Characteristics and Clinical Implications of a Clinical Decision Support System

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Palliative Care, Chronic Illness, Opioid Use

Intervention / Treatment
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* Other: Clinical Decision Support System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: There are no exclusion criteria for clinicians. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Clinical Decision Support System<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacogenomics