Skip to content

Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03233438
Enrollment
91
Registered
2017-07-28
Start date
2017-07-24
Completion date
2018-10-30
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Bacterial Skin and Skin Structure Infection, Bacterial Infections

Keywords

Critical Pathways, Health Facilities, Clinical Protocols, Patient Satisfaction, Absenteeism, Anti-Bacterial Agents, Quality of Life, Economics, Medical, Health Resources, Health resource utilization, Acute bacterial skin and skin structure infection (ABSSSI)

Brief summary

The purpose of this study is to assess the effect of a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) compared to usual care for the treatment of ABSSI (Acute Bacterial Skin and Skin Structure Infections)

Interventions

DRUGDalbavancin

Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.

DRUGUsual Care

Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.

Sponsors

Allergan
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Admitted patients who meets the clinical definition for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) * Known or suspected gram-positive infection.

Exclusion criteria

* Known or suspected gram-negative infections, anaerobic infections, or fungemia * Known or suspected infections that are severe, life threatening or are not included in the ABSSSI Food and Drug Administration (FDA) guidance * Injection drug users with a fever * Severe neurological disorder leading to immobility or confined to a wheelchair * Bilateral Lower extremity involvement of the suspected infection.

Design outcomes

Primary

MeasureTime frame
Number of Infection-related Total Admitted Hospital Days44 Days

Secondary

MeasureTime frameDescription
Number of Total Admitted Hospital Days44 Days
Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time44 Days
Number of Participants With Infection-related Hospitalizations44 Days
Number of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care Unit44 Days
Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the HospitalFollow-up: 30 Days
Number of Participants With Infection-related Emergency Department (ED) Visits44 Days
Number of Participants With Infection-related Outpatient Healthcare Visits44 Days
Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy44 Days
Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy44 Days
Change From Baseline in Response to Treatment at End of Treatment VisitBaseline, Day 14Response to treatment (healthcare provider assessment) comparing response at the Day 14 visit. Response to treatment will be defined through an assessment of erythema (measurement of lesion characteristics) and the absence of fever
Number of Participants With Serious Adverse Events (SAEs)44 Days
Patient Satisfaction With Care: Overall Health14 DaysPatient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Wait in Emergency Room14 DaysPatients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Patient Satisfaction With Care: Hospitalization14 DaysPatient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Satisfaction With Hospital Stay14 DaysPatients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay14 DaysPatient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections14 DaysPatient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy14 DaysPatients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV14 DaysPatient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV14 DaysPatient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living14 DaysPatient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy14 DaysPatient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day14 DaysPatients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV14 DaysPatients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV14 DaysPatient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV14 DaysPatient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Satisfaction With Care: Find Value in a Physician14 DaysPatient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment QuestionnaireDay 10-14
Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient QuestionnaireDay 14The SF-12 yields a physical and a mental health component summary score (referred to as physical component summary score \[PCS\] and mental component summary score \[MCS\]). The PCS and MCS follow a t-score distribution, i.e. mean of 50 and standard deviation of 10 in the general US population, meaning all scores above or below 50 are above and below the average, respectively, in the US general population.
Healthcare Costs44 DaysCost of hospital inpatient stays, ED visits, healthcare visits, procedures, and biological tests

Countries

United States

Participant flow

Participants by arm

ArmCount
Usual Care
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
48
New Critical Pathway
The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
42
Total90

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up49
Overall StudyNo recording of dalbavancin01
Overall StudyWithdrawal by Subject21

