Clinical trial NCT03951090: Geriatric Assessment Reporting in Real Time (GARRT) in Non-electively Hospitalized Older Cancer Patients
Official title: Geriatric Assessment Reporting in Real Time (GARRT) in Non-electively Hospitalized Older Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oncology
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 148
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Referral rate for GA-identified deficits in intervention and control groups
timeFrame: 2 years
Secondary outcomes:
measure: Referral to Physical and Occupational therapy
timeFrame: 2 years
measure: Referral to Geriatic Consultation
timeFrame: 2 years
measure: Referral to Clinical Pharmacist
timeFrame: 2 years
measure: Referral to Nutritionist
timeFrame: 2 years
measure: Referral to psyhcosocial support team
timeFrame: 2 years
measure: Physician Reported New information
timeFrame: 2 years
measure: Physician Reported Satisfaction
timeFrame: 2 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Trevor Jolly, MBBS
role: PRINCIPAL_INVESTIGATOR
References: