Adverse Drug EventsMARQUISNCT01337063
Multi-Center Medication Reconciliation Quality Improvement Study
A study testing Mentored medication reconciliation quality improvement in people with Adverse Drug Events and Medication Administered in Error, run by Brigham and Women's Hospital at 6 sites in United States.
Trial summary
Patients often have problems after they leave the hospital, in part because errors are made in the medications they are prescribed. The goal of this project is to develop a more accurate and safe medication prescription process when patients enter and leave the hospital and implement this process at six U.S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Drug Events, Medication Administered in Error
- What is being tested?
- Mentored medication reconciliation quality improvement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,836 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2011to Sep 2014
- 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
- Age 18 and over
- Admitted to inpatient medical or surgical services
Who cannot join
- Vulnerable populations (pregnant women, prisoners, institutionalized individuals)
- Under 18 years
- Hospital staff subjects:
- Personnel directly involved in the medication reconciliation process, which depending on the site might include residents, physician assistants, inpatient attending physicians, nurses, pharmacists, and pharmacy technicians.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Presbyterian Hospital
Charlotte, North Carolina, 28204
University of Chicago Hospitals and Clinics
Chicago, Illinois, 60637
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097
University of California, San Francisco
San Francisco, California, 94143
Sioux Falls VA Medical Center
Sioux Falls, South Dakota, 57105
Baystate Health
Springfield, Massachusetts, 01199
About this study
Patients often have problems after they leave the hospital, in part because errors are made in the medications they are prescribed. The goal of this project is to develop a more accurate and safe medication prescription process when patients enter and leave the hospital and implement this process at six U.S. hospitals. The investigators will measure the success of the project and develop lessons learned so this process can be applied to other hospitals.
Read the detailed description
Unintentional medication discrepancies during transitions in care (such as hospitalization and subsequent discharge) are very common and represent a major threat to patient safety. One solution to this problem is medication reconciliation. In response to Joint Commission requirements, most hospitals have developed medication reconciliation processes, but some have been more successful than others, and there are reports of pro-forma compliance without substantial improvements in patient safety. There is now collective experience about effective approaches to medication reconciliation, but these have yet to be consolidated, evaluated rigorously, and disseminated effectively.
This project's findings should provide valuable lessons to all hospitals regarding the best ways to design and implement medication reconciliation interventions to improve medication safety during transitions in care.
SPECIFIC AIMS:
Aim 1: Develop a toolkit consolidating the best practice recommendations for medication reconciliation
Aim 2: Conduct a multi-center mentored quality improvement project in which each site adapts the tools for its own environment and implements them
Aim 3: Assess the effects of a mentored medication reconciliation quality improvement intervention on unintentional medication discrepancies with potential for patient harm
Aim 4: Conduct rigorous program evaluation to determine the most important components of a medication reconciliation program and how best to implement it
- Being tested
- Mentored medication reconciliation quality improvement
- Keywords
- Adverse drug events
- 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.
Mentored medication reconciliation quality improvementOther
Based on expert recommendations from a recent conference on medication reconciliation sponsored by the Society of Hospital Medicine and funded by AHRQ, investigators will engage a steering committee and conduct a second conference to operationalize these recommendations into a set of "best practice" guidelines, standards, and tools to be adapted by each of 6 participating sites. After training mentors and developing data collection tools, a mentored quality improvement project will be conducted for 21 months, in which each site works to improve medication reconciliation using the toolkit and with mentorship in the form of two site visits and monthly phone calls.
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention | No intervention | Usual care regarding medication reconciliation as currently practiced at each participating site. |
| Intervention | Experimental | Improved medication reconciliation process using continuous quality improvement methods, mentored implementation, and an implementation guide. Receives: Other: Mentored medication reconciliation quality improvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be unintentional medication discrepancies in admission orders and discharge orders with potential for patient harm
The primary outcome will be determined by a study pharmacist who will take a "gold standard" medication history on 5 patients per week, then compare that history to the medical team's medication history, to admission orders, and to discharge orders. Any unintentional medication discrepancies in orders will be recorded. A physician adjudicator will then make a final determination regarding whether an error occurred, the type of error, the potential for patient harm, and the potential severity.
Measured: 6 months prior to implementation of intervention to 21 months during intervention
Secondary outcomes (3)
Patient satisfaction
Patient Satisfaction will be assessed using data from the HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) survey. This survey is already administered to a sample of patients from all hospitals; we will measure both global satisfaction and questions related to medications (e.g., "before giving you any new medications, how often did hospital staff tell you what the medicine was for," and "before giving you any new medications, how often did hospital staff describe possible site effects in a way you could understand.")
