Care Transition Intervention for Hospitalized Patients With Advanced Cancer

Study Overview
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Brief Summary
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This study is examining whether a care transition intervention, CONTINUUM (CONTINUity of care Under Management by video visits), consisting of a supportive care-focused video visit with an oncology nurse practitioner (NP) within three business days of hospital discharge, may improve post-discharge transitions of care for recently hospitalized patients with advanced cancer.

Detailed Description
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To address the rising incidence and burden of hospital readmissions for patients with advanced cancer, the investigators developed a population-specific care transition intervention based upon the scholarly literature and our qualitative study. The intervention, CONTINUUM (CONTINUity of care Under Management by video visits), consists of a video visit conducted by an oncology NP within three business days of hospital discharge, to: (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. From 01/07/21 to 05/28/21, the investigators conducted a pilot trial of CONTINUUM in 48 patients with advanced cancer recently discharged from the Massachusetts General Hospital Cancer Center (NCT04640714). The investigators found that the intervention was feasible and acceptable in our population. The investigators are now conducting a randomized controlled trial of the CONTINUUM intervention versus standard of care, to study whether CONTINUUM improves patients' confidence in managing their health condition, as measured by the Patient Activation Measure-13. The investigators will also assess the efficacy of CONTINUUM for improving patient satisfaction with clinician communication, and physical and psychological symptom burden. Lastly, the investigators will explore the effect of the intervention on hospital readmissions within 30-days. Study procedures include random assignment to either the CONTINUUM intervention or standard oncology care following hospital discharge, questionnaires and medical record data collection. Participants are expected to be on the study for up to 40 days after hospital discharge. It is anticipated that about 286 people will take part in this research study.

Official Title
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Randomized Trial of a Care Transition Intervention for Hospitalized Patients With Advanced Cancer

Conditions
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Cancer, Follow-Up Care, Consultation, Remote, Advanced Cancer

Intervention / Treatment
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* Other: CONTINUUM Intervention
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >= 18 years First unplanned admission to the oncology service at Massachusetts General Hospital (MGH) since diagnosis of advanced cancer Known diagnosis of advanced breast, thoracic, genitourinary, or gastrointestinal cancer Receiving ongoing oncology care at MGH Verbal fluency in English Internet/wifi or telephone access Residing in Massachusetts at the time of hospital discharge 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CONTINUUM Intervention Post-Hospital Discharge<br>Participants will receive CONTINUUM intervention visit with a nurse practitioner within three business days of hospital discharge and complete questionnaires about their cancer and care. | Other: CONTINUUM Intervention<br>* The intervention, CONTINUUM (CONTINUity of care Under Management by video visits), consists of a video visit conducted by an oncology nurse practitioner within three business days of hospital discharge, to: (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.<br>|
| Active Comparator: Usual Care Post-Hospital Discharge<br>Participants will receive standard oncology care following hospital discharge with follow-up appointments scheduled per primary team and participant preferences. Participants will complete questionnaires about their cancer and care. | Other: Usual Care<br>* Patients assigned to the usual care group will have their post-discharge follow-up scheduled per hospital, outpatient oncology team, and patient preference.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' Confidence in Managing their Health Condition using the Patient Activation Measure-13 (PAM-13) | Compare change in the PAM-13 from baseline to 10-15 days post-discharge between study groups. The PAM-13 is scored 0-100 with higher scores indicating greater confidence in managing one's health condition. | Baseline to 10-15 days after hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Communication using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Communication subscale | Compare differences in CAHPS-Communication at up to 10-15 days post-discharge between study groups. CAHPS-Communication has a composite score (score range 0-20) with higher scores indicating better satisfaction. As recommended by CAHPS, we will also analyze specific differences in CAHPS-Communication individual items, which relate to patients' assessment of whether clinicians discussed 1) illness course expectations, 2) what is most important to the patient, and 3) how the treatment plan should match what is most important to the patient. These items are scored as Yes vs. No responses. | Up to 10-15 days after hospital discharge | 
| Symptom Burden using the Edmonton Symptom Assessment Scale (ESAS-r) | Compare change in the Edmonton Symptom Assessment System-Revised (ESAS-r) total score and physical sub-scale between baseline and 10-15 days of discharge between study groups. Scores on the ESAS-r range from 0-100 with higher scores indicating worse symptom burden. Scores on the ESAS-Physical sub-scale range from 0-70 with higher scores indicating worse symptom burden. | Baseline to 10-15 days after hospital discharge | 
| Psychological Symptoms using the Patient Health Questionnaire-4 (PHQ-4) | Compare change in the Patient Health Questionnaire-4 (PHQ-4) between baseline and 10-15 days of discharge between study groups. 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 10-15 days after hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Follow-Up Care, Care Services, Home, Consultation, Remote, Advanced Cancer, Hospitalization, Care Transition Intervention