Comorbidities and Coexisting ConditionsNCT04727567
Evaluation of a Personalized Care Management Program for High Hospital Utilizers
An observational study of Comorbidities and Coexisting Conditions, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This randomized clinical trial intends to evaluate the effectiveness of enrollment in Atrium Health's Multiple Visit Patient (MVP) care management program compared to usual care on reducing 12-month total inpatient hospital utilization among patients with high past volume of hospital inpatient stays. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comorbidities and Coexisting Conditions
- How many people
- 454 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2020to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients included in the evaluable population for this project, will have their data inform the final outcomes assessment. All patients who meet the inclusion and exclusion criteria in both groups will be assessed for the primary outcome (intent to treat).
Who may be able to join
- 18 years of age or older
- 4 or more inpatient hospital visits across Atrium Health Metro hospitals in 2019
Who cannot join
- Existing MVP participants
- Patients who at the time of identification for the MVP program are:
- Actively enrolled in a Levine Cancer Institute oncology navigation program
- Actively receiving hospice or palliative care
- Attributed to a primary care provider at an outside healthcare system
- Patients whose primary residence is a skilled nursing facility
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health - Care Management Program
Charlotte, North Carolina, 28203
About this study
Official title: Effect of a Personalized Care Management Program on Hospital Inpatient Stays Among High Utilizers: A Randomized Clinical Trial
This randomized clinical trial intends to evaluate the effectiveness of enrollment in Atrium Health's Multiple Visit Patient (MVP) care management program compared to usual care on reducing 12-month total inpatient hospital utilization among patients with high past volume of hospital inpatient stays.
Read the detailed description
The list of patients with four or more inpatient hospital visits in 2019 will be pulled from the Atrium Health electronic data warehouse (EDW) by IAS Clinical Quality Analytics, and eligibility for the MVP program of patients on this list will be determined by the Population Health's Care Management team based on predefined eligibility criteria. IAS CORE will randomize eligible participants into one of two groups: 1) MVP program; or 2) usual care.
Population Health's Multiple Visit Patient (MVP) care management program aims to manage health and lower hospital utilization among patients with a history of high inpatient hospital stays at Atrium Health. Patients eligible for the program have four or more inpatient visits over the 12-month period prior to enrollment. Once enrolled, each MVP program participant receives on-going support from an assigned MVP care manager and larger care management team, including the following core program components:
- customized care plan developed for each patient at the time of enrollment
- routine, virtual health monitoring and collaborative care management team-based review
- personalized navigation and coordination across multidisciplinary Atrium Health services, as needed
- education, health coaching, and support via telephonic and in-person interactions, as needed
The control group will receive usual care.
Upon completion of the 12-month period during which outcomes data will be accrued, the study will evaluate whether 12-month participation in the MVP program care management program, compared to usual care, reduced inpatient hospital use.
