NCT04829188

Brief Summary

An adaptive platform trial to compare effectiveness of different care models to prevent readmissions for patients hospitalized with sepsis or lower respiratory tract infection. The primary outcome is number of days spent at home within 90 days after hospital discharge.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,288

participants targeted

Target at P75+ for not_applicable sepsis

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable sepsis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

March 30, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

3.7 years

First QC Date

March 26, 2021

Last Update Submit

January 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post-discharge home days

    days alive and at home

    90 days after discharge to home

Secondary Outcomes (8)

  • Functional Status (measured by PROMIS Physical Function-for Mobility Aid Users-SF)

    baseline, 90 days

  • Health-related Quality of Life (measured by Quality of Life Enjoyment and Satisfaction Questionnaire-SF)

    baseline, 90 days

  • Transition to Hospice

    measured at 90 days after discharge to home

  • Emergent outpatient utilization

    measured at 90 days after discharge to home

  • Hospital readmissions

    measured at 7 days

  • +3 more secondary outcomes

Study Arms (5)

Structured Telephone Support (STS)

ACTIVE COMPARATOR

Post-discharge assessment, education, and medication reconciliation delivered telephonically by a health plan case manager, home care as needed, and follow-up with the primary care provider (PCP) within seven days post-discharge.

Behavioral: Structured Telephone Support (STS)

Low-intensity Remote Patient Monitoring (RPM) + Standard Response Team (RPM-Low, Standard Team)

ACTIVE COMPARATOR

Questions are pushed to members patients times per week for up to 90 days post-discharge. Questions are limited to those checking vital signs that indicate worsening of infection. Patient answers to RPM questions trigger High or Medium alerts, which trigger a response by members of the intervention care team. RPM alerts are screened by a nurse-staffed call center. Nurses determine whether emergency care is needed. If not, nurses contact the patient and/or the patients' primary care provider (PCP) or specialist to coordinate care and ensure timely follow-up.

Behavioral: Low-intensity Remote Patient Monitoring (RPM-Low)Behavioral: Standard Response Team

High-intensity Remote Patient Monitoring (RPM) plus the Standard Team (RPM-High, Standard Team)

ACTIVE COMPARATOR

Questions are pushed to patients multiple times per week for up to 90 days post-discharge. Questions include monitoring vital signs for worsening infection but also ask about factors that would indicate worsening of underlying heart or lung conditions, such as weight gain or shortness of breath. Patient answers to RPM questions trigger High or Medium alerts, which trigger a response by members of the intervention care team. RPM alerts are screened by a nurse-staffed call center. Nurses determine whether emergency care is needed. If not, nurses contact the patient and/or the patients' primary care provider (PCP) or specialist to coordinate care and ensure timely follow-up.

Behavioral: High-intensity Remote Patient Monitoring (RPM-High)Behavioral: Standard Response Team

Low-intensity Remote Patient Monitoring (RPM) + Enhanced Team (RPM-Low, Enhanced Team)

ACTIVE COMPARATOR

Questions are pushed to patients multiple times per week for up to 90 days post-discharge. Questions are limited to those checking vital signs that indicate worsening of infection. Patient answers to RPM questions trigger High or Medium alerts, which trigger a response by members of the intervention care team. RPM alerts are screened by a nurse-staffed call center. Nurses determine whether emergency care is needed. If not, the call center alerts a multidisciplinary care team that is led by a certified registered nurse practitioner (CRNP). CRNPs, who operate in a palliative care role, have prescribing authority and can modify care plans. In addition to reacting to RPM triggers, team members (e.g., CRNP, social workers, nurses) meet with the patient in-person or virtually in the week after discharge and at least twice more in the next 90 days, conduct assessments and a pharmacy review, develop care plans, and discuss advance directives).

Behavioral: Low-intensity Remote Patient Monitoring (RPM-Low)Behavioral: Enhanced Response Team

High-intensity Remote Patient Monitoring (RPM) plus the Enhanced Team (RPM-High, Enhanced Team)

ACTIVE COMPARATOR

Questions are pushed to patients multiple times per week for up to 90 days post-discharge. Questions include monitoring vital signs for worsening infection but also ask about factors that would indicate worsening of underlying heart or lung conditions, such as weight gain or shortness of breath. Patient answers to RPM questions trigger High or Medium alerts, which trigger a response by members of the intervention care team. RPM alerts are screened by a nurse-staffed call center. Nurses determine whether emergency care is needed. If not, the call center alerts a multidisciplinary care team that is led by a certified registered nurse practitioner (CRNP). CRNPs, who operate in a palliative care role, have prescribing authority and can modify care plans.Team members (e.g., CRNP, social workers, nurses) address RPM triggers, meet with the patient three times, pharmacy review, develop care plans, and discuss advance directives).

