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Care Transition Intervention for Hospitalized Patients With Advanced Cancer

10 februari 2022 uppdaterad av: Jennifer Temel, MD, Massachusetts General Hospital

Randomized Trial of a Care Transition Intervention for Hospitalized Patients With Advanced Cancer

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

286

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02114
        • Rekrytering
        • Massachusetts General Hospital Cancer Center
        • Kontakt:
        • Huvudutredare:
          • Jennifer S Temel, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: 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.
Aktiv komparator: 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.
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Patients' Confidence in Managing their Health Condition using the Patient Activation Measure-13 (PAM-13)
Tidsram: 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.
Baseline to 10-15 days after hospital discharge

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Quality of Communication using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Communication subscale
Tidsram: 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.
Up to 10-15 days after hospital discharge
Symptom Burden using the Edmonton Symptom Assessment Scale (ESAS-r)
Tidsram: 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.
Baseline to 10-15 days after hospital discharge
Psychological Symptoms using the Patient Health Questionnaire-4 (PHQ-4)
Tidsram: 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.
Baseline to 10-15 days after hospital discharge

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
30-day Hospital Readmissions
Tidsram: Up to 30 days after discharge
Compare hospital readmissions within 30 days of discharge between study groups.
Up to 30 days after discharge

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Massachusetts General Hospital

Samarbetspartners

Conquer Cancer Foundation

Utredare

  • Huvudutredare: Jennifer S Temel, MD, Massachusetts General Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 december 2021

Primärt slutförande (Förväntat)

1 oktober 2023

Avslutad studie (Förväntat)

1 december 2023

Studieregistreringsdatum

Först inskickad

20 november 2021

Först inskickad som uppfyllde QC-kriterierna

20 november 2021

Första postat (Faktisk)

2 december 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 februari 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 februari 2022

Senast verifierad

1 februari 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 21-501

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

Data can be shared no earlier than 1 year following the date of publication

Kriterier för IPD Sharing Access

Contact the Partners Innovations team at http://www.partners.org/innovation

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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