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

• Status: Completed
• Conditions: Oncology
• Intervention / Treatment: Other: Results of the brief geriatric assessment; Other: No results of brief geriatric assessments

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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	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

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	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	Number of times physical and occupation therapy referral was given in Intervention and Control group	2 years
Referral to Geriatic Consultation	Number of times a Geriatric Consultation referral was given in Intervention and Control group	2 years
Referral to Clinical Pharmacist	Number of times Clinical Pharmacist referral was given in Intervention and Control group	2 years
Referral to Nutritionist	Number of times Nutritionist referral was given in Intervention and Control group	2 years
Referral to psyhcosocial support team	Number of times psychosocial support referral was given in Intervention and Control group	2 years
Physician Reported New information	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	Number of times physician indicate "yes" report was helpful when asked "Is this report useful"	2 years

Collaborators and Investigators

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

Study record dates

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: Neoplasms
• 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