Acute Bacterial Skin and Skin Structure Infections
Conditions
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
This study will evaluate a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) for the treatment of ABSSSI compared to usual care.
Interventions
DRUGUsual Care
Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
DRUGDalbavancin
Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.
Sponsors
Allergan
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
* Presents to the Emergency Department (ED) and 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
| Measure | Time frame |
|---|---|
| Hospital Admission Rate at Initial Episode of Care | 44 Days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Length of Stay in Emergency Department (ED) During the Initial Episode of Care | Initial Care: 14 Days | Time spent in ED in hours from triage to release (either admitted to the hospital, admitted to observation, or released to home) |
| Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time | 44 Days | Number of all major surgical interventions unexpected or expected that required operating room time |
| Number of Infection-related Total Admitted Hospital Days | 44 Days | — |
| Number of Participants With Infection-related Hospitalizations | 44 Days | Number of days of hospitalization during the initial hospitalization (for those initially hospitalized) and all other infection-related hospitalizations |
| Number of Participants With Infection-related Hospitalizations During Initial Care and Follow-up That Resulted in Admission to Intensive Care Unit | 44 Days | — |
| Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital or Release From the ED | Follow-up: 30 Days | — |
| Number of Participants With Infection-related Emergency Department (ED) Visits | 44 Days | — |
| Number of Participants With Infection-related Outpatient Healthcare Visits | 44 Days | — |
| Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy | 44 Days | — |
| Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy | 44 Days | — |
| Number of Participants With Serious Adverse Events (SAEs) | 44 Days | — |
| Patient Satisfaction With Care: Overall Health | Day 14 | Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported). |
| Patient Satisfaction With Care: Wait in Emergency Room | Day 14 | Patients 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: Hospitalization | Day 14 | Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported). |
| Patient Satisfaction With Care: Satisfaction With Hospital Stay | Day 14 | Patients 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 Stay | Day 14 | Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported). |
| Number of Total Admitted Hospital Days | 44 Days | Number of days during the initial hospitalization (for those initially hospitalized) and all other hospitalizations |
| Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy | Day 14 | Patients 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 IV | Day 14 | Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported). |
| Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | 14 Days | Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported). |
| Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living | Day 14 | Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported). |
| Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy | Day 14 | Patient 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 Day | Day 14 | Patients 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 IV | Day 14 | Patients 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: Time to Travel to Appointments to Receive IV | 14 days | Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported). |
| Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider | 14 days | Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported). |
| Patient Satisfaction With Care: Healthcare Setting Preferred if Treated Again for a Skin Infection With IV | 14 Days | Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported). |
| Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care | 14 Days | Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported). |
| Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV | Day 14 | Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported). |
| Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV | Day 14 | Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported). |
| Patient Satisfaction With Care: Find Value in a Physician | Day 14 | Patient 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 Questionnaire | Day 14 | Number of days with lost/reduced productivity during follow-up, as measured with Work Productivity and Activity Impairment (WPAI) Questionnaire |
| Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire | Day 14 | 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. |
| Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections | Day 14 | Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI. | 156 |
| 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. | 153 |
| Total | 309 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 0 |
| Overall Study | Lost to Follow-up | 35 | 24 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Usual Care | New Critical Pathway | Total |
|---|---|---|---|
| Age, Customized 20-29 years | 28 Participants | 14 Participants | 42 Participants |
| Age, Customized <20 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Customized 30-39 years | 31 Participants | 40 Participants | 71 Participants |
| Age, Customized 40-49 years | 25 Participants | 29 Participants | 54 Participants |
| Age, Customized 50-59 years | 37 Participants | 31 Participants | 68 Participants |
| Age, Customized 60-69 years | 22 Participants | 24 Participants | 46 Participants |
| Age, Customized 70-79 years | 8 Participants | 9 Participants | 17 Participants |
| Age, Customized 80-89 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Customized 90-98 years | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 39 Participants | 43 Participants | 82 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 116 Participants | 107 Participants | 223 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 6 Participants | 2 Participants | 8 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 30 Participants | 39 Participants | 69 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 17 Participants | 16 Participants | 33 Participants |
| Race/Ethnicity, Customized Patient chose not to answer | 13 Participants | 3 Participants | 16 Participants |
| Race/Ethnicity, Customized White or Caucasian | 89 Participants | 91 Participants | 180 Participants |
| Sex: Female, Male Female | 56 Participants | 54 Participants | 110 Participants |
| Sex: Female, Male Male | 100 Participants | 99 Participants | 199 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 156 | 2 / 153 |
| other Total, other adverse events | 4 / 156 | 16 / 153 |
| serious Total, serious adverse events | 11 / 156 | 16 / 153 |
Outcome results
Primary
Hospital Admission Rate at Initial Episode of Care
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Hospital Admission Rate at Initial Episode of Care | No | 96 Participants |