Baseline characteristics

CharacteristicUsual CareNew Critical PathwayTotal
Age, Customized
20-29 years
6 Participants5 Participants11 Participants
Age, Customized
<20 years
0 Participants0 Participants0 Participants
Age, Customized
30-39 years
6 Participants8 Participants14 Participants
Age, Customized
40-49 years
4 Participants8 Participants12 Participants
Age, Customized
50-59 years
7 Participants5 Participants12 Participants
Age, Customized
60-69 years
10 Participants5 Participants15 Participants
Age, Customized
70-79 years
4 Participants3 Participants7 Participants
Age, Customized
80-89 years
7 Participants7 Participants14 Participants
Age, Customized
90-98 years
4 Participants1 Participants5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants8 Participants15 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
38 Participants26 Participants64 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants8 Participants11 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Asian
1 Participants1 Participants2 Participants
Race/Ethnicity, Customized
Black or African American
1 Participants7 Participants8 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Other
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Patient chose not to answer
10 Participants5 Participants15 Participants
Race/Ethnicity, Customized
White or Caucasian
36 Participants28 Participants64 Participants
Sex: Female, Male
Female
24 Participants20 Participants44 Participants
Sex: Female, Male
Male
24 Participants22 Participants46 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 480 / 42
other
Total, other adverse events
0 / 483 / 42
serious
Total, serious adverse events
1 / 483 / 42

Outcome results

Primary

Number of Infection-related Total Admitted Hospital Days

Time frame: 44 Days

Population: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.

ArmMeasureValue (MEAN)Dispersion
Usual CareNumber of Infection-related Total Admitted Hospital Days4.8 DaysStandard Deviation 2.55
New Critical PathwayNumber of Infection-related Total Admitted Hospital Days3.2 DaysStandard Deviation 2.48
p-value: 0.00395% CI: [0.6, 2.6]t-test, 2 sided
Secondary

Change From Baseline in Response to Treatment at End of Treatment Visit

Response to treatment (healthcare provider assessment) comparing response at the Day 14 visit. Response to treatment will be defined through an assessment of erythema (measurement of lesion characteristics) and the absence of fever

Time frame: Baseline, Day 14

Population: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CareChange From Baseline in Response to Treatment at End of Treatment VisitComplete response24 Participants
Usual CareChange From Baseline in Response to Treatment at End of Treatment VisitPartial response0 Participants
Usual CareChange From Baseline in Response to Treatment at End of Treatment VisitFailure12 Participants
Usual CareChange From Baseline in Response to Treatment at End of Treatment VisitUnknown12 Participants
New Critical PathwayChange From Baseline in Response to Treatment at End of Treatment VisitUnknown9 Participants
New Critical PathwayChange From Baseline in Response to Treatment at End of Treatment VisitComplete response24 Participants
New Critical PathwayChange From Baseline in Response to Treatment at End of Treatment VisitFailure9 Participants
New Critical PathwayChange From Baseline in Response to Treatment at End of Treatment VisitPartial response0 Participants
Secondary

Healthcare Costs

Cost of hospital inpatient stays, ED visits, healthcare visits, procedures, and biological tests

Time frame: 44 Days

Population: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.

ArmMeasureValue (MEAN)Dispersion
Usual CareHealthcare Costs13772.9 USDStandard Deviation 7166.95
New Critical PathwayHealthcare Costs9421.6 USDStandard Deviation 7122.57
Secondary

Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital

Time frame: Follow-up: 30 Days

Population: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the HospitalNone47 Participants
Usual CareNumber of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital1 Occurrence1 Participants
New Critical PathwayNumber of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the HospitalNone39 Participants
New Critical PathwayNumber of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital1 Occurrence3 Participants
Secondary

Number of Participants With Infection-related Emergency Department (ED) Visits

Time frame: 44 Days

Population: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Participants With Infection-related Emergency Department (ED) VisitsNone46 Participants
Usual CareNumber of Participants With Infection-related Emergency Department (ED) Visits1 Occurrence2 Participants
New Critical PathwayNumber of Participants With Infection-related Emergency Department (ED) VisitsNone40 Participants
New Critical PathwayNumber of Participants With Infection-related Emergency Department (ED) Visits1 Occurrence2 Participants
Secondary

Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy

Time frame: 44 Days

Population: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic TherapyNone45 Participants
Usual CareNumber of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy1 Occurrence3 Participants
New Critical PathwayNumber of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic TherapyNone41 Participants
New Critical PathwayNumber of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy1 Occurrence1 Participants
Secondary

Number of Participants With Infection-related Hospitalizations

Time frame: 44 Days

Population: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Participants With Infection-related Hospitalizations1 Occurrence48 Participants
Usual CareNumber of Participants With Infection-related Hospitalizations2 Occurrences0 Participants
New Critical PathwayNumber of Participants With Infection-related Hospitalizations1 Occurrence39 Participants
New Critical PathwayNumber of Participants With Infection-related Hospitalizations2 Occurrences3 Participants
Secondary

