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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 90 days
Awards & highlights
ACCOMPLISH Trial 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.Check my eligibility
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.See study design
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.
ACCOMPLISH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was discharged to my home, an independent living, or a skilled nursing facility.
Select...
I am over 21 and hospitalized for sepsis or a lung infection.
ACCOMPLISH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post-discharge home days
Secondary outcome measures
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 moreACCOMPLISH 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).
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Who is running the clinical trial?
University of PittsburghLead Sponsor
1,722 Previous Clinical Trials
16,341,278 Total Patients Enrolled
8 Trials studying Sepsis
15,272 Patients Enrolled for Sepsis
Patient-Centered Outcomes Research InstituteOTHER
551 Previous Clinical Trials
29,995,790 Total Patients Enrolled
1 Trials studying Sepsis
1,204 Patients Enrolled for Sepsis
Namita Ahuja Yende, MDPrincipal InvestigatorUPMC Health Plan
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Eligibility Criteria:
This trial includes the following eligibility 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.I stayed in a skilled nursing facility for more than 28 days after hospital discharge.My risk of being readmitted to the hospital is moderate or high.I failed a cognitive test and don't have someone to make decisions for me.I was discharged to a facility for long-term or intensive care.You are currently enrolled in the UPMC Advanced Illness Care program.You do not have a documented case of Pneumocystis pneumonia (PCP).I have severe, ongoing problems with my memory or thinking.
Research Study Groups:
This trial has the following groups:- Group 1: High-intensity Remote Patient Monitoring (RPM) plus the Enhanced Team (RPM-High, Enhanced Team)
- Group 2: Structured Telephone Support (STS)
- Group 3: Low-intensity Remote Patient Monitoring (RPM) + Standard Response Team (RPM-Low, Standard Team)
- Group 4: High-intensity Remote Patient Monitoring (RPM) plus the Standard Team (RPM-High, Standard Team)
- Group 5: Low-intensity Remote Patient Monitoring (RPM) + Enhanced Team (RPM-Low, Enhanced Team)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers still recruiting volunteers for this experiment?
"Yes, the clinicaltrials.gov platform indicates that this trial is actively seeking participants. It was initially published on March 30th 2021 and has been revised for the last time on August 8th 2022; 1668 individuals are sought from a single centre."
Answered by AI
How many individuals are being accepted as participants in this clinical trial?
"Affirmative. Clinicaltrials.gov data confirms that, as of 8/8/2022, this trial is still recruiting participants - 1668 in total from a single medical site since it was initially posted on 3/30/2021."
Answered by AI
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