A Study Evaluating the Use of Potential Predictors of Readmission in Hospitalized Medicine Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: The Focus is to Test a Survey Predicting Readmissions; Inpatient Internal Medicine Patients
• Intervention / Treatment: Behavioral: Pharmacist services

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inpatient on Internal Medicine service at UIH (University at Illinois Health Hospital)
• Adults > 18 years of age, fluency in English

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Intervention; Only surveys will be done and re admissions tracked. No additional interventions based on survey results will be done.
Experimental: Intervention; 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.	Behavioral: Pharmacist services; Additional pharmacist/pharmacy student follow-ups, counseling, and other services

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of readmissions after 1 month	Number of readmissions after 30 days post-discharge	30 days post-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of readmissions after 2 months	Number of readmissions after 60 days post-discharge	60 days post-discharge

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Investigators: Principal Investigator: Mat Thambi, PharmD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): February 27, 2018

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: December 31, 2018
• First Posted (Actual): January 2, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2020
• Last Update Submitted That Met QC Criteria: September 22, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Survey; Readmissions
• Other Study ID Numbers: 2016-0748

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No