Care Transition Intervention for Patients With Cancer

• ClinicalTrials.gov Identifier: NCT04640714
• Recruitment Status: Completed
• First Posted: November 23, 2020
• Last Update Posted: November 19, 2021
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Jennifer Temel, MD, Massachusetts General Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Advanced Cancer; Home Care, Hospital-Based	Behavioral: CONTINUity of care Under Management by Video visits (CONTINUUM-V)	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 58 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Care Transition Intervention for Hospitalized Patients With Advanced Cancer
• Actual Study Start Date: January 7, 2021
• Actual Primary Completion Date: May 28, 2021
• Actual Study Completion Date: July 14, 2021

Arms and Interventions

Arm

Intervention/treatment

Experimental: CONTINUity of care Under Management by Video visits (CONTINUUM-V); 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); Video visit by nurse practitioner within 3 business days of hospital discharge.

Outcome Measures

Primary Outcome Measures :

1. Feasibility using enrollment and retention on study [ Time Frame: Discharge to 3 business days ]
   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.

Secondary Outcome Measures :

1. Patients' Confidence in Managing their Health Condition using the Patient Activation Measure (PAM-13) [ Time Frame: Baseline to 15 days after discharge ]
   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.
2. Symptom Burden using the Edmonton Symptom Assessment Scale (ESAS-r) [ Time Frame: Baseline to 15 days after discharge ]
   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).
3. Psychological Symptoms using the Patient Health Questionnaire-4 (PHQ-4) [ Time Frame: Baseline to 15 days after discharge ]
   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.
4. Patient Satisfaction using the Patient Satisfaction Questionnaire [ Time Frame: 10 to 15 days after discharge ]
   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.

Other Outcome Measures:

1. 30-day Hospital Readmissions [ Time Frame: Discharge to 30 days after discharge ]
   The investigators will assess whether study participants had a hospital re-admission within 30 days of discharge using the Electronic Health Record

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Age >= 18 years
2. Unplanned admission to the oncology service at Massachusetts General Hospital (MGH)
3. 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.
4. Receiving ongoing oncology care at MGH
5. Verbal fluency in English
6. Must have internet/wifi/cellular data access

Exclusion Criteria:

1. Admitted electively
2. Discharged to a location other than home or expired during admission
3. Discharged with hospice services

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

• Principal Investigator: Jennifer S Temel, MD; Massachusetts General Hospital

More Information

• Responsible Party: Jennifer Temel, MD, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT04640714
• Other Study ID Numbers: 20-418
• First Posted: November 23, 2020
• Last Update Posted: November 19, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jennifer Temel, MD, Massachusetts General Hospital:

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

Additional relevant MeSH terms:

Neoplasms