| Usual Care | Hospital Admission Rate at Initial Episode of Care | Yes | 60 Participants |
| New Critical Pathway | Hospital Admission Rate at Initial Episode of Care | Yes | 27 Participants |
| New Critical Pathway | Hospital Admission Rate at Initial Episode of Care | No | 126 Participants |
p-value: <0.00195% CI: [0.156, 0.532]Fisher Exact
Secondary
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. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Number of Infection-related Total Admitted Hospital Days | 2.0 Days | Standard Deviation 3.06 |
| New Critical Pathway | Number of Infection-related Total Admitted Hospital Days | 1.0 Days | Standard Deviation 2.36 |
p-value: 0.002t-test, 1 sided
Secondary
Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital or Release From the ED
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. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital or Release From the ED | 7 Participants |
| New Critical Pathway | Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital or Release From the ED | 12 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. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Number of Participants With Infection-related Emergency Department (ED) Visits | 22 Participants |
| New Critical Pathway | Number of Participants With Infection-related Emergency Department (ED) Visits | 19 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. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy | 1 occurence | 2 Participants |
| New Critical Pathway | Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy | 1 occurence | 1 Participants |
Secondary
Number of Participants With Infection-related Hospitalizations
Number of days of hospitalization during the initial hospitalization (for those initially hospitalized) and all other 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. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants With Infection-related Hospitalizations | None | 85 Participants |
| Usual Care | Number of Participants With Infection-related Hospitalizations | Any | 60 Participants |
| New Critical Pathway | Number of Participants With Infection-related Hospitalizations | None | 110 Participants |
| New Critical Pathway | Number of Participants With Infection-related Hospitalizations | Any | 31 Participants |
Secondary
Number of Participants With Infection-related Hospitalizations During Initial Care and Follow-up 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. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants With Infection-related Hospitalizations During Initial Care and Follow-up That Resulted in Admission to Intensive Care Unit | Admission to ICU | 3 Participants |
| New Critical Pathway | Number of Participants With Infection-related Hospitalizations During Initial Care and Follow-up That Resulted in Admission to Intensive Care Unit | Admission to ICU | 0 Participants |
Secondary
Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time
Number of all major surgical interventions unexpected or expected 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. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time | No Surgeries | 107 Participants |
| Usual Care | Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time | Any Surgeries | 38 Participants |
| New Critical Pathway | Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time | No Surgeries | 106 Participants |
| New Critical Pathway | Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time | Any Surgeries | 35 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. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Number of Participants With Infection-related Outpatient Healthcare Visits | 57 Participants |
| New Critical Pathway | Number of Participants With Infection-related Outpatient Healthcare Visits | 39 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants With Serious Adverse Events (SAEs) | 11 Participants |
| New Critical Pathway | Number of Participants With Serious Adverse Events (SAEs) | 16 Participants |
Secondary
Number of Total Admitted Hospital Days
Number of days during the initial hospitalization (for those initially hospitalized) and all other hospitalizations
Time frame: 44 Days
Population: FAS population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Number of Total Admitted Hospital Days | 2.3 Days | Standard Deviation 3.74 |
| New Critical Pathway | Number of Total Admitted Hospital Days | 1.2 Days | Standard Deviation 2.58 |
p-value: 0.005t-test, 1 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. 119 and 122 patients provided any and all survey data in the usual care group and the new critical pathway group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire | Mental Health Component Score | 51.2 Score on a Scale | Standard Deviation 10.36 |
| Usual Care | Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire | Physical Health Component Score | 46.4 Score on a Scale | Standard Deviation 10.36 |
| New Critical Pathway | Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire | Mental Health Component Score | 52.6 Score on a Scale | Standard Deviation 9.63 |
| New Critical Pathway | Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire | Physical Health Component Score | 47.8 Score on a Scale | Standard Deviation 9.39 |
Secondary
Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time frame: 14 days
Population: 119 \& 124 patients provided any survey data in the usual care group \& new critical pathway group; 87 \& 119 patients received IV antibiotic therapy in the usual care group \& new critical pathway group; 86 and 118 patients answered this question in the usual care group \& new critical pathway group, respectively.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider | 16 - 30 minutes | 7 Participants |
| Usual Care | Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider | More than 90 minutes | 2 Participants |
| Usual Care | Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider | Less than 15 minutes | 4 Participants |
| Usual Care | Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider | I did not need to wait for my appointments | 67 Participants |
| Usual Care | Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider | 31 - 60 minutes | 3 Participants |
| Usual Care | Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider | I don't remember | 0 Participants |
| Usual Care | Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider | 61 - 90 minutes | 3 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider | I don't remember | 2 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider | Less than 15 minutes | 17 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider | 16 - 30 minutes | 10 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider | 61 - 90 minutes | 2 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider | More than 90 minutes | 8 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider | I did not need to wait for my appointments | 75 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider | 31 - 60 minutes | 4 Participants |
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: Day 14
