Effect of Synapse Medicine Decision Support on Inpatient Pharmacist Efficacy and Efficiency

February 7, 2023 updated by: Jeffrey L. Schnipper, MD.,MPH., Brigham and Women's Hospital

Effect of Synapse Medicine Decision Support on Inpatient Pharmacist Efficacy and Efficiency: a Hybrid Type 2 Implementation Study

Adverse drug events (ADE) are common and dangerous in the hospital and following discharge to the ambulatory setting. One cause of ADEs in both settings is medication regimen inappropriateness, including polypharmacy, drug-drug interactions, and medications that are inappropriate or inappropriately dosed given patients' age, renal, and hepatic function. Hospitalization provides a good opportunity to investigate medication appropriateness given new or worsening conditions and available expertise. Inpatient pharmacists are medication experts and often round with medical teams, but they may not always have all the information available at their fingertips to make optimal recommendations regarding medication appropriateness for each patient. Clinical decision support to pharmacists at the point of care has potential to improve the speed, quantity, and quality of medication recommendations to inpatient teams; any subsequent improvements to medication regimen appropriateness have the potential to reduce ADEs in the hospital and after discharge.

Specific Aims and Objectives

Aim 1: Implement real-time decision support regarding medication regimen appropriateness among pharmacists who round with inpatient medical teams.

Aim 2: Determine the effects of this intervention on the number of medication regimen recommendations and time spent per recommendation

Aim 3: Evaluate the use and usability of the decision support tool and develop strategies to mitigate barriers and promote facilitators of implementation using mixed methods implementation science approaches.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This will be a prospective pre-post mixed methods hybrid type 2 effectiveness-implementation study. The study will take place at BWH and at Vanderbilt University Medical Center (VUMC). The direct subjects will be the inpatient pharmacists (4 at each site) who round with general medicine teams. Patients will be indirect subjects as pharmacists provide medication recommendations regarding these patients to the clinicians on each team with or without the Synapse software. We estimate this number of patients to be 3 new admitted patients per day per team x 56 days x 8 teams = 1344 patients (672 at MGB sites). Patients can be any patients admitted to these general medicine service teams at BWH and VUMC. The pharmacists are trained hospital pharmacists who round with general medicine service teams and approve inpatient medication orders. There are no local site restrictions. VUMC will cede IRB approval to the MGB IRB.

Study Type

Interventional

Enrollment (Anticipated)

672

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • any patient that the inpatient pharmacists care for on the inpatient medical team they round with

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pharmacist team post-intervention
The direct subjects will be the inpatient pharmacists who round with general medicine teams and approve inpatient medication orders. They will be given full access to the Synapse Medicine medication decision support platform.
Other: Synapse medicine platform
Intervention is the Synapse medicine platform for inpatient pharmacists. This software analyzes drug-related risks based on each patient's clinical characteristics
NO_INTERVENTION: Pharmacist team pre-intervention
Pre-intervention, the inpatient pharmacists will round with general medicine teams and approve inpatient medication orders under conditions of usual care. They will base their recommendations on their knowledge and training and any tools (electronic or otherwise) that they choose to use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the number of medication recommendations made per patient
Time Frame: pre- and post-intervention periods: 4 weeks each per pharmacist
Change from pre- to post-intervention in the number of recommendations regarding medication changes made by pharmacists per patient
pre- and post-intervention periods: 4 weeks each per pharmacist

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the time spent per recommendation per patient
Time Frame: pre- and post-intervention periods: 4 weeks each per pharmacist
Change from pre- to post-intervention in time spent per patient evaluating regimen appropriateness divided by the number of recommendations for that patient
pre- and post-intervention periods: 4 weeks each per pharmacist

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Vanderbilt University Medical Center
Synapse Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2023

Primary Completion (ANTICIPATED)

September 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

July 7, 2022

First Submitted That Met QC Criteria

July 12, 2022

First Posted (ACTUAL)

July 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022P000659

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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