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

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.

Study Overview

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

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Lineberger Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Trevor Jolly, MBBS, UNC Lineberger Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2016

Primary Completion (Actual)

April 24, 2018

Study Completion (Actual)

April 24, 2018

Study Registration Dates

First Submitted

May 13, 2019

First Submitted That Met QC Criteria

May 14, 2019

First Posted (Actual)

May 15, 2019

Study Record Updates

Last Update Posted (Actual)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 14, 2019

Last Verified

May 1, 2019

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

No

Studies a U.S. FDA-regulated device product

No

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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