Care Transition Intervention for Hospitalized Patients With Advanced Cancer
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| ClinicalTrials.gov Identifier: NCT05142345 |
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Recruitment Status :
Recruiting
First Posted : December 2, 2021
Last Update Posted : February 11, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer Follow-Up Care Consultation, Remote Advanced Cancer | Other: CONTINUUM Intervention Other: Usual Care | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 286 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Randomized Trial of a Care Transition Intervention for Hospitalized Patients With Advanced Cancer |
| Actual Study Start Date : | December 15, 2021 |
| Estimated Primary Completion Date : | October 2023 |
| Estimated Study Completion Date : | December 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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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. |
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Active Comparator: 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.
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Other: 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. |
- Patients' Confidence in Managing their Health Condition using the Patient Activation Measure-13 (PAM-13) [ Time Frame: Baseline to 10-15 days after hospital discharge ]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.
- Quality of Communication using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Communication subscale [ Time Frame: Up to 10-15 days after hospital discharge ]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.
- Symptom Burden using the Edmonton Symptom Assessment Scale (ESAS-r) [ Time Frame: Baseline to 10-15 days after hospital discharge ]Compare change in the Edmonton Symptom Assessment System-Revised (ESAS-r) total score and physical sub-scale between baseline and 10-15 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.
- Psychological Symptoms using the Patient Health Questionnaire-4 (PHQ-4) [ Time Frame: Baseline to 10-15 days after hospital discharge ]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.
- 30-day Hospital Readmissions [ Time Frame: Up to 30 days after discharge ]Compare hospital readmissions within 30 days of discharge between study groups.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05142345
| Contact: Jennifer S Temel, MD | (617) 724-4000 | jtemel@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital Cancer Center | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Jennifer S Temel, MD 617-724-4000 jtemel@mgh.harvard.edu | |
| Principal Investigator: Jennifer S Temel, MD | |
| Principal Investigator: | Jennifer S Temel, MD | Massachusetts General Hospital |
| Responsible Party: | Jennifer Temel, MD, Principal Investigator, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT05142345 |
| Other Study ID Numbers: |
21-501 |
| First Posted: | December 2, 2021 Key Record Dates |
| Last Update Posted: | February 11, 2022 |
| Last Verified: | February 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
| Time Frame: | Data can be shared no earlier than 1 year following the date of publication |
| Access Criteria: | Contact the Partners Innovations team at http://www.partners.org/innovation |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cancer Follow-Up Care Care Services, Home Consultation, Remote |
Advanced Cancer Hospitalization Care Transition Intervention |
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Neoplasms |