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Regional Data Exchange to Improve Medication Safety

Implementing a Regional Data Exchange Tool to Improve Medication Use and Safety

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01239121
Enrollment
402
Registered
2010-11-11
Start date
2012-02-29
Completion date
2016-06-30
Last updated
2016-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Toxicity

Keywords

drug toxicity, drug interactions, electronic health records, medical errors

Brief summary

Medication reconciliation, a process by which a provider obtains and documents a thorough medication history with specific attention to comparing current and previous medication use, can prevent medication-related errors and harm. The aims of this study are: 1) To adapt medication reconciliation to include information from a computerized regional health information exchange (RHIO) in the Bronx, 2) To conduct a trial of the adapted medication reconciliation process and examine effects on medication errors, harm, and hospital costs, and 3) To identify factors that are barriers to adoption of the RHIO tool by James J. Peters (Bronx) VA providers. Findings from this project will provide an understanding of the effect of the RHIO tool on reducing harmful VA and non-VA medication use. It will also provide information on the feasibility of incorporating RHIO tool use into every day work flow for pharmacists and physicians.

Detailed description

Medication reconciliation, a process by which a provider obtains and documents a thorough medication history with specific attention to comparing current and previous medication use, can prevent medication-related errors and harm. The most important barrier to effective medication reconciliation is the unreliability of patients' own reports about their medication use and incomplete provider history-taking. The James J. Peters VA (JJP VA) participates in the Bronx RHIO, a New York State-funded health information exchange organization that in October 2008 implemented clinical data information exchange among the largest healthcare providers in the Bronx. JJP VA providers can now access clinical data, including medication use, from non-VA facilities with patients' consent. The aims of this study are: 1) To adapt a medication reconciliation process to include information from a regional health information exchange (RHIO), 2) To conduct a controlled trial of a medication reconciliation process at the time of hospital admission either enhanced or not enhanced with data from a regional health information exchange, and examine effects on transition drug risk, adverse drug events, and total inpatient costs, and 3) To identify system and provider factors that impede and facilitate adoption of the information exchange tool for routine use by VA providers. The investigators plan to conduct qualitative and quantitative studies. First the investigators will perform cognitive task analysis (CTA) to examine providers' decision-making and to map RHIO tool functions while providers interface with the tool, with interview questions to identify factors that facilitate or hinder use. Second, the investigators will enroll patients admitted to 2 inpatient units at the JJP VA, and assign them to receive usual medication reconciliation or RHIO-enhanced medication reconciliation with a notification to physicians about the patient's non-VA services that can be viewed in the RHIO. The investigators will measure transition drug risk and ADEs by medical record review and patient interview, and measure inpatient costs with administrative cost data from national VA datasets. Third, the investigators will conduct CTA with pharmacists and physicians at the end of the quantitative study who are expert in use of the tool to characterize differences in cognitive processes from prior to the quantitative study. This will supply information on system and provider factors that impede and facilitate adoption of the tool for routine use, and on potential improvements in the tool. Findings from this project will provide an understanding of the effect of real-time review of Veteran's non-VA medication use -- enabled by a Regional Health Information Organization (RHIO) tool -- on reducing duplicative VA and non-VA medication use and adverse drug events in Veterans. It will also provide information on the feasibility and effectiveness of incorporating RHIO tool access and use into every day work flow for VA pharmacist and physician providers.

Interventions

OTHERHIE-Enhanced Medication Reconciliation

Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist

OTHEROptimal Medication Reconciliation without HIE

Medication reconciliation implemented by a pharmacist without regional health information exchange

Sponsors

University of Victoria
CollaboratorOTHER
Weill Medical College of Cornell University
CollaboratorOTHER
Icahn School of Medicine at Mount Sinai
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Veterans admitted to James J. Peters VA hospital units 6B, 7B, 7C, or 8B or seen as outpatients in the Geriatrics Primary care clinic, who have an identity match in the Bronx RHIO, who consent to participate in the Bronx RHIO, and who stay on the unit at least 24 hours

Exclusion criteria

* Cannot be transferred from another James J. Peters VA hospital unit

Design outcomes

Primary

MeasureTime frameDescription
Transition Drug RiskDuring hospital stay and up to 1 month after hospital dischargeRating of potential for harm to patient from hospital medication discrepancies by record review. Minimum=0 Maximum=no maximum. Higher values represent increased detection of medication discrepancies. Although medication discrepancies are undesirable, increasing their detection might facilitate prevention of adverse drug events.