- Conditions
- Comorbidities and Coexisting Conditions
- Keywords
- Patient Care Management, Patient Hospital Admissions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Visit Patient (MVP) Program | The MVP program aims to manage health and lower hospital utilization among patients with a history of high inpatient hospital stays at Atrium Health. Patients eligible for the program have four or more inpatient visits over the 12-month period prior to enrollment. Once enrolled, each MVP program participant receives on-going support from an assigned MVP care manager and larger care management team, including the following core program components: customized care plan developed for each patient at the time of enrollment routine, virtual health monitoring and collaborative care management team-based review personalized navigation and coordination across multidisciplinary Atrium Health services, as needed. Education, health coaching, and support via telephonic and in-person interactions, as needed. | |
| Usual Care | Atrium Health standard of care. Patient's post-discharge usual care depends on the inpatient care management assessment at last hospital admission. Patients can be discharged to home and receive no further care, or home with home health, or to a skilled nursing facility (SNF) or another type of Continuing Care facility. Patients can be referred to advanced illness management, hospice, and Community Care Partners by the inpatient care manager. Patient can be referred to Ambulatory Care Management for care management also via telehealth, by a primary care physician or the Transitions Clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of inpatient (IP) hospital encounters over a 12 month period
Inpatient encounter is defined as an admission to an Atrium Health acute care hospital
Measured: 12 months
Secondary outcomes (17)
Number of inpatient hospital encounters over a 6 month period
Inpatient encounter is defined as an admission to an Atrium Health acute care hospital
Measured: 6 months
Combined Inpatient and Observational hospital encounters - Atrium only
Combined number of IP and OBS encounters at Atrium Health hospitals
Measured: 6 months
Combined Inpatient and Observational hospital encounters - non-Atrium included
Combined number of IP and OBS encounters at Atrium Health and non-Atrium Health hospitals
Measured: 6 months
Combined Inpatient and Observational hospital encounters - Atrium only
Combined number of IP and OBS encounters at Atrium Health hospitals
Measured: 12 month
Combined Inpatient and Observational hospital encounters - non-Atrium included
Combined number of IP and OBS encounters at Atrium Health and non-Atrium Health hospitals
Measured: 12 month
Inpatient Readmission
Among patients with at least 1 encounter during the study period, 30-day all cause non-elective inpatient readmission rate to any AH hospital
Measured: 6 month
Inpatient Readmission
Among patients with at least 1 encounter during the study period, 30-day all cause non-elective inpatient readmission rate to any AH hospital
Measured: 12 month
Inpatient Readmission - Same Hospital
Among patients with at least 1 encounter during the study period, 30-day all cause non-elective inpatient readmission rate to the same AH hospital as the index encounter
Measured: 6 month
Inpatient Readmission - Same Hospital
Among patients with at least 1 encounter during the study period, 30-day all cause non-elective inpatient readmission rate to the same AH hospital as the index encounter
Measured: 12 month
Emergency Department Encounters
Number of patient emergency department encounters
Measured: 6 month
Emergency Department Encounters
Number of patient emergency department encounters
Measured: 12 month
Mortality
Dichotomous indicator of all-cause mortality within 6 months from the beginning of the study period
Measured: 6 month
Mortality
Dichotomous indicator of all-cause mortality within 12 months from the beginning of the study period
Measured: 12 month
Hospital Bed Days (Inpatient)
Total length of stay (LOS) in days (discharge date to admissions date) for acute care IP utilization
Measured: 6 month
Hospital Bed Days (Inpatient)
Total length of stay (LOS) in days (discharge date to admissions date) for acute care IP utilization
Measured: 12 month
Hospital Charges
Total accrued hospital billed charges for inpatient encounter at Atrium Health primary enterprise acute care facilities.
Measured: 6 month
Hospital Charges
Total accrued hospital billed charges for inpatient encounter at Atrium Health primary enterprise acute care facilities.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start23 Apr 2020
- Primary completion1 May 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comorbidities and Coexisting ConditionsStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alica Sparling, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727567
- Sponsor's protocol ID
- IRB00082498
- Other IDs
- 04-20-10E
- Status last verified
- Sep 2021
- First submitted
- 12 Jan 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Personalized Care Management Program on Hospital Inpatient Stays Among High Utilizers: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04727567
- Acronym / sponsor ID
- IRB00082498
- Conditions
- Comorbidities and Coexisting Conditions
- Keywords
- Patient Care Management, Patient Hospital Admissions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial intends to evaluate the effectiveness of enrollment in Atrium Health's Multiple Visit Patient (MVP) care management program compared to usual care on reducing 12-month total inpatient hospital utilization among patients with high past volume of hospital inpatient stays.
Detailed description
The list of patients with four or more inpatient hospital visits in 2019 will be pulled from the Atrium Health electronic data warehouse (EDW) by IAS Clinical Quality Analytics, and eligibility for the MVP program of patients on this list will be determined by the Population Health's Care Management team based on predefined eligibility criteria. IAS CORE will randomize eligible participants into one of two groups: 1) MVP program; or 2) usual care.
