Trial Outcomes & Findings for Regional Data Exchange to Improve Medication Safety (NCT NCT01239121)

Last Updated: 2016-08-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

402 participants

Primary outcome timeframe

During hospital stay and up to 1 month after hospital discharge

Results posted on

2016-08-15

Participant Flow

Participant milestones

Participant milestones
Measure	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	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	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
Overall Study STARTED	188	199	15
Overall Study COMPLETED	186	195	15
Overall Study NOT COMPLETED	2	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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	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
Overall Study Withdrawal by Subject	2	4	0

Baseline Characteristics

Regional Data Exchange to Improve Medication Safety

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HIE-Enhanced Medication Reconciliation n=186 Participants 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	Optimal Medication Reconciliation Without HIE n=195 Participants 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	Pilot HIE-Enhanced Outpatient Medication Reconciliation n=15 Participants 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	Total n=396 Participants Total of all reporting groups
Age, Continuous	59.7 years STANDARD_DEVIATION 14.4 • n=5 Participants	60.8 years STANDARD_DEVIATION 14.5 • n=7 Participants	86.4 years STANDARD_DEVIATION 6.8 • n=5 Participants	60.5 years STANDARD_DEVIATION 14.1 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	0 Participants n=5 Participants	13 Participants n=4 Participants
Sex: Female, Male Male	180 Participants n=5 Participants	188 Participants n=7 Participants	15 Participants n=5 Participants	383 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	44 Participants n=5 Participants	55 Participants n=7 Participants	1 Participants n=5 Participants	100 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	138 Participants n=5 Participants	138 Participants n=7 Participants	11 Participants n=5 Participants	287 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Black or African American	121 Participants n=5 Participants	120 Participants n=7 Participants	4 Participants n=5 Participants	245 Participants n=4 Participants
Race (NIH/OMB) White	57 Participants n=5 Participants	64 Participants n=7 Participants	9 Participants n=5 Participants	130 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	12 Participants n=4 Participants
Region of Enrollment United States	186 participants n=5 Participants	195 participants n=7 Participants	15 participants n=5 Participants	396 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HIE-Enhanced Medication Reconciliation n=186 Participants 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	Optimal Medication Reconciliation Without HIE n=195 Participants 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	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
Transition Drug Risk	6.4 units: risk-weighted discrepancies Standard Deviation 5.9	5.8 units: risk-weighted discrepancies Standard Deviation 5.0	—

SECONDARY outcome

Timeframe: 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.

Actual harm to patient from hospital medication discrepancies by record review

Outcome measures

Outcome measures
Measure	HIE-Enhanced Medication Reconciliation n=186 Participants 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	Optimal Medication Reconciliation Without HIE n=195 Participants 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	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
Adverse Drug Events	19 participants	18 participants	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	HIE-Enhanced Medication Reconciliation n=120 Participants 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	Optimal Medication Reconciliation Without HIE n=108 Participants 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	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
Medication-related Symptoms	24 participants	21 participants	—

Adverse Events

HIE-Enhanced Medication Reconciliation

Serious events: 39 serious events

Other events: 24 other events

Deaths: 0 deaths

Optimal Medication Reconciliation Without HIE

Serious events: 36 serious events

Other events: 21 other events

Deaths: 0 deaths

Pilot HIE-Enhanced Outpatient Medication Reconciliation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	HIE-Enhanced Medication Reconciliation n=120 participants at risk；n=186 participants at risk 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	Optimal Medication Reconciliation Without HIE n=108 participants at risk；n=195 participants at risk 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	Pilot HIE-Enhanced Outpatient Medication Reconciliation n=15 participants at risk 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
Investigations Hospital Readmission	21.0% 39/186 • Participants were followed for adverse events during the hospital stay (up to a maximum of 30 days) and up to 30 days after hospital discharge.	18.5% 36/195 • Participants were followed for adverse events during the hospital stay (up to a maximum of 30 days) and up to 30 days after hospital discharge.	0.00% 0/15 • Participants were followed for adverse events during the hospital stay (up to a maximum of 30 days) and up to 30 days after hospital discharge.

Other adverse events

Other adverse events
Measure	HIE-Enhanced Medication Reconciliation n=120 participants at risk；n=186 participants at risk 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	Optimal Medication Reconciliation Without HIE n=108 participants at risk；n=195 participants at risk 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	Pilot HIE-Enhanced Outpatient Medication Reconciliation n=15 participants at risk 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
Investigations Medication-related symptoms	20.0% 24/120 • Participants were followed for adverse events during the hospital stay (up to a maximum of 30 days) and up to 30 days after hospital discharge.	19.4% 21/108 • Participants were followed for adverse events during the hospital stay (up to a maximum of 30 days) and up to 30 days after hospital discharge.	— 0/0 • Participants were followed for adverse events during the hospital stay (up to a maximum of 30 days) and up to 30 days after hospital discharge.

Additional Information

Kenneth Boockvar

James J. Peters VA Medical Center

Phone: 718-584-9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place