SepsisACCOMPLISHNCT04829188
Comparative Effectiveness of Readmission Reduction Interventions for Individuals With Sepsis or Pneumonia
A study testing Structured Telephone Support (STS), Low-intensity Remote Patient Monitoring (RPM-Low) and High-intensity Remote Patient Monitoring (RPM-High) in people with Sepsis and Pneumonia, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sepsis, Pneumonia, Lower Resp Tract Infection
- What is being tested?
- Structured Telephone Support (STS), Low-intensity Remote Patient Monitoring (RPM-Low) and High-intensity Remote Patient Monitoring (RPM-High)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,296 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2021to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sepsis, Pneumonia, Lower Resp Tract Infection, Covid19
- Being tested
- Structured Telephone Support (STS), Low-intensity Remote Patient Monitoring (RPM-Low), High-intensity Remote Patient Monitoring (RPM-High), Standard Response Team, Enhanced Response Team
- Medical subject headings
- Sepsis, Pneumonia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Telephone Support (STS)Behavioural
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.
Low-intensity Remote Patient Monitoring (RPM-Low)Behavioural
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.
High-intensity Remote Patient Monitoring (RPM-High)Behavioural
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.
Standard Response TeamBehavioural
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.
Enhanced Response TeamBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Structured Telephone Support (STS) | Active comparator | Post-discharge assessment, education, and medication review delivered telephonically by a nurse or health plan case manager, home care as needed, and follow-up with the primary care provider (PCP) within seven days post-discharge. Receives: Behavioral: Structured Telephone Support (STS) |
| Low-intensity Remote Patient Monitoring (RPM) + Standard Response Team (RPM-Low, Standard Team) | Active comparator | Questions focus on signs of worsening infection and are pushed to participants twice weekly for up to 90 days post-discharge. Patient responses to RPM questions trigger High or Medium alerts, which 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. Receives: Behavioral: Low-intensity Remote Patient Monitoring (RPM-Low); Behavioral: Standard Response Team |
| High-intensity Remote Patient Monitoring (RPM) plus the Standard Team (RPM-High, Standard Team) | Active comparator | Questions focus on signs of worsening infection and worsening underlying heart or lung conditions. Questions are pushed to participants twice weekly for up to 90 days post-discharge. Patient responses to RPM questions trigger High or Medium alerts, which 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. Receives: Behavioral: High-intensity Remote Patient Monitoring (RPM-High); Behavioral: Standard Response Team |
| Low-intensity Remote Patient Monitoring (RPM) + Enhanced Team (RPM-Low, Enhanced Team) | Active comparator | Questions focus on signs of worsening infection and are pushed to participants twice weekly for up to 90 days post-discharge. Patient responses to RPM questions trigger High or Medium alerts, which are screened by a nurse-staffed call center. Nurses determine whether emergency care is needed. If not, nurses triage responses among 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 and nurses) meet with the patient 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. Receives: Behavioral: Low-intensity Remote Patient Monitoring (RPM-Low); Behavioral: Enhanced Response Team |
| High-intensity Remote Patient Monitoring (RPM) plus the Enhanced Team (RPM-High, Enhanced Team) | Active comparator | Questions focus on signs of worsening infection and worsening underlying heart or lung conditions. Questions are pushed to participants twice weekly for up to 90 days post-discharge. Patient responses to RPM questions trigger High or Medium alerts, which are screened by a nurse-staffed call center. Nurses determine whether emergency care is needed. If not, nurses triage responses among 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 and nurses) meet with the patient 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. Receives: Behavioral: High-intensity Remote Patient Monitoring (RPM-High); Behavioral: Enhanced Response Team |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-discharge Home Days
The primary endpoint was post-discharge home days, a composite of survival (non-survivors receive a value of -1) and number of days the patient was alive and at home within the 90-days following hospital discharge. Days at home excluded time spent in hospital and skilled nursing, rehabilitation, and long-term ventilatory care facilities. Although for survivors the unit of measurement is number of days at home within 90 days following hospital discharge, for non-survivors the value is unitless. Therefore, overall the measure is a unitless ordinal variable.
Measured: 90 days after discharge to home
Secondary outcomes (15)
Mortality
Mortality will be assessed via claims data to see if and when the member/participant passes away.
