Characteristics and Clinical Implications of a Clinical Decision Support System

Opioid Use Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03295097
• Other study ID #: TRHC2017-SERD101
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Illness
• Opioid Use
• Palliative Care

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