Medication ReconciliationNCT00296426
Implementation and Evaluation of a Medical Reconciliation Protocol at Brigham and Women's Hospital
A study testing New technology - PAML in people with Medication Reconciliation, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
An incomplete understanding of patients' preadmission medications and failure to reconcile these with medications ordered in the hospital and at discharge are major, previously unappreciated, causes of adverse drug events (ADEs). 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?
- New technology - PAML
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Aug 2010
- 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
- Must be inpatients on the General Medical Service at Brigham and Women's Hospital
Who cannot join
- Any other patients at BWH hospital
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Implementation and Evaluation of a Medical Reconciliation Protocol
An incomplete understanding of patients' preadmission medications and failure to reconcile these with medications ordered in the hospital and at discharge are major, previously unappreciated, causes of adverse drug events (ADEs). The Joint Commission for Accreditation of Healthcare Organizations has now mandated a process for reconciling all medications at hospital admission and discharge. The best ways to implement medication reconciliation and the impact on patient outcomes are unknown. We, the researchers at at Brigham and Women's Hospital, will design and implement a medication reconciliation process with two major components: 1) information technology to integrate medication reconciliation into the current workflow at Brigham and Women's Hospital (BWH); and 2) process re-design involving physicians, nurses, and pharmacists to ensure that reconciliation takes place. We will then conduct a randomized controlled trial on the General Medical Service of BWH to evaluate the effects of this new process on reducing medication reconciliation errors with the potential to cause patient harm (potential ADEs).
Read the detailed description
The primary outcome will be medication reconciliation errors with a potential for causing harm (potential ADEs). Secondary outcomes will include the different types of reconciliation errors, hospital length of stay, emergency department visits and hospital readmissions within 30 days of discharge, resident/nurse satisfaction, and compliance with the reconciliation process. To measure medication reconciliation errors, we will use a method similar to that suggested by the Massachusetts Coalition for the Prevention of Medical Errors. A study pharmacist, separate from the floor pharmacist, will determine each patient's preadmission medication regimen at the time of hospital discharge, using patient and family interviews and any additional information needed to validate the list. This list will then be compared with the preadmission medication list compiled by the intern to identify any errors in identifying preadmission medications. The list will also be compared with the admission and discharge medication orders in order to identify unexplained discrepancies. Questions will be resolved by communication between the study pharmacist and the ordering intern. Reports of all potential medication reconciliation errors will be presented in blinded fashion to two physician reviewers, who will judge whether a reconciliation error has taken place and its potential for harm. All medication reconciliation errors will be recorded, as well as each of the individual types: inaccuracies in the preadmission medication list, unexplained discrepancies with the admission medication orders, and unexplained discrepancies in the discharge orders. This methodology is similar to that used in other studies of medication errors conducted at BWH. This process will allow pharmacists to ethically report any problems to the medical team prior to discharge, while still allowing for a full measurement of medical errors. Hospital length of stay, emergency department visits, and hospital readmissions will be measured using hospital administrative data. Resident and nurse satisfaction and perceived quality of patient care will be measured using web-based surveys. Compliance with the reconciliation process will be measured by electronic tracking of the use and timing of: 1) PAML building and signing by the ordering intern, 2) reconciliation of all PAML medications within 24 hours of admission, and 3) reconciliation of the PAML and discharge medication orders by the ordering clinician at the time of discharge.
- Conditions
- Medication Reconciliation
- Being tested
- New technology - PAML
- Keywords
- Adverse Drug Event, Inpatients, Outcome assessment
- 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.
New technology - PAMLProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | control patients admitted to hospital floors received usual care |
| Intervention | Experimental | computerized medication reconciliation tool and process redesign involving physicians, nurses, and pharmacists Receives: Procedure: New technology - PAML |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study startMay 2006
- Primary completionAug 2010
- Study completionAug 2010
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 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey L. Schnipper, MD.,MPH., Brigham and Women's Hospital
- Investigators
- Jeffrey L Schnipper, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296426
- Sponsor's protocol ID
- 2005-P-002458/1
- Status last verified
- Aug 2019
- First submitted
- 24 Feb 2006
- Last updated
- 13 Aug 2019
- Results posted
- No
Publications
Schnipper JL, Hamann C, Ndumele CD, Liang CL, Carty MG, Karson AS, Bhan I, Coley CM, Poon E, Turchin A, Labonville SA, Diedrichsen EK, Lipsitz S, Broverman CA, McCarthy P, Gandhi TK. Effect of an electronic medication reconciliation application and process redesign on potential adverse drug events: a cluster-randomized trial. Arch Intern Med. 2009 Apr 27;169(8):771-80. doi: 10.1001/archinternmed.2009.51.
