Chronic IllnessNCT03295097
Characteristics and Clinical Implications of a Clinical Decision Support System
A study testing Clinical Decision Support System in people with Chronic Illness and Opioid Use, run by Hospice of Henderson County, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Illness, Opioid Use, Palliative Care
- What is being tested?
- Clinical Decision Support System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Mar 2018to 21 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hospice of Henderson County, Inc. d/b/a Four Seasons Compassion for Life
Flat Rock, North Carolina, 28731
MJHS Hospice and Palliative Care
New York, New York, 10006
About this study
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
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.
- Conditions
- Chronic Illness, Opioid Use, Palliative Care
- Being tested
- Clinical Decision Support System
- Keywords
- pharmacogenomics
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision Support SystemOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Decision Support System | Other | 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. Receives: Other: Clinical Decision Support System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Feasibility
Clinical questionnaire to determine feasibility of the system
Measured: through study completion, an average of 24 months
Clinician Usability
Clinical questionnaire to determine usability of the system
Measured: through study completion, an average of 24 months
Secondary outcomes (2)
Patient Quality of Life
Functional Assessment of Chronic Illness - Palliative (FACIT-PAL)
Measured: through study completion,an average of 24 months
Patient Pain
Numerical Rating Scale to assess pain
Measured: through study completion, an average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start8 Mar 2018
- Primary completion21 Jan 2020
- Study completion21 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospice of Henderson County, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Tabula Rasa HealthCare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295097
- Sponsor's protocol ID
- TRHC2017-SERD101
- Status last verified
- Feb 2020
- First submitted
- 23 Aug 2017
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03295097
- Acronym / sponsor ID
- TRHC2017-SERD101
- Conditions
- Chronic Illness, Opioid Use, Palliative Care
- Keywords
- pharmacogenomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospice of Henderson County, Inc.University, hospital or other
- Collaborators
- Tabula Rasa HealthCare
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 21 Jan 2020 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 27 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical Decision Support System | Other | Other: Clinical Decision Support SystemThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Physicians or nurse practitioners who are practicing hospice and palliative care
- Responsible for making and implementing decisions about opioid therapy for pain
- > 18 years of age
- Palliative Performance Score ≥ 30%
- Reside in the community or at a nursing home
Key exclusion criteria (8 listed)
- There are no exclusion criteria for clinicians.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Decision Support SystemThe 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. | Other | Clinical Decision Support System |
Primary outcome
Clinician Feasibility
Time frame: through study completion, an average of 24 months
Clinical questionnaire to determine feasibility of the system
Clinician Usability
Time frame: through study completion, an average of 24 months
Clinical questionnaire to determine usability of the system
2 secondary outcomes
Patient Quality of Life
Time frame: through study completion,an average of 24 months
Patient Pain
Time frame: through study completion, an average of 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Support System in people with Chronic Illness and Opioid Use, run by Hospice of Henderson County, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Feasibility (time frame: through study completion, an average of 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.