Medication ReconciliationPhase 3MedMatchNCT01195051
Medication Reconciliation Technology to Improve Quality of Transitional Care
A Phase 3 study testing Electronic medication reconciliation in people with Medication Reconciliation, run by Indiana University at 1 site in United States.
Trial summary
This study addresses the problem of inadequate medication reconciliation as patients cross boundaries between inpatient and outpatient care (ambulatory care). The purpose of this study is to determine whether a new, computer-based application, integrated with electronic prescribing, improves erroneous discrepancies… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Reconciliation
- What is being tested?
- Electronic medication reconciliation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,818 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Apr 2012
- Phase
- Phase 3
- 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
- Patients admitted to the Medicine Service during a 12-month period
- Physicians who provide inpatient or ambulatory care for participating patients.
- Pharmacists who provide care for participating patients.
Who cannot join
- Patients admitted but not seen in a primary-care clinic within the preceding 12 months
- If an enrolled subject is determined to be a prisoner or pregnant woman, then the study will discontinue the subject for research purposes or will submit an amendment at that time.
Trial locations and contacts
1 site in 1 country.
About this study
This study addresses the problem of inadequate medication reconciliation as patients cross boundaries between inpatient and outpatient care (ambulatory care). The purpose of this study is to determine whether a new, computer-based application, integrated with electronic prescribing, improves erroneous discrepancies between pre-hospital medications and medications upon patients' return to ambulatory care.
Read the detailed description
This project will test a systems-based intervention of the electronic medical records system. The specific aims of this study are to integrate a new electronic medication reconciliation (MR) system with an electronic prescribing system, conduct a randomized controlled trial of MR, and determine whether electronic facilitation of MR alters MR and the incidence of medication errors in ambulatory care. On a patient's hospital admission, a new Web-based MR module will receive an automatically compiled outpatient medication list. Following discussion with the patient, medical personnel will update the list, which will then be delivered to the computer-based provider order entry system and become actionable for prescribing. Main outcomes include adverse drug events and erroneous discrepancies between the pre-admission medication list and the medication list upon the patient's return to ambulatory care. We hypothesize that electronic facilitation of inpatient MR will improve completion of MR and will decrease the incidence of drug-related medical errors.
- Conditions
- Medication Reconciliation
- Being tested
- Electronic medication reconciliation
- Keywords
- Medication Reconciliation, Inpatient, Electronic Medical Records
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic medication reconciliationOther
Also called MedMatch
A new, computer-based application will be used to document and prescribe outpatient medications in the inpatient setting.
| Study group | Role | What they receive |
|---|---|---|
| Electronic medication reconciliation | Experimental | Providers have access to a new, computer-based application to facilitate documentation and prescribing of outpatient medications in the inpatient setting. Receives: Other: Electronic medication reconciliation |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reconciliation of outpatient medications
Number and fraction of outpatient medications prescribed or addressed as to why prescribing did not occur. Number and fraction of cases with MR by a pharmacist. Number and fraction of cases undergoing any MR. Number and fraction of cases where any outpatient medications were not prescribed or addressed as to why prescribing did not occur.
Measured: Hospital admission, transfer, and discharge; 1 year
Secondary outcomes (8)
Measurement of potential for harm and potential severity of harm
For each medication discrepancy, the study team will reach consensus about potential for harm and potential severity of harm. The study team will adopt the following framework: little or no confidence (e.g., omission of multivitamin); slight to modest confidence (e.g., docusate 200 mg every morning, instead of 100 mg twice daily); less than 50% chance but close call (e.g., omission of as-needed enema at discharge); more than 50% chance but close call (e.g., omission of fluticasone twice daily at discharge); or strong confidence (e.g., omission of as-needed haloperidol).
Measured: Hospital discharge; 1 year
Measurement and analysis of providers' perspectives
We will conduct a before-and-after survey of providers. Providers will be surveyed about satisfaction with care, managing medications, and usefulness of local information systems in managing medications.
Measured: Start and end of trial; 1 year
Measurement and analysis of patients' perspectives
The inpatient geriatrics consultation service has begun calling patients who received geriatrics consultation and were subsequently discharged to home. The calls are made by telephone within 72 hours of discharge. Patients are asked eight to ten questions, addressing satisfaction with care, receipt of information about medications, and adherence to medications.
Measured: Hospital discharge; 1 year
Reportable financial and organizational dimensions
We will track and report hours required for several parts of the development and implementation, as follows: hours required for new technical development; and hours providers spend in learning about system and how to use it.
Measured: Start of trial; time 0 and 1 year
Utilization of intervention
Fraction of intervention admissions for which Web-based medication list was reviewed or modified. Mean duration of use of Web-based application. Fraction of intervention admissions, transfers, and discharges for which new medication list was used to order medications. Fraction of medications on medication list that were ordered on admission, transfer, and discharge. Timing of when medication reconciliation occurred.
Measured: Hospital admission, transfer, and discharge; 1 year
Measurement and analysis of drug-related medical errors
At discharge, we will assess for unintentional medication discrepancies at discharge. At ambulatory followup, we will assess whether the medications should have been prescribed at discharge. When a patient is discharged from the hospital and resumes ambulatory care, the patient is expected to adhere to the discharge prescriptions. Each discharge will be reviewed by members of the study team, to determine, for each medication listed on the pre-admission medication list but not prescribed at discharge, whether the discrepancy was intentional or unintentional.