Number of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care Unit

Time frame: 44 Days

Population: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care UnitAdmission to ICU0 Participants
New Critical PathwayNumber of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care UnitAdmission to ICU0 Participants
Secondary

Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time

Time frame: 44 Days

Population: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Participants With Infection-related Major Surgical Interventions That Required Operating Room TimeNo Surgeries48 Participants
Usual CareNumber of Participants With Infection-related Major Surgical Interventions That Required Operating Room TimeExpected Surgeries0 Participants
New Critical PathwayNumber of Participants With Infection-related Major Surgical Interventions That Required Operating Room TimeNo Surgeries41 Participants
New Critical PathwayNumber of Participants With Infection-related Major Surgical Interventions That Required Operating Room TimeExpected Surgeries1 Participants
Secondary

Number of Participants With Infection-related Outpatient Healthcare Visits

Time frame: 44 Days

Population: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Participants With Infection-related Outpatient Healthcare VisitsNone26 Participants
Usual CareNumber of Participants With Infection-related Outpatient Healthcare VisitsAny22 Participants
New Critical PathwayNumber of Participants With Infection-related Outpatient Healthcare VisitsNone20 Participants
New Critical PathwayNumber of Participants With Infection-related Outpatient Healthcare VisitsAny22 Participants
Secondary

Number of Participants With Serious Adverse Events (SAEs)

Time frame: 44 Days

Population: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Participants With Serious Adverse Events (SAEs)1 Participants
New Critical PathwayNumber of Participants With Serious Adverse Events (SAEs)3 Participants
Secondary

Number of Total Admitted Hospital Days

Time frame: 44 Days

Population: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.

ArmMeasureValue (MEAN)Dispersion
Usual CareNumber of Total Admitted Hospital Days4.9 DaysStandard Deviation 2.62
New Critical PathwayNumber of Total Admitted Hospital Days3.2 DaysStandard Deviation 2.48
p-value: 0.00395% CI: [0.6, 2.8]t-test, 2 sided
Secondary

Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire

The SF-12 yields a physical and a mental health component summary score (referred to as physical component summary score \[PCS\] and mental component summary score \[MCS\]). The PCS and MCS follow a t-score distribution, i.e. mean of 50 and standard deviation of 10 in the general US population, meaning all scores above or below 50 are above and below the average, respectively, in the US general population.

Time frame: Day 14

Population: FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 42 and 34 patients completed all survey questions in the usual care group and new critical pathway group, respectively.

ArmMeasureGroupValue (MEAN)Dispersion
Usual CarePatient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient QuestionnaireMental Health Component Score43.9 score on a scaleStandard Deviation 10.28
Usual CarePatient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient QuestionnairePhysical Health Component Score40.5 score on a scaleStandard Deviation 11.37
New Critical PathwayPatient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient QuestionnaireMental Health Component Score50.8 score on a scaleStandard Deviation 10.85
New Critical PathwayPatient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient QuestionnairePhysical Health Component Score46.3 score on a scaleStandard Deviation 11.15
Secondary

Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy

Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

Time frame: 14 Days

Population: FAS Population. 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all survey questions in the usual care group \& new critical pathway group; 42 \& 33 patients answered this survey question in the usual care group \& new critical pathway group, respectively.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CarePatient Satisfaction With Care: Concerned About Receiving Your IV TherapyA little of the time13 Participants
Usual CarePatient Satisfaction With Care: Concerned About Receiving Your IV TherapyMost of the time1 Participants
Usual CarePatient Satisfaction With Care: Concerned About Receiving Your IV TherapySome of the time3 Participants
Usual CarePatient Satisfaction With Care: Concerned About Receiving Your IV TherapyAll of the time2 Participants
Usual CarePatient Satisfaction With Care: Concerned About Receiving Your IV TherapyNone of the time23 Participants
New Critical PathwayPatient Satisfaction With Care: Concerned About Receiving Your IV TherapyAll of the time1 Participants
New Critical PathwayPatient Satisfaction With Care: Concerned About Receiving Your IV TherapyNone of the time26 Participants
New Critical PathwayPatient Satisfaction With Care: Concerned About Receiving Your IV TherapyA little of the time4 Participants
New Critical PathwayPatient Satisfaction With Care: Concerned About Receiving Your IV TherapySome of the time1 Participants
New Critical PathwayPatient Satisfaction With Care: Concerned About Receiving Your IV TherapyMost of the time1 Participants
Secondary

Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV

Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

Time frame: 14 Days

Population: 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all questions in the usual care group \& new critical pathway group; 43 \& 33 patients answered this question in the usual care group \& new critical pathway group, respectively. Patients may have checked multiple responses.

ArmMeasureGroupValue (NUMBER)
Usual CarePatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVGot in the way of work/school11 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVGot in way of performing daily normal activities11 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVGot in the way of providing care to others5 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVIV antibiotic therapy was expensive2 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVRequired me to make appointments0 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVAdministered at healthcare setting w/limited hours0 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVRequired traveling to and from appointments0 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVRequired to wait to be seen by provider0 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVIV antibiotic therapy took too long to administer4 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVAdministered too frequently4 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVRequired having a PICC or central line inserted7 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVCaused an IV site infection1 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVIV antibiotic therapy made me feel worse10 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVNot adequately monitored by healthcare providers3 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVNot administered by skilled healthcare providers0 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVIV antibiotic therapy made me feel concerned7 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVRequired a nurse/healthcare worker coming to home0 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVRequired administration to self/caregiver at home0 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVOther1 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVNot dissatisfied w/receiving IV antibiotic therapy19 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVRequired administration to self/caregiver at home1 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVGot in the way of work/school3 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVRequired having a PICC or central line inserted2 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVGot in way of performing daily normal activities3 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVIV antibiotic therapy made me feel concerned3 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVGot in the way of providing care to others1 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVCaused an IV site infection0 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVIV antibiotic therapy was expensive0 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVNot dissatisfied w/receiving IV antibiotic therapy22 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVRequired me to make appointments0 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVIV antibiotic therapy made me feel worse3 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVAdministered at healthcare setting w/limited hours0 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVRequired a nurse/healthcare worker coming to home1 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVRequired traveling to and from appointments1 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVNot adequately monitored by healthcare providers0 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVRequired to wait to be seen by provider5 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVOther0 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVIV antibiotic therapy took too long to administer1 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVNot administered by skilled healthcare providers0 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IVAdministered too frequently1 Participants
Secondary

Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV

Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

Time frame: 14 Days

Population: 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all questions in the usual care group \& new critical pathway group; 43 \& 33 patients answered this question in the usual care group \& new critical pathway group, respectively. Patients may have checked multiple responses.

ArmMeasureGroupValue (NUMBER)
Usual CarePatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVAllowed me to return to work/school14 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVAllowed me to return to daily normal activities15 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVAllowed me to return to providing care to others8 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVIV antibiotic therapy was affordable6 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVAdministered at appointments that I could schedule2 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVAdministered quickly once arrived at appt2 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVAdministered at setting that had convenient hours3 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVEnsured regular monitoring by healthcare providers22 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVAdministered by skilled healthcare providers24 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVIV antibiotic therapy made me feel better19 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVAllowed to receive care for skin infection at home7 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVConvenient to administer by self/caregiver at home4 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVOther3 Participants
Usual CarePatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVNot satisfied with receiving IV antibiotic therapy3 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVAllowed to receive care for skin infection at home9 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVAllowed me to return to work/school15 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVEnsured regular monitoring by healthcare providers10 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVAllowed me to return to daily normal activities20 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVOther1 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVAllowed me to return to providing care to others11 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVAdministered by skilled healthcare providers18 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVIV antibiotic therapy was affordable4 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVConvenient to administer by self/caregiver at home0 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVAdministered at appointments that I could schedule1 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVIV antibiotic therapy made me feel better16 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVAdministered quickly once arrived at appt3 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVNot satisfied with receiving IV antibiotic therapy2 Participants
New Critical PathwayPatient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IVAdministered at setting that had convenient hours7 Participants
Secondary

Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay

Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

Time frame: 14 Days

Population: 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all questions in the usual care group \& new critical pathway group; 42 \& 34 patients answered this question in the usual care group \& new critical pathway group, respectively. Patients may have checked multiple responses.

