Readmission Reduction Interventions for Sepsis or Pneumonia

(ACCOMPLISH Trial)

Overseen By Kelly Williams, PhD MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Pregnancy, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

1288 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the idea that Readmission Reduction Interventions for Sepsis or Pneumonia is an effective treatment?

The available research shows that Rapid Response Teams (RRTs), which are part of Readmission Reduction Interventions, help in detecting and responding to patients whose health is getting worse. Although the studies don't directly measure the effectiveness of these interventions for sepsis or pneumonia, they suggest that RRTs can improve patient care by responding quickly to health declines. This implies that such interventions could be beneficial for conditions like sepsis or pneumonia, where quick response is crucial. ^{1 2 3 4 5}

What safety data exists for readmission reduction interventions for sepsis or pneumonia?

The provided research primarily discusses Rapid Response Teams (RRTs) in hospital settings, focusing on their activation, outcomes, and organizational structures. However, it does not directly address safety data for interventions like Enhanced Response Team, Remote Patient Monitoring, or Structured Telephone Support specifically for sepsis or pneumonia readmission reduction. The studies highlight the role of RRTs in managing critically ill patients and improving outcomes, but specific safety data for the mentioned interventions is not detailed in these abstracts. ^{6 7 8 9 10}

Is the treatment in the trial 'Readmission Reduction Interventions for Sepsis or Pneumonia' promising?

Yes, the treatment is promising. Remote patient monitoring (RPM) has shown potential in reducing hospital readmissions and improving patient satisfaction by allowing patients to be monitored at home. This approach can help hospitals manage resources better and provide quality care, especially in challenging times. ^{11 12 13 14 15}

Research Team

Kalpana Char, MD

Principal Investigator

UPMC Health Plan

Sachin Yende, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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.

Inclusion Criteria

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

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

Medicare Fee-for-Service enrollees

Exclusion Criteria

PCP disapproves of the patient being enrolled in remote patient monitoring

Known to be pregnant

I stayed in a skilled nursing facility for more than 28 days after hospital discharge.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive structured telephone support or remote patient monitoring for up to 90 days post-discharge

12 weeks

Multiple virtual interactions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Enhanced Response Team
• High-intensity Remote Patient Monitoring (RPM-High)
• Low-intensity Remote Patient Monitoring (RPM-Low)
• Standard Response Team
• Structured Telephone Support (STS)

Trial Overview 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.

Participant Groups

Group I: High-intensity Remote Patient Monitoring (RPM) plus the Enhanced Team (RPM-High, Enhanced Team) Active Control 2 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 Control 1 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 Control 2 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 Control 2 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 Control 2 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).

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Findings from Research

In a study of 5,491 hospitalized patients who activated rapid response teams, the Hamilton Early Warning Score (HEWS) demonstrated a sensitivity of 75.9% and specificity of 67.6% for predicting in-hospital mortality, indicating it is a reliable tool for assessing patient risk.

The National Early Warning Score 2 (NEWS2) showed higher sensitivity at 84.5% but lower specificity at 49.0%, suggesting that while it may identify more at-risk patients, it also has a higher rate of false positives compared to HEWS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic accuracy of the Hamilton Early Warning Score (HEWS) and the National Early Warning Score 2 (NEWS2) among hospitalized patients assessed by a rapid response team. Fernando, SM., Fox-Robichaud, AE., Rochwerg, B., et al.[2020]

The study explored the effectiveness of Rapid Response Team Interventions (RRTI) in medical-surgical patients, revealing five significant differences between patients who received RRTI and those who did not, indicating potential benefits in patient outcomes.

There was a notable variation in the time taken to call for RRTI after criteria were documented, ranging from 0 to 238 minutes, suggesting that timely intervention may be critical for improving patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Leading to Rapid Response Team Interventions in Adult Medical-Surgical Patients. Tarver, CM., Stuenkel, D.[2017]

Crew resource management training for team leaders significantly improved team performance during rapid response team activations, with adherence to ideal task lists and communication protocols increasing notably after the training.

The training led to enhanced dynamics in leadership, teamwork, and task management, as measured by the Team Emergency Assessment Measure, indicating that effective leadership training can positively influence the entire team's performance, even for untrained members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Pediatric Rapid Response Team Performance Through Crew Resource Management Training of Team Leaders. Siems, A., Cartron, A., Watson, A., et al.[2017]

The implementation of automated vital sign monitoring and warning score calculations led to a significant reduction in the incidence of cardiopulmonary resuscitation (CPR) events, decreasing from 3.8 to 2.3 per 1000 inpatient days, indicating improved patient safety.