Population Health's Multiple Visit Patient (MVP) care management program aims to manage health and lower hospital utilization among patients with a history of high inpatient hospital stays at Atrium Health. Patients eligible for the program have four or more inpatient visits over the 12-month period prior to enrollment. Once enrolled, each MVP program participant receives on-going support from an assigned MVP care manager and larger care management team, including the following core program components:
- customized care plan developed for each patient at the time of enrollment
- routine, virtual health monitoring and collaborative care management team-based review
- personalized navigation and coordination across multidisciplinary Atrium Health services, as needed
- education, health coaching, and support via telephonic and in-person interactions, as needed
The control group will receive usual care.
Upon completion of the 12-month period during which outcomes data will be accrued, the study will evaluate whether 12-month participation in the MVP program care management program, compared to usual care, reduced inpatient hospital use.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Visit Patient (MVP) Program | – | –The MVP program aims to manage health and lower hospital utilization among patients with a history of high inpatient hospital stays at Atrium Health. Patients eligible for the program have four or more inpatient visits over the 12-month period prior to enrollment. Once enrolled, each MVP program participant receives on-going support from an assigned MVP care manager and larger care management team, including the following core program components: customized care plan developed for each patient at the time of enrollment routine, virtual health monitoring and collaborative care management team-based review personalized navigation and coordination across multidisciplinary Atrium Health services, as needed. Education, health coaching, and support via telephonic and in-person interactions, as needed. |
| Usual Care | – | –Atrium Health standard of care. Patient's post-discharge usual care depends on the inpatient care management assessment at last hospital admission. Patients can be discharged to home and receive no further care, or home with home health, or to a skilled nursing facility (SNF) or another type of Continuing Care facility. Patients can be referred to advanced illness management, hospice, and Community Care Partners by the inpatient care manager. Patient can be referred to Ambulatory Care Management for care management also via telehealth, by a primary care physician or the Transitions Clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included in the evaluable population for this project, will have their data inform the final outcomes assessment. All patients who meet the inclusion and exclusion criteria in both groups will be assessed for the primary outcome (intent to treat).
Key inclusion criteria (2 listed)
- 18 years of age or older
- 4 or more inpatient hospital visits across Atrium Health Metro hospitals in 2019
Key exclusion criteria (6 listed)
- Existing MVP participants
- Patients who at the time of identification for the MVP program are:
- Actively enrolled in a Levine Cancer Institute oncology navigation program
- Actively receiving hospice or palliative care
- Attributed to a primary care provider at an outside healthcare system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of inpatient (IP) hospital encounters over a 12 month period
Time frame: 12 months
Inpatient encounter is defined as an admission to an Atrium Health acute care hospital
17 secondary outcomes
Number of inpatient hospital encounters over a 6 month period
Time frame: 6 months
Combined Inpatient and Observational hospital encounters - Atrium only
Time frame: 6 months
Combined Inpatient and Observational hospital encounters - non-Atrium included
Time frame: 6 months
Combined Inpatient and Observational hospital encounters - Atrium only
Time frame: 12 month
Combined Inpatient and Observational hospital encounters - non-Atrium included
Time frame: 12 month
Inpatient Readmission
Time frame: 6 month
Inpatient Readmission
Time frame: 12 month
Inpatient Readmission - Same Hospital
Time frame: 6 month
Inpatient Readmission - Same Hospital
Time frame: 12 month
Emergency Department Encounters
Time frame: 6 month
Emergency Department Encounters
Time frame: 12 month
Mortality
Time frame: 6 month
Mortality
Time frame: 12 month
Hospital Bed Days (Inpatient)
Time frame: 6 month
Hospital Bed Days (Inpatient)
Time frame: 12 month
Hospital Charges
Time frame: 6 month
Hospital Charges
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Alica Sparling, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Comorbidities and Coexisting Conditions, run by Wake Forest University Health Sciences 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 2 inclusion and 6 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 22 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of inpatient (IP) hospital encounters over a 12 month period (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2022.