Acute IllnessNCT05232799
Care Anywhere With Community Paramedics Program to Reduce Hospitalization
A study testing Care Anywhere with Community Paramedics program in people with Acute Illness, run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this research is to compare the effectiveness of the Care Anywhere with Community Paramedics program with usual care in a pragmatic randomized controlled trial. The goal of the Care Anywhere with Community Paramedics program is to prevent or shorten hospitalizations among patients who are being treated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Illness
- What is being tested?
- Care Anywhere with Community Paramedics program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jan 2022to 31 Mar 2023
- Phase
- Interventional
- 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
Who may be able to join
- Adult (age ≥ 18 years) patients currently admitted to the ED, hospital or are in a pre-hospital setting but being considered for referral to the ED or hospital in Mayo Clinic Rochester, MN and Barron, WI but do not require hospital-level monitoring or care other than services that could be delivered by CPs in the ambulatory setting.
- Must reside within approximately a 40-mile radius of Rochester, MN or within the service radius of Barron, WI.
- Participants who require assistance with activities of daily living, or who are at increased risk for falls, need to have a caregiver available at home
Who cannot join
- Referring clinician and the community paramedic service do not believe the patient to be clinically appropriate for outpatient care with the CACP program.
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
- Clinical, behavioral, or cognitive instability, determined by the referring clinician or the CACP service.
- Living conditions unsafe for CPs to enter (patient refuses to secure weapons or animals prior to CP's arrival).
- Enrolled in the trial during an earlier hospitalization or ED visit.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic Health System
Barron, Wisconsin, 54812
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Community Paramedic Hospitalization Reduction and Mitigation Program: Pragmatic Clinical Trial
The purpose of this research is to compare the effectiveness of the Care Anywhere with Community Paramedics program with usual care in a pragmatic randomized controlled trial. The goal of the Care Anywhere with Community Paramedics program is to prevent or shorten hospitalizations among patients who are being treated in the clinic/ambulatory setting ("prehospital setting"), emergency department, or hospital and are clinically appropriate to be cared for at home with community paramedic services.
Read the detailed description
This pragmatic randomized controlled trial will randomize, with 1:1 allocation, 240 adults being treated in the pre-hospital setting, emergency department or hospital to either availability of the Care Anywhere with Community Paramedics (CACP) program or to no availability of the CACP program (i.e. usual care). Patients randomized to the CACP program will be able to receive in-home medical care - as ordered by their treating clinicians - from the Mayo Clinic Ambulance Community Paramedic Service. Primary outcome is going to be days alive spent at home without hospitalization (excluding planned admissions), emergency department visits, or skilled nursing facility care.
- Conditions
- Acute Illness
- Being tested
- Care Anywhere with Community Paramedics program
- Keywords
- Community Paramedicine, Acute care, Home care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Anywhere with Community Paramedics programOther
Outpatient management with supportive services provided by the community paramedic team.
| Study group | Role | What they receive |
|---|---|---|
| Care Anywhere with Community Paramedics program | Experimental | Subjects will be discharged from a pre-hospital setting, Emergency Department or the hospital with community paramedic services ordered and overseen by the treating clinical team per current standard of care. Receives: Other: Care Anywhere with Community Paramedics program |
| Standard of Care | No intervention | Subjects will receive continued usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days spent outside the hospital and ED
The number of days spent outside the hospital and ED during the 30 days following enrollment to the trial. (not in the hospital, ED, or nursing home; not counting planned admissions)
Measured: 30 days
Secondary outcomes (6)
Patients with an ED visit hospitalization or death
Proportion of patients with an ED visit, hospitalization, or death within 30-days of the day following randomization
Measured: 30 days
CACP Program patient satisfaction
Percentage of patients who are "extremely likely" or "very likely" to recommend the program
Measured: 30 days
Health related quality of life
EQ-5D survey
Measured: 30 days
Treatment burden
Relevant components of the PETS survey
Measured: 30 days
Community Paramedic satisfaction with the CACP program
CP survey
Measured: 30 days
Referring clinician satisfaction with the CACP program
Clinician Survey
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start21 Jan 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute IllnessStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rozalina G. McCoy, Mayo Clinic
- Investigators
- Rozalina McCoy, MD, MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232799
- Sponsor's protocol ID
- 21-010816
- Status last verified
- Oct 2023
- First submitted
- 27 Jan 2022
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ridgeway JL, Lampman MA, Haugo OA, Glasgow A, Smith JL, Menser TL, Sundt WJS, Krpata TS, Juntunen MB, Liedl CP, Hentz JG, McCoy JJ, Ducharme-Smith A, McCoy RG. Exploring implementation and sustainability of a community paramedicine model to reduce hospitalizations: a pragmatic randomized trial. BMC Health Serv Res. 2026 Apr 17;26(1):763. doi: 10.1186/s12913-026-14532-z.
PubMed 41992204Ridgeway JL, Sundt WJS, Krpata TS, Glasgow A, Smith OA, Lampman MA, Smith-Stellflug JL, Menser TL, Juntunen MB, Liedl CP, Hentz JG, McCoy JJ, McCoy RG. Evaluating adoption and reach in a pragmatic randomized trial of community paramedicine for intermediate acuity patient care. J Clin Transl Sci. 2024 Oct 17;8(1):e199. doi: 10.1017/cts.2024.646. eCollection 2024.
