Skip to content

Characteristics and Clinical Implications of a Clinical Decision Support System

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03295097
Enrollment
100
Registered
2017-09-27
Start date
2018-03-08
Completion date
2020-01-21
Last updated
2021-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Illness, Opioid Use, Palliative Care

Keywords

pharmacogenomics

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.

Interventions

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.

Sponsors

Tabula Rasa HealthCare
CollaboratorINDUSTRY
Hospice of Henderson County, Inc.
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinician Feasibilitythrough study completion, an average of 24 monthsClinical questionnaire to determine feasibility of the system
Clinician Usabilitythrough study completion, an average of 24 monthsClinical questionnaire to determine usability of the system

Secondary

MeasureTime frameDescription
Patient Quality of Lifethrough study completion,an average of 24 monthsFunctional Assessment of Chronic Illness - Palliative (FACIT-PAL)
Patient Painthrough study completion, an average of 24 monthsNumerical Rating Scale to assess pain

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026