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Implementation of the NPMS Obstetric Hemorrhage Bundle at a Tertiary Center: Utilization of the Delphi Method

Primary Purpose

Pregnancy Hemorrhage, Postpartum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Survey
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pregnancy Hemorrhage

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ≥ five years of experience on the L&D unit
  • current employment on the L&D unit > 20h per week
  • prior involvement in clinical obstetric hemorrhage situations

Exclusion Criteria:

  • none

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Anesthesiologists

Obstetricians

Registered Nurses

Surgical Technicians

Arm Description

Total: 11 Intervention: Survey

Total: 11 Intervention: Survey

Total: 10 Intervention: Survey

Total: 6 Intervention: Survey

Outcomes

Primary Outcome Measures

Questionnaire of Obstetric Hemorrhage Bundle Components not Currently Adequately Implemented

Secondary Outcome Measures

Questionnaire of Perceived Barriers to Implementation of Obstetric Hemorrhage Bundle Components
Questionnaire of Feasibility of Implementation of Obstetric Hemorrhage Bundle Components
Questionnaire on Impact of Implementation of Obstetric Hemorrhage Bundle Components on Patient Care

Full Information

First Posted
January 3, 2017
Last Updated
January 10, 2017
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03018119
Brief Title
Implementation of the NPMS Obstetric Hemorrhage Bundle at a Tertiary Center: Utilization of the Delphi Method
Official Title
Implementation of the National Partnership for Maternal Safety Obstetric Hemorrhage Bundle at a Tertiary Center: Utilization of the Delphi Method
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The National Partnership for Maternal Safety (NPMS) developed an obstetric hemorrhage consensus bundle to provide every United States birthing facility consistent, validated practice guidelines. To facilitate implementation of each element of this bundle at the participants large tertiary center, the investigators utilized the Delphi method to identify deficiencies, perceived barriers to implementation, and multidisciplinary consensus on changes with high feasibility and impact on patient care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Hemorrhage, Postpartum Hemorrhage

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anesthesiologists
Arm Type
Active Comparator
Arm Description
Total: 11 Intervention: Survey
Arm Title
Obstetricians
Arm Type
Active Comparator
Arm Description
Total: 11 Intervention: Survey
Arm Title
Registered Nurses
Arm Type
Active Comparator
Arm Description
Total: 10 Intervention: Survey
Arm Title
Surgical Technicians
Arm Type
Active Comparator
Arm Description
Total: 6 Intervention: Survey
Intervention Type
Other
Intervention Name(s)
Survey
Primary Outcome Measure Information:
Title
Questionnaire of Obstetric Hemorrhage Bundle Components not Currently Adequately Implemented
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Questionnaire of Perceived Barriers to Implementation of Obstetric Hemorrhage Bundle Components
Time Frame
4 weeks
Title
Questionnaire of Feasibility of Implementation of Obstetric Hemorrhage Bundle Components
Time Frame
6 months
Title
Questionnaire on Impact of Implementation of Obstetric Hemorrhage Bundle Components on Patient Care
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ≥ five years of experience on the L&D unit current employment on the L&D unit > 20h per week prior involvement in clinical obstetric hemorrhage situations Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michaela Farber, MD, MS
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26091046
Citation
Main EK, Goffman D, Scavone BM, Low LK, Bingham D, Fontaine PL, Gorlin JB, Lagrew DC, Levy BS. National Partnership for Maternal Safety: consensus bundle on obstetric hemorrhage. Anesth Analg. 2015 Jul;121(1):142-148. doi: 10.1097/AOG.0000000000000869. Erratum In: Anesth Analg. 2019 Dec;129(6):e206.
Results Reference
background

Learn more about this trial

Implementation of the NPMS Obstetric Hemorrhage Bundle at a Tertiary Center: Utilization of the Delphi Method

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