Clinical trial NCT03295097: Characteristics and Clinical Implications of a Clinical Decision Support System
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Illness
Opioid Use
Palliative Care
Keywords: pharmacogenomics
Lead sponsor: Hospice of Henderson County, Inc.
Sponsor class: OTHER
Collaborators: name: Tabula Rasa HealthCare
First posted: 2017-09-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinician Feasibility
timeFrame: through study completion, an average of 24 months
measure: Clinician Usability
timeFrame: through study completion, an average of 24 months
Secondary outcomes:
measure: Patient Quality of Life
timeFrame: through study completion,an average of 24 months
measure: Patient Pain
timeFrame: through study completion, an average of 24 months
Other outcomes:
Locations:
city: New York
country: United States
facility: MJHS Hospice and Palliative Care
state: New York
city: Flat Rock
country: United States
facility: Hospice of Henderson County, Inc. d/b/a Four Seasons Compassion for Life
state: North Carolina
Study officials:
References: