Back to resultsComparative Effectiveness of Readmission Reduction Interventions for Individuals With Sepsis or Pneumonia (ACCOMPLISH)
Primary Purpose
Sepsis, Pneumonia, Lower Resp Tract Infection
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Structured Telephone Support (STS)
Low-intensity Remote Patient Monitoring (RPM-Low)
High-intensity Remote Patient Monitoring (RPM-High)
Standard Response Team
Enhanced Response Team
Sponsored by
About this trial
This is an interventional health services research trial for Sepsis
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
Sites / Locations
- UPMC PresbyterianRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Structured Telephone Support (STS)
Low-intensity Remote Patient Monitoring (RPM) + Standard Response Team (RPM-Low, Standard Team)
High-intensity Remote Patient Monitoring (RPM) plus the Standard Team (RPM-High, Standard Team)
Low-intensity Remote Patient Monitoring (RPM) + Enhanced Team (RPM-Low, Enhanced Team)
High-intensity Remote Patient Monitoring (RPM) plus the Enhanced Team (RPM-High, Enhanced Team)
Arm Description
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.
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.
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.
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).
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).
Outcomes
Primary Outcome Measures
Post-discharge home days
days alive and at home
Secondary Outcome Measures
Functional Status (measured by PROMIS Physical Function-for Mobility Aid Users-SF)
Functional Status will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - for Mobility Aid Users-SF. This measures one's ability to stand, walk, and perform activities of daily living if some participants utilize mobility aids such as wheelchairs. The minimum score for patients who can walk 25 feet is 11 and the maximum 55. The minimum score for patients who cannot walk 25 feet is 8 and the maximum score is 40. Higher scores indicate better function status for both groups.
Health-related Quality of Life (measured by Quality of Life Enjoyment and Satisfaction Questionnaire-SF)
Health-related Quality of Life will be measured using the Quality of Life Enjoyment and Satisfaction Questionnaire-SF. The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report measure designed to enable investigators to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item self-administered questionnaire that captures life satisfaction over the past week. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). A total score is derived from 14 items with a maximum score of 70 and with higher scores indicating greater life satisfaction and enjoyment.
Transition to Hospice
Transition to Hospice will be assessed via health insurance claims.
Emergent outpatient utilization
Emergent outpatient utilization includes emergency department visits and urgent care visits. It will be assessed via claims data at 90 days for study participants.
Hospital readmissions
Readmissions will be assessed via health insurance claims for any inpatient admissions after index admission.
Hospital readmissions
Readmissions will be assessed via health insurance claims for any inpatient admissions after index admission.
Hospital readmissions
Readmissions will be assessed via health insurance claims for any inpatient admissions after index admission.
Mortality
Mortality will be assessed via claims data to see if and when the member/participant passes away.
Full Information
NCT ID
NCT04829188
First Posted
March 26, 2021
Last Updated
July 26, 2023
Sponsor
University of Pittsburgh
Collaborators
Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04829188
Brief Title
Comparative Effectiveness of Readmission Reduction Interventions for Individuals With Sepsis or Pneumonia
Acronym
ACCOMPLISH
Official Title
Comparative Effectiveness of Readmission Reduction Interventions for Individuals With Sepsis or Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2021 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Patient-Centered Outcomes Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Pneumonia, Lower Resp Tract Infection, Covid19
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1668 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Structured Telephone Support (STS)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Low-intensity Remote Patient Monitoring (RPM) + Standard Response Team (RPM-Low, Standard Team)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High-intensity Remote Patient Monitoring (RPM) plus the Standard Team (RPM-High, Standard Team)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Low-intensity Remote Patient Monitoring (RPM) + Enhanced Team (RPM-Low, Enhanced Team)
Arm Type
Active Comparator
Arm Description
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).
Arm Title
High-intensity Remote Patient Monitoring (RPM) plus the Enhanced Team (RPM-High, Enhanced Team)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Structured Telephone Support (STS)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low-intensity Remote Patient Monitoring (RPM-Low)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
High-intensity Remote Patient Monitoring (RPM-High)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Response Team
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Response Team
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post-discharge home days
Description
days alive and at home
Time Frame
90 days after discharge to home
Secondary Outcome Measure Information:
Title
Functional Status (measured by PROMIS Physical Function-for Mobility Aid Users-SF)
Description
Functional Status will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - for Mobility Aid Users-SF. This measures one's ability to stand, walk, and perform activities of daily living if some participants utilize mobility aids such as wheelchairs. The minimum score for patients who can walk 25 feet is 11 and the maximum 55. The minimum score for patients who cannot walk 25 feet is 8 and the maximum score is 40. Higher scores indicate better function status for both groups.
Time Frame
baseline, 90 days
Title
Health-related Quality of Life (measured by Quality of Life Enjoyment and Satisfaction Questionnaire-SF)
Description
Health-related Quality of Life will be measured using the Quality of Life Enjoyment and Satisfaction Questionnaire-SF. The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report measure designed to enable investigators to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item self-administered questionnaire that captures life satisfaction over the past week. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). A total score is derived from 14 items with a maximum score of 70 and with higher scores indicating greater life satisfaction and enjoyment.
Time Frame
baseline, 90 days
Title
Transition to Hospice
Description
Transition to Hospice will be assessed via health insurance claims.
Time Frame
measured at 90 days after discharge to home
Title
Emergent outpatient utilization
Description
Emergent outpatient utilization includes emergency department visits and urgent care visits. It will be assessed via claims data at 90 days for study participants.
Time Frame
measured at 90 days after discharge to home
Title
Hospital readmissions
Description
Readmissions will be assessed via health insurance claims for any inpatient admissions after index admission.
Time Frame
measured at 7 days
Title
Hospital readmissions
Description
Readmissions will be assessed via health insurance claims for any inpatient admissions after index admission.
Time Frame
measured at 30 days
Title
Hospital readmissions
Description
Readmissions will be assessed via health insurance claims for any inpatient admissions after index admission.
Time Frame
measured at 90 days
Title
Mortality
Description
Mortality will be assessed via claims data to see if and when the member/participant passes away.
Time Frame
measured at 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristin Mayes, MS
Phone
3179184282
Email
mayeskl@upmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Williams, PhD MPH
Phone
4124541198
Email
williamsk17@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kalpana Char, MD
Organizational Affiliation
UPMC Health Plan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sachin Yende, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Namita Ahuja Yende
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Effectiveness of Readmission Reduction Interventions for Individuals With Sepsis or Pneumonia
We'll reach out to this number within 24 hrs