Care Transition Intervention for Patients With Cancer

Advanced Cancer Clinical Trial

Official title:

Care Transition Intervention for Hospitalized Patients With Advanced Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04640714
• Other study ID #: 20-418
• Status: Completed
• Phase: N/A
• Start date: January 7, 2021
• Est. completion date: July 14, 2021

Study information

• Verified date: November 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: July 14, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Home Care, Hospital-Based
• Neoplasms

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	30-day Hospital Readmissions	The investigators will assess whether study participants had a hospital re-admission within 30 days of discharge using the Electronic Health Record	Discharge to 30 days after discharge
Primary	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	Patients' Confidence in Managing their Health Condition using the Patient Activation Measure (PAM-13)	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.	Baseline to 15 days after discharge
Secondary	Symptom Burden using the Edmonton Symptom Assessment Scale (ESAS-r)	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).	Baseline to 15 days after discharge
Secondary	Psychological Symptoms using the Patient Health Questionnaire-4 (PHQ-4)	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.	Baseline to 15 days after discharge
Secondary	Patient Satisfaction using the Patient Satisfaction Questionnaire	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.	10 to 15 days after discharge