HospitalizationNCT00370916
Reducing Transition Drug Risk
A study testing Physician-initiated medication reconciliation and Pharmacist-initiated medication reconciliation in people with Hospitalization, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Patient transfer between sites of care is regular practice during an episode of care in our current health care system. Yet inter-site transfer is associated with lapses in care quality that adversely affect patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospitalization
- What is being tested?
- Physician-initiated medication reconciliation and Pharmacist-initiated medication reconciliation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 612 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Sep 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
- All patients who were admitted to the JJ Peters (Bronx) VA Hospital general medical wards (units 7A and 7B) between 10/05-2/06 and stayed least 24 hours
Who cannot join
- Patients who were transferred to one of the study units wards (units 7A and 7B) from another JJ Peters (Bronx) VA Hospital acute care unit (e.g., an intensive care unit), or who stayed in the hospital less than 24 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468
About this study
Official title: Reducing Transition Drug Risks After Patient Transfer
Patient transfer between sites of care is regular practice during an episode of care in our current health care system. Yet inter-site transfer is associated with lapses in care quality that adversely affect patient outcomes. A common iatrogenic harm precipitated at the time of transfer is harm from drug prescribing, or adverse drug events (ADEs). In this study we will evaluate a medication reconciliation tool developed to help providers make effective prescribing decisions at the time of transfer between VA sites of care (Improved Prescribing after Transfer (IPT)). We will evaluate the quantitative effectiveness of the tool in reducing transition drug risk and ADEs. We additionally will conduct focus group discussions and cognitive task analysis among end-users to better understand how providers make drug-prescribing decisions at the time of transfer and to assess factors influencing effective use of the tool.
Read the detailed description
This is a 2-phase study in which we will employ mixed quantitative and qualitative methods to conduct an evaluation of the IPT tool while improving our understanding of provider prescribing decisions at the time of patient transfer. In Phase 1 we will conduct a 5-month controlled trial among all admissions to 2 units at J.J. Peters (Bronx) VA Medical Center. We will compare IPT with usual care, and compare physician and pharmacist forms of IPT implementation with regard to, as primary outcome, transition drug risk, and, as secondary outcomes, ADEs, provider prescribing-decisions, and hospital utilization. In Phase 2, which will run concurrently with Phase 1, we will perform cognitive task analysis to examine providers' decision-making and to map IPT tool functions while providers interface with the tool, and perform focus group interviews with representative IPT users to identify factors that facilitate or hinder adoption. Results of cognitive analysis and focus groups will be used to identify tool deficiencies to consider for redesign.
- Conditions
- Hospitalization
- Being tested
- Physician-initiated medication reconciliation, Pharmacist-initiated medication reconciliation
- Keywords
- Clinical Decision Support Systems, Continuity of Patient Care, Medication Errors, Drug Adverse Effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician-initiated medication reconciliationBehavioural
Physician house staff performed and documented medication reconciliation after hospital admission with the assistance of a CPRS template
Pharmacist-initiated medication reconciliationBehavioural
Pharmacist performed and documented medication reconciliation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Physician-initiated medication reconciliation Receives: Behavioral: Physician-initiated medication reconciliation |
| Arm 2 | Experimental | Pharmacist-initiated medication reconciliation Receives: Behavioral: Pharmacist-initiated medication reconciliation |
| Arm 3 | No intervention | No formal medication reconciliation |
What is being measured
The primary outcome is the main question the study is designed to answer.
High risk drug discrepancies
Measured: After hospital admission and discharge
Secondary outcomes (1)
Drug discrepancy adverse events
Measured: During the hospital stay and 1 month after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study startOct 2005
- Primary completionMar 2006
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HospitalizationStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 612 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- University of Victoria, Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Kenneth S Boockvar, MD MS, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370916
- Sponsor's protocol ID
- IAB 05-204
- Status last verified
- Dec 2010
- First submitted
- 30 Aug 2006
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Boockvar KS, Santos SL, Kushniruk A, Johnson C, Nebeker JR. Medication reconciliation: barriers and facilitators from the perspectives of resident physicians and pharmacists. J Hosp Med. 2011 Jul-Aug;6(6):329-37. doi: 10.1002/jhm.891.
PubMed 21834114Kushniruk AW, Santos SL, Pourakis G, Nebeker JR, Boockvar KS. Cognitive analysis of a medication reconciliation tool: applying laboratory and naturalistic approaches to system evaluation. Stud Health Technol Inform. 2011;164:203-7.
PubMed 21335711Boockvar KS, Blum S, Kugler A, Livote E, Mergenhagen KA, Nebeker JR, Signor D, Sung S, Yeh J. Effect of admission medication reconciliation on adverse drug events from admission medication changes. Arch Intern Med. 2011 May 9;171(9):860-1. doi: 10.1001/archinternmed.2011.163. No abstract available.
PubMed 21555668Mergenhagen KA, Blum SS, Kugler A, Livote EE, Nebeker JR, Ott MC, Signor D, Sung S, Yeh J, Boockvar KS. Pharmacist- versus physician-initiated admission medication reconciliation: impact on adverse drug events. Am J Geriatr Pharmacother. 2012 Aug;10(4):242-50. doi: 10.1016/j.amjopharm.2012.06.001. Epub 2012 Jul 20.
