HospitalismNCT04365673
LACE+ and MRS Score Readmission Rate Assessment
An observational study of Hospitalism, run by Tabula Rasa HealthCare at 1 site in United States.
Trial summary
A study to demonstrate that the LACE+ score in non-inferior to the medication risk score when predicting 30-day readmission post hospital discharge. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Hospitalism
- What is being tested?
- Pharmacist transition of care consultation
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2020to 1 Mar 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 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Information will be collected from an internal data collection excel used to provide monthly outcome intervention reports to the local Tucson hospital.
Who may be able to join
- Those referred to receive transition of care services between January 2018 to December 2019 and were discharged on 10 or more medications.
Who cannot join
- 89 years or older
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Predictive Strength of the LACE+ Index With the MedWise Rise Score on Hospital Readmission Rates: a Non-inferiority Observational Study
A study to demonstrate that the LACE+ score in non-inferior to the medication risk score when predicting 30-day readmission post hospital discharge.
Read the detailed description
The objective of this study is evaluate a program that provides transition of care services to a local Tucson hospital involving activities designed to reduce 30 day post hospital discharge readmission rates. The organization has had a fee for service contract with this hospital since 2017 to provide pharmacist delivered transition of care services. The organization collects internal tracking outcome data as part of the contract deliverable and is required to report it to the hospital once per month. The investigators look to assess LACE+ and medication risk scores to learn if there is an association with the 30 day post hospital discharge readmission rate post pharmacist intervention. The outcomes will not be generalizable and will be reported back to the hospital client to demonstrate value added.
- Conditions
- Hospitalism
- Being tested
- Pharmacist transition of care consultation
- Keywords
- LACE, medication risk score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist transition of care consultationOther
Pharmacist-delivered comprehensive medication review
| Study group | Role | What they receive |
|---|---|---|
| Readmitted | Patients that were readmitted within 30 days post hospital discharge Receives: Other: Pharmacist transition of care consultation | |
| Not readmitted | Patients that were not readmitted within 30 days post hospital discharge Receives: Other: Pharmacist transition of care consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission
Readmission within 30-days post hospital discharge
Measured: 2018 - 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start7 Jul 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Why it stopped: Terminated: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Lack of data to demonstrate sufficient power.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HospitalismStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tabula Rasa HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Bingham, PharmD, Principal investigator, Tabula Rasa HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365673
- Sponsor's protocol ID
- TRHC_RD_LACEMRS_2020
- Status last verified
- Mar 2022
- First submitted
- 24 Apr 2020
- Last updated
- 17 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Predictive Strength of the LACE+ Index With the MedWise Rise Score on Hospital Readmission Rates: a Non-inferiority Observational Study
- ClinicalTrials.gov ID
- NCT04365673
- Acronym / sponsor ID
- TRHC_RD_LACEMRS_2020
- Conditions
- Hospitalism
- Keywords
- LACE, medication risk score
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Lack of data to demonstrate sufficient power.
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tabula Rasa HealthCareIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 28 Apr 2020 (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.
A study to demonstrate that the LACE+ score in non-inferior to the medication risk score when predicting 30-day readmission post hospital discharge.
Detailed description
The objective of this study is evaluate a program that provides transition of care services to a local Tucson hospital involving activities designed to reduce 30 day post hospital discharge readmission rates. The organization has had a fee for service contract with this hospital since 2017 to provide pharmacist delivered transition of care services. The organization collects internal tracking outcome data as part of the contract deliverable and is required to report it to the hospital once per month. The investigators look to assess LACE+ and medication risk scores to learn if there is an association with the 30 day post hospital discharge readmission rate post pharmacist intervention. The outcomes will not be generalizable and will be reported back to the hospital client to demonstrate value added.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Readmitted | – | Other: Pharmacist transition of care consultationPatients that were readmitted within 30 days post hospital discharge |
| Not readmitted | – | Other: Pharmacist transition of care consultationPatients that were not readmitted within 30 days post hospital discharge |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Information will be collected from an internal data collection excel used to provide monthly outcome intervention reports to the local Tucson hospital.
Key inclusion criteria (1 listed)
- Those referred to receive transition of care services between January 2018 to December 2019 and were discharged on 10 or more medications.
Key exclusion criteria (1 listed)
- 89 years or older
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 |
|---|---|---|
| Pharmacist transition of care consultationPharmacist-delivered comprehensive medication review | Other | Not readmitted, Readmitted |
Primary outcome
Readmission
Time frame: 2018 - 2019
Readmission within 30-days post hospital discharge
Results and safety
The study was stopped early (reason given: Terminated: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Lack of data to demonstrate sufficient power.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Jennifer Bingham, PharmD principal investigator
Tabula Rasa HealthCare
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 Hospitalism, run by Tabula Rasa HealthCare 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 17 Mar 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 was stopped early (reason given: Terminated: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Lack of data to demonstrate sufficient power.). Results are not available in the source record.
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?
Readmission (time frame: 2018 - 2019). 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 17 Mar 2022.