ArmMeasureGroupValue (NUMBER)
Usual CarePatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayHospital stay interfered with work/school13 Participants
Usual CarePatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayStay got in way of daily normal activities17 Participants
Usual CarePatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayStay got in the way of providing care to others10 Participants
Usual CarePatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayHospital stay was expensive7 Participants
Usual CarePatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayDid not provide adequate monitoring by providers4 Participants
Usual CarePatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayDid not provide well trained healthcare providers3 Participants
Usual CarePatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayHospital stay made me feel worse4 Participants
Usual CarePatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayHospital stay made me feel concerned11 Participants
Usual CarePatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayHospital stay was uncomfortable12 Participants
Usual CarePatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayHospital stay disrupted my sleep24 Participants
Usual CarePatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayOther5 Participants
Usual CarePatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayI was not dissatisfied with my hospital stay12 Participants
New Critical PathwayPatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayOther6 Participants
New Critical PathwayPatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayHospital stay interfered with work/school6 Participants
New Critical PathwayPatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayHospital stay made me feel worse1 Participants
New Critical PathwayPatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayStay got in way of daily normal activities8 Participants
New Critical PathwayPatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayHospital stay disrupted my sleep10 Participants
New Critical PathwayPatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayStay got in the way of providing care to others5 Participants
New Critical PathwayPatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayHospital stay made me feel concerned7 Participants
New Critical PathwayPatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayHospital stay was expensive4 Participants
New Critical PathwayPatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayI was not dissatisfied with my hospital stay12 Participants
New Critical PathwayPatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayDid not provide adequate monitoring by providers4 Participants
New Critical PathwayPatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayHospital stay was uncomfortable7 Participants
New Critical PathwayPatient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital StayDid not provide well trained healthcare providers1 Participants
Secondary

Patient Satisfaction With Care: Find Value in a Physician

Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

Time frame: 14 Days

Population: FAS Population. 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all survey questions in the usual care group \& new critical pathway group; 43 \& 34 patients answered this survey question in the usual care group \& new critical pathway group, respectively.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CarePatient Satisfaction With Care: Find Value in a PhysicianDefinitely not1 Participants
Usual CarePatient Satisfaction With Care: Find Value in a PhysicianProbably not1 Participants
Usual CarePatient Satisfaction With Care: Find Value in a PhysicianProbably so7 Participants
Usual CarePatient Satisfaction With Care: Find Value in a PhysicianDefinitely so34 Participants
New Critical PathwayPatient Satisfaction With Care: Find Value in a PhysicianDefinitely so30 Participants
New Critical PathwayPatient Satisfaction With Care: Find Value in a PhysicianDefinitely not1 Participants
New Critical PathwayPatient Satisfaction With Care: Find Value in a PhysicianProbably so2 Participants
New Critical PathwayPatient Satisfaction With Care: Find Value in a PhysicianProbably not1 Participants
Secondary

Patient Satisfaction With Care: Hospitalization

Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

Time frame: 14 Days

Population: FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and new critical pathway group, respectively.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CarePatient Satisfaction With Care: HospitalizationYes43 Participants
Usual CarePatient Satisfaction With Care: HospitalizationNo0 Participants
New Critical PathwayPatient Satisfaction With Care: HospitalizationYes34 Participants
New Critical PathwayPatient Satisfaction With Care: HospitalizationNo0 Participants
Secondary

Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living

Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

Time frame: 14 Days

Population: FAS Population. 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all survey questions in the usual care group \& new critical pathway group; 42 \& 33 patients answered this survey question in the usual care group \& new critical pathway group, respectively.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CarePatient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily LivingA little of the time4 Participants
Usual CarePatient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily LivingMost of the time6 Participants
Usual CarePatient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily LivingSome of the time3 Participants
Usual CarePatient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily LivingAll of the time12 Participants
Usual CarePatient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily LivingNone of the time17 Participants
New Critical PathwayPatient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily LivingAll of the time1 Participants
New Critical PathwayPatient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily LivingNone of the time26 Participants
New Critical PathwayPatient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily LivingA little of the time5 Participants
New Critical PathwayPatient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily LivingSome of the time0 Participants
New Critical PathwayPatient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily LivingMost of the time1 Participants
Secondary

