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Characteristics and Clinical Implications of a Clinical Decision Support System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03295097
Recruitment Status : Completed
First Posted : September 27, 2017
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
Tabula Rasa HealthCare
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Illness Opioid Use Palliative Care Other: Clinical Decision Support System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : March 8, 2018
Actual Primary Completion Date : January 21, 2020
Actual Study Completion Date : January 21, 2020

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Clinician Feasibility [ Time Frame: through study completion, an average of 24 months ]
    Clinical questionnaire to determine feasibility of the system

  2. Clinician Usability [ Time Frame: through study completion, an average of 24 months ]
    Clinical questionnaire to determine usability of the system


Secondary Outcome Measures :
  1. Patient Quality of Life [ Time Frame: through study completion,an average of 24 months ]
    Functional Assessment of Chronic Illness - Palliative (FACIT-PAL)

  2. Patient Pain [ Time Frame: through study completion, an average of 24 months ]
    Numerical Rating Scale to assess pain



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295097


Locations
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United States, New York
MJHS Hospice and Palliative Care
New York, New York, United States, 10006
United States, North Carolina
Hospice of Henderson County, Inc. d/b/a Four Seasons Compassion for Life
Flat Rock, North Carolina, United States, 28731
Sponsors and Collaborators
Hospice of Henderson County, Inc.
Tabula Rasa HealthCare
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Responsible Party: Hospice of Henderson County, Inc.
ClinicalTrials.gov Identifier: NCT03295097    
Other Study ID Numbers: TRHC2017-SERD101
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospice of Henderson County, Inc.:
pharmacogenomics
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes