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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02858778
Other study ID # BCBSMF PSACO
Secondary ID
Status Active, not recruiting
Phase N/A
First received July 20, 2016
Last updated August 3, 2016
Start date June 2016

Study information

Verified date August 2016
Source Wayne State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

A prospective randomized controlled trial studying the ordering of palliative care consultations in the emergency department (Ig) versus later palliative care consultations in the hospital--ICU or hospital ward(Cg). Patients will be randomly allocated to Ig or Cg with a 1:1 ratio.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 120
Est. completion date
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- Greater than or equal to 65 years old

- Treated in a resuscitation room for unstable vital signs or respiratory compromise

- One or more of the following:

- Advanced or metastatic solid organ cancer

- End stage organ failure of the heart, lung/COPD, kidney on dialysis, hepatic encephalopathy

- Suspected sepsis

- Advanced dementia, end-state multiple sclerosis or Parkinson's disease

- Status post cardiac arrest with coma (Glascow coma score <7)

- Patient is from a skilled nursing facility

Exclusion Criteria:

- Lack decision capacity and have no relative available during ED stay to consent to the study (legally authorized representative—LAR)

- Enrolled in hospice care prior to randomization

- A copy of a completed advance directive which names a designated proxy provided physically to the medical team prior to randomization

- Wearing a DNR bracelet

- Have been previously enrolled in this study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care


Intervention

Other:
Early order of palliative care consultation


Locations

Country Name City State
United States Detroit Medical Center Detroit Receiving Hospital Detroit Michigan
United States Detroit Medical Center Sinai Grace Hospital Detroit Michigan

Sponsors (2)

Lead Sponsor Collaborator
Wayne State University Blue Cross Blue Shield of Michigan Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The difference in the percentage of patients with a completed advance directive (AD) in Ig vs.Cg 1 year No
Secondary The proportion of billed CMS ACP-CPT codes in Ig vs. Cg The proportion of patients who received an ACP CMS billing codes (which took effect in January 2016), in Ig vs. Cg will be evaluated using one or both of the new CPT codes for Advance care planning (ACP) services…including the explanation and discussion of advance directives such as standard forms (with the completion of such forms, when performed) by the physician or other qualified health profession; first 30 (15-45)minutes, face to face with the patients, family member(s) and/or surrogate Code 99497; and each additional 30 (46-75 minutes)—Code 99498 (Federal Register, 2015). 30 days from enrolled patients' hospital discharge No
Secondary Matches of care received to patient-specific preferences in Ig vs. Cg The investigators will align treatment preferences with medical orders, replicated as reported in the study by Mack et al. Proportions of patients coded as having a match will be compared across the treatment and control groups. For everyone who gets ACP during the study, patients or their surrogates will be asked by a member of the care team—either palliative care if they are consulted, or the hospital based care team if they are not: "If you could choose, would you prefer (a) treatment that focuses on attempting to extend your time as much as possible, even if doing so means more pain and discomfort, or (b) a plan of care that focuses on relieving pain and discomfort and improving quality of life, even though that may mean not living as long. 1 year No
Secondary Patient/family satisfaction with care in Ig vs. Cg This outcome will be measured on a continuous scale. The net-promoter score will be measured at baseline (at randomization) and at hospital discharge for a change in value. It is measured on a scale of 1-10. Whoever signs the consent (patient of LAR) will be asked the net promoter score, and that will be reassessed by them at discharge, unless the patient has died—and the variable will then be recorded as missing. The PSQ will be administered by research assistants at the time of the patient's discharge. If the patient is incapacitated, then it will be asked of the patient's closest family caregiver. So PSQ is only at discharge of patient or available, most involved, family caregiver. Baseline No
Secondary Amount of hospice referrals in Ig vs. Cg 1 year No
Secondary Hospital total direct costs for the index visit in Ig vs. Cg 1 year No
Secondary Hospital and ICU length of stay in Ig vs. Cg 1 year No
Secondary Average days in hospice in Ig vs. Cg 1 year No
Secondary Hospital margin contribution for the index visit in Ig vs. Cg 1 year No
Secondary Time to consultation in Ig vs. Cg groups 1 year No
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