Care Transition Intervention for Hospitalized Patients With Advanced Cancer

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05142345
• Other study ID #: 21-501
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: December 2023

Study information

• Verified date: February 2022
• Source: Massachusetts General Hospital
• Contact: Jennifer S Temel, MD
• Phone: (617) 724-4000
• Email: jtemel[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 286
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Cancer
• Follow-Up Care
• Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Conquer Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	30-day Hospital Readmissions	Compare hospital readmissions within 30 days of discharge between study groups.	Up to 30 days after discharge
Primary	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	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
Secondary	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
Secondary	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