Measured: 6 months prior to implementation of intervention to 21 months during intervention
Administrative outcomes
Emergency Department (ED) or hospital readmission to the same institution within 30 days of discharge, using computerized hospital records of all eligible patients.
Measured: 6 months prior to implementation of intervention to 21 months during intervention
Total medication discrepancies
As with Outcome 1, but without adjudication for potential for harm
Measured: 6 months prior to implementation of intervention to 21 months during intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Adverse Drug EventsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,836 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Hospital Medicine, Vanderbilt University, University of Wisconsin, Madison, University of California, San Francisco, Baystate Health, University of Chicago, Presbyterian Hospital, Charlotte, Sioux Falls VA Health Care System, Emory Johns Creek Hospital
- 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
- NCT01337063
- Sponsor's protocol ID
- 2010P001814
- Other IDs
- 1R18HS019598
- Acronym
- MARQUIS
- Status last verified
- Nov 2015
- First submitted
- 15 Apr 2011
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Coleman EA, Smith JD, Raha D, Min SJ. Posthospital medication discrepancies: prevalence and contributing factors. Arch Intern Med. 2005 Sep 12;165(16):1842-7. doi: 10.1001/archinte.165.16.1842.
PubMed 16157827Cornish PL, Knowles SR, Marchesano R, Tam V, Shadowitz S, Juurlink DN, Etchells EE. Unintended medication discrepancies at the time of hospital admission. Arch Intern Med. 2005 Feb 28;165(4):424-9. doi: 10.1001/archinte.165.4.424.
PubMed 15738372Schnipper JL, Kirwin JL, Cotugno MC, Wahlstrom SA, Brown BA, Tarvin E, Kachalia A, Horng M, Roy CL, McKean SC, Bates DW. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Intern Med. 2006 Mar 13;166(5):565-71. doi: 10.1001/archinte.166.5.565.
PubMed 16534045Institute for Healthcare Improvement. Medication Reconciliation Review. 2007; http://www.ihi.org/IHI/Topics/PatientSafety/MedicationSystems/Tools/Medication+Reconciliation+Review.htm. Accessed January 7, 2010.
Tam VC, Knowles SR, Cornish PL, Fine N, Marchesano R, Etchells EE. Frequency, type and clinical importance of medication history errors at admission to hospital: a systematic review. CMAJ. 2005 Aug 30;173(5):510-5. doi: 10.1503/cmaj.045311.
PubMed 16129874Pippins JR, Gandhi TK, Hamann C, Ndumele CD, Labonville SA, Diedrichsen EK, Carty MG, Karson AS, Bhan I, Coley CM, Liang CL, Turchin A, McCarthy PC, Schnipper JL. Classifying and predicting errors of inpatient medication reconciliation. J Gen Intern Med. 2008 Sep;23(9):1414-22. doi: 10.1007/s11606-008-0687-9. Epub 2008 Jun 19.
PubMed 18563493Vira T, Colquhoun M, Etchells E. Reconcilable differences: correcting medication errors at hospital admission and discharge. Qual Saf Health Care. 2006 Apr;15(2):122-6. doi: 10.1136/qshc.2005.015347.
PubMed 16585113Wortman SB. Medication reconciliation in a community, nonteaching hospital. Am J Health Syst Pharm. 2008 Nov 1;65(21):2047-54. doi: 10.2146/ajhp080091.
PubMed 18945865Schnipper 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 19398689Doyle E. Medication reconciliation done right. Today's Hospitalist. September 2009.
Coffey M, Cornish P, Koonthanam T, Etchells E, Matlow A. Implementation of admission medication reconciliation at two academic health sciences centres: challenges and success factors. Healthc Q. 2009;12 Spec No Patient:102-9. doi: 10.12927/hcq.2009.20719.
PubMed 19667786Brown C, Lilford R. Evaluating service delivery interventions to enhance patient safety. BMJ. 2008 Dec 17;337:a2764. doi: 10.1136/bmj.a2764. No abstract available.
PubMed 19091764Schnipper JL, Roumie CL, Cawthon C, Businger A, Dalal AK, Mugalla I, Eden S, Jacobson TA, Rask KJ, Vaccarino V, Gandhi TK, Bates DW, Johnson DC, Labonville S, Gregory D, Kripalani S; PILL-CVD Study Group. Rationale and design of the Pharmacist Intervention for Low Literacy in Cardiovascular Disease (PILL-CVD) study. Circ Cardiovasc Qual Outcomes. 2010 Mar;3(2):212-9. doi: 10.1161/CIRCOUTCOMES.109.921833.
