Care Transition Intervention for Patients With Cancer

NCT04640714 | Completed DMC

• 1 other identifier: 20-418
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Cancer; Home Care, Hospital-Based

Keywords

Advanced Cancer; Home Care, Hospital-Based; Transitions of Care; Care Transition Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patients' Confidence in Managing their Health Condition using the Patient Activation Measure (PAM-13)

  Baseline to 15 days after discharge

• Symptom Burden using the Edmonton Symptom Assessment Scale (ESAS-r)

  Baseline to 15 days after discharge

• Psychological Symptoms using the Patient Health Questionnaire-4 (PHQ-4)

  Baseline to 15 days after discharge

• Patient Satisfaction using the Patient Satisfaction Questionnaire

  10 to 15 days after discharge

Other Outcomes (1)

• 30-day Hospital Readmissions

  Discharge to 30 days after discharge

Study Arms (1)

CONTINUity of care Under Management by Video visits (CONTINUUM-V)

EXPERIMENTAL

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)

Interventions

CONTINUity of care Under Management by Video visits (CONTINUUM-V) BEHAVIORAL

Video visit by nurse practitioner within 3 business days of hospital discharge.

CONTINUity of care Under Management by Video visits (CONTINUUM-V)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Admitted electively
• Discharged to a location other than home or expired during admission
• Discharged with hospice services

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Study Officials

• Jennifer S Temel, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 23, 2020
• Study Start: January 7, 2021
• Primary Completion: May 28, 2021
• Study Completion: July 14, 2021
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)