Secondary

MeasureTime frameDescription
Adverse Drug EventsDuring hospital stay and up to 1 month after hospital dischargeActual harm to patient from hospital medication discrepancies by record review
Medication-related SymptomsUp to 1 month after hospital dischargePatient's self-report of medication-related symptoms by telephone questionnaire

Countries

United States

Participant flow

Participants by arm

ArmCount
HIE-Enhanced Medication Reconciliation
Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months) HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist
186
Optimal Medication Reconciliation Without HIE
Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months) Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange
195
Pilot HIE-Enhanced Outpatient Medication Reconciliation
Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist
15
Total396

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyWithdrawal by Subject240

Baseline characteristics

CharacteristicHIE-Enhanced Medication ReconciliationTotalPilot HIE-Enhanced Outpatient Medication ReconciliationOptimal Medication Reconciliation Without HIE
Age, Continuous59.7 years
STANDARD_DEVIATION 14.4
60.5 years
STANDARD_DEVIATION 14.1
86.4 years
STANDARD_DEVIATION 6.8
60.8 years
STANDARD_DEVIATION 14.5
Ethnicity (NIH/OMB)
Hispanic or Latino
44 Participants100 Participants1 Participants55 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
138 Participants287 Participants11 Participants138 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants9 Participants3 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
121 Participants245 Participants4 Participants120 Participants
Race (NIH/OMB)
More than one race
1 Participants5 Participants1 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants4 Participants1 Participants2 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants12 Participants0 Participants6 Participants
Race (NIH/OMB)
White
57 Participants130 Participants9 Participants64 Participants
Region of Enrollment
United States
186 participants396 participants15 participants195 participants
Sex: Female, Male
Female
6 Participants13 Participants0 Participants7 Participants
Sex: Female, Male
Male
180 Participants383 Participants15 Participants188 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
24 / 12021 / 1080 / 0
serious
Total, serious adverse events
39 / 18636 / 1950 / 15

Outcome results

Primary

Transition Drug Risk

Rating of potential for harm to patient from hospital medication discrepancies by record review. Minimum=0 Maximum=no maximum. Higher values represent increased detection of medication discrepancies. Although medication discrepancies are undesirable, increasing their detection might facilitate prevention of adverse drug events.

Time frame: During hospital stay and up to 1 month after hospital discharge

Population: Outcome not ascertained in the third arm because those participants were not hospitalized.

ArmMeasureValue (MEAN)Dispersion
HIE-Enhanced Medication ReconciliationTransition Drug Risk6.4 units: risk-weighted discrepanciesStandard Deviation 5.9
Optimal Medication Reconciliation Without HIETransition Drug Risk5.8 units: risk-weighted discrepanciesStandard Deviation 5
p-value: 0.17595% CI: [-0.27, 1.5]Regression, Linear
Secondary

Adverse Drug Events

Actual harm to patient from hospital medication discrepancies by record review

Time frame: During hospital stay and up to 1 month after hospital discharge

Population: Outcome not ascertained in the third arm because those participants were not hospitalized.

ArmMeasureValue (NUMBER)
HIE-Enhanced Medication ReconciliationAdverse Drug Events19 participants
Optimal Medication Reconciliation Without HIEAdverse Drug Events18 participants
p-value: 0.96495% CI: [0.49, 2.1]Regression, Logistic
Secondary

Medication-related Symptoms

Patient's self-report of medication-related symptoms by telephone questionnaire

Time frame: Up to 1 month after hospital discharge

Population: For this outcome 66 and 87 participants unable to be reached by telephone in first and second arms, respectively.~Outcome not ascertained in the third arm because those participants were not hospitalized.

ArmMeasureValue (NUMBER)
HIE-Enhanced Medication ReconciliationMedication-related Symptoms24 participants
Optimal Medication Reconciliation Without HIEMedication-related Symptoms21 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026