Characteristics and Clinical Implications of a Clinical Decision Support System

NCT03295097 | Completed

• 1 other identifier: TRHC2017-SERD101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Illness; Opioid Use; Palliative Care

Keywords

pharmacogenomics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Patient Quality of Life

  through study completion,an average of 24 months

• Patient Pain

  through study completion, an average of 24 months

Study Arms (1)

Clinical Decision Support System

OTHER

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

Interventions

Clinical Decision Support System OTHER

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.

Clinical Decision Support System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospice of Henderson County, Inc.: lead
• Tabula Rasa HealthCare: collaborator

Study Sites (2)

MJHS Hospice and Palliative Care

New York, New York, 10006, United States

Location

Hospice of Henderson County, Inc. d/b/a Four Seasons Compassion for Life

Flat Rock, North Carolina, 28731, United States

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: September 27, 2017
• Study Start: March 8, 2018
• Primary Completion: January 21, 2020
• Study Completion: January 21, 2020
• Last Updated: February 17, 2021

Record last verified: 2020-02

Locations

US (2)