NCT05459155

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
672

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

July 7, 2022

Last Update Submit

February 7, 2023

Conditions

Keywords

Hospitalized Patients

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in the time spent per recommendation per patient

    pre- and post-intervention periods: 4 weeks each per pharmacist

Study Arms (2)

Pharmacist team post-intervention

EXPERIMENTAL

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

Pharmacist team pre-intervention

NO 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.

Interventions

Intervention is the Synapse medicine platform for inpatient pharmacists. This software analyzes drug-related risks based on each patient's clinical characteristics

Pharmacist team post-intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

InfectionsHeart DiseasesLung DiseasesKidney DiseasesLiver DiseasesGastrointestinal Diseases

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesRespiratory Tract DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Prospective pre-post mixed methods hybrid type 2 effectiveness-implementation study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 7, 2022

First Posted

July 14, 2022

Study Start

March 1, 2023

Primary Completion

September 1, 2023

Study Completion

December 1, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02