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

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05459155
Collaborator
Synapse Medicine (Other), Vanderbilt University Medical Center (Other)
672
2
15

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Synapse medicine platform
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
672 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Prospective pre-post mixed methods hybrid type 2 effectiveness-implementation studyProspective pre-post mixed methods hybrid type 2 effectiveness-implementation study
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Effect of Synapse Medicine Decision Support on Inpatient Pharmacist Efficacy and Efficiency: a Hybrid Type 2 Implementation Study
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in the number of medication recommendations made per patient [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

Secondary Outcome Measures

  1. Change in the time spent per recommendation per patient [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • any patient that the inpatient pharmacists care for on the inpatient medical team they round with
Exclusion Criteria:
  • N/A

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Brigham and Women's Hospital
  • Synapse Medicine
  • Vanderbilt University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jeffrey L. Schnipper, MD.,MPH., Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT05459155
Other Study ID Numbers:
  • 2022P000659
First Posted:
Jul 14, 2022
Last Update Posted:
Jul 14, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jeffrey L. Schnipper, MD.,MPH., Professor of Medicine, Brigham and Women's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 14, 2022