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INSPIRE Trial for Abdominal Infections

Sponsor
Harvard Pilgrim Health Care (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05423743
Collaborator
HCA Healthcare, Inc (Other), University of California, Irvine (Other), University of Massachusetts, Amherst (Other), Brigham and Women's Hospital (Other), Rush University (Other)
102
Enrollment
101
Locations
2
Arms
76
Anticipated Duration (Months)
1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The INSPIRE Abdominal Infection Trial is a cluster-randomized controlled trial of HCA Healthcare hospitals comparing routine empiric antibiotic stewardship practices with real-time, precision medicine computerized physician order entry (CPOE) smart prompts providing the probability that a non-critically ill adult admitted with abdominal infection is infected with a resistant pathogen.

Note: enrolled "subjects" represent 102 individual HCA Healthcare hospitals that have been randomized into 92 clusters.

Condition or Disease Intervention/Treatment Phase
  • Other: Arm 1: Routine Care
  • Other: Arm 2: INSPIRE CPOE Smart Prompt for Abdominal Infection
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This cluster-randomized trial will assess a novel quality improvement antibiotic stewardship strategy for empiric antibiotic selection.This cluster-randomized trial will assess a novel quality improvement antibiotic stewardship strategy for empiric antibiotic selection.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The INSPIRE-ASP Trial (INtelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) for Abdominal (ABD) Infections
Anticipated Study Start Date :
Aug 2, 2022
Anticipated Primary Completion Date :
Dec 1, 2027
Anticipated Study Completion Date :
Dec 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm 1: Routine Care

Continuation of routine antibiotic stewardship strategies.

Other: Arm 1: Routine Care
Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards
Active Comparator: Arm 2: INSPIRE CPOE Smart Prompt

Use of a computerized physician order entry (CPOE) smart prompt alert to guide empiric choice of antibiotics for abdominal infection in non-critically ill patients in the first 3 days of hospitalization.

Other: Arm 2: INSPIRE CPOE Smart Prompt for Abdominal Infection
Quality improvement intervention: computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimate of having an abdominal infection due to a multidrug-resistant organism (MDRO) and recommends appropriate antibiotic choice for non-critically ill patients in the first 3 days of hospitalization. Continuation of other antibiotic stewardship activities in accordance with national standards.

Outcome Measures

Primary Outcome Measures

  1. Empiric Extended-Spectrum Days of Therapy (Empiric ES-DOT) [12 month intervention]

    The number of different extended-spectrum antibiotics per empiric day, summed across the first 3 days of hospitalization.

Secondary Outcome Measures

  1. Vancomycin Days of Therapy per Empiric Day [12 months]

    The number of days Vancomycin was received on the first 3 days of hospitalization.

  2. Antipseudomonal Antibiotic Days of Therapy per Empiric Day [12 months]

    The number of different antipseudomonal antibiotics, per empiric day, summed across the first 3 days of hospitalization.

Other Outcome Measures

  1. Intensive Care Unit (ICU) Transfer [Safety Outcome] [12 months]

    Days to ICU transfer, from hospital days ≥ 3 and ≤ 14.

  2. Length-of-stay [Safety Outcome] [12 months]

    Days from hospital admission until discharge or hospital day 14, where admission day is hospital day 1.

  3. Extended-Spectrum Days of Therapy with Inpatient Extended-Spectrum (ES) Antibiotic Treatment after Empiric Period [12 months]

    The number of different ES antibiotics received each day, on hospital days ≥4 and ≤14. Note: this outcome is intended for a secondary manuscript

  4. Empiric and Total Antibiotic Costs [12 months]

    Empiric and total antibiotic costs for abdominal infection during hospitalization. Note: this outcome is intended for a secondary manuscript.

  5. Incidence of Hospital-Onset C. difficile [12 months]

    Hospital-onset C. difficile positive tests (specimen obtained) on hospital days ≥4 and ≤14. Note: this outcome is intended for a secondary manuscript.

