Clinical trial NCT04829188: Comparative Effectiveness of Readmission Reduction Interventions for Individuals with Sepsis or Pneumonia
Official title: Comparative Effectiveness of Readmission Reduction Interventions for Individuals with Sepsis or Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Pneumonia
Lower Resp Tract Infection
Covid19
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2021-04-02
Enrollment: 1288
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: This study implements an adaptive platform trial to compare effectiveness of different care models to prevent readmissions for patients hospitalized with sepsis or lower respiratory tract infection and discharged to home (with or without a short stay in a skilled nursing facility prior to going home): structured telephone support (STS); low-intensity remote patient monitoring (RPM-Low); and high-intensity remote patient monitoring (RPM-High). The remote patient monitoring models will be staffed by a physician or a nurse (Standard Team) or by a dedicated nurse-practitioner (NP)-led multidisciplinary team (Enhanced Team). Patients will be randomized to one of five arms: STS, RPM-Low + Standard Team, RPM-Low + Enhanced Team, RPM-High + Standard Team, and RPM-High + Enhanced Team. Using response adaptive randomization (RAR), interim outcome results will be used to modify the random allocation of patients to each study arm. The primary outcome is number of days spent at home within 90 days after hospital discharge. Patient-reported functional status and quality of life data will be collected in addition to electronic health record (EHR) and claims-based data to measure health care utilization. Qualitative interviews with patients and providers will provide insight into the effectiveness of the implementation process.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Post-discharge home days
timeFrame: 90 days after discharge to home
Secondary outcomes:
measure: Functional Status (measured by PROMIS Physical Function-for Mobility Aid Users-SF)
timeFrame: baseline, 90 days
measure: Health-related Quality of Life (measured by Quality of Life Enjoyment and Satisfaction Questionnaire-SF)
timeFrame: baseline, 90 days
measure: Transition to Hospice
timeFrame: measured at 90 days after discharge to home
measure: Emergent outpatient utilization
timeFrame: measured at 90 days after discharge to home
measure: Hospital readmissions
timeFrame: measured at 7 days
measure: Hospital readmissions
timeFrame: measured at 30 days
measure: Hospital readmissions
timeFrame: measured at 90 days
measure: Mortality
timeFrame: measured at 90 days
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
Study officials:
affiliation: UPMC Health Plan
name: Kalpana Char, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Sachin Yende, MD
role: PRINCIPAL_INVESTIGATOR
References: