Back to resultsCharacteristics and Clinical Implications of a Clinical Decision Support System
Primary Purpose
Chronic Illness, Opioid Use, Palliative Care
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Decision Support System
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Illness focused on measuring pharmacogenomics
Eligibility Criteria
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
Sites / Locations
- MJHS Hospice and Palliative Care
- Hospice of Henderson County, Inc. d/b/a Four Seasons Compassion for Life
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Clinical Decision Support System
Arm Description
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.
Outcomes
Primary Outcome Measures
Clinician Feasibility
Clinical questionnaire to determine feasibility of the system
Clinician Usability
Clinical questionnaire to determine usability of the system
Secondary Outcome Measures
Patient Quality of Life
Functional Assessment of Chronic Illness - Palliative (FACIT-PAL)
Patient Pain
Numerical Rating Scale to assess pain
Full Information
NCT ID
NCT03295097
First Posted
August 23, 2017
Last Updated
February 16, 2021
Sponsor
Hospice of Henderson County, Inc.
Collaborators
Tabula Rasa HealthCare
1. Study Identification
Unique Protocol Identification Number
NCT03295097
Brief Title
Characteristics and Clinical Implications of a Clinical Decision Support System
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 8, 2018 (Actual)
Primary Completion Date
January 21, 2020 (Actual)
Study Completion Date
January 21, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospice of Henderson County, Inc.
Collaborators
Tabula Rasa HealthCare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Illness, Opioid Use, Palliative Care
Keywords
pharmacogenomics
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinical Decision Support System
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Clinical Decision Support System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinician Feasibility
Description
Clinical questionnaire to determine feasibility of the system
Time Frame
through study completion, an average of 24 months
Title
Clinician Usability
Description
Clinical questionnaire to determine usability of the system
Time Frame
through study completion, an average of 24 months
Secondary Outcome Measure Information:
Title
Patient Quality of Life
Description
Functional Assessment of Chronic Illness - Palliative (FACIT-PAL)
Time Frame
through study completion,an average of 24 months
Title
Patient Pain
Description
Numerical Rating Scale to assess pain
Time Frame
through study completion, an average of 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
MJHS Hospice and Palliative Care
City
New York
State/Province
New York
ZIP/Postal Code
10006
Country
United States
Facility Name
Hospice of Henderson County, Inc. d/b/a Four Seasons Compassion for Life
City
Flat Rock
State/Province
North Carolina
ZIP/Postal Code
28731
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Characteristics and Clinical Implications of a Clinical Decision Support System
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