The Focus is to Test a Survey Predicting ReadmissionsNCT03791541
A Study Evaluating the Use of Potential Predictors of Readmission in Hospitalized Medicine Patients
A study testing Pharmacist services in people with The Focus is to Test a Survey Predicting Readmissions and Inpatient Internal Medicine Patients, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The primary objective of this study is the development and implementation of a survey administered to hospitalized patients on Internal Medicine that can be used in conjunction with previously validated predictive indices to identify patients at risk for readmission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Focus is to Test a Survey Predicting Readmissions, Inpatient Internal Medicine Patients
- What is being tested?
- Pharmacist services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 27 Feb 2018
- 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
- Inpatient on Internal Medicine service at UIH (University at Illinois Health Hospital)
- Adults > 18 years of age, fluency in English
Who cannot join
- Prisoners
- Active illicit substance abuse per admitting History \& Physical note in EMR (Electronic Medical Record)
- Admitted for alcohol withdrawal or abuse
- Nursing home resident likely to be discharged back to a nursing home
- Unable to provide informed consent
- Unable to complete survey (e.g., dementia)
- Unable to communicate verbally (aphasia)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
The primary objective of this study is the development and implementation of a survey administered to hospitalized patients on Internal Medicine that can be used in conjunction with previously validated predictive indices to identify patients at risk for readmission. The survey consists of previously validated as well as investigator developed survey instruments that will assess the following: health literacy, numeracy, medication adherence, self-efficacy, and tolerance. The predictive indices are the LACE, Charlson Comorbidity Index (included in LACE), and the Comorbidity Polypharmacy Score (CPS) which have been previously validated for risk of readmissions. The survey consists of both closed and open ended questions. A part of the survey will be administered by the study personnel while the rest is a questionnaire-based survey that will be completed by the subjects. Study personnel will be with the subjects in an open dialogue while subjects are completing the survey to answer any questions and identify questions that may be confusing or bias subjects. Approximately 30 days after hospital discharge, patients will be contacted via telephone to ask how many admissions and/or Emergency Department (ED) visits they have had since discharge. A correlation analysis will be done of the different aspects of the survey to determine whether there are redundancies. A regression analysis will be done to determine the predictive ability of the survey combined with predictive indices for readmission.
Read the detailed description
Many patients are readmitted to the hospital shortly after discharge. Twenty percent of Medicare beneficiaries discharged were re-hospitalized within 30 days at a cost to Medicare estimated at $17.4 billion. This problem does not only affect the elderly. Medicaid enrollees aged 21-64 had 10.7% 30-day readmission rate. Identifying which patients are at highest risk is important for allocating resources to those high risk individuals.
Several studies have attempted to retrospectively identify medical conditions, medications, labs, and vitals associated with increased risk of readmission with different levels of success. Examples of these include the Charlson Comorbidity Index, LACE, and the Comorbidity Polypharmacy Score. Although not always developed for use in predicting readmissions, they have been subsequently associated with this.
While these indices examine objective data, it is thought that health beliefs, abilities, and behaviors can also affect the risk of readmissions. Health literacy in particular has been shown to be associated with 30 day readmissions after an acute myocardial infarction and in general medical patients. Low numeracy has been associated with increased risk of 30 day readmission in patients with acute heart failure.
Inpatient questionnaires are able to identify patients who are more likely than others to be readmitted. Additionally, objective qualities such as insurance status, comorbidities, and admissions within the past year are predictors of readmission. Due to the unique patient populations at different health systems, an institution-specific approach is necessary to analyze the specific factors contributing to readmission. Therefore, a survey will be used to gauge the most predictive factors of readmissions and ED visits, including objective and subjective sections. After further research and modification, the survey will potentially serve as a tool for clinicians to select the best approach to post-discharge care and follow-up.
This pilot will attempt to test a survey for predicting readmission through measurements of health literacy, numeracy, medication adherence, self-efficacy, and tolerance, and in conjunction with co-morbidity indices.
