Medication Administered in ErrorNCT00740675
Ambulatory Medication Reconciliation Following Hospital Discharge
A study testing Outpatient Medication Reconciliation in people with Medication Administered in Error and Adverse Drug Events, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
Adverse drug events (ADEs) after hospital discharge are common. The purpose of this research study is see if we can design an electronic tool given to your primary care provider (PCP) that will reduce adverse drug events, hospital readmissions, and emergency department visits after you are discharged from the hospital. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Administered in Error, Adverse Drug Events
- What is being tested?
- Outpatient Medication Reconciliation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 912 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to Feb 2011
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients admitted to BWH or MGH who plan to follow up with a PCP in one of 12 primary care practices affiliated with BWH or MGH.
- Patients will need to meet the following criteria:
- 1) be 55 years or older,
- 2) be admitted to the participating delivery system's hospital during the study period for a non-psychiatric condition,
- 3) have no plans to enter hospice,
- 4) be discharged back to the community,
Show all 20Show fewer
- 5) be prescribed 5 or more medications at discharge, including at least one of the following:
- antibiotics,
- insulin,
- antihypertensives,
- anti-rejection,
- antiarrhythmics,
- inhalers,
- antiepileptics,
- antianginals,
- pain medications,
- oral hypoglycemics,
- steroids,
- anticoagulants.
- These drugs were selected because they require close monitoring, increase risk for drug-drug interactions, have a narrow therapeutic window, or are known to increase risk for ADEs in the older adult population
Who cannot join
- Unable to provide informed consent and has no proxy who administers patient's medications and can provide informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham & Women's Hospital
Boston, Massachusetts, 02120
About this study
Official title: Ambulatory Medication Reconciliation Following Hospital Discharge: Project 4 From "Center for Education and Research on Therapeutics (CERT) on Health Information Technology"
Adverse drug events (ADEs) after hospital discharge are common. The purpose of this research study is see if we can design an electronic tool given to your primary care provider (PCP) that will reduce adverse drug events, hospital readmissions, and emergency department visits after you are discharged from the hospital.
Read the detailed description
The objective of this research is to reduce the incidence of post-discharge medication discrepancies, preventable and ameliorable ADEs, hospital readmissions, and ED visits through the use of HIT. The proposed tool will prompt primary care physicians to perform medication reconciliation at the first post-discharge outpatient visit, clearly display and organize preadmission and discharge medication regimens, and facilitate the creation of the new post-discharge medication list with just a few keystrokes. Using methodologies from prior studies at BWH, we will evaluate the intervention in a two-site RCT. The study will be conducted at Brigham and Women's Hospital and Massachusetts General Hospital, taking advantage of our rich experience with designing and testing new informatics applications, including one for inpatient medication reconciliation.
- Being tested
- Outpatient Medication Reconciliation
- Keywords
- adverse drug events, outpatient
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient Medication ReconciliationOther
The post-discharge medication reconciliation module has the following features:
- Presents the (preadmission) ambulatory medication list and the hospital discharge medication list side-by-side, sorted by class, with all identical medications lined up next to each other and all differences in the two regimens highlighted.
- Allows users to update the ambulatory medication list with a few keystrokes (i.e., to accept individual changes made during the hospitalization).
- Allows reconciliation to be performed in full (e.g., for PCPs who are responsible for the entire medication list) or in part (e.g., for specialists).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | At post-discharge follow-up visit with PCP, PCP views:
1. Discharge medication reconciliation screen.
2. Prompts to perform post-discharge reconciliation at the first post-discharge visit. Receives: Other: Outpatient Medication Reconciliation |
| Uusual care | No intervention | PCPs manage the patient's medications after hospital discharge as they normally would. |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of at least one serious medication error per patient
Measured: 30 days post-discharge
Secondary outcomes (2)
ED visits and non-scheduled hospital readmissions and ED visits
Measured: within 30 days of discharge
Accuracy of medication list in ambulatory electronic medical record
Measured: 30 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 posted25 Aug 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2009
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication Administered in ErrorStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 912 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- David W Bates, MD, MSc, Study director, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740675
- Sponsor's protocol ID
- 1U18 HS016790-01
- Status last verified
- Jan 2011
- First submitted
- 28 Dec 2007
- Last updated
- 6 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Medication Reconciliation Following Hospital Discharge: Project 4 From "Center for Education and Research on Therapeutics (CERT) on Health Information Technology"
- ClinicalTrials.gov ID
- NCT00740675
- Acronym / sponsor ID
- 1U18 HS016790-01
- Keywords
- adverse drug events, outpatient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 912 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Feb 2011 (estimated)
- First posted
- 25 Aug 2008 (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.
Adverse drug events (ADEs) after hospital discharge are common. The purpose of this research study is see if we can design an electronic tool given to your primary care provider (PCP) that will reduce adverse drug events, hospital readmissions, and emergency department visits after you are discharged from the hospital.
Detailed description
The objective of this research is to reduce the incidence of post-discharge medication discrepancies, preventable and ameliorable ADEs, hospital readmissions, and ED visits through the use of HIT. The proposed tool will prompt primary care physicians to perform medication reconciliation at the first post-discharge outpatient visit, clearly display and organize preadmission and discharge medication regimens, and facilitate the creation of the new post-discharge medication list with just a few keystrokes. Using methodologies from prior studies at BWH, we will evaluate the intervention in a two-site RCT. The study will be conducted at Brigham and Women's Hospital and Massachusetts General Hospital, taking advantage of our rich experience with designing and testing new informatics applications, including one for inpatient medication reconciliation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Outpatient Medication ReconciliationAt post-discharge follow-up visit with PCP, PCP views: 1. Discharge medication reconciliation screen. 2. Prompts to perform post-discharge reconciliation at the first post-discharge visit. |
| Uusual care | No intervention | –PCPs manage the patient's medications after hospital discharge as they normally would. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients admitted to BWH or MGH who plan to follow up with a PCP in one of 12 primary care practices affiliated with BWH or MGH.
- Patients will need to meet the following criteria:
Key exclusion criteria (1 listed)
- Unable to provide informed consent and has no proxy who administers patient's medications and can 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 |
|---|---|---|
| Outpatient Medication ReconciliationThe post-discharge medication reconciliation module has the following features: 1. Presents the (preadmission) ambulatory medication list and the hospital discharge medication list side-by-side, sorted by class, with all identical medications lined up next to each other and all differences in the two regimens highlighted. 2. Allows users to update the ambulatory medication list with a few keystrokes (i.e., to accept individual changes made during the hospitalization). 3. Allows reconciliation to be performed in full (e.g., for PCPs who are responsible for the entire medication list) or in part (e.g., for specialists). | Other | 1 |
Primary outcome
presence of at least one serious medication error per patient
Time frame: 30 days post-discharge
2 secondary outcomes
ED visits and non-scheduled hospital readmissions and ED visits
Time frame: within 30 days of discharge
Accuracy of medication list in ambulatory electronic medical record
Time frame: 30 days post discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2011.
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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.
David W Bates, MD, MSc study director
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient Medication Reconciliation in people with Medication Administered in Error and Adverse Drug Events, run by Brigham and Women's Hospital at 2 sites 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 20 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: status not confirmed, as of the sponsor's last update on 6 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
presence of at least one serious medication error per patient (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 6 Jan 2011.