PubMed 20233982Agency for Healthcare Research and Quality. CAHPS Hospital Survey (H-CAHPS) 2009; https://www.cahps.ahrq.gov/content/products/HOSP/PROD_HOSP_Intro.asp?p=1022&s=221. Accessed January 15, 2010.
Parry C, Mahoney E, Chalmers SA, Coleman EA. Assessing the quality of transitional care: further applications of the care transitions measure. Med Care. 2008 Mar;46(3):317-22. doi: 10.1097/MLR.0b013e3181589bdc.
PubMed 18388847
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Medication Reconciliation Quality Improvement Study
- ClinicalTrials.gov ID
- NCT01337063
- Acronym / sponsor ID
- MARQUIS / 2010P001814
- Keywords
- Adverse drug events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,836 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Society of Hospital Medicine, Vanderbilt University, University of Wisconsin, Madison, University of California, San Francisco, Baystate Health, University of Chicago, Presbyterian Hospital, Charlotte, Sioux Falls VA Health Care System, Emory Johns Creek Hospital
- Study start
- Mar 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 18 Apr 2011 (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.
Patients often have problems after they leave the hospital, in part because errors are made in the medications they are prescribed. The goal of this project is to develop a more accurate and safe medication prescription process when patients enter and leave the hospital and implement this process at six U.S. hospitals. The investigators will measure the success of the project and develop lessons learned so this process can be applied to other hospitals.
Detailed description
Unintentional medication discrepancies during transitions in care (such as hospitalization and subsequent discharge) are very common and represent a major threat to patient safety. One solution to this problem is medication reconciliation. In response to Joint Commission requirements, most hospitals have developed medication reconciliation processes, but some have been more successful than others, and there are reports of pro-forma compliance without substantial improvements in patient safety. There is now collective experience about effective approaches to medication reconciliation, but these have yet to be consolidated, evaluated rigorously, and disseminated effectively.
This project's findings should provide valuable lessons to all hospitals regarding the best ways to design and implement medication reconciliation interventions to improve medication safety during transitions in care.
SPECIFIC AIMS:
Aim 1: Develop a toolkit consolidating the best practice recommendations for medication reconciliation
Aim 2: Conduct a multi-center mentored quality improvement project in which each site adapts the tools for its own environment and implements them
Aim 3: Assess the effects of a mentored medication reconciliation quality improvement intervention on unintentional medication discrepancies with potential for patient harm
Aim 4: Conduct rigorous program evaluation to determine the most important components of a medication reconciliation program and how best to implement it
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention | No intervention | –Usual care regarding medication reconciliation as currently practiced at each participating site. |
| Intervention | Experimental | Other: Mentored medication reconciliation quality improvementImproved medication reconciliation process using continuous quality improvement methods, mentored implementation, and an implementation guide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 and over
- Admitted to inpatient medical or surgical services
Key exclusion criteria (4 listed)
- Vulnerable populations (pregnant women, prisoners, institutionalized individuals)
- Under 18 years
- Personnel directly involved in the medication reconciliation process, which depending on the site might include residents, physician assistants, inpatient attending physicians, nurses, pharmacists, and pharmacy technicians.
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 |
|---|---|---|
| Mentored medication reconciliation quality improvementBased on expert recommendations from a recent conference on medication reconciliation sponsored by the Society of Hospital Medicine and funded by AHRQ, investigators will engage a steering committee and conduct a second conference to operationalize these recommendations into a set of "best practice" guidelines, standards, and tools to be adapted by each of 6 participating sites. After training mentors and developing data collection tools, a mentored quality improvement project will be conducted for 21 months, in which each site works to improve medication reconciliation using the toolkit and with mentorship in the form of two site visits and monthly phone calls. | Other | Intervention |
Primary outcome
The primary outcome will be unintentional medication discrepancies in admission orders and discharge orders with potential for patient harm
Time frame: 6 months prior to implementation of intervention to 21 months during intervention
The primary outcome will be determined by a study pharmacist who will take a "gold standard" medication history on 5 patients per week, then compare that history to the medical team's medication history, to admission orders, and to discharge orders. Any unintentional medication discrepancies in orders will be recorded. A physician adjudicator will then make a final determination regarding whether an error occurred, the type of error, the potential for patient harm, and the potential severity.
3 secondary outcomes
Patient satisfaction
Time frame: 6 months prior to implementation of intervention to 21 months during intervention
Administrative outcomes
Time frame: 6 months prior to implementation of intervention to 21 months during intervention
Total medication discrepancies
Time frame: 6 months prior to implementation of intervention to 21 months during intervention
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 Nov 2015.