Population: 119 \& 124 patients provided any survey data in the usual care group \& new critical pathway group; 87 \& 119 patients received IV antibiotic therapy in the usual care group \& new critical pathway group; 87 and 118 patients answered this question in the usual care group \& new critical pathway group, respectively.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy | A little of the time | 8 Participants |
| Usual Care | Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy | Most of the time | 5 Participants |
| Usual Care | Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy | Some of the time | 8 Participants |
| Usual Care | Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy | All of the time | 4 Participants |
| Usual Care | Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy | None of the time | 62 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy | All of the time | 4 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy | None of the time | 80 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy | A little of the time | 19 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy | Some of the time | 12 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy | Most of the time | 3 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: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively. Patients may have checked multiple responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Administered at healthcare setting w/limited hours | 1 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Caused an IV site infection | 0 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | IV antibiotic therapy was expensive | 0 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | IV antibiotic therapy made me feel worse | 2 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Required traveling to and from appointments | 0 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Not adequately monitored by healthcare providers | 1 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Got in the way of providing care to others | 1 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Not administered by skilled healthcare providers | 1 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Required to wait to be seen by provider | 1 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | IV antibiotic therapy made me feel concerned | 2 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Required me to make appointments | 1 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Required a nurse/healthcare worker coming to home | 0 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | IV antibiotic therapy took too long to administer | 1 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Required administration to self/caregiver at home | 0 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Got in way of performing daily normal activities | 3 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Other | 4 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Required having a PICC or central line inserted | 2 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Not dissatisfied w/receiving IV antibiotic therapy | 72 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Got in the way of work/school | 2 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Not dissatisfied w/receiving IV antibiotic therapy | 105 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Got in the way of work/school | 1 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Got in way of performing daily normal activities | 4 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Got in the way of providing care to others | 1 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | IV antibiotic therapy was expensive | 0 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Required me to make appointments | 0 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Administered at healthcare setting w/limited hours | 0 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Required traveling to and from appointments | 0 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Required to wait to be seen by provider | 2 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | IV antibiotic therapy took too long to administer | 3 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Required having a PICC or central line inserted | 2 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Caused an IV site infection | 0 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | IV antibiotic therapy made me feel worse | 2 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Not adequately monitored by healthcare providers | 0 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Not administered by skilled healthcare providers | 0 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | IV antibiotic therapy made me feel concerned | 2 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Required a nurse/healthcare worker coming to home | 0 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Required administration to self/caregiver at home | 0 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV | Other | 1 Participants |
Secondary
Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time frame: 14 Days
Population: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively. Patients may have checked multiple responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care | I would not prefer outpatient care | 38 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care | To avoid hospital stay for 1 or more nights | 52 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care | To allow me to return to work/school | 37 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care | To return to performing daily normal living | 48 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care | To allow me to return to providing care to others | 27 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care | Outpatient care would be more affordable | 21 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care | Outpatient care would be more convenient | 43 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care | To ensure monitoring by healthcare providers | 10 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care | Administered by skilled healthcare providers | 17 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care | Other | 3 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care | To ensure monitoring by healthcare providers | 22 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care | I would not prefer outpatient care | 14 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care | Outpatient care would be more affordable | 38 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care | To avoid hospital stay for 1 or more nights | 91 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care | Other | 1 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care | To allow me to return to work/school | 44 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care | Outpatient care would be more convenient | 64 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care | To return to performing daily normal living | 65 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care | Administered by skilled healthcare providers | 27 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care | To allow me to return to providing care to others | 36 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: Day 14
