Characteristics and Clinical Implications of a Clinical Decision Support System

Not Applicable

Completed

• Conditions: Chronic Illness; Opioid Use; Palliative Care
• Interventions: Other: Clinical Decision Support System

• Registration Number: NCT03295097
• Lead Sponsor: Hospice of Henderson County, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-09-26
• Study First Posted: 2017-09-27
• Study Start: 2018-03-08
• Primary Completion: 2020-01-21
• Study Completion: 2020-01-21
• Status Verified: 2020-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clinical Decision Support System	Clinical Decision Support System	The Clinical Decision Support System is composed of pharmacogenomic results and a pharmacist evaluated drug to drug interaction review. This system provides clinicians with patient-specific genetic information on opioid responsiveness and multi-drug interactions.

Primary Outcome Measures

Name	Time	Method
Clinician Feasibility	through study completion, an average of 24 months	Clinical questionnaire to determine feasibility of the system
Clinician Usability	through study completion, an average of 24 months	Clinical questionnaire to determine usability of the system

Secondary Outcome Measures

Name	Time	Method
Patient Pain	through study completion, an average of 24 months	Numerical Rating Scale to assess pain
Patient Quality of Life	through study completion,an average of 24 months	Functional Assessment of Chronic Illness - Palliative (FACIT-PAL)

Trial Locations

Locations (2)

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, United States