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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONTINUity of care Under Management by Video visits (CONTINUUM-V) | Experimental | Participants with advanced cancer will receive a video visit conducted by an oncology Nurse Practitioner (NP) within three (3) business days of hospital discharge. The visit will involve: (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. Participant and clinician may also be interviewed for their feedback on the video visit. The ultimate goal of the intervention is to improve patients' confidence in managing their health condition and reduce burdensome health care utilization after discharge, particularly reducing 30-day hospital readmissions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CONTINUity of care Under Management by Video visits (CONTINUUM-V) | Behavioral | Video visit by nurse practitioner within 3 business days of hospital discharge. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer S Temel, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation
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| Baseline to 15 days after discharge |
| 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 |
| 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 |
| 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 |