Population: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively. Patients may have checked multiple responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | IV antibiotic therapy was affordable | 29 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Allowed me to return to daily normal activities | 48 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Administered by skilled healthcare providers | 51 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Administered at appointments that I could schedule | 4 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | IV antibiotic therapy made me feel better | 55 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Allowed me to return to providing care to others | 38 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Allowed to receive care for skin infection at home | 4 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Administered quickly once arrived at appt | 4 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Convenient to administer by self/caregiver at home | 2 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Ensured regular monitoring by healthcare providers | 26 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Other | 4 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Administered at setting that had convenient hours | 3 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Not satisfied with receiving IV antibiotic therapy | 9 Participants |
| Usual Care | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Allowed me to return to work/school | 37 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Not satisfied with receiving IV antibiotic therapy | 3 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Allowed me to return to work/school | 50 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Allowed me to return to daily normal activities | 81 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Allowed me to return to providing care to others | 52 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | IV antibiotic therapy was affordable | 45 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Administered at appointments that I could schedule | 11 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Administered quickly once arrived at appt | 17 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Administered at setting that had convenient hours | 16 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Ensured regular monitoring by healthcare providers | 29 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Administered by skilled healthcare providers | 58 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | IV antibiotic therapy made me feel better | 80 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Allowed to receive care for skin infection at home | 10 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Convenient to administer by self/caregiver at home | 4 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV | Other | 8 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: Day 14
Population: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively. Patients may have checked multiple responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | I was not dissatisfied with my hospital stay | 33 Participant |
| Usual Care | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Hospital stay disrupted my sleep | 12 Participant |
| Usual Care | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Other | 7 Participant |
| Usual Care | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Hospital stay interfered with work/school | 11 Participant |
| Usual Care | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Stay got in way of daily normal activities | 11 Participant |
| Usual Care | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Stay got in the way of providing care to others | 8 Participant |
| Usual Care | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Hospital stay was expensive | 2 Participant |
| Usual Care | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Did not provide adequate monitoring by providers | 3 Participant |
| Usual Care | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Did not provide well trained healthcare providers | 3 Participant |
| Usual Care | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Hospital stay made me feel worse | 3 Participant |
| Usual Care | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Hospital stay made me feel concerned | 14 Participant |
| Usual Care | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Hospital stay was uncomfortable | 11 Participant |
| New Critical Pathway | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Hospital stay made me feel concerned | 7 Participant |
| New Critical Pathway | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Hospital stay was uncomfortable | 5 Participant |
| New Critical Pathway | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Hospital stay was expensive | 6 Participant |
| New Critical Pathway | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Hospital stay disrupted my sleep | 6 Participant |
| New Critical Pathway | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Hospital stay made me feel worse | 0 Participant |
| New Critical Pathway | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | I was not dissatisfied with my hospital stay | 12 Participant |
| New Critical Pathway | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Did not provide adequate monitoring by providers | 1 Participant |
| New Critical Pathway | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Hospital stay interfered with work/school | 8 Participant |
| New Critical Pathway | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Other | 2 Participant |
| New Critical Pathway | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Stay got in way of daily normal activities | 10 Participant |
| New Critical Pathway | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Did not provide well trained healthcare providers | 0 Participant |
| New Critical Pathway | Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay | Stay got in the way of providing care to others | 8 Participant |
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: Day 14
Population: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group; 115 and 123 patients answered this survey question in the usual care group \& new critical pathway group, respectively.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Patient Satisfaction With Care: Find Value in a Physician | Definitely not | 13 Participants |
| Usual Care | Patient Satisfaction With Care: Find Value in a Physician | Probably not | 13 Participants |
| Usual Care | Patient Satisfaction With Care: Find Value in a Physician | Probably so | 38 Participants |