PubMed 19398689
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of a Medical Reconciliation Protocol
- ClinicalTrials.gov ID
- NCT00296426
- Acronym / sponsor ID
- 2005-P-002458/1
- Conditions
- Medication Reconciliation
- Keywords
- Adverse Drug Event, Inpatients, Outcome assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 27 Feb 2006 (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.
An incomplete understanding of patients' preadmission medications and failure to reconcile these with medications ordered in the hospital and at discharge are major, previously unappreciated, causes of adverse drug events (ADEs). The Joint Commission for Accreditation of Healthcare Organizations has now mandated a process for reconciling all medications at hospital admission and discharge. The best ways to implement medication reconciliation and the impact on patient outcomes are unknown. We, the researchers at at Brigham and Women's Hospital, will design and implement a medication reconciliation process with two major components: 1) information technology to integrate medication reconciliation into the current workflow at Brigham and Women's Hospital (BWH); and 2) process re-design involving physicians, nurses, and pharmacists to ensure that reconciliation takes place. We will then conduct a randomized controlled trial on the General Medical Service of BWH to evaluate the effects of this new process on reducing medication reconciliation errors with the potential to cause patient harm (potential ADEs).
Detailed description
The primary outcome will be medication reconciliation errors with a potential for causing harm (potential ADEs). Secondary outcomes will include the different types of reconciliation errors, hospital length of stay, emergency department visits and hospital readmissions within 30 days of discharge, resident/nurse satisfaction, and compliance with the reconciliation process. To measure medication reconciliation errors, we will use a method similar to that suggested by the Massachusetts Coalition for the Prevention of Medical Errors. A study pharmacist, separate from the floor pharmacist, will determine each patient's preadmission medication regimen at the time of hospital discharge, using patient and family interviews and any additional information needed to validate the list. This list will then be compared with the preadmission medication list compiled by the intern to identify any errors in identifying preadmission medications. The list will also be compared with the admission and discharge medication orders in order to identify unexplained discrepancies. Questions will be resolved by communication between the study pharmacist and the ordering intern. Reports of all potential medication reconciliation errors will be presented in blinded fashion to two physician reviewers, who will judge whether a reconciliation error has taken place and its potential for harm. All medication reconciliation errors will be recorded, as well as each of the individual types: inaccuracies in the preadmission medication list, unexplained discrepancies with the admission medication orders, and unexplained discrepancies in the discharge orders. This methodology is similar to that used in other studies of medication errors conducted at BWH. This process will allow pharmacists to ethically report any problems to the medical team prior to discharge, while still allowing for a full measurement of medical errors. Hospital length of stay, emergency department visits, and hospital readmissions will be measured using hospital administrative data. Resident and nurse satisfaction and perceived quality of patient care will be measured using web-based surveys. Compliance with the reconciliation process will be measured by electronic tracking of the use and timing of: 1) PAML building and signing by the ordering intern, 2) reconciliation of all PAML medications within 24 hours of admission, and 3) reconciliation of the PAML and discharge medication orders by the ordering clinician at the time of discharge.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –control patients admitted to hospital floors received usual care |
| Intervention | Experimental | Procedure: New technology - PAMLcomputerized medication reconciliation tool and process redesign involving physicians, nurses, and pharmacists |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be inpatients on the General Medical Service at Brigham and Women's Hospital
Key exclusion criteria (1 listed)
- Any other patients at BWH hospital
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 |
|---|---|---|
| New technology - PAML | Procedure or surgery | Intervention |
Primary outcome
Not reported in the source record.
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 13 Aug 2019.
- Derived from this study: PubMed 19398689Schnipper JL, Hamann C, Ndumele CD, Liang CL, Carty MG, Karson AS, Bhan I, Coley CM, Poon E, Turchin A, Labonville SA, Diedrichsen EK, Lipsitz S, Broverman CA, McCarthy P, Gandhi TK. Effect of an electronic medication reconciliation application and process redesign on potential adverse drug events: a cluster-randomized trial. Arch Intern Med. 2009 Apr 27;169(8):771-80. doi: 10.1001/archinternmed.2009.51.
Related trials for Medication Reconciliation
Not yet recruiting
Optimization of Medical Time in the Emergency Department: Impact of an AI-Based System on Prescription Entry
Drug-related Iatrogenesis, Emergency Department
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.
Jeffrey L Schnipper, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New technology - PAML in people with Medication Reconciliation, run by Brigham and Women's Hospital 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 1 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: finished, as of the sponsor's last update on 13 Aug 2019. 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00296426, 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 13 Aug 2019; AzTrials last refreshed its copy on 6 Nov 2026.