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OpenTrials
Completed

NCT Number: NCT03295097

Characteristics and Clinical Implications of a Clinical Decision Support System

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MJHS Hospice and Palliative Care, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospice of Henderson County, Inc.

Other

Collaborators

  • Tabula Rasa HealthCare

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 27, 2017
Registry last updated
Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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