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

Heart Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05459155
• Other study ID #: 2022P000659
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2023
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 672
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Heart Diseases
• Infections
• Kidney Diseases
• Liver Diseases
• Lung Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Synapse Medicine, Vanderbilt University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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