Measured: measured at 90 days
Number of Days Alive and at Home Among Survivors
Equivalent to the primary outcome (post-discharge home days) among survivors at 90 days.
Measured: 90 days
7-day Hospital Readmissions (Composite With Mortality)
Composite ordinal outcome of death (lowest value), inpatient readmission, or no readmissions (highest value) by day 7. Readmissions were assessed via health insurance claims for any inpatient admissions after index admission.
Measured: measured at 7 days
7-day Hospital Readmissions (Among Survivors)
Inpatient readmission or no readmission within 7 days of index hospitalization discharge, among survivors to 7 days.
Measured: Index hospital discharge to 7 days
30-day Hospital Readmissions (Composite With Mortality)
Composite ordinal outcome of death (lowest value), inpatient readmission, or no readmissions (highest value) by day 7. Readmissions were assessed via health insurance claims for any inpatient admissions after index admission.
Measured: measured at 30 days after index discharge
30-day Hospital Readmissions (Among Survivors)
Inpatient readmission or no readmission within 30 days of index hospitalization discharge, among survivors to 30 days.
Measured: 30 days from index hospital discharge
90-day Hospital Readmissions (Composite With Mortality)
Composite ordinal outcome of death (lowest value), inpatient readmission, or no readmissions (highest value) by day 90. Readmissions were assessed via health insurance claims for any inpatient admissions after index admission.
Measured: measured at 90 days
90-day Hospital Readmissions (Among Survivors)
90-day hospital readmissions among 90-day survivors
Measured: 90 days after index admission discharge
Functional Status Composite With Death (Measured by PROMIS Physical Function-for Mobility Aid Users-SF)
Functional Status was 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. Patients who died prior to receiving a PROMIS score were given a score of 56.
Measured: 90 days after randomization
Functional Status Among 90-day Survivors (Measured by PROMIS Physical Function-for Mobility Aid Users-SF)
Functional status scores among 90-day survivors (measured by PROMIS Physical Function-for Mobility Aid Users-SF) among 90-day survivors
Measured: 90 days after randomization
Health-related Quality of Life Composite With Death (Measured by Quality of Life Enjoyment and Satisfaction Questionnaire-SF)
Health-related Quality of Life was 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. Deaths prior to the measurement of quality of life scores were assigned a value of 13.A total of N=415 90-day survivors were missing HRqOL, and these outcomes were multiply imputed.
Measured: 90 days from randomization
Health-related Quality of Life Among 90-day Survivors (Measured by Quality of Life Enjoyment and Satisfaction Questionnaire-SF)
Health-related Quality of Life was 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. Deaths prior to the measurement of quality of life scores were removed from the analysis. Q-LES-Q scores missing for N=415 were multiply imputed.
Measured: 90 days after randomization
Number of Emergent Outpatient Uses at 90 Days, as a Composite With Death
Emergent outpatient utilization includes emergency department visits and urgent care visits. It was assessed via claims data at 90 days for study participants. The composite outcome was equal to 20 if the patient died during the 90-day follow-up, even if they experienced some ED visits.
Measured: measured at 90 days after randomization
Number of Emergent Outpatient Uses Among Survivors at 90 Days
Emergent outpatient utilization includes emergency department visits and urgent care visits. It was assessed via claims data at 90 days for study participants. Analysis limited to survivors at 90 days.
Measured: 90 days after randomization
Transition to Hospice
Transition to Hospice will be assessed via health insurance claims.
Measured: measured at 90 days after discharge to home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start30 Mar 2021
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,296 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Jatin Dave, University of Pittsburgh Medical Center
- Investigators
- Kalpana Char, MD, Principal investigator, UPMC Health PlanSachin Yende, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829188
- Sponsor's protocol ID
- STUDY20080130
- Acronym
- ACCOMPLISH
- Status last verified
- Jul 2026
- First submitted
- 26 Mar 2021
- Last updated
- 26 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yende S, Talisa VB, Mayes K, Williams K, Malito A, Mayr FB, Angus DC, Awdish R, Liang Q, Rak KJ, Barnes J, Lorenzi E, Viele K, Chang CH, McCauley C, Quintana M, McGlothlin A, Khandwala F, Dave J. Remote Monitoring Approaches to Reduce Readmissions After Infection and Sepsis: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jun 1;9(6):e2616641. doi: 10.1001/jamanetworkopen.2026.16641.