While the number of Rapid Response Team (RRT) activations increased, the overall hospital length of stay and mortality rates decreased, suggesting that early detection and intervention through automation can enhance the effectiveness of RRTs without increasing ICU admissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-Rapid Response Team (Tele-RRT): The effect of implementing patient safety network system on outcomes of medical patients-A before and after cohort study. Balshi, AN., Al-Odat, MA., Alharthy, AM., et al.[2023]

A multidisciplinary team improved the documentation and communication of patients' desired limitations of medical therapy (LOMTs) in a cardiology setting, ensuring that care during rapid response team (RRT) events aligned with patients' wishes.

After implementing educational strategies and simulations over 6 months, the documentation of LOMTs increased from 76% to 82.5%, demonstrating the effectiveness of these interventions in enhancing patient-centered care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ensuring Rapid Response Team Care Aligns With Patients' Limitations of Medical Therapy: A Quality Improvement Project. Mininni, NC., Whiteman, K., Stephens, K., et al.[2023]

In a study of 4522 patients at a Brazilian hospital, nighttime rapid response team (RRT) calls were not linked to higher in-hospital mortality compared to daytime calls, indicating that the timing of RRT activation may not affect patient outcomes.

However, the study found that fewer RRT calls occurred during nursing handover periods, specifically at 7:00, 13:00, and 19:00, and these times were associated with increased mortality, suggesting that communication lapses during handovers could impact patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between time of day for rapid response team activation and mortality. Boniatti, MM., de Loreto, MS., Mazzutti, G., et al.[2023]

Rapid response team calls are significantly less frequent during the early morning hours (1 AM to 6:59 AM), which correlates with higher in-hospital mortality rates, particularly peaking at 7 AM.

The study analyzed 282,710 rapid response team calls across 274 hospitals from 2005 to 2015, revealing that patients who experienced calls during the early morning had more severe clinical deterioration, indicating a need for improved utilization of rapid response teams during these critical hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Survival and Time of Day for Rapid Response Team Calls in a National Registry. Churpek, MM., Edelson, DP., Lee, JY., et al.[2018]

In a study of 52 rapid response team (RRT) events, a significant number of patients experienced uncontrolled symptoms: 44% had uncontrolled pain, 39% had uncontrolled dyspnea, and 35% had uncontrolled anxiety at the conclusion of the RRT intervention.

Symptom assessments by RRT clinicians were infrequent, with only 62% assessing pain, 38% assessing dyspnea, and 21% assessing anxiety, highlighting a gap in effective symptom management during critical care situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid Response Events in Hospitalized Patients: Patient Symptoms and Clinician Communication. Austin, CA., Choudhury, S., Lincoln, T., et al.[2021]

In a study of 8083 pediatric admissions, the source of admission significantly influenced the likelihood of activating a rapid response team (RRT), with emergency department admissions having higher odds of RRT activation compared to planned elective admissions and those following surgery.

Patients admitted through planned elective procedures had notably lower odds of RRT activation, especially within the first 48 hours, and this source of admission was also linked to better survival rates upon discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Admission Source Is Associated With the Risk of Rapid Response Team Activation in a Children's Hospital. Kamzan, AD., Tsoi, S., Arslanian, T., et al.[2023]

The Rapid Response Team (RRT) at Memorial Sloan Kettering Cancer Center has significantly expanded from 2009 to 2021, utilizing advanced practice providers (APPs) trained in critical care to enhance patient management for critically ill patients.

The RRT has developed 11 pathways and interventions that improve multidisciplinary collaboration and patient care, with ongoing monitoring and quality assurance to adapt to the complex needs of oncology patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Rapid Response Team (RRT) System at a Cancer Center: Innovative Approaches to System Organization and Clinical RRT Pathways. Buchholz, T., Barzola, M., Tayban, Y., et al.[2023]

The remote patient monitoring (RPM) program for COVID-19 patients requiring oxygen after discharge successfully enrolled 75 patients and led to a shorter hospital length of stay (LOS) of 4.8 days compared to 6.1 days in a control group of 150 patients, indicating improved healthcare efficiency.

