Characteristics and Clinical Implications of a Clinical Decision Support System



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:March 8, 2018
End Date:February 1, 2020
Contact:Janet Bull, MD
Email:jbull@fourseasonscfl.org
Phone:828-692-6178

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A Prospective Multicenter Cohort Study to Evaluate The Characteristics and Clinical Implications of a Clinical Decision Support System and of Pharmacogenomic Information Relevant to Polypharmacy Actions in Patients With Advanced Illness Who Are Receiving Multiple Drugs for Pain and Other Disorders

The investigators propose to study the feasibility, acceptability, usability and outcomes of
a new clinical decision support system for clinicians of opioid therapy in the context of
specialist palliative care for serious chronic illness. The system provides clinicians with
patient-specific genetic information on opioid responsiveness and multi-drug interactions.
This clinical decision support system should improve the clinician's ability to identify the
optimal pain medication and dosage, and reduce risks associated with multi-drug treatment.
Investigators will conduct clinician survey's to collection information about the clinical
decision support system. Investigators will also conduct patient related questionnaires to
determine any benefits or improvements in quality of life and symptom management from the
clinical decision support system.


Inclusion Criteria:

Clinicians will be eligible if:

1. Physicians or nurse practitioners who are practicing hospice and palliative care

2. Responsible for making and implementing decisions about opioid therapy for pain

Patients will be identified by their treating clinicians. Patients will be eligible if:

1. > 18 years of age

2. Palliative Performance Score ≥ 30%

3. Reside in the community or at a nursing home

4. Have >1 serious chronic illness

5. Have an assessed life-expectancy of at least 4 weeks

6. Have a history of pain and have been taking prescribed opioid medication with a
regimen that provides a minimum dose of 20 mg morphine or equivalent per day in
scheduled doses for at least one week prior to recruitment

7. Is expected to continue opioid therapy for the duration of study participation

8. Is taking > 4 non-opioid medications, each in a regimen providing continuous treatment
of pain or another disorder

9. Is expected to continue drug therapy for the duration of study participation

10. Able to read, understand, and provide Informed Consent to participate

Exclusion Criteria:

There are no exclusion criteria for clinicians.

Patients will be excluded if:

1. Pregnant women or women trying to become pregnant or nursing. Women of childbearing
potential must use an acceptable method of birth control for the duration of the
study. (acceptable forms are oral birth control pills, condoms in combination with
spermicide foam, IUD, transdermal patches, birth control implants, vaginal ring)

2. Palliative Performance Score <30%

3. Have taken an investigational product in the last 30 days

4. Current use of illicit substances

5. Immediate family members of site staff, or site staff may not be enrolled in the study
without first obtaining IRB authorization

6. Any other medical or physical abnormality, disease, or disorder that would prohibit
the patient from completing study procedures in the judgement of the investigator
We found this trial at
2
sites
571 South Allen Road
Flat Rock, North Carolina 28731
Principal Investigator: Janet Bull, MD
Phone: 828-692-6178
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39 Broadway
New York, New York 10006
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