- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03951090
Geriatric Assessment Reporting in Real Time (GARRT) in Non-electively Hospitalized Older Cancer Patients
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
North Carolina
-
Chapel Hill, North Carolina, Förenta staterna, 27599
- UNC Lineberger Comprehensive Cancer Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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
|
Aktiv komparator: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Referral rate for GA-identified deficits in intervention and control groups
Tidsram: 2 years
|
Number of participants with at least one referral for a GA-idenfied deficit
|
2 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Referral to Physical and Occupational therapy
Tidsram: 2 years
|
Number of times physical and occupation therapy referral was given in Intervention and Control group
|
2 years
|
Referral to Geriatic Consultation
Tidsram: 2 years
|
Number of times a Geriatric Consultation referral was given in Intervention and Control group
|
2 years
|
Referral to Clinical Pharmacist
Tidsram: 2 years
|
Number of times Clinical Pharmacist referral was given in Intervention and Control group
|
2 years
|
Referral to Nutritionist
Tidsram: 2 years
|
Number of times Nutritionist referral was given in Intervention and Control group
|
2 years
|
Referral to psyhcosocial support team
Tidsram: 2 years
|
Number of times psychosocial support referral was given in Intervention and Control group
|
2 years
|
Physician Reported New information
Tidsram: 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
Tidsram: 2 years
|
Number of times physician indicate "yes" report was helpful when asked "Is this report useful"
|
2 years
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Trevor Jolly, MBBS, UNC Lineberger Comprehensive Cancer Center
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- LCCC 1538
Läkemedels- och apparatinformation, studiedokument
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