| Usual Care | Patient Satisfaction With Care: Find Value in a Physician | Definitely so | 51 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Find Value in a Physician | Definitely so | 73 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Find Value in a Physician | Definitely not | 5 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Find Value in a Physician | Probably so | 37 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Find Value in a Physician | Probably not | 8 Participants |
Secondary
Patient Satisfaction With Care: Healthcare Setting Preferred if Treated Again for a 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. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group; 116 and 123 patients answered this question in the usual care group \& new critical pathway group, respectively.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Patient Satisfaction With Care: Healthcare Setting Preferred if Treated Again for a Skin Infection With IV | Overnight hospital stay for one or more nights | 42 Participants |
| Usual Care | Patient Satisfaction With Care: Healthcare Setting Preferred if Treated Again for a Skin Infection With IV | Outpatient care: Brief hospital visit w/no stay | 74 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Healthcare Setting Preferred if Treated Again for a Skin Infection With IV | Overnight hospital stay for one or more nights | 17 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Healthcare Setting Preferred if Treated Again for a Skin Infection With IV | Outpatient care: Brief hospital visit w/no stay | 106 Participants |
Secondary
Patient Satisfaction With Care: Hospitalization
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time frame: Day 14
Population: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Patient Satisfaction With Care: Hospitalization | Yes | 63 Participants |
| Usual Care | Patient Satisfaction With Care: Hospitalization | No | 56 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Hospitalization | Yes | 27 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Hospitalization | No | 97 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: Day 14
Population: 119 \& 124 patients provided any survey data in the usual care group \& new critical pathway group; 87 \& 119 patients received IV antibiotic therapy in the usual care group \& new critical pathway group; 87 and 118 patients answered this question in the usual care group \& new critical pathway group, respectively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living | A little of the time | 6 Participants |
| Usual Care | Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living | Most of the time | 5 Participants |
| Usual Care | Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living | Some of the time | 6 Participants |
| Usual Care | Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living | All of the time | 4 Participants |
| Usual Care | Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living | None of the time | 66 Participants |
| New Critical Pathway | Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living | All of the time | 2 Participants |
| New Critical Pathway | Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living | None of the time | 94 Participants |
| New Critical Pathway | Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living | A little of the time | 10 Participants |
| New Critical Pathway | Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living | Some of the time | 11 Participants |
| New Critical Pathway | Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living | Most of the time | 1 Participants |
Secondary
Patient Satisfaction With Care: Overall Health
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time frame: Day 14
Population: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Patient Satisfaction With Care: Overall Health | Very good | 38 Participants |
| Usual Care | Patient Satisfaction With Care: Overall Health | Fair | 30 Participants |
| Usual Care | Patient Satisfaction With Care: Overall Health | Good | 35 Participants |
| Usual Care | Patient Satisfaction With Care: Overall Health | Poor | 4 Participants |
| Usual Care | Patient Satisfaction With Care: Overall Health | Excellent | 12 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Overall Health | Poor | 8 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Overall Health | Excellent | 22 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Overall Health | Very good | 31 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Overall Health | Good | 40 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Overall Health | Fair | 23 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: Day 14
Population: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections | Yes | 87 Participants |
| Usual Care | Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections | No | 32 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections | Yes | 119 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections | No | 5 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: Day 14
Population: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group; 117 and 121 patients answered this survey question in the usual care group \& new critical pathway group, respectively.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV | Regimen 1 | 65 Participants |
| Usual Care | Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV | Regimen 2 | 14 Participants |
| Usual Care | Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV | Regimen 3 | 38 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV | Regimen 1 | 107 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV | Regimen 2 | 6 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV | Regimen 3 | 8 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: Day 14
Population: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 63 and 27 patients had a hospital stay in the usual care group and new critical pathway group, respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Patient Satisfaction With Care: Satisfaction With Hospital Stay | 8.2 Scores on a Scale | Standard Deviation 2.19 |
| New Critical Pathway | Patient Satisfaction With Care: Satisfaction With Hospital Stay | 8.0 Scores on a Scale | Standard Deviation 1.85 |
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: Day 14
Population: 119 \& 124 patients provided any survey data in the usual care group \& new critical pathway group; 87 \& 119 patients received IV antibiotic therapy in the usual care group \& new critical pathway group; 86 and 119 patients answered this question in the usual care group \& new critical pathway group, respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy | 8.7 Scores on a Scale | Standard Deviation 2.16 |
| New Critical Pathway | Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy | 9.0 Scores on a Scale | Standard Deviation 1.63 |
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: Day 14
Population: 119 \& 124 patients provided any survey data in the usual care group \& new critical pathway group; 87 \& 119 patients received IV antibiotic therapy in the usual care group \& new critical pathway group; 85 and 118 patients answered this question in the usual care group \& new critical pathway group, respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV | 8.6 Scores on a Scale | Standard Deviation 1.87 |