  6. Incidence of Hospital-Onset MDRO-Positive Cultures [12 months]

    Newly-detected hospital-onset MDRO-positive cultures on hospital days ≥4 and ≤14. Includes total MDRO and specific MDRO subsets. Note: this outcome is intended for a secondary manuscript.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Facility Inclusion Criteria:

  1. HCA Healthcare hospitals admitting adults for abdominal infection

  2. Facility use of MEDITECH as their electronic health record system

Facility Exclusion Criteria:

Note: unit of randomization is the hospital, however the computerized physician order entry (CPOE) alert intervention will calculate risk estimates for adults age >=18 admitted to non-intensive care unit wards and who are ordered to receive extended-spectrum antibiotics for abdominal infection.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Riverside Community Hospital Riverside California United States 92501
2 Regional Medical Center of San Jose San Jose California United States 95116
3 Good Samaritan Hospital San Jose California United States 95124
4 Los Robles Hospital & Medical Center Thousand Oaks California United States 91362
5 West Hills Hospital & Medical Center West Hills California United States 91307
6 The Medical Center of Aurora Aurora Colorado United States 80012
7 Swedish Medical Center Englewood Colorado United States 80113
8 Sky Ridge Medical Center Lone Tree Colorado United States 80124
9 North Suburban Medical Center Thornton Colorado United States 80229
10 Blake Medical Center Bradenton Florida United States 34209
11 Brandon Regional Hospital Brandon Florida United States 33511
12 Oak Hill Hospital Brooksville Florida United States 34613
13 Englewood Community Hospital Englewood Florida United States 34223
14 Lawnwood Regional Medical Center Fort Pierce Florida United States 34950
15 Fort Walton Beach Medical Center Fort Walton Beach Florida United States 32547
16 Regional Medical Center of Bayonet Point Hudson Florida United States 34667
17 Memorial Hospital Jacksonville Jacksonville Florida United States 32216
18 Lake City Medical Center Lake City Florida United States 32055
19 Largo Medical Center Largo Florida United States 33770
20 Northwest Medical Center Margate Florida United States 33063
21 Mercy Hospital Miami Florida United States 33133
22 Kendall Regional Medical Center Miami Florida United States 33175
23 Orange Park Medical Center Orange Park Florida United States 32073
24 Oviedo Medical Center Oviedo Florida United States 32765
25 Gulf Coast Regional Medical Center Panama City Florida United States 32405
26 Fawcett Memorial Hospital Port Charlotte Florida United States 33952
27 St. Lucie Medical Center Port Saint Lucie Florida United States 34952
28 Palms of Pasadena Saint Petersburg Florida United States 33707
29 Northside Hospital Saint Petersburg Florida United States 33709
30 St. Petersburg General Hospital Saint Petersburg Florida United States 33710
31 Doctors Hospital of Sarasota Sarasota Florida United States 34233
32 South Bay Hospital Sun City Center Florida United States 33573
33 Capital Regional Medical Center Tallahassee Florida United States 32308
34 HCA Florida South Tampa Hospital Tampa Florida United States 33609
35 HCA Florida West Tampa Hospital Tampa Florida United States 33615
36 Medical Center of Trinity Trinity Florida United States 34655
37 JFK Medical Center - North Campus West Palm Beach Florida United States 33407
38 Fairview Park Hospital Dublin Georgia United States 31040
39 Eastern Idaho Regional Medical Center Idaho Falls Idaho United States 83404
40 Menorah Medical Center Overland Park Kansas United States 66209
41 Overland Park Regional Medical Center Overland Park Kansas United States 66215
42 Wesley Medical Center Wichita Kansas United States 67214
43 Wesley Woodlawn Hospital & ER Wichita Kansas United States 67220
44 TriStar Greenview Regional Hospital Bowling Green Kentucky United States 41204
45 Lakeview Regional Medical Center Covington Louisiana United States 70433
46 Tulane Medical Center New Orleans Louisiana United States 70112
47 Centerpoint Medical Center Independence Missouri United States 64057
48 Research Medical Center Kansas City Missouri United States 64132
49 Lee's Summit Medical Center Lee's Summit Missouri United States 64063
50 Southern Hills Hospital & Medical Center Las Vegas Nevada United States 89109
51 Sunrise Hospital & Medical Center Las Vegas Nevada United States 89109
52 Trident Medical Center Charleston South Carolina United States 29406
