Risk Stratification for Patients With Hospital-diagnosed Advanced Lung Cancer

Study Overview
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Brief Summary
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This study explores whether supportive care interventions that might reduce rehospitalization could be implemented and feasible, in subjects within a high-risk group of subjects with newly diagnosed hospitalized advanced lung cancer (ALC). Subjects will be considered high risk if they have small cell histology, longer than 8 days hospitalization, high comorbidity, emergency department use or hospitalization in the previous 6 months, prescription of a wheelchair on hospital discharge, or Black and/or Hispanic race. Supportive care interventions such as navigation and palliative care will be recommended for this group. All hospitalized subjects with newly diagnosed ALC will be offered web- or telephone-based patient-reported outcome (PRO) symptom monitoring for 90 days following hospital discharge if they provide consent. Medical record evaluation of consented subjects will provide data for risk assessment and the high-risk group definition. Healthcare utilization including emergency department visits, hospitalizations, outpatient palliative care, and cancer treatment received will be compared.

Official Title
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Development of an Enhanced Risk Stratification System for Patients With Hospital-diagnosed Advanced Lung Cancer

Conditions
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Lung Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years at the time of screening. Hospital-diagnosed Advanced lung cancer with histological confirmation of disease or suspected lung cancer in the opinion of the treating oncologist. For PROs only 1. Able to complete a web-based or telephonic symptom survey. Exclusion Criteria: 1. Enrollment in hospice upon discharge from the index hospitalization For PROs only Inability to read or speak English. Dementia, altered mental status, or any psychiatric condition as determined by the clinical or study team that would prohibit the understanding or rendering of informed consent. Current incarceration. Any condition that would prohibit the patient from completing PROs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low risk<br>Subjects will be considered low risk if they have non-small cell histology, a length of hospital stay <= 8 days, no or low comorbidity, no emergency department use or hospitalization in the 6 months prior, no wheelchair requirement when hospital discharge, or other than Black and/or Hispanic race. | |
| High risk<br>Subjects will be considered high risk if they have small cell histology, a length of hospital stay > 8 days, high comorbidity, emergency department use or hospitalization in the 6 months prior, prescription of a wheelchair when hospital discharge, or Black and/or Hispanic race. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of the risk-based stratification system implementation - contacted | The success of the risk-based stratification system implementation- contacted will be determined by the ratio of subjects who were contacted to the whole group is equal to or higher than 70%, in the high-risk group. | Up to 5 days | 
| Success of the risk-based stratification system implementation - referred | The success of the risk-based stratification system implementation- referred will be determined by the ratio of subjects who were referred to the whole group is equal to or higher than 70%, in the high-risk group. | Up to 5 days | 
| Success of the risk-based stratification system implementation - navigation | The success of the risk-based stratification system implementation- navigation will be determined by the ratio of subjects who received guidance to the whole group is equal to or higher than 70%, in the high-risk group. | Up to 16 days | 
| Success of the risk-based stratification system implementation - palliative care | The success of the risk-based stratification system implementation - palliative care will be determined by the ratio of subjects who received palliative care to the whole group is equal to or higher than 70%, in the high-risk group. | Up to 16 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to receipt of outpatient palliative care | The time to receipt of outpatient palliative care will be defined as the time between the date of palliative care and hospital discharge based on the high-risk and low-risk groups. | Up to 90 days | 
| Acceptability of the supportive care intervention | Acceptability of the supportive care intervention will be assessed by the percentage of subjects who attend supportive care consultations as determined through electronic health records ( EHR) review. | Up to 180 days | 
| Acceptability of the risk stratification system the time to complete for providers | Acceptability of the risk stratification system time to complete for providers will be assessed by the time to complete risk stratification per subject. | Up to 90 days | 
| Acceptability of the risk stratification system time to complete thoracic oncology clinical team | Acceptability of the risk stratification system time to complete the thoracic oncology clinical team will be assessed by the perceived usefulness to the thoracic oncology clinical team | Up to 90 days | 
| Implementation of PRO-based symptom monitoring | Implementation of patient reported outcomes (PRO)-based symptom monitoring will be determined by the percentage of eligible subjects who complete weekly PROs and the percentage of concerning symptoms reported to the clinical team of more than 70. | Up to 90 days | 
| Implementation of PRO-based symptom monitoring reported to clinical team | Implementation of PRO-based symptom monitoring will be determined by the percentage of concerning symptoms reported to the clinical team. | Up to 90 days | 
| Acceptability of PRO-based symptom monitoring subject | Acceptability of PRO-based symptom monitoring to subjects will be measured by the percentage of eligible subjects who agree to participate in the patient-reported outcome report (PRO) system (success: >66%). | Up to 90 days | 
| Acceptability of PRO-based symptom monitoring to the clinical team | Acceptability of PRO-based symptom monitoring to the clinical team will be determined by the percentage of concerning symptoms resulting in action by any member of the clinical team.(success: >75% reporting somewhat useful, useful, or very useful). | Up to 90 days | 
| Acceptability of PRO-based symptom monitoring to the thoracic oncology clinical team | Acceptability of PRO-based symptom monitoring to the clinical team will be determined by the percentage of concerning symptoms perceived usefulness to the thoracic oncology clinical team (success: >75% reporting somewhat useful, useful, or very useful). | Up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Cancer, High-Risk, patient reported outcome