| New Critical Pathway | Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV | 8.8 Scores on a Scale | Standard Deviation 1.88 |
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: Day 14
Population: 119 \& 124 patients provided any survey data in the usual care group \& new critical pathway group; 87 \& 119 patients received IV antibiotic therapy in the usual care group \& new critical pathway group; 85 and 118 patients answered this question in the usual care group \& new critical pathway group, respectively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day | 8.4 Scores on a scale | Standard Deviation 2.36 |
| New Critical Pathway | Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day | 9.0 Scores on a scale | Standard Deviation 1.7 |
Secondary
Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time frame: 14 days
Population: 119 \& 124 patients provided any survey data in the usual care group \& new critical pathway group; 87 \& 119 patients received IV antibiotic therapy in the usual care group \& new critical pathway group; 86 and 118 patients answered this question in the usual care group \& new critical pathway group, respectively.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV | 31 - 60 minutes | 2 Participants |
| Usual Care | Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV | More than 90 minutes | 2 Participants |
| Usual Care | Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV | 16 - 30 minutes | 5 Participants |
| Usual Care | Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV | I did not need to travel to my appointments | 68 Participants |
| Usual Care | Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV | 61 - 90 minutes | 1 Participants |
| Usual Care | Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV | I don't remember | 1 Participants |
| Usual Care | Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV | Less than 15 minutes | 7 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV | I don't remember | 0 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV | Less than 15 minutes | 19 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV | 16 - 30 minutes | 17 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV | 31 - 60 minutes | 4 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV | 61 - 90 minutes | 1 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV | More than 90 minutes | 0 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV | I did not need to travel to my appointments | 77 Participants |
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: Day 14
Population: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group; 117 and 123 patients answered this survey question in the usual care group \& new critical pathway group, respectively.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV | About 30 minutes or less | 73 Participants |
| Usual Care | Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV | About 1 hour | 28 Participants |
| Usual Care | Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV | About 1.5 to 2 hours | 13 Participants |
| Usual Care | Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV | About 3 hours or longer | 3 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV | About 3 hours or longer | 1 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV | About 30 minutes or less | 87 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV | About 1.5 to 2 hours | 3 Participants |
| New Critical Pathway | Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV | About 1 hour | 32 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: Day 14
Population: FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Patient Satisfaction With Care: Wait in Emergency Room | 7.8 scores on a scale | Standard Deviation 2.63 |
| New Critical Pathway | Patient Satisfaction With Care: Wait in Emergency Room | 8.3 scores on a scale | Standard Deviation 2.25 |
Secondary
Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire
Number of days with lost/reduced productivity during follow-up, as measured with Work Productivity and Activity Impairment (WPAI) Questionnaire
Time frame: Day 14
Population: FAS population. 119 and 123 patients provided any survey data in the usual care group and the new critical pathway group; 53 and 48 patients completed all survey questions in the usual care group and new critical pathway group, respectively. 61 and 56 were employed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire | Absenteeism | 17.4 Percentage | Standard Deviation 31.96 |
| Usual Care | Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire | Impairment while working | 14.5 Percentage | Standard Deviation 24.14 |
| Usual Care | Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire | Overall work impairment | 21.3 Percentage | Standard Deviation 29.04 |
| Usual Care | Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire | Activity impairment | 24.2 Percentage | Standard Deviation 34.06 |
| New Critical Pathway | Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire | Activity impairment | 15.9 Percentage | Standard Deviation 28.88 |
| New Critical Pathway | Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire | Absenteeism | 18.9 Percentage | Standard Deviation 33.49 |
| New Critical Pathway | Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire | Overall work impairment | 16.4 Percentage | Standard Deviation 26.82 |
| New Critical Pathway | Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire | Impairment while working | 10.8 Percentage | Standard Deviation 22.3 |
Secondary
Total Length of Stay in Emergency Department (ED) During the Initial Episode of Care
Time spent in ED in hours from triage to release (either admitted to the hospital, admitted to observation, or released to home)
Time frame: Initial Care: 14 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Total Length of Stay in Emergency Department (ED) During the Initial Episode of Care | 7.7 Hours | Standard Deviation 9.09 |
| New Critical Pathway | Total Length of Stay in Emergency Department (ED) During the Initial Episode of Care | 6.1 Hours | Standard Deviation 3.94 |
p-value: 0.05t-test, 1 sided
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. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy | Peripheral IV | 93 Participants |
| Usual Care | Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy | Central line | 0 Participants |
| Usual Care | Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy | PICC line | 1 Participants |
| Usual Care | Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy | No Line | 143 Participants |
| New Critical Pathway | Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy | No Line | 136 Participants |
| New Critical Pathway | Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy | Peripheral IV | 141 Participants |
| New Critical Pathway | Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy | PICC line | 1 Participants |
| New Critical Pathway | Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy | Central line | 0 Participants |