- Conditions
- The Focus is to Test a Survey Predicting Readmissions, Inpatient Internal Medicine Patients
- Being tested
- Pharmacist services
- Keywords
- Readmissions, Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist servicesBehavioural
Additional pharmacist/pharmacy student follow-ups, counseling, and other services
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | No intervention | Only surveys will be done and re admissions tracked. No additional interventions based on survey results will be done. |
| Intervention | Experimental | Pharmacist Services
Surveys plus increased outpatient pharmacist/pharmacy student services including but not limited to pre and post clinic visit phone calls, prescription counseling, and helping with adherence and compliance with medications. Increased services will be given based on survey results. Receives: Behavioral: Pharmacist services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of readmissions after 1 month
Number of readmissions after 30 days post-discharge
Measured: 30 days post-discharge
Secondary outcomes (1)
Number of readmissions after 2 months
Number of readmissions after 60 days post-discharge
Measured: 60 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start1 Feb 2017
- Primary completion1 Dec 2017
- Study completion27 Feb 2018
Why it stopped: Pilot study results not meaningful. Students researchers graduated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Focus is to Test a Survey Predicting ReadmissionsStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- targeted, cost-effective interventions based on results of surveys and other factors studied will be applied to study arm to see if re-admissions can be prevented
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathew Thambi, University of Illinois Chicago
- Investigators
- Mat Thambi, PharmD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791541
- Sponsor's protocol ID
- 2016-0748
- Status last verified
- Sep 2020
- First submitted
- 20 Dec 2018
- Last updated
- 24 Sep 2020
- 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 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Use of Potential Predictors of Readmission in Hospitalized Medicine Patients
- ClinicalTrials.gov ID
- NCT03791541
- Acronym / sponsor ID
- 2016-0748
- Conditions
- The Focus is to Test a Survey Predicting Readmissions, Inpatient Internal Medicine Patients
- Keywords
- Readmissions, Survey
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Pilot study results not meaningful. Students researchers graduated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 27 Feb 2018 (actual)
- First posted
- 2 Jan 2019 (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 primary objective of this study is the development and implementation of a survey administered to hospitalized patients on Internal Medicine that can be used in conjunction with previously validated predictive indices to identify patients at risk for readmission. The survey consists of previously validated as well as investigator developed survey instruments that will assess the following: health literacy, numeracy, medication adherence, self-efficacy, and tolerance. The predictive indices are the LACE, Charlson Comorbidity Index (included in LACE), and the Comorbidity Polypharmacy Score (CPS) which have been previously validated for risk of readmissions. The survey consists of both closed and open ended questions. A part of the survey will be administered by the study personnel while the rest is a questionnaire-based survey that will be completed by the subjects. Study personnel will be with the subjects in an open dialogue while subjects are completing the survey to answer any questions and identify questions that may be confusing or bias subjects. Approximately 30 days after hospital discharge, patients will be contacted via telephone to ask how many admissions and/or Emergency Department (ED) visits they have had since discharge. A correlation analysis will be done of the different aspects of the survey to determine whether there are redundancies. A regression analysis will be done to determine the predictive ability of the survey combined with predictive indices for readmission.
Detailed description
Many patients are readmitted to the hospital shortly after discharge. Twenty percent of Medicare beneficiaries discharged were re-hospitalized within 30 days at a cost to Medicare estimated at $17.4 billion. This problem does not only affect the elderly. Medicaid enrollees aged 21-64 had 10.7% 30-day readmission rate. Identifying which patients are at highest risk is important for allocating resources to those high risk individuals.
Several studies have attempted to retrospectively identify medical conditions, medications, labs, and vitals associated with increased risk of readmission with different levels of success. Examples of these include the Charlson Comorbidity Index, LACE, and the Comorbidity Polypharmacy Score. Although not always developed for use in predicting readmissions, they have been subsequently associated with this.
While these indices examine objective data, it is thought that health beliefs, abilities, and behaviors can also affect the risk of readmissions. Health literacy in particular has been shown to be associated with 30 day readmissions after an acute myocardial infarction and in general medical patients. Low numeracy has been associated with increased risk of 30 day readmission in patients with acute heart failure.
Inpatient questionnaires are able to identify patients who are more likely than others to be readmitted. Additionally, objective qualities such as insurance status, comorbidities, and admissions within the past year are predictors of readmission. Due to the unique patient populations at different health systems, an institution-specific approach is necessary to analyze the specific factors contributing to readmission. Therefore, a survey will be used to gauge the most predictive factors of readmissions and ED visits, including objective and subjective sections. After further research and modification, the survey will potentially serve as a tool for clinicians to select the best approach to post-discharge care and follow-up.
This pilot will attempt to test a survey for predicting readmission through measurements of health literacy, numeracy, medication adherence, self-efficacy, and tolerance, and in conjunction with co-morbidity indices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- targeted, cost-effective interventions based on results of surveys and other factors studied will be applied to study arm to see if re-admissions can be prevented
| Arm | Type | Receives |
|---|---|---|
| No Intervention | No intervention | –Only surveys will be done and re admissions tracked. No additional interventions based on survey results will be done. |
| Intervention | Experimental | Behavioral: Pharmacist servicesPharmacist Services Surveys plus increased outpatient pharmacist/pharmacy student services including but not limited to pre and post clinic visit phone calls, prescription counseling, and helping with adherence and compliance with medications. Increased services will be given based on survey results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inpatient on Internal Medicine service at UIH (University at Illinois Health Hospital)
- Adults > 18 years of age, fluency in English
Key exclusion criteria (7 listed)
- Prisoners
- Active illicit substance abuse per admitting History \& Physical note in EMR (Electronic Medical Record)
- Admitted for alcohol withdrawal or abuse
- Nursing home resident likely to be discharged back to a nursing home
- Unable to provide informed 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 |
|---|---|---|
| Pharmacist servicesAdditional pharmacist/pharmacy student follow-ups, counseling, and other services | Behavioural | Intervention |
Primary outcome
Number of readmissions after 1 month
Time frame: 30 days post-discharge
Number of readmissions after 30 days post-discharge
1 secondary outcome
Number of readmissions after 2 months
Time frame: 60 days post-discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Individual participant dataSharing planned: No
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.
Mat Thambi, PharmD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist services in people with The Focus is to Test a Survey Predicting Readmissions and Inpatient Internal Medicine Patients, run by University of Illinois Chicago 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 7 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: withdrawn, as of the sponsor's last update on 24 Sep 2020. 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 withdrawn before enrolling participants, so there are no results.
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 readmissions after 1 month (time frame: 30 days post-discharge). 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 24 Sep 2020.