Measured: Hospital discharge; 1 year
Measurement of adverse drug events and near misses
We will count deaths and will identify and assess adverse drug events (ADEs). The following kinds of triggers will be used to identify encounters that might reflect ADEs: diagnostic codes for diagnoses associated with ADEs, potential ADEs, or medication errors; use of specific drugs suggesting that an ADE may have occurred; potentially dangerous drug combinations; combinations of drugs and symptoms (e.g., angiotensin converting enzyme inhibitor and cough); combinations of diagnoses and drugs; and combinations of drugs and miscellaneous.
Measured: Hospital discharge; 1 year
Medication discrepancies between pre-admission and ambulatory followup
Mean number of erroneous discrepancies between pre-admission and ambulatory followup
Measured: Ambulatory followup; 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication ReconciliationStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,818 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Regenstrief Institute, Inc., Wishard Health Services
- Responsible party
- Sponsor
- Investigators
- Michael Weiner, MD, MPH, Principal investigator, Indiana University School of Medicine, Department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195051
- Sponsor's protocol ID
- 0910-19
- Other IDs
- R18HS018183
- Acronym
- MedMatch
- Status last verified
- Mar 2014
- First submitted
- 12 Jul 2010
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cadwallader J, Spry K, Morea J, Russ AL, Duke J, Weiner M. Design of a medication reconciliation application: facilitating clinician-focused decision making with data from multiple sources. Appl Clin Inform. 2013 Mar 13;4(1):110-25. doi: 10.4338/ACI-2012-12-RA-0057. Print 2013.
PubMed 23650492
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Reconciliation Technology to Improve Quality of Transitional Care
- ClinicalTrials.gov ID
- NCT01195051
- Acronym / sponsor ID
- MedMatch / 0910-19
- Conditions
- Medication Reconciliation
- Keywords
- Medication Reconciliation, Inpatient, Electronic Medical Records
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,818 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Regenstrief Institute, Inc., Wishard Health Services
- Study start
- Nov 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 3 Sep 2010 (estimated)
- 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.
This study addresses the problem of inadequate medication reconciliation as patients cross boundaries between inpatient and outpatient care (ambulatory care). The purpose of this study is to determine whether a new, computer-based application, integrated with electronic prescribing, improves erroneous discrepancies between pre-hospital medications and medications upon patients' return to ambulatory care.
Detailed description
This project will test a systems-based intervention of the electronic medical records system. The specific aims of this study are to integrate a new electronic medication reconciliation (MR) system with an electronic prescribing system, conduct a randomized controlled trial of MR, and determine whether electronic facilitation of MR alters MR and the incidence of medication errors in ambulatory care. On a patient's hospital admission, a new Web-based MR module will receive an automatically compiled outpatient medication list. Following discussion with the patient, medical personnel will update the list, which will then be delivered to the computer-based provider order entry system and become actionable for prescribing. Main outcomes include adverse drug events and erroneous discrepancies between the pre-admission medication list and the medication list upon the patient's return to ambulatory care. We hypothesize that electronic facilitation of inpatient MR will improve completion of MR and will decrease the incidence of drug-related medical errors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic medication reconciliation | Experimental | Other: Electronic medication reconciliationProviders have access to a new, computer-based application to facilitate documentation and prescribing of outpatient medications in the inpatient setting. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted to the Medicine Service during a 12-month period
- Physicians who provide inpatient or ambulatory care for participating patients.
- Pharmacists who provide care for participating patients.
Key exclusion criteria (2 listed)
- Patients admitted but not seen in a primary-care clinic within the preceding 12 months
- If an enrolled subject is determined to be a prisoner or pregnant woman, then the study will discontinue the subject for research purposes or will submit an amendment at that time.
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 |
|---|---|---|
| Electronic medication reconciliationAlso: MedMatchA new, computer-based application will be used to document and prescribe outpatient medications in the inpatient setting. | Other | Electronic medication reconciliation |
Primary outcome
Reconciliation of outpatient medications
Time frame: Hospital admission, transfer, and discharge; 1 year
Number and fraction of outpatient medications prescribed or addressed as to why prescribing did not occur. Number and fraction of cases with MR by a pharmacist. Number and fraction of cases undergoing any MR. Number and fraction of cases where any outpatient medications were not prescribed or addressed as to why prescribing did not occur.
8 secondary outcomes
Measurement of potential for harm and potential severity of harm
Time frame: Hospital discharge; 1 year
Measurement and analysis of providers' perspectives
Time frame: Start and end of trial; 1 year
Measurement and analysis of patients' perspectives
Time frame: Hospital discharge; 1 year
Reportable financial and organizational dimensions
Time frame: Start of trial; time 0 and 1 year
Utilization of intervention
Time frame: Hospital admission, transfer, and discharge; 1 year
Measurement and analysis of drug-related medical errors
Time frame: Hospital discharge; 1 year
Measurement of adverse drug events and near misses
Time frame: Hospital discharge; 1 year
Medication discrepancies between pre-admission and ambulatory followup
Time frame: Ambulatory followup; 18 months
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 Mar 2014.
- Background: PubMed 23650492Cadwallader J, Spry K, Morea J, Russ AL, Duke J, Weiner M. Design of a medication reconciliation application: facilitating clinician-focused decision making with data from multiple sources. Appl Clin Inform. 2013 Mar 13;4(1):110-25. doi: 10.4338/ACI-2012-12-RA-0057. Print 2013.
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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.
Michael Weiner, MD, MPH principal investigator
Indiana University School of Medicine, Department of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Electronic medication reconciliation in people with Medication Reconciliation, run by Indiana University 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 3 inclusion and 2 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 Mar 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reconciliation of outpatient medications (time frame: Hospital admission, transfer, and discharge; 1 year). 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 NCT01195051, which also lists 1 linked publication.
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 Mar 2014.