Patient Satisfaction With Care: Overall Health

Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

Time frame: 14 Days

Population: FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and new critical pathway group, respectively.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CarePatient Satisfaction With Care: Overall HealthVery good16 Participants
Usual CarePatient Satisfaction With Care: Overall HealthFair10 Participants
Usual CarePatient Satisfaction With Care: Overall HealthGood9 Participants
Usual CarePatient Satisfaction With Care: Overall HealthPoor6 Participants
Usual CarePatient Satisfaction With Care: Overall HealthExcellent2 Participants
New Critical PathwayPatient Satisfaction With Care: Overall HealthPoor1 Participants
New Critical PathwayPatient Satisfaction With Care: Overall HealthExcellent8 Participants
New Critical PathwayPatient Satisfaction With Care: Overall HealthVery good10 Participants
New Critical PathwayPatient Satisfaction With Care: Overall HealthGood7 Participants
New Critical PathwayPatient Satisfaction With Care: Overall HealthFair8 Participants
Secondary

Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections

Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

Time frame: 14 Days

Population: FAS Population. 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all survey questions in the usual care group \& new critical pathway group; 43 \& 33 patients answered this survey question in the usual care group \& new critical pathway group, respectively.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CarePatient Satisfaction With Care: Received IV Antibiotic Therapy for Skin InfectionsYes43 Participants
Usual CarePatient Satisfaction With Care: Received IV Antibiotic Therapy for Skin InfectionsNo0 Participants
New Critical PathwayPatient Satisfaction With Care: Received IV Antibiotic Therapy for Skin InfectionsYes33 Participants
New Critical PathwayPatient Satisfaction With Care: Received IV Antibiotic Therapy for Skin InfectionsNo1 Participants
Secondary

Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV

Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

Time frame: 14 Days

Population: FAS Population. 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all survey questions in the usual care group \& new critical pathway group; 43 \& 34 patients answered this survey question in the usual care group \& new critical pathway group, respectively.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CarePatient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IVRegimen 128 Participants
Usual CarePatient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IVRegimen 26 Participants
Usual CarePatient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IVRegimen 39 Participants
New Critical PathwayPatient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IVRegimen 133 Participants
New Critical PathwayPatient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IVRegimen 20 Participants
New Critical PathwayPatient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IVRegimen 31 Participants
Secondary

Patient Satisfaction With Care: Satisfaction With Hospital Stay

Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.

Time frame: 14 Days

Population: FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and new critical pathway group, respectively.

ArmMeasureValue (MEAN)Dispersion
Usual CarePatient Satisfaction With Care: Satisfaction With Hospital Stay7.4 scores on a scaleStandard Deviation 2.35
New Critical PathwayPatient Satisfaction With Care: Satisfaction With Hospital Stay7.4 scores on a scaleStandard Deviation 2.72
Secondary

Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy

Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.

Time frame: 14 Days

Population: FAS Population. 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all survey questions in the usual care group \& new critical pathway group; 43 \& 33 patients answered this survey question in the usual care group \& new critical pathway group, respectively.

ArmMeasureValue (MEAN)Dispersion
Usual CarePatient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy7.1 scores on a scaleStandard Deviation 2.83
New Critical PathwayPatient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy8.1 scores on a scaleStandard Deviation 2.26
Secondary

Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV

Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.

Time frame: 14 Days

Population: FAS Population. 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all survey questions in the usual care group \& new critical pathway group; 43 \& 33 patients answered this survey question in the usual care group \& new critical pathway group, respectively.

ArmMeasureValue (MEAN)Dispersion
Usual CarePatient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV7.5 scores on a scaleStandard Deviation 2.58
New Critical PathwayPatient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV8.9 scores on a scaleStandard Deviation 1.9
Secondary

Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day

Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.

