Clinical trial NCT05142345: Care Transition Intervention for Hospitalized Patients with Advanced Cancer
Official title: Randomized Trial of a Care Transition Intervention for Hospitalized Patients with Advanced Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Follow-Up Care
Consultation, Remote
Advanced Cancer
Keywords: Cancer
Follow-Up Care
Care Services, Home
Consultation, Remote
Advanced Cancer
Hospitalization
Care Transition Intervention
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Conquer Cancer Foundation
First posted: 2021-12-02
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patients' Confidence in Managing their Health Condition using the Patient Activation Measure-13 (PAM-13)
timeFrame: Baseline to 10-15 days after hospital discharge
Secondary outcomes:
measure: Quality of Communication using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Communication subscale
timeFrame: Up to 10-15 days after hospital discharge
measure: Symptom Burden using the Edmonton Symptom Assessment Scale (ESAS-r)
timeFrame: Baseline to 10-15 days after hospital discharge
measure: Psychological Symptoms using the Patient Health Questionnaire-4 (PHQ-4)
timeFrame: Baseline to 10-15 days after hospital discharge
Other outcomes:
measure: 30-day Hospital Readmissions
timeFrame: Up to 30 days after discharge
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Daniel E Lage, MD
role: PRINCIPAL_INVESTIGATOR
References: