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

Primary Purpose

Infections, Heart Diseases, Lung Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Synapse medicine platform
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Infections focused on measuring Hospitalized Patients

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Pharmacist team post-intervention

    Pharmacist team pre-intervention

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    July 7, 2022
    Last Updated
    February 7, 2023
    Sponsor
    Brigham and Women's Hospital
    Collaborators
    Synapse Medicine, Vanderbilt University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05459155
    Brief Title
    Effect of Synapse Medicine Decision Support on Inpatient Pharmacist Efficacy and Efficiency
    Official Title
    Effect of Synapse Medicine Decision Support on Inpatient Pharmacist Efficacy and Efficiency: a Hybrid Type 2 Implementation Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    September 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brigham and Women's Hospital
    Collaborators
    Synapse Medicine, Vanderbilt University Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infections, Heart Diseases, Lung Diseases, Kidney Diseases, Liver Diseases, Gastrointestinal Diseases
    Keywords
    Hospitalized Patients

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Prospective pre-post mixed methods hybrid type 2 effectiveness-implementation study
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    672 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pharmacist team post-intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Pharmacist team pre-intervention
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Synapse medicine platform
    Intervention Description
    Intervention is the Synapse medicine platform for inpatient pharmacists. This software analyzes drug-related risks based on each patient's clinical characteristics
    Primary Outcome Measure Information:
    Title
    Change in the number of medication recommendations made per patient
    Description
    Change from pre- to post-intervention in the number of recommendations regarding medication changes made by pharmacists per patient
    Time Frame
    pre- and post-intervention periods: 4 weeks each per pharmacist
    Secondary Outcome Measure Information:
    Title
    Change in the time spent per recommendation per patient
    Description
    Change from pre- to post-intervention in time spent per patient evaluating regimen appropriateness divided by the number of recommendations for that patient
    Time Frame
    pre- and post-intervention periods: 4 weeks each per pharmacist

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: any patient that the inpatient pharmacists care for on the inpatient medical team they round with Exclusion Criteria: N/A

    12. IPD Sharing Statement

    Learn more about this trial

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

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