Behavioral: High-intensity Remote Patient Monitoring (RPM-High)Behavioral: Enhanced Response Team

Interventions

Structured telephone support (STS) consists of post-discharge assessment, education, and medication reconciliation delivered telephonically by a health plan case manager, home care as needed, and follow-up with the primary care within seven days post-discharge.

Structured Telephone Support (STS)

Questions are pushed to members multiple times per week for up to 90 days post-discharge. Questions are limited to those checking vital signs that indicate worsening of infection. Patient answers to RPM questions trigger High or Medium alerts, which trigger a response by members of the intervention care team.

Low-intensity Remote Patient Monitoring (RPM) + Enhanced Team (RPM-Low, Enhanced Team)Low-intensity Remote Patient Monitoring (RPM) + Standard Response Team (RPM-Low, Standard Team)

Questions are pushed to members multiple times per week for up to 90 days post-discharge. Questions include monitoring vital signs for worsening infection but also ask about factors that would indicate worsening of underlying heart or lung conditions, such as weight gain or shortness of breath. Patient answers to RPM questions trigger High or Medium alerts, which trigger a response by members of the intervention care team.

High-intensity Remote Patient Monitoring (RPM) plus the Enhanced Team (RPM-High, Enhanced Team)High-intensity Remote Patient Monitoring (RPM) plus the Standard Team (RPM-High, Standard Team)

RPM alerts are screened by a nurse-staffed call center. Nurses determine whether emergency care is needed. If not, nurses contact the patient and/or the patients' PCP or specialist to coordinate care and ensure timely follow-up.

High-intensity Remote Patient Monitoring (RPM) plus the Standard Team (RPM-High, Standard Team)Low-intensity Remote Patient Monitoring (RPM) + Standard Response Team (RPM-Low, Standard Team)

RPM alerts are screened by a nurse-staffed call center. Nurses determine whether emergency care is needed. If not, the call center alerts a multidisciplinary care team that is led by a certified registered nurse practitioner (CRNP). CRNPs, who operate in a palliative care role, have prescribing authority and can modify care plans. In addition to reacting to RPM triggers, team members (e.g., CRNP, social workers, nurses) meet with the patient in-person or virtually in the week after discharge and at least twice more in the next 90 days, conduct assessments and a pharmacy review, develop care plans, and discuss advance directives.

High-intensity Remote Patient Monitoring (RPM) plus the Enhanced Team (RPM-High, Enhanced Team)Low-intensity Remote Patient Monitoring (RPM) + Enhanced Team (RPM-Low, Enhanced Team)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • UPMC Health Plan members
  • Medicare Fee-for-Service enrollees
  • Age 21+ -Hospitalized with a primary diagnosis of sepsis or lower respiratory tract infection, --
  • Discharged to home, independent living facility, or skilled nursing facility
  • Readmission risk is moderate or high

You may not qualify if:

  • Admitted from hospice;
  • Discharged to hospice, inpatient rehabilitation, or a long term acute care facility;
  • Known to be pregnant;
  • Current enrollment in another remote patient monitoring program;
  • Failure of the Callahan 6 item cognitive screen and do not have a proxy to consent;
  • No access to a technological device required to participate in remote patient monitoring program;
  • Current enrollment in UPMC Advanced Illness Care program;
  • Severe, persistent cognitive impairment;
  • No documented PCP;
  • PCP disapproves of the patient being enrolled in remote patient monitoring;
  • Discharged from hospital to skilled nursing facility and stay at the skilled nursing facility for greater than 28 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Mayes K, Talisa VB, Malito A, Mayr FB, Williams K, Char K, Wadas R, Lorenzi E, Viele K, Awdish R, Angus DC, Chang CH, Yende S. Design and methods of an adaptive trial to test comparative effectiveness of readmission reduction approaches following infection and sepsis hospitalizations (ACCOMPLISH). Contemp Clin Trials Commun. 2025 Jun 19;46:101504. doi: 10.1016/j.conctc.2025.101504. eCollection 2025 Aug.

MeSH Terms

Conditions

SepsisPneumoniaCOVID-19

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesPneumonia, ViralVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Study Officials

  • Kalpana Char, MD

    UPMC Health Plan

    PRINCIPAL INVESTIGATOR
  • Sachin Yende, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Vice President

Study Record Dates

First Submitted

March 26, 2021

First Posted

April 2, 2021

Study Start

March 30, 2021

Primary Completion

December 15, 2024

Study Completion

December 15, 2024

Last Updated

January 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations