Advanced Cancer, Cancer, Consultation, Remote, Follow-Up Care
Conditions
Keywords
Cancer, Follow-Up Care, Care Services, Home, Consultation, Remote, Advanced Cancer, Hospitalization, Care Transition Intervention
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. It is anticipated that about 286 people will take part in this research study.
Interventions
OTHERCONTINUUM 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.
OTHERUsual Care
Patients assigned to the usual care group will have their post-discharge follow-up scheduled per hospital, outpatient oncology team, and patient preference.
Sponsors
Conquer Cancer Foundation
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients' Confidence in Managing their Health Condition using the Patient Activation Measure-13 (PAM-13) | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Communication using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Communication subscale | Up to 10-20 days after hospital discharge | Compare differences in CAHPS-Communication at up to 10-20 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. |
| Symptom Burden using the Edmonton Symptom Assessment Scale (ESAS-r) | Baseline to 10-20 days after hospital discharge | Compare change in the Edmonton Symptom Assessment System-Revised (ESAS-r) total score and physical sub-scale between baseline and 10-20 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. |
| Psychological Symptoms using the Patient Health Questionnaire-4 (PHQ-4) | Baseline to 10-20 days after hospital discharge | Compare change in the Patient Health Questionnaire-4 (PHQ-4) between baseline and 10-20 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
| Measure | Time frame | Description |
|---|---|---|
| 30-day Hospital Readmissions | Up to 30 days after discharge | Compare hospital readmissions within 30 days of discharge between study groups. |
Countries
United States
Outcome results
None listed