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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03295097
Other study ID # TRHC2017-SERD101
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 8, 2018
Est. completion date January 21, 2020

Study information

Verified date February 2020
Source Hospice of Henderson County, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date January 21, 2020
Est. primary completion date January 21, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Clinical Decision Support System
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.

Locations

Country Name City State
United States Hospice of Henderson County, Inc. d/b/a Four Seasons Compassion for Life Flat Rock North Carolina
United States MJHS Hospice and Palliative Care New York New York

Sponsors (2)

Lead Sponsor Collaborator
Hospice of Henderson County, Inc. Tabula Rasa HealthCare

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinician Feasibility Clinical questionnaire to determine feasibility of the system through study completion, an average of 24 months
Primary Clinician Usability Clinical questionnaire to determine usability of the system through study completion, an average of 24 months
Secondary Patient Quality of Life Functional Assessment of Chronic Illness - Palliative (FACIT-PAL) through study completion,an average of 24 months
Secondary Patient Pain Numerical Rating Scale to assess pain through study completion, an average of 24 months
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