to six weeks post ICU discharge
Primary	Site of death (ICU, hospital, home, hospice nursing home)		From enrollment to six weeks post ICU discharge