- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03951090
Geriatric Assessment Reporting in Real Time (GARRT) in Non-electively Hospitalized Older Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study evaluates the impact of geriatric assessment reporting in real-time (GARRT) on key hospital based outcomes in non-electively hospitalized older (> 70 years) adults with cancer. Participants will be randomly assigned to the GARRT group, or the control group. All participants will fill out user friendly questionnaire called the geriatric assessment. The results of the geriatric assessment will be given to the physicians of participants in the GARRT group in real-time. The physicians of participants in the control group will not receive real time results.
This study will compare the referral rates of participants in each group to determine if providing real-time results of the geriatric assessment impact referral rates.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- UNC Lineberger Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 70 years or older.
- English speaking.
- Admitted to UNC Hospitals non-electively within 72 hours.
- Biopsy proven solid tumor or myeloma or lymphoma.
- Newly diagnosed cancer patients for whom active cancer directed therapy is planned within the next six months or patients on active cancer directed therapy either currently or within the previous 6 months.
- Signed written IRB-approved informed consent.
Exclusion Criteria:
- Patients meeting any of the following exclusion criteria at baseline will be excluded from study participation. Patients with a life expectancy <6 weeks
- Patients who are <48 hours post-surgery.
- Patients who are admitted to an intensive care setting.
- Patients with acute myeloma lymphoma (AML) or other high grade hematologic malignancies.
- Patients undergoing bone marrow transplant or admitted to the bone marrow transplant unit.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GARRT Arm
Participants in this arm complete an brief geriatric assessment, and the results of these assessments are given to providers with recommendations to address deficits identified by the geriatric assessment
|
Providers will receive results of the brief geriatric assessment with recommendations for address deficits identified through the results of the brief geriatric assessment
|
Active Comparator: Control Arm
Providers of participants of this group will not receive the results of the brief geriatric assessments.
These participants will receive standard of care treatment
|
Providers will not receive results of the brief geriatric assessment.
Participants will receive standard of care treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Referral rate for GA-identified deficits in intervention and control groups
Time Frame: 2 years
|
Number of participants with at least one referral for a GA-idenfied deficit
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Referral to Physical and Occupational therapy
Time Frame: 2 years
|
Number of times physical and occupation therapy referral was given in Intervention and Control group
|
2 years
|
Referral to Geriatic Consultation
Time Frame: 2 years
|
Number of times a Geriatric Consultation referral was given in Intervention and Control group
|
2 years
|
Referral to Clinical Pharmacist
Time Frame: 2 years
|
Number of times Clinical Pharmacist referral was given in Intervention and Control group
|
2 years
|
Referral to Nutritionist
Time Frame: 2 years
|
Number of times Nutritionist referral was given in Intervention and Control group
|
2 years
|
Referral to psyhcosocial support team
Time Frame: 2 years
|
Number of times psychosocial support referral was given in Intervention and Control group
|
2 years
|
Physician Reported New information
Time Frame: 2 years
|
Number of times physicians answer "yes" to the questions "did report provide new information about patient deficits that would warrant a referral"
|
2 years
|
Physician Reported Satisfaction
Time Frame: 2 years
|
Number of times physician indicate "yes" report was helpful when asked "Is this report useful"
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Trevor Jolly, MBBS, UNC Lineberger Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCCC 1538
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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