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Readmission Reduction Interventions for Sepsis or Pneumonia (ACCOMPLISH Trial)

N/A

Recruiting

Led By Namita Ahuja Yende, MD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Discharged to home, independent living facility, or skilled nursing facility

Age 21+ hospitalized with a primary diagnosis of sepsis or lower respiratory tract infection

Must not have

Failure of the Callahan 6 item cognitive screen and do not have a proxy to consent

Discharged to hospice, inpatient rehabilitation, or a long term acute care facility

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing different care models to see which one is better at preventing readmissions for patients who have been hospitalized with sepsis or lower respiratory tract infection. The primary outcome is the number of days spent at home within 90 days after hospital discharge.

Who is the study for?

This trial is for adults over 21 who were hospitalized with sepsis or a lower respiratory infection, have a moderate to high risk of readmission, and are going home or to certain facilities. They must be Medicare enrollees or UPMC Health Plan members. Excluded are those with no PCP approval for RPM, pregnant women, long-term skilled nursing facility residents, lacking technology for RPM participation, severe cognitive issues without a proxy, hospice patients, and current participants in similar programs.

What is being tested?

The study compares different care models aimed at preventing hospital readmissions after discharge from sepsis or lung infections. Patients will receive either standard care team support; enhanced team support; high-intensity remote monitoring; structured phone support; or low-intensity remote monitoring to see which method keeps them at home longer post-discharge.

What are the potential side effects?

Since this trial involves non-medical interventions like remote patient monitoring and telephone support rather than drugs or medical procedures, traditional side effects aren't expected. However, there may be privacy concerns related to the use of technology-based follow-up methods.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was discharged to my home, an independent living, or a skilled nursing facility.

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I am over 21 and hospitalized for sepsis or a lung infection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I failed a cognitive test and don't have someone to make decisions for me.

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I was discharged to a facility for long-term or intensive care.

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I have severe, ongoing problems with my memory or thinking.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Post-discharge home days

Secondary study objectives

Emergent outpatient utilization

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

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

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Active Control

Group I: High-intensity Remote Patient Monitoring (RPM) plus the Enhanced Team (RPM-High, Enhanced Team)Active Control2 Interventions

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).

Group II: Structured Telephone Support (STS)Active Control1 Intervention

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.

Group III: Low-intensity Remote Patient Monitoring (RPM) + Standard Response Team (RPM-Low, Standard Team)Active Control2 Interventions

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.

Group IV: High-intensity Remote Patient Monitoring (RPM) plus the Standard Team (RPM-High, Standard Team)Active Control2 Interventions

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.

Group V: Low-intensity Remote Patient Monitoring (RPM) + Enhanced Team (RPM-Low, Enhanced Team)Active Control2 Interventions

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).

0 / 5Eligibility criteria met