InfectionsNCT05459155
Effect of Synapse Medicine Decision Support on Inpatient Pharmacist Efficacy and Efficiency
A study testing Synapse medicine platform in people with Infections and Heart Diseases, run by Brigham and Women's Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infections, Heart Diseases, Lung Diseases
- What is being tested?
- Synapse medicine platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,485 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2023to 2 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- any patient that the inpatient pharmacists care for on the inpatient medical team they round with
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: 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
Read more
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.
Read the 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.
- Conditions
- Infections, Heart Diseases, Lung Diseases, Kidney Diseases, Liver Diseases, Gastrointestinal Diseases
- Being tested
- Synapse medicine platform
- Keywords
- Hospitalized Patients
- Medical subject headings
- Infections, Heart Diseases, Lung Diseases, Kidney Diseases, Liver Diseases, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synapse medicine platformOther
Intervention is the Synapse medicine platform for inpatient pharmacists. This software analyzes drug-related risks based on each patient's clinical characteristics
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: pre- and post-intervention periods: 4 weeks each per pharmacist
Secondary outcomes (1)
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
Measured: pre- and post-intervention periods: 4 weeks each per pharmacist
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start31 May 2023
- Primary completion30 Oct 2024
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Prospective pre-post mixed methods hybrid type 2 effectiveness-implementation study
- Masking
- None (open label)
- Enrolment
- 1,485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Synapse Medicine, Vanderbilt University Medical Center
- Responsible party
- Principal investigator, Jeffrey L. Schnipper, MD.,MPH., Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459155
- Sponsor's protocol ID
- 2022P000659
- Status last verified
- Aug 2026
- First submitted
- 7 Jul 2022
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Synapse Medicine Decision Support on Inpatient Pharmacist Efficacy and Efficiency: a Hybrid Type 2 Implementation Study
- ClinicalTrials.gov ID
- NCT05459155
- Acronym / sponsor ID
- 2022P000659
- Conditions
- Infections, Heart Diseases, Lung Diseases, Kidney Diseases, Liver Diseases, Gastrointestinal Diseases
- Keywords
- Hospitalized Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,485 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Synapse Medicine, Vanderbilt University Medical Center
- Study start
- 31 May 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective pre-post mixed methods hybrid type 2 effectiveness-implementation study
| Arm | Type | Receives |
|---|---|---|
| Pharmacist team post-intervention | Experimental | Other: Synapse medicine platformThe 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- any patient that the inpatient pharmacists care for on the inpatient medical team they round with
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synapse medicine platformIntervention is the Synapse medicine platform for inpatient pharmacists. This software analyzes drug-related risks based on each patient's clinical characteristics | Other | Pharmacist team post-intervention |
Primary outcome
Change in the number of medication recommendations made per patient
Time frame: 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
1 secondary outcome
Change in the time spent per recommendation per patient
Time frame: pre- and post-intervention periods: 4 weeks each per pharmacist
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synapse medicine platform in people with Infections and Heart Diseases, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of medication recommendations made per patient (time frame: pre- and post-intervention periods: 4 weeks each per pharmacist). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.