Trial Outcomes & Findings for Enhanced, Personalized and Integrated Care for Infection Management at the Point-Of-Care (NCT NCT04013737)

Results Overview

This will be measured by assessing the appropriateness of prescriptions recommended by the system compared to current clinical practice. Appropriateness is determined by evaluating prescribing against current clinical guidelines or infection expert opinion on best practice and is expressed as a proportion of the total number of antibiotic prescriptions made. Each individual patient has a single antibiotic prescription evaluated.

Recruitment status

COMPLETED

Target enrollment

33 participants

Primary outcome timeframe

Single prescription at the time of antimicrobial prescribing assessment (e.g. at the time antibiotics were prescribed)

Results posted on

2021-08-31

Participant Flow

Professionals recruited = 15 Patients recruited for prospective study of engagement tool = 18

15 healthcare professionals were recruited who would be using the tool to make antibiotic prescribing decisions. 18 patients were enrolled in the pre- post- assessment of the impact of a patient-communication tool within the system on knowledge and understanding of their infection and its management.

Participant milestones

Participant milestones
Measure	Patients and Public Prospective evaluation of knowledge and understanding of infections pre- and post- a patient communication intervention.	Prescribers Quantitative evaluation of the impact of using a clinical decision support system to support antibiotic decision making. EPIC IMPOC: Clinical Decision Support System for antibiotic prescribing.
Overall Study STARTED	18	15
Overall Study COMPLETED	18	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age not collect

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients and Public n=18 Participants Exploration of patient and public engagement with antibiotic decision making in secondary care. Qualitative evaluation and co-design of interventions. Prospective evaluation of intervention. EPIC IMPOC: Clinical Decision Support System for antibiotic prescribing.	Prescribers n=15 Participants Quantitative and qualitative evaluation of the impact of using a clinical decision support system to support antibiotic decision making. EPIC IMPOC: Clinical Decision Support System for antibiotic prescribing.	Total n=33 Participants Total of all reporting groups
Age, Continuous	66 Years n=18 Participants • Age not collect	—	66 Years n=18 Participants • Age not collect
Sex: Female, Male Female	8 Participants n=18 Participants	7 Participants n=15 Participants	15 Participants n=33 Participants
Sex: Female, Male Male	10 Participants n=18 Participants	8 Participants n=15 Participants	18 Participants n=33 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Single prescription at the time of antimicrobial prescribing assessment (e.g. at the time antibiotics were prescribed)

Population: 15 prescribers made 224 antimicrobial prescriptions during the study period which were analysed for the outcome measure.

This will be measured by assessing the appropriateness of prescriptions recommended by the system compared to current clinical practice. Appropriateness is determined by evaluating prescribing against current clinical guidelines or infection expert opinion on best practice and is expressed as a proportion of the total number of antibiotic prescriptions made. Each individual patient has a single antibiotic prescription evaluated.

Outcome measures

Outcome measures
Measure	Appropriateness of Antibiotic Prescribing n=224 Prescriptions made by participants Proportion of appropriate recommendations made using the case-based-reasoning algorithm out of 224 prescriptions input into the system by participants.
Percentage of Appropriate Antimicrobial Prescriptions Recommended	90 percentage of prescriptions appropriate

PRIMARY outcome

Timeframe: Single time point before and after use of the device in the study

Population: Patients in hospital.

This was assessment was a single time point at baseline (Pre-intervention) and single time point after use of the device in the study. Scores were pre-determined based on anticipated answers provided by participants pre- and post- intervention using a bespoke mark scheme (https://aricjournal.biomedcentral.com/articles/10.1186/s13756-018-0333-1). Participants could score between 0 (lowest) and 13 (highest) marks based on their responses to questions assessing knowledge and understanding.

Outcome measures

Outcome measures
Measure	Appropriateness of Antibiotic Prescribing n=18 Participants Proportion of appropriate recommendations made using the case-based-reasoning algorithm out of 224 prescriptions input into the system by participants.
Evaluation of Effectiveness Assessed by User Acceptance of the Device Pre-intervention	3 score on a scale Interval 2.0 to 5.0
Evaluation of Effectiveness Assessed by User Acceptance of the Device Post-intervention	10 score on a scale Interval 6.0 to 11.0

Adverse Events

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Head of Operations

Health Protection Research Unit in HCAI and AMR, Imperial College London

Phone: 020 3313 2732

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place