Time frame: 14 Days

Population: FAS Population. 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all survey questions in the usual care group \& new critical pathway group; 43 \& 33 patients answered this survey question in the usual care group \& new critical pathway group, respectively.

ArmMeasureValue (MEAN)Dispersion
Usual CarePatient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day7.3 scores on a scaleStandard Deviation 2.63
New Critical PathwayPatient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day8.7 scores on a scaleStandard Deviation 1.89
Secondary

Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV

Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).

Time frame: 14 Days

Population: FAS Population. 43 \& 34 patients provided any survey data in the usual care group \& new critical pathway group; 40 \& 32 patients completed all survey questions in the usual care group \& new critical pathway group; 41 \& 34 patients answered this survey question in the usual care group \& new critical pathway group, respectively.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CarePatient Satisfaction With Care: Time Willing to Spend Receiving Each IVAbout 30 minutes or less23 Participants
Usual CarePatient Satisfaction With Care: Time Willing to Spend Receiving Each IVAbout 1 hour10 Participants
Usual CarePatient Satisfaction With Care: Time Willing to Spend Receiving Each IVAbout 1.5 to 2 hours5 Participants
Usual CarePatient Satisfaction With Care: Time Willing to Spend Receiving Each IVAbout 3 hours or longer3 Participants
New Critical PathwayPatient Satisfaction With Care: Time Willing to Spend Receiving Each IVAbout 3 hours or longer1 Participants
New Critical PathwayPatient Satisfaction With Care: Time Willing to Spend Receiving Each IVAbout 30 minutes or less22 Participants
New Critical PathwayPatient Satisfaction With Care: Time Willing to Spend Receiving Each IVAbout 1.5 to 2 hours1 Participants
New Critical PathwayPatient Satisfaction With Care: Time Willing to Spend Receiving Each IVAbout 1 hour10 Participants
Secondary

Patient Satisfaction With Care: Wait in Emergency Room

Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.

Time frame: 14 Days

Population: FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and new critical pathway group, respectively.

ArmMeasureValue (MEAN)Dispersion
Usual CarePatient Satisfaction With Care: Wait in Emergency Room5.1 scores on a scaleStandard Deviation 3.34
New Critical PathwayPatient Satisfaction With Care: Wait in Emergency Room6.9 scores on a scaleStandard Deviation 3.12
Secondary

Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire

Time frame: Day 10-14

Population: FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively.14 and 9 patients completed all survey questions in the usual care group and new critical pathway group, respectively. 17 and 20 patients were employed.

ArmMeasureGroupValue (MEAN)Dispersion
Usual CarePatient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment QuestionnaireAbsenteeism49.9 PercentageStandard Deviation 38.49
Usual CarePatient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment QuestionnaireImpairment while working47.9 PercentageStandard Deviation 40.03
Usual CarePatient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment QuestionnaireOverall work impairment59.3 PercentageStandard Deviation 39.16
Usual CarePatient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment QuestionnaireActivity impairment60.2 PercentageStandard Deviation 38.85
New Critical PathwayPatient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment QuestionnaireActivity impairment18.5 PercentageStandard Deviation 26.23
New Critical PathwayPatient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment QuestionnaireAbsenteeism36.7 PercentageStandard Deviation 46.09
New Critical PathwayPatient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment QuestionnaireOverall work impairment18.0 PercentageStandard Deviation 23.39
New Critical PathwayPatient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment QuestionnaireImpairment while working8.9 PercentageStandard Deviation 9.28
Secondary

Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy

Time frame: 44 Days

Population: Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CareUse of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic TherapyCentral Line0 Participants
Usual CareUse of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic TherapyPICC Line1 Participants
Usual CareUse of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic TherapyPeripheral IV27 Participants
Usual CareUse of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic TherapyNo Line20 Participants
New Critical PathwayUse of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic TherapyNo Line0 Participants
New Critical PathwayUse of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic TherapyCentral Line0 Participants
New Critical PathwayUse of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic TherapyPeripheral IV42 Participants
New Critical PathwayUse of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic TherapyPICC Line0 Participants

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026