PubMed 22819386
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Transition Drug Risks After Patient Transfer
- ClinicalTrials.gov ID
- NCT00370916
- Acronym / sponsor ID
- IAB 05-204
- Conditions
- Hospitalization
- Keywords
- Clinical Decision Support Systems, Continuity of Patient Care, Medication Errors, Drug Adverse Effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 612 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- University of Victoria, Icahn School of Medicine at Mount Sinai
- Study start
- Oct 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 1 Sep 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.
Patient transfer between sites of care is regular practice during an episode of care in our current health care system. Yet inter-site transfer is associated with lapses in care quality that adversely affect patient outcomes. A common iatrogenic harm precipitated at the time of transfer is harm from drug prescribing, or adverse drug events (ADEs). In this study we will evaluate a medication reconciliation tool developed to help providers make effective prescribing decisions at the time of transfer between VA sites of care (Improved Prescribing after Transfer (IPT)). We will evaluate the quantitative effectiveness of the tool in reducing transition drug risk and ADEs. We additionally will conduct focus group discussions and cognitive task analysis among end-users to better understand how providers make drug-prescribing decisions at the time of transfer and to assess factors influencing effective use of the tool.
Detailed description
This is a 2-phase study in which we will employ mixed quantitative and qualitative methods to conduct an evaluation of the IPT tool while improving our understanding of provider prescribing decisions at the time of patient transfer. In Phase 1 we will conduct a 5-month controlled trial among all admissions to 2 units at J.J. Peters (Bronx) VA Medical Center. We will compare IPT with usual care, and compare physician and pharmacist forms of IPT implementation with regard to, as primary outcome, transition drug risk, and, as secondary outcomes, ADEs, provider prescribing-decisions, and hospital utilization. In Phase 2, which will run concurrently with Phase 1, we will perform cognitive task analysis to examine providers' decision-making and to map IPT tool functions while providers interface with the tool, and perform focus group interviews with representative IPT users to identify factors that facilitate or hinder adoption. Results of cognitive analysis and focus groups will be used to identify tool deficiencies to consider for redesign.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Physician-initiated medication reconciliationPhysician-initiated medication reconciliation |
| Arm 2 | Experimental | Behavioral: Pharmacist-initiated medication reconciliationPharmacist-initiated medication reconciliation |
| Arm 3 | No intervention | –No formal medication reconciliation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who were admitted to the JJ Peters (Bronx) VA Hospital general medical wards (units 7A and 7B) between 10/05-2/06 and stayed least 24 hours
Key exclusion criteria (1 listed)
- Patients who were transferred to one of the study units wards (units 7A and 7B) from another JJ Peters (Bronx) VA Hospital acute care unit (e.g., an intensive care unit), or who stayed in the hospital less than 24 hours
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 |
|---|---|---|
| Physician-initiated medication reconciliationPhysician house staff performed and documented medication reconciliation after hospital admission with the assistance of a CPRS template | Behavioural | Arm 1 |
| Pharmacist-initiated medication reconciliationPharmacist performed and documented medication reconciliation | Behavioural | Arm 2 |
Primary outcome
High risk drug discrepancies
Time frame: After hospital admission and discharge
1 secondary outcome
Drug discrepancy adverse events
Time frame: During the hospital stay and 1 month after hospital discharge
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 7 Apr 2015.
- Results publication: PubMed 21834114Boockvar KS, Santos SL, Kushniruk A, Johnson C, Nebeker JR. Medication reconciliation: barriers and facilitators from the perspectives of resident physicians and pharmacists. J Hosp Med. 2011 Jul-Aug;6(6):329-37. doi: 10.1002/jhm.891.
- Results publication: PubMed 21335711Kushniruk AW, Santos SL, Pourakis G, Nebeker JR, Boockvar KS. Cognitive analysis of a medication reconciliation tool: applying laboratory and naturalistic approaches to system evaluation. Stud Health Technol Inform. 2011;164:203-7.
- Results publication: PubMed 21555668Boockvar KS, Blum S, Kugler A, Livote E, Mergenhagen KA, Nebeker JR, Signor D, Sung S, Yeh J. Effect of admission medication reconciliation on adverse drug events from admission medication changes. Arch Intern Med. 2011 May 9;171(9):860-1. doi: 10.1001/archinternmed.2011.163. No abstract available.
- Derived from this study: PubMed 22819386Mergenhagen KA, Blum SS, Kugler A, Livote EE, Nebeker JR, Ott MC, Signor D, Sung S, Yeh J, Boockvar KS. Pharmacist- versus physician-initiated admission medication reconciliation: impact on adverse drug events. Am J Geriatr Pharmacother. 2012 Aug;10(4):242-50. doi: 10.1016/j.amjopharm.2012.06.001. Epub 2012 Jul 20.
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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.
Kenneth S Boockvar, MD MS principal investigator
James J. Peters Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician-initiated medication reconciliation and Pharmacist-initiated medication reconciliation in people with Hospitalization, run by US Department of Veterans Affairs 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 7 Apr 2015. 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.
What does the primary outcome measure?
High risk drug discrepancies (time frame: After hospital admission and discharge). 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 NCT00370916, which also lists 4 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 7 Apr 2015.