Status:
COMPLETED
Characteristics and Clinical Implications of a Clinical Decision Support System
Lead Sponsor:
Hospice of Henderson County, Inc.
Collaborating Sponsors:
Tabula Rasa HealthCare
Conditions:
Chronic Illness
Opioid Use
Eligibility:
All Genders
18+ years
Phase:
NA
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 pallia...
Eligibility Criteria
Inclusion
- Clinicians will be eligible if:
- Physicians or nurse practitioners who are practicing hospice and palliative care
- Responsible for making and implementing decisions about opioid therapy for pain
- Patients will be identified by their treating clinicians. Patients will be eligible if:
- \> 18 years of age
- Palliative Performance Score ≥ 30%
- Reside in the community or at a nursing home
- Have \>1 serious chronic illness
- Have an assessed life-expectancy of at least 4 weeks
- 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
- Is expected to continue opioid therapy for the duration of study participation
- Is taking \> 4 non-opioid medications, each in a regimen providing continuous treatment of pain or another disorder
- Is expected to continue drug therapy for the duration of study participation
- Able to read, understand, and provide Informed Consent to participate
Exclusion
- There are no exclusion criteria for clinicians.
- Patients will be excluded if:
- 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)
- Palliative Performance Score \<30%
- Have taken an investigational product in the last 30 days
- Current use of illicit substances
- Immediate family members of site staff, or site staff may not be enrolled in the study without first obtaining IRB authorization
- Any other medical or physical abnormality, disease, or disorder that would prohibit the patient from completing study procedures in the judgement of the investigator
Key Trial Info
Start Date :
March 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03295097
Start Date
March 8 2018
End Date
January 21 2020
Last Update
February 17 2021
Active Locations (2)
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1
MJHS Hospice and Palliative Care
New York, New York, United States, 10006
2
Hospice of Henderson County, Inc. d/b/a Four Seasons Compassion for Life
Flat Rock, North Carolina, United States, 28731