53 Grand Strand Medical Center Myrtle Beach South Carolina United States 29572
54 Parkridge Medical Center Chattanooga Tennessee United States 37404
55 Parkridge East Hospital Chattanooga Tennessee United States 37412
56 TriStar Horizon Medical Center Dickson Tennessee United States 37055
57 TriStar Hendersonville Medical Center Hendersonville Tennessee United States 37075
58 TriStar Centennial Medical Center Nashville Tennessee United States 37203
59 TriStar Southern Hills Medical Center Nashville Tennessee United States 37211
60 TriStar StoneCrest Medical Center Smyrna Tennessee United States 37167
61 Medical City Arlington Arlington Texas United States 76015
62 St. David's Medical Center Austin Texas United States 78705
63 St. David's North Austin Medical Center Austin Texas United States 78758
64 Valley Regional Medical Center Brownsville Texas United States 78526
65 HCA Houston Healthcare Conroe Conroe Texas United States 77304
66 Corpus Christi Medical Center - Bay Area Corpus Christi Texas United States 78412
67 Corpus Christi Medical Center - Doctors Regional Corpus Christi Texas United States 78412
68 Corpus Christi Medical Center - Heart Hospital Corpus Christi Texas United States 78412
69 Medical City Dallas Dallas Texas United States 75230
70 Medical City Denton Denton Texas United States 76210
71 Las Palmas Medical Center El Paso Texas United States 79902
72 Del Sol Medical Center El Paso Texas United States 79925
73 Medical City Fort Worth Fort Worth Texas United States 76104
74 Medical City Alliance Fort Worth Texas United States 76177
75 Medical City Frisco Frisco Texas United States 75034
76 HCA Houston Healthcare West Houston Texas United States 77082
77 Medical City Las Colinas Irving Texas United States 75039
78 HCA Houston Healthcare Kingwood Kingwood Texas United States 77339
79 Medical City Lewisville Lewisville Texas United States 75057
80 Methodist Hospital Northeast Live Oak Texas United States 78233
81 Rio Grande Regional Hospital Main Campus McAllen Texas United States 78503
82 Medical City McKinney McKinney Texas United States 75069
83 Medical City North Hills North Richland Hills Texas United States 76180
84 HCA Houston Healthcare Southeast Pasadena Texas United States 77504
85 HCA Houston Healthcare Pearland Pearland Texas United States 77584
86 Medical City Plano Plano Texas United States 75075
87 St. David's Round Rock Medical Center Round Rock Texas United States 78681
88 Methodist Hospital Texsan San Antonio Texas United States 78201
89 Methodist Hospital Metropolitan San Antonio Texas United States 78212
90 Methodist Hospital | Specialty and Transplant San Antonio Texas United States 78229
91 Methodist Hospital San Antonio Texas United States 78229
92 HCA Houston Healthcare Mainland Texas City Texas United States 77591
93 Medical City Weatherford Weatherford Texas United States 76086
94 HCA Houston Healthcare Clear Lake Webster Texas United States 77598
95 Ogden Regional Medical Center Ogden Utah United States 84405
96 LewisGale Hospital Montgomery Blacksburg Virginia United States 24060
97 LewisGale Hospital Pulaski Pulaski Virginia United States 24301
98 Reston Hospital Center Reston Virginia United States 20190
99 CJW Medical Center (Chippenham & Johnston Willis Campuses) Richmond Virginia United States 23225
100 Henrico Doctors' Hospital Richmond Virginia United States 23229
101 LewisGale Medical Center Salem Virginia United States 24153

Sponsors and Collaborators

  • Harvard Pilgrim Health Care
  • HCA Healthcare, Inc
  • University of California, Irvine
  • University of Massachusetts, Amherst
  • Brigham and Women's Hospital
  • Rush University

Investigators

  • Study Director: Shruti Gohil, MD, MPH, UC Irvine Division of Infectious Diseases
  • Principal Investigator: Susan Huang, MD, MPH, UC Irvine Division of Infectious Diseases
  • Principal Investigator: Richard Platt, MD, MS, Harvard Pilgrim Health Care Institute/Harvard Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Richard Platt, MD, MSc, Professor and Chair, Department of Population Medicine, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier:
NCT05423743
Other Study ID Numbers:
  • PH000763B_ABD
First Posted:
Jun 21, 2022
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Richard Platt, MD, MSc, Professor and Chair, Department of Population Medicine, Harvard Pilgrim Health Care
ABD
CPOE
Empiric Therapy
Additional relevant MeSH terms:
Infections
Communicable Diseases

Study Results

No Results Posted as of Jun 21, 2022