Characteristics and Clinical Implications of a Clinical Decision Support System

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

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.

Study Overview

• Status: Completed
• Conditions: Palliative Care; Opioid Use; Chronic Illness
• Intervention / Treatment: Other: Clinical Decision Support System

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10006
      • MJHS Hospice and Palliative Care
  • North Carolina
    • Flat Rock, North Carolina, United States, 28731
      • Hospice of Henderson County, Inc. d/b/a Four Seasons Compassion for Life

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Feasibility	Clinical questionnaire to determine feasibility of the system	through study completion, an average of 24 months
Clinician Usability	Clinical questionnaire to determine usability of the system	through study completion, an average of 24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospice of Henderson County, Inc.
• Collaborators: Tabula Rasa HealthCare

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2018
• Primary Completion (Actual): January 21, 2020
• Study Completion (Actual): January 21, 2020

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (Actual): September 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: pharmacogenomics
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: TRHC2017-SERD101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No