Randomized Trial of a Care Transition Intervention for Hospitalized Patients With Advanced Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 286
- Locations
- 2
- Primary Endpoint
- Patients' Confidence in Managing their Health Condition using the Patient Activation Measure-13 (PAM-13)
Study Overview
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.
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 54 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age >= 18 years
- •First unplanned admission since diagnosis of advanced cancer to to the oncology service at Massachusetts General Hospital (MGH) or the medicine service with oncology consultation
- •Known diagnosis of advanced breast, thoracic, genitourinary, gastrointestinal cancers, sarcoma, or melanoma
- •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
Arms & Interventions
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.
Intervention: CONTINUUM Intervention (Other)
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.
Intervention: Usual Care (Other)
Outcomes
Primary Outcomes
Patients' Confidence in Managing their Health Condition using the Patient Activation Measure-13 (PAM-13)
Time Frame: Baseline to 10-20 days after hospital discharge
Compare change in the PAM-13 from baseline to 10-20 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.
Patients' Confidence in Managing their Health Condition using the Patient Activation Measure-13 (PAM-13)
Time Frame: Baseline to 10-20 days after hospital discharge
Compare change in the PAM-13 from baseline to 10-20 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 Outcomes
- Quality of Communication using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Communication subscale(Up to 10-20 days after hospital discharge)
- Symptom Burden using the Edmonton Symptom Assessment Scale (ESAS-r)(Baseline to 10-20 days after hospital discharge)
- Psychological Symptoms using the Patient Health Questionnaire-4 (PHQ-4)(Baseline to 10-20 days after hospital discharge)
- Quality of Communication using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Communication subscale(Up to 10-20 days after hospital discharge)
- Symptom Burden using the Edmonton Symptom Assessment Scale (ESAS-r)(Baseline to 10-20 days after hospital discharge)
- Psychological Symptoms using the Patient Health Questionnaire-4 (PHQ-4)(Baseline to 10-20 days after hospital discharge)
Investigators
Daniel E Lage, MD, MSc
Principal Investigator
Massachusetts General Hospital