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

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: Completed
• Conditions: Liver Diseases; Gastrointestinal Diseases; Heart Diseases; Infections; Lung Diseases; Kidney Diseases
• Intervention / Treatment: Other: Synapse medicine platform

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 (Actual): 1485
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

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	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	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

• Sponsor: Brigham and Women's Hospital
• Collaborators: Vanderbilt University Medical Center; Synapse Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): June 2, 2026

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): September 3, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Hospitalized Patients
• Additional Relevant MeSH Terms: Urogenital Diseases; Cardiovascular Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Respiratory Tract Diseases; Digestive System Diseases; Gastrointestinal Diseases; Lung Diseases; Heart Diseases; Infections; Liver Diseases; Kidney Diseases
• 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