PubMed 42275060Mayes K, Talisa VB, Malito A, Mayr FB, Williams K, Char K, Wadas R, Lorenzi E, Viele K, Awdish R, Angus DC, Chang CH, Yende S. Design and methods of an adaptive trial to test comparative effectiveness of readmission reduction approaches following infection and sepsis hospitalizations (ACCOMPLISH). Contemp Clin Trials Commun. 2025 Jun 19;46:101504. doi: 10.1016/j.conctc.2025.101504. eCollection 2025 Aug.
PubMed 40642111
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Readmission Reduction Interventions for Individuals With Sepsis or Pneumonia
- ClinicalTrials.gov ID
- NCT04829188
- Acronym / sponsor ID
- ACCOMPLISH / STUDY20080130
- Conditions
- Sepsis, Pneumonia, Lower Resp Tract Infection, Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,296 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Posted 26 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Structured Telephone Support (STS) | Active comparator | Behavioral: Structured Telephone Support (STS)Post-discharge assessment, education, and medication review delivered telephonically by a nurse or health plan case manager, home care as needed, and follow-up with the primary care provider (PCP) within seven days post-discharge. |
| Low-intensity Remote Patient Monitoring (RPM) + Standard Response Team (RPM-Low, Standard Team) | Active comparator | Behavioral: Low-intensity Remote Patient Monitoring (RPM-Low), Behavioral: Standard Response TeamQuestions focus on signs of worsening infection and are pushed to participants twice weekly for up to 90 days post-discharge. Patient responses to RPM questions trigger High or Medium alerts, which 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. |
| High-intensity Remote Patient Monitoring (RPM) plus the Standard Team (RPM-High, Standard Team) | Active comparator | Behavioral: High-intensity Remote Patient Monitoring (RPM-High), Behavioral: Standard Response TeamQuestions focus on signs of worsening infection and worsening underlying heart or lung conditions. Questions are pushed to participants twice weekly for up to 90 days post-discharge. Patient responses to RPM questions trigger High or Medium alerts, which 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. |
| Low-intensity Remote Patient Monitoring (RPM) + Enhanced Team (RPM-Low, Enhanced Team) | Active comparator | Behavioral: Low-intensity Remote Patient Monitoring (RPM-Low), Behavioral: Enhanced Response TeamQuestions focus on signs of worsening infection and are pushed to participants twice weekly for up to 90 days post-discharge. Patient responses to RPM questions trigger High or Medium alerts, which are screened by a nurse-staffed call center. Nurses determine whether emergency care is needed. If not, nurses triage responses among 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 and nurses) meet with the patient 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. |
| High-intensity Remote Patient Monitoring (RPM) plus the Enhanced Team (RPM-High, Enhanced Team) | Active comparator | Behavioral: High-intensity Remote Patient Monitoring (RPM-High), Behavioral: Enhanced Response TeamQuestions focus on signs of worsening infection and worsening underlying heart or lung conditions. Questions are pushed to participants twice weekly for up to 90 days post-discharge. Patient responses to RPM questions trigger High or Medium alerts, which are screened by a nurse-staffed call center. Nurses determine whether emergency care is needed. If not, nurses triage responses among 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 and nurses) meet with the patient 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 may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Telephone Support (STS)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. | Behavioural | Structured Telephone Support (STS) |
| Low-intensity Remote Patient Monitoring (RPM-Low)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. | Behavioural | Low-intensity Remote Patient Monitoring (RPM) + Enhanced Team (RPM-Low, Enhanced Team), Low-intensity Remote Patient Monitoring (RPM) + Standard Response Team (RPM-Low, Standard Team) |
| High-intensity Remote Patient Monitoring (RPM-High)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. | Behavioural | High-intensity Remote Patient Monitoring (RPM) plus the Enhanced Team (RPM-High, Enhanced Team), High-intensity Remote Patient Monitoring (RPM) plus the Standard Team (RPM-High, Standard Team) |
| Standard Response TeamRPM 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. | Behavioural | High-intensity Remote Patient Monitoring (RPM) plus the Standard Team (RPM-High, Standard Team), Low-intensity Remote Patient Monitoring (RPM) + Standard Response Team (RPM-Low, Standard Team) |
| Enhanced Response TeamRPM 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. | Behavioural | High-intensity Remote Patient Monitoring (RPM) plus the Enhanced Team (RPM-High, Enhanced Team), Low-intensity Remote Patient Monitoring (RPM) + Enhanced Team (RPM-Low, Enhanced Team) |
Primary outcome
Post-discharge Home Days
Time frame: 90 days after discharge to home
The primary endpoint was post-discharge home days, a composite of survival (non-survivors receive a value of -1) and number of days the patient was alive and at home within the 90-days following hospital discharge. Days at home excluded time spent in hospital and skilled nursing, rehabilitation, and long-term ventilatory care facilities. Although for survivors the unit of measurement is number of days at home within 90 days following hospital discharge, for non-survivors the value is unitless. Therefore, overall the measure is a unitless ordinal variable.
