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Care Transition Intervention for Hospitalized Patients With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT05142345
Recruitment Status : Recruiting
First Posted : December 2, 2021
Last Update Posted : February 11, 2022
Sponsor:
Collaborator:
Conquer Cancer Foundation
Information provided by (Responsible Party):
Jennifer Temel, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Cancer Follow-Up Care Consultation, Remote Advanced Cancer Other: CONTINUUM Intervention Other: Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized Trial of a Care Transition Intervention for Hospitalized Patients With Advanced Cancer
Actual Study Start Date : December 15, 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Experimental: CONTINUUM Intervention Post-Hospital Discharge
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
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.

Active Comparator: Usual Care Post-Hospital Discharge
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
Patients assigned to the usual care group will have their post-discharge follow-up scheduled per hospital, outpatient oncology team, and patient preference.




Primary Outcome Measures :
  1. Patients' Confidence in Managing their Health Condition using the Patient Activation Measure-13 (PAM-13) [ Time Frame: Baseline to 10-15 days after hospital discharge ]
    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.


Secondary Outcome Measures :
  1. Quality of Communication using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Communication subscale [ Time Frame: Up to 10-15 days after hospital discharge ]
    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.

  2. Symptom Burden using the Edmonton Symptom Assessment Scale (ESAS-r) [ Time Frame: Baseline to 10-15 days after hospital discharge ]
    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.

  3. Psychological Symptoms using the Patient Health Questionnaire-4 (PHQ-4) [ Time Frame: Baseline to 10-15 days after hospital discharge ]
    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.


Other Outcome Measures:
  1. 30-day Hospital Readmissions [ Time Frame: Up to 30 days after discharge ]
    Compare hospital readmissions within 30 days of discharge between study groups.



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05142345


Contacts
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Contact: Jennifer S Temel, MD (617) 724-4000 jtemel@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jennifer S Temel, MD    617-724-4000    jtemel@mgh.harvard.edu   
Principal Investigator: Jennifer S Temel, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Conquer Cancer Foundation
Investigators
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Principal Investigator: Jennifer S Temel, MD Massachusetts General Hospital
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Responsible Party: Jennifer Temel, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT05142345    
Other Study ID Numbers: 21-501
First Posted: December 2, 2021    Key Record Dates
Last Update Posted: February 11, 2022
Last Verified: February 2022
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

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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:
Cancer
Follow-Up Care
Care Services, Home
Consultation, Remote
Advanced Cancer
Hospitalization
Care Transition Intervention
Additional relevant MeSH terms:
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Neoplasms