Care Transition Intervention for Patients With Cancer

Study Overview
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Brief Summary
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This research study is investigating an intervention called CONTINUity of care Under Management by Video visits (CONTINUUM-V). CONTINUUM-V involves a video visit with an oncology nurse practitioner within three business days of hospital discharge for patients with advanced cancer with the goal of reducing burdensome care transitions after hospitalization, including hospital readmissions.

Detailed Description
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This is a single-site, single-arm pilot trial to assess the feasibility and acceptability of a CONTINUUM-V for patients with advanced cancer The research study procedures include: A video visit with a nurse practitioner within three business days of hospital discharge Questionnaires asking about demographic information (e.g. sex, ethnicity, income) and participant experience with cancer (e.g. symptoms and confidence in managing their health condition) A satisfaction survey to assess the participants' impressions of the intervention and any suggestions the participants may have Data collection from their medical record One time interview of participant and clinician for feedback on CONTINUUM-V Participants will be in this research study for up to 45 days after hospital discharge. 54 patients and 4 clinicians took part in this research study. The Conquer Cancer Foundation and the Rising Tide Foundation for Clinical Cancer Research are supporting this research study by providing a Career Pathway Grant in Symptom Management to support the research team.

Official Title
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Care Transition Intervention for Hospitalized Patients With Advanced Cancer

Conditions
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Advanced Cancer, Home Care, Hospital-Based

Intervention / Treatment
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* Behavioral: CONTINUity of care Under Management by Video visits (CONTINUUM-V)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >= 18 years Unplanned admission to the oncology service at Massachusetts General Hospital (MGH) Known diagnosis of advanced breast, thoracic, genitourinary, or gastrointestinal cancers. Advanced cancer defined as not being treated with curative intent as determined by clinic notes and chemotherapy order entry. Receiving ongoing oncology care at MGH Verbal fluency in English Must have internet/wifi/cellular data access Exclusion Criteria: Admitted electively Discharged to a location other than home or expired during admission Discharged with hospice services

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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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CONTINUity of care Under Management by Video visits (CONTINUUM-V)<br>Participants with advanced cancer will receive a video visit conducted by an oncology Nurse Practitioner (NP) within three (3) business days of hospital discharge. The visit will involve: (1) reconcile medications, (2) manage symptoms, (3) review the post-hospital care plan for hospitalization-specific issues, and (4) schedule follow-up with the outpatient oncology team. Participant and clinician may also be interviewed for their feedback on the video visit. The ultimate goal of the intervention is to improve patients' confidence in managing their health condition and reduce burdensome health care utilization after discharge, particularly reducing 30-day hospital readmissions. | Behavioral: CONTINUity of care Under Management by Video visits (CONTINUUM-V)<br>* Video visit by nurse practitioner within 3 business days of hospital discharge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility using enrollment and retention on study | The intervention will be deemed feasible if at least 70% of eligible patients participate in the study, and if at least 70% complete the video visit within three business days of discharge. | Discharge to 3 business days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' Confidence in Managing their Health Condition using the Patient Activation Measure (PAM-13) | The investigators will use the Patient Activation Measure 13 (PAM-13) to assess participants' confidence in managing their health condition at baseline and within 10-15 days of discharge (post-intervention). The PAM-13 is scored 0-100 with higher scores indicating greater confidence in managing one's health condition. | Baseline to 15 days after discharge | 
| Symptom Burden using the Edmonton Symptom Assessment Scale (ESAS-r) | The investigators will use a modified version of the self-administered, revised Edmonton Symptom Assessment System (ESAS-r) to assess participants' symptoms at baseline and within 10-15 days of discharge (post-intervention). The ESAS-r assesses pain, fatigue, drowsiness, nausea, appetite, dyspnea, depression, anxiety, and well being over the previous 24 hours. The ESAS-r also includes constipation. Individual symptoms are scored on a scale from 0 (reflecting absence of the symptom) to 10 (reflecting the worst possible severity). The investigators will compute the composite ESAS physical and total symptom variables that included scores of participants' physical symptoms (pain, fatigue, drowsiness, nausea, appetite, dyspnea, constipation) and total symptoms (pain, fatigue, drowsiness, nausea, appetite, dyspnea, depression, anxiety, well being, constipation). | Baseline to 15 days after discharge | 
| Psychological Symptoms using the Patient Health Questionnaire-4 (PHQ-4) | The investigators will use the Patient Health Questionnaire-4 (PHQ-4) to assess psychological symptoms at baseline and within 10-15 days of discharge (post-intervention). The PHQ-4 is a 4-item tool that contains two 2-item subscales assessing depression and anxiety symptoms. Both subscales and the composite PHQ-4 score can also be evaluated continuously, with higher scores indicating worse psychological distress. Scores on each subscale range from 0 to 6. | Baseline to 15 days after discharge | 
| Patient Satisfaction using the Patient Satisfaction Questionnaire | The investigators will use the patient satisfaction questionnaire within 10-15 days after discharge. The participants will be asked how useful the participants found the intervention, on a 0 to 10 scale, with 0 being not useful at all and 10 being extremely useful. | 10 to 15 days after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Cancer, Home Care, Hospital-Based, Transitions of Care, Care Transition Intervention