- Background: PubMed 16157827Coleman EA, Smith JD, Raha D, Min SJ. Posthospital medication discrepancies: prevalence and contributing factors. Arch Intern Med. 2005 Sep 12;165(16):1842-7. doi: 10.1001/archinte.165.16.1842.
- Background: PubMed 15738372Cornish PL, Knowles SR, Marchesano R, Tam V, Shadowitz S, Juurlink DN, Etchells EE. Unintended medication discrepancies at the time of hospital admission. Arch Intern Med. 2005 Feb 28;165(4):424-9. doi: 10.1001/archinte.165.4.424.
- Background: PubMed 16534045Schnipper JL, Kirwin JL, Cotugno MC, Wahlstrom SA, Brown BA, Tarvin E, Kachalia A, Horng M, Roy CL, McKean SC, Bates DW. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Intern Med. 2006 Mar 13;166(5):565-71. doi: 10.1001/archinte.166.5.565.
- BackgroundInstitute for Healthcare Improvement. Medication Reconciliation Review. 2007; http://www.ihi.org/IHI/Topics/PatientSafety/MedicationSystems/Tools/Medication+Reconciliation+Review.htm. Accessed January 7, 2010.
- Background: PubMed 16129874Tam VC, Knowles SR, Cornish PL, Fine N, Marchesano R, Etchells EE. Frequency, type and clinical importance of medication history errors at admission to hospital: a systematic review. CMAJ. 2005 Aug 30;173(5):510-5. doi: 10.1503/cmaj.045311.
- Background: PubMed 18563493Pippins JR, Gandhi TK, Hamann C, Ndumele CD, Labonville SA, Diedrichsen EK, Carty MG, Karson AS, Bhan I, Coley CM, Liang CL, Turchin A, McCarthy PC, Schnipper JL. Classifying and predicting errors of inpatient medication reconciliation. J Gen Intern Med. 2008 Sep;23(9):1414-22. doi: 10.1007/s11606-008-0687-9. Epub 2008 Jun 19.
- Background: PubMed 16585113Vira T, Colquhoun M, Etchells E. Reconcilable differences: correcting medication errors at hospital admission and discharge. Qual Saf Health Care. 2006 Apr;15(2):122-6. doi: 10.1136/qshc.2005.015347.
- Background: PubMed 18945865Wortman SB. Medication reconciliation in a community, nonteaching hospital. Am J Health Syst Pharm. 2008 Nov 1;65(21):2047-54. doi: 10.2146/ajhp080091.
- Background: 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.
- BackgroundDoyle E. Medication reconciliation done right. Today's Hospitalist. September 2009.
- Background: PubMed 19667786Coffey M, Cornish P, Koonthanam T, Etchells E, Matlow A. Implementation of admission medication reconciliation at two academic health sciences centres: challenges and success factors. Healthc Q. 2009;12 Spec No Patient:102-9. doi: 10.12927/hcq.2009.20719.
- Background: PubMed 19091764Brown C, Lilford R. Evaluating service delivery interventions to enhance patient safety. BMJ. 2008 Dec 17;337:a2764. doi: 10.1136/bmj.a2764. No abstract available.
Related trials for Adverse Drug Events
RecruitingObservational study
Two-Year Weight Loss With GLP-1 Medications Compared With Sleeve Gastrectomy in Adults With Obesity
Obesity & Overweight
Recruiting
Predicting Reactions and Effects of Drugs Immunotherapy and Complications Through Oncosafety (PREDICTO Clinical Study)
Solid Tumor Malignancies, Solid Cancers
Active, not recruitingPhase 1/2
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
Healthy Volunteer, Hypersensitivity Reactions
RecruitingObservational study
Reduction of Adverse Drug Events and Readmissions
Pharmacogenomic Testing for Medication Management
RecruitingPhase 1
A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions and Subcutaneous Injections of ABBV-519 in Adult Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)
Systemic Lupus Erythematosus, Rheumatoid Arthritis
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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentored medication reconciliation quality improvement in people with Adverse Drug Events and Medication Administered in Error, run by Brigham and Women's Hospital at 6 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 2 inclusion and 4 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 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
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?
The primary outcome will be unintentional medication discrepancies in admission orders and discharge orders with potential for patient harm (time frame: 6 months prior to implementation of intervention to 21 months during intervention). 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 NCT01337063, which also lists 32 linked publications.
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 Nov 2015.