Patient satisfaction with the RPM program was high, and it did not negatively affect the rates of emergency department visits or hospital readmissions, suggesting that RPM can be a safe and effective strategy for managing post-acute care in COVID-19 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and impact on length of stay of a post-discharge remote patient monitoring program for acutely hospitalized COVID-19 pneumonia patients. Kuo, S., Aledia, A., O'Connell, R., et al.[2022]

A survey of 3172 patients enrolled in a remote patient monitoring (RPM) program showed that 88.97% felt comfortable managing their health from home, indicating high patient engagement and satisfaction with the program.

93.58% of participants expressed readiness to graduate from the RPM program after meeting their health goals, and 92.76% would recommend RPM to others, demonstrating the program's effectiveness in managing both acute and chronic conditions outside of traditional healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Satisfaction With a Multisite, Multiregional Remote Patient Monitoring Program for Acute and Chronic Condition Management: Survey-Based Analysis. Haddad, TC., Maita, KC., Inselman, JW., et al.[2023]

A nationwide study of 405 patients with hospital-onset sepsis found that those treated in hospitals with all-day rapid response teams (RRTs) had a lower in-hospital mortality rate compared to those in hospitals with part-day RRTs, although the difference was not statistically significant before adjustments.

After adjusting for other factors, the study revealed that all-day RRTs were associated with a significant reduction in in-hospital mortality, with an adjusted odds ratio of 0.57, indicating that continuous availability of RRTs can improve outcomes for patients with sepsis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mortality of patients with hospital-onset sepsis in hospitals with all-day and non-all-day rapid response teams: a prospective nationwide multicenter cohort study. Hyun, DG., Lee, SY., Ahn, JH., et al.[2022]

Remote patient monitoring (RPM) significantly reduces hospitalizations for heart failure by 23% and for any cause by 13%, based on a meta-analysis of 21 randomized clinical trials involving 5715 patients.

RPM is cost-effective, saving between €300 to €1000 per patient compared to usual care, while also providing a slight increase in quality-adjusted life years (QALYs), making it a favorable option for heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic impact of remote patient monitoring: an integrated economic model derived from a meta-analysis of randomized controlled trials in heart failure. Klersy, C., De Silvestri, A., Gabutti, G., et al.[2022]

The remote patient monitoring (RPM) program developed by West Tennessee Healthcare for discharged COVID-19 patients resulted in a low readmission rate of 4.96% in the 24-hour monitored group, suggesting its effectiveness in preventing readmissions.

This RPM program allowed healthcare resources to be better allocated to more critical patients while still providing quality care to those with less severe conditions, highlighting its potential benefits in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case Report on the Effectiveness of Virtual Monitoring of Postdischarge COVID-19 Positive Patients in a Rural Hospital Setting: A Retrospective Review. Sulieman, L., Ashworth, D., Wright, A., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Prognostic accuracy of the Hamilton Early Warning Score (HEWS) and the National Early Warning Score 2 (NEWS2) among hospitalized patients assessed by a rapid response team. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Factors Leading to Rapid Response Team Interventions in Adult Medical-Surgical Patients. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Improving Pediatric Rapid Response Team Performance Through Crew Resource Management Training of Team Leaders. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Tele-Rapid Response Team (Tele-RRT): The effect of implementing patient safety network system on outcomes of medical patients-A before and after cohort study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Ensuring Rapid Response Team Care Aligns With Patients' Limitations of Medical Therapy: A Quality Improvement Project. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Association between time of day for rapid response team activation and mortality. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Association Between Survival and Time of Day for Rapid Response Team Calls in a National Registry. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Rapid Response Events in Hospitalized Patients: Patient Symptoms and Clinician Communication. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Admission Source Is Associated With the Risk of Rapid Response Team Activation in a Children's Hospital. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

A Rapid Response Team (RRT) System at a Cancer Center: Innovative Approaches to System Organization and Clinical RRT Pathways. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Implementation and impact on length of stay of a post-discharge remote patient monitoring program for acutely hospitalized COVID-19 pneumonia patients. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

Patient Satisfaction With a Multisite, Multiregional Remote Patient Monitoring Program for Acute and Chronic Condition Management: Survey-Based Analysis. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Mortality of patients with hospital-onset sepsis in hospitals with all-day and non-all-day rapid response teams: a prospective nationwide multicenter cohort study. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Economic impact of remote patient monitoring: an integrated economic model derived from a meta-analysis of randomized controlled trials in heart failure. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

A Case Report on the Effectiveness of Virtual Monitoring of Postdischarge COVID-19 Positive Patients in a Rural Hospital Setting: A Retrospective Review. [2023]