15 secondary outcomes
Mortality
Time frame: measured at 90 days
Number of Days Alive and at Home Among Survivors
Time frame: 90 days
7-day Hospital Readmissions (Composite With Mortality)
Time frame: measured at 7 days
7-day Hospital Readmissions (Among Survivors)
Time frame: Index hospital discharge to 7 days
30-day Hospital Readmissions (Composite With Mortality)
Time frame: measured at 30 days after index discharge
30-day Hospital Readmissions (Among Survivors)
Time frame: 30 days from index hospital discharge
90-day Hospital Readmissions (Composite With Mortality)
Time frame: measured at 90 days
90-day Hospital Readmissions (Among Survivors)
Time frame: 90 days after index admission discharge
Functional Status Composite With Death (Measured by PROMIS Physical Function-for Mobility Aid Users-SF)
Time frame: 90 days after randomization
Functional Status Among 90-day Survivors (Measured by PROMIS Physical Function-for Mobility Aid Users-SF)
Time frame: 90 days after randomization
Health-related Quality of Life Composite With Death (Measured by Quality of Life Enjoyment and Satisfaction Questionnaire-SF)
Time frame: 90 days from randomization
Health-related Quality of Life Among 90-day Survivors (Measured by Quality of Life Enjoyment and Satisfaction Questionnaire-SF)
Time frame: 90 days after randomization
Number of Emergent Outpatient Uses at 90 Days, as a Composite With Death
Time frame: measured at 90 days after randomization
Number of Emergent Outpatient Uses Among Survivors at 90 Days
Time frame: 90 days after randomization
Transition to Hospice
Time frame: measured at 90 days after discharge to home
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42275060Yende S, Talisa VB, Mayes K, Williams K, Malito A, Mayr FB, Angus DC, Awdish R, Liang Q, Rak KJ, Barnes J, Lorenzi E, Viele K, Chang CH, McCauley C, Quintana M, McGlothlin A, Khandwala F, Dave J. Remote Monitoring Approaches to Reduce Readmissions After Infection and Sepsis: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jun 1;9(6):e2616641. doi: 10.1001/jamanetworkopen.2026.16641.
- Derived from this study: PubMed 40642111Mayes K, Talisa VB, Malito A, Mayr FB, Williams K, Char K, Wadas R, Lorenzi E, Viele K, Awdish R, Angus DC, Chang CH, Yende S. Design and methods of an adaptive trial to test comparative effectiveness of readmission reduction approaches following infection and sepsis hospitalizations (ACCOMPLISH). Contemp Clin Trials Commun. 2025 Jun 19;46:101504. doi: 10.1016/j.conctc.2025.101504. eCollection 2025 Aug.
- Individual participant dataSharing planned: No
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Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kalpana Char, MD principal investigator
UPMC Health Plan
Sachin Yende, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Telephone Support (STS), Low-intensity Remote Patient Monitoring (RPM-Low) and High-intensity Remote Patient Monitoring (RPM-High) in people with Sepsis and Pneumonia, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-discharge Home Days (time frame: 90 days after discharge to home). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04829188, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.