Reducing Transition Drug Risk

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
Reducing Transition Drug Risks After Patient Transfer

Conditions
-----------------
Hospitalization

Intervention / Treatment
-----------------
* Behavioral: Physician-initiated medication reconciliation
* Behavioral: Pharmacist-initiated medication reconciliation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Physician-initiated medication reconciliation | Behavioral: Physician-initiated medication reconciliation<br>* Physician house staff performed and documented medication reconciliation after hospital admission with the assistance of a CPRS template<br>|
| Experimental: Arm 2<br>Pharmacist-initiated medication reconciliation | Behavioral: Pharmacist-initiated medication reconciliation<br>* Pharmacist performed and documented medication reconciliation<br>|
| No Intervention: Arm 3<br>No formal medication reconciliation | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High risk drug discrepancies |  | After hospital admission and discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug discrepancy adverse events |  | During the hospital stay and 1 month after hospital discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clinical Decision Support Systems, Continuity of Patient Care, Medication Errors, Drug Adverse Effects