PubMed 39655042Ridgeway JL, Gerdes EOW, Dodge A, Liedl CP, Juntunen MB, Sundt WJS, Glasgow A, Lampman MA, Fink AL, Severson SB, Lin G, Sampson RR, Peterson RP, Murley BM, Klassen AB, Luke A, Friedman PA, Buechler TE, Newman JS, McCoy RG. Community paramedic hospital reduction and mitigation program: study protocol for a randomized pragmatic clinical trial. Trials. 2023 Feb 20;24(1):122. doi: 10.1186/s13063-022-07034-w.
PubMed 36805692
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Paramedic Hospitalization Reduction and Mitigation Program: Pragmatic Clinical Trial
- ClinicalTrials.gov ID
- NCT05232799
- Acronym / sponsor ID
- 21-010816
- Conditions
- Acute Illness
- Keywords
- Community Paramedicine, Acute care, Home care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 10 Feb 2022 (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.
The purpose of this research is to compare the effectiveness of the Care Anywhere with Community Paramedics program with usual care in a pragmatic randomized controlled trial. The goal of the Care Anywhere with Community Paramedics program is to prevent or shorten hospitalizations among patients who are being treated in the clinic/ambulatory setting ("prehospital setting"), emergency department, or hospital and are clinically appropriate to be cared for at home with community paramedic services.
Detailed description
This pragmatic randomized controlled trial will randomize, with 1:1 allocation, 240 adults being treated in the pre-hospital setting, emergency department or hospital to either availability of the Care Anywhere with Community Paramedics (CACP) program or to no availability of the CACP program (i.e. usual care). Patients randomized to the CACP program will be able to receive in-home medical care - as ordered by their treating clinicians - from the Mayo Clinic Ambulance Community Paramedic Service. Primary outcome is going to be days alive spent at home without hospitalization (excluding planned admissions), emergency department visits, or skilled nursing facility care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care Anywhere with Community Paramedics program | Experimental | Other: Care Anywhere with Community Paramedics programSubjects will be discharged from a pre-hospital setting, Emergency Department or the hospital with community paramedic services ordered and overseen by the treating clinical team per current standard of care. |
| Standard of Care | No intervention | –Subjects will receive continued usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (age ≥ 18 years) patients currently admitted to the ED, hospital or are in a pre-hospital setting but being considered for referral to the ED or hospital in Mayo Clinic Rochester, MN and Barron, WI but do not require hospital-level monitoring or care other than services that could be delivered by CPs in the ambulatory setting.
- Must reside within approximately a 40-mile radius of Rochester, MN or within the service radius of Barron, WI.
- Participants who require assistance with activities of daily living, or who are at increased risk for falls, need to have a caregiver available at home
Key exclusion criteria (5 listed)
- Referring clinician and the community paramedic service do not believe the patient to be clinically appropriate for outpatient care with the CACP program.
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
- Clinical, behavioral, or cognitive instability, determined by the referring clinician or the CACP service.
- Living conditions unsafe for CPs to enter (patient refuses to secure weapons or animals prior to CP's arrival).
- Enrolled in the trial during an earlier hospitalization or ED visit.
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 |
|---|---|---|
| Care Anywhere with Community Paramedics programOutpatient management with supportive services provided by the community paramedic team. | Other | Care Anywhere with Community Paramedics program |
Primary outcome
Number of days spent outside the hospital and ED
Time frame: 30 days
The number of days spent outside the hospital and ED during the 30 days following enrollment to the trial. (not in the hospital, ED, or nursing home; not counting planned admissions)
6 secondary outcomes
Patients with an ED visit hospitalization or death
Time frame: 30 days
CACP Program patient satisfaction
Time frame: 30 days
Health related quality of life
Time frame: 30 days
Treatment burden
Time frame: 30 days
Community Paramedic satisfaction with the CACP program
Time frame: 30 days
Referring clinician satisfaction with the CACP program
Time frame: 30 days
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 5 Oct 2023.
- Derived from this study: PubMed 41992204Ridgeway JL, Lampman MA, Haugo OA, Glasgow A, Smith JL, Menser TL, Sundt WJS, Krpata TS, Juntunen MB, Liedl CP, Hentz JG, McCoy JJ, Ducharme-Smith A, McCoy RG. Exploring implementation and sustainability of a community paramedicine model to reduce hospitalizations: a pragmatic randomized trial. BMC Health Serv Res. 2026 Apr 17;26(1):763. doi: 10.1186/s12913-026-14532-z.
- Derived from this study: PubMed 39655042Ridgeway JL, Sundt WJS, Krpata TS, Glasgow A, Smith OA, Lampman MA, Smith-Stellflug JL, Menser TL, Juntunen MB, Liedl CP, Hentz JG, McCoy JJ, McCoy RG. Evaluating adoption and reach in a pragmatic randomized trial of community paramedicine for intermediate acuity patient care. J Clin Transl Sci. 2024 Oct 17;8(1):e199. doi: 10.1017/cts.2024.646. eCollection 2024.
- Derived from this study: PubMed 36805692Ridgeway JL, Gerdes EOW, Dodge A, Liedl CP, Juntunen MB, Sundt WJS, Glasgow A, Lampman MA, Fink AL, Severson SB, Lin G, Sampson RR, Peterson RP, Murley BM, Klassen AB, Luke A, Friedman PA, Buechler TE, Newman JS, McCoy RG. Community paramedic hospital reduction and mitigation program: study protocol for a randomized pragmatic clinical trial. Trials. 2023 Feb 20;24(1):122. doi: 10.1186/s13063-022-07034-w.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Rozalina McCoy, MD, MS principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Anywhere with Community Paramedics program in people with Acute Illness, run by Mayo Clinic at 2 sites 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 3 inclusion and 5 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 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 days spent outside the hospital and ED (time frame: 30 days). 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 NCT05232799, which also lists 3 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 5 Oct 2023.