Virtual Continuity and Its Impact on Complex Hospitalized Patients' Care

March 27, 2015 updated by: University of Pittsburgh
Communication between physicians caring for a patient in the hospital and that patient's primary care provider is less than optimal, and can lead to diminished health care quality and safety. This project will lead to better communication between physicians and could decrease medication errors that tend to occur as the patient goes from hospital to home.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Communication between physicians caring for hospitalized patients and those patients' primary care providers (PCPs) is often suboptimal. Hospital-based information systems can improve communication by automating information exchange between hospital physicians and PCPs, and perhaps, as a result, improve the quality and safety of health care. MedTrak, the University of Pittsburgh Medical Center (UPMC) electronic physician communication tool, has proven successful and is poised to move forward with an initiative the investigators call virtual continuity, allowing PCPs to follow their patients electronically if they cannot do so physically. Virtual continuity will include: emails to PCPs triggered by clinical events with embedded links to electronic medical record data and communication portals, medication lists electronically delivered to PCPs at admission and discharge, and immediate PCP notification of discharge with pertinent clinical details. To evaluate virtual continuity, the investigators will examine the frequency of discharge medication errors in complex medical patients using a pre-post study design of virtual continuity compared to usual communication. Medication errors will be ascertained using accepted methods. The investigators will also investigate differences in rehospitalization, post discharge emergency department visit and PCP follow up rates. The IT cost of implementing and maintaining the virtual continuity intervention will also be assessed. Virtual continuity will allow PCPs to participate more directly in the care of their hospitalized patients. Improved communication could lead to higher-quality patient care and greater patient care safety for hospitalized patients with complex medical problems.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
835

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213-2582
        • UPMC Presbyterian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Are admitted to UPMC Presbyterian General Medicine, Geriatrics, Cardiology, or Surgery inpatient services;
  • Are 18 years of age or older;
  • Are currently receiving 5 or more medications;
  • Have 2 or more comorbid conditions present, defined using the Elixhauser comorbidity system (Med Care 1998;36:8-27 and Med Care. 2005 Nov; 43(11): 1130-9 ). These comorbidities are: congestive heart failure, cardiac arrhythmias, valvular disease, pulmonary circulation disorders, peripheral vascular disorders, hypertension, paralysis, other neurologic disorders, chronic pulmonary disease, diabetes uncomplicated, diabetes complicated, hypothyroidism, renal failure, liver disease, peptic ulcer disease excluding bleeding, AIDS/HIV disease, lymphoma, metastatic cancer, solid tumor without metastasis, rheumatoid arthritis/collagen vascular diseases, coagulopathy, obesity, weight loss, fluid and electrolyte disorders, blood loss anemia, deficiency anemias, alcohol abuse, drug abuse, psychoses, and depression
  • Have a Primary Care Physician who has outpatient data included on EPIC electronic health record.

Exclusion Criteria:

  • Are admitted to critical care units;
  • Are admitted from skilled nursing facilities;
  • Have dementia;
  • Were previously enrolled in the study
  • Are organ transplant recipients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: (Usual) MedTrak system of PCP notification
MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital.
Experimental: Automated communication tools
An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP.
Other: Automated communication tools

Automated communication tools will include:

  • PCP notification of patient admission and location
  • Data on medications begun on admission
  • Automated alerts on changes in patient status and location while the patient is hospitalized
  • Links to the EMR and to hospital physician contact information on all email alerts
  • Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP
  • Automatic reporting to PCPs of test results pending at discharge
  • Electronic delivery of final discharge summaries

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Medication Errors at Hospital Discharge
Time Frame: Approximately 1-30 days
Medication name, dose, and frequency of administration for patient pre-admission medications will be recorded. Medications received during the hospitalization and discharge medications will be obtained by medical record review following hospital discharge. Pre-admission medications will be compared to discharge medications and differences will be considered discharge medication variances. Two trained pharmacists will independently review medication variances to determine clinical indications or medication errors.
Approximately 1-30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient PCP Visits, Emergency Room Visits and Rehospitalizations Within 30 Days Post-discharge.
Time Frame: Within 30 post-discharge from hospital
Details regarding patient PCP follow-up office appointments, ER visits and rehospitalizations occuring within 30 days post-discharge will be collected from the EMR.
Within 30 post-discharge from hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Agency for Healthcare Research and Quality (AHRQ)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kenneth J Smith, MD, MS, University of Pittsburgh Medical Center, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3130920

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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