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Geriatric Assessment Reporting in Real Time (GARRT) in Non-electively Hospitalized Older Cancer Patients

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: NCT03951090
Recruitment Status : Completed
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Description
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Brief Summary:
This study prospectively evaluates the impact of geriatric assessment reporting in real-time (GARRT) on key hospital based outcomes in a cohort of non-electively hospitalized older (> 70 years) adults with cancer.

Condition or disease Intervention/treatment Phase
Oncology Other: Results of the brief geriatric assessment Other: No results of brief geriatric assessments Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is an un-blinded, 2-arm randomized control trial of a brief, user friendly GA report in real time which summarizes GA-identified deficits and includes recommendations for evidence informed multidisciplinary interventions to address these deficits.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Geriatric Assessment Reporting in Real Time (GARRT) in Non-electively Hospitalized Older Cancer Patients
Actual Study Start Date : April 25, 2016
Actual Primary Completion Date : April 24, 2018
Actual Study Completion Date : April 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
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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
 Other: Results of the brief 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
 Other: No results of brief geriatric assessments
Providers will not receive results of the brief geriatric assessment. Participants will receive standard of care treatment


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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. Referral to Geriatic Consultation [ Time Frame: 2 years ]
    Number of times a Geriatric Consultation referral was given in Intervention and Control group

  3. Referral to Clinical Pharmacist [ Time Frame: 2 years ]
    Number of times Clinical Pharmacist referral was given in Intervention and Control group

  4. Referral to Nutritionist [ Time Frame: 2 years ]
    Number of times Nutritionist referral was given in Intervention and Control group

  5. Referral to psyhcosocial support team [ Time Frame: 2 years ]
    Number of times psychosocial support referral was given in Intervention and Control group

  6. 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"

  7. Physician Reported Satisfaction [ Time Frame: 2 years ]
    Number of times physician indicate "yes" report was helpful when asked "Is this report useful"


Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT03951090


Locations
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United States, North Carolina
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
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Principal Investigator: Trevor Jolly, MBBS UNC Lineberger Comprehensive Cancer Center
More Information
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03951090    
Other Study ID Numbers: LCCC 1538
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms