Other Specified Complications of Labor and DeliveryVDDNCT01822158
Vaginal Delivery Debrief Checklist to Improve Team Communication
A study testing Vaginal Delivery Debrief Checklist in people with Other Specified Complications of Labor and Delivery, run by Providence Health & Services at 1 site in United States.
Trial summary
This study is to determine if using a standardized debrief checklist after vaginal delivery improves communication between the vaginal delivery health care team members and if using the checklist increases a sense of enhanced communication between team members. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Other Specified Complications of Labor and Delivery
- What is being tested?
- Vaginal Delivery Debrief Checklist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2013to 31 Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Registered Nurses (RNs) and Licensed Practical Nurses (LPNs) in the Women's and Children's Services Department who attend vaginal deliveries as well as providers who attend vaginal deliveries at Providence St Peter Hospital Family Birth Center in Olympia Washington (WA).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence St Peter Hospital 413 Lilly RD NE
Olympia, Washington, 98506
About this study
Official title: Vaginal Delivery Debrief: A Nursing Research Study
This study is to determine if using a standardized debrief checklist after vaginal delivery improves communication between the vaginal delivery health care team members and if using the checklist increases a sense of enhanced communication between team members.
Read the detailed description
This is a study for providers who are a part of the health care team involved with vaginal delivery of newborns. A checklist has been developed that may improve communication between team members following birth. The goal of this study is to evaluate whether the checklist improves or enhances team member communication.
- Being tested
- Vaginal Delivery Debrief Checklist
- Keywords
- Vaginal Delivery, Debrief, Medical Team Communication, Obstetrical Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Delivery Debrief ChecklistOther
Participating team members will utilize Vaginal Delivery Debrief checklist
| Study group | Role | What they receive |
|---|---|---|
| vaginal delivery debrief checklist | Other | Utilization of a Vaginal Delivery Debrief Checklist after vaginal deliveries for a period of three months, by team members who have consented to be a part of this study and who are present at vaginal deliveries. The Vaginal Delivery Debrief checklist consists of 2 levels. The first level includes a list of 6 key elements, such as APGAR scores,estimated blood loss, perineal repair, etc. The second level,or extended debrief, occurs whenever unanticipated outcomes, such as low APGAR scores, postpartum hemorrhage or a difficult delivery occurs. Team members complete the checklist after each delivery they attend. Receives: Other: Vaginal Delivery Debrief Checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if there is a change in satisfaction with team communication following the use of a structured debrief checklist after vaginal deliveries.
An electronic opinion survey will be administered to participants both pre and post checklist utilization. The survey was derived from communication literature on medical teams such as the collaboration items and 3 subscales from the labour and delivery version of the Safety Attitudes Questionnaire (SAQ) and the Agency for Healthcare Research and Quality (AHRQ) TeamSTEPPS training program for high functioning medical teams.
Measured: Within 6 months of data collection
Secondary outcomes (1)
Determine if the use of a vaginal delivery debrief checklist will reduce documentation of conflicting data in the electronic medical record.
Utilizing the pre-validated Vaginal Delivery Debrief Medical Record Audit Tool, records will be examined pre and post use of the Vaginal Delivery Debrief Checklist. Assessment will be made to determine if there are fewer conflicting data points in the electronic medical record (EMR) for key elements following use of the Vaginal Delivery Debrief Checklist.
Measured: Within 6 months of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study start12 May 2013
- Primary completion31 Oct 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Specified Complications of Labor and DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daren B Sachet, RN, BSN, MPA, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822158
- Sponsor's protocol ID
- PHS PSPH N 002
- Acronym
- VDD
- Status last verified
- Mar 2019
- First submitted
- 20 Mar 2013
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Delivery Debrief: A Nursing Research Study
- ClinicalTrials.gov ID
- NCT01822158
- Acronym / sponsor ID
- VDD / PHS PSPH N 002
- Keywords
- Vaginal Delivery, Debrief, Medical Team Communication, Obstetrical Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Study start
- 12 May 2013 (actual)
- Primary completion
- 31 Oct 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to determine if using a standardized debrief checklist after vaginal delivery improves communication between the vaginal delivery health care team members and if using the checklist increases a sense of enhanced communication between team members.
Detailed description
This is a study for providers who are a part of the health care team involved with vaginal delivery of newborns. A checklist has been developed that may improve communication between team members following birth. The goal of this study is to evaluate whether the checklist improves or enhances team member communication.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vaginal delivery debrief checklist | Other | Other: Vaginal Delivery Debrief ChecklistUtilization of a Vaginal Delivery Debrief Checklist after vaginal deliveries for a period of three months, by team members who have consented to be a part of this study and who are present at vaginal deliveries. The Vaginal Delivery Debrief checklist consists of 2 levels. The first level includes a list of 6 key elements, such as APGAR scores,estimated blood loss, perineal repair, etc. The second level,or extended debrief, occurs whenever unanticipated outcomes, such as low APGAR scores, postpartum hemorrhage or a difficult delivery occurs. Team members complete the checklist after each delivery they attend. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Registered Nurses (RNs) and Licensed Practical Nurses (LPNs) in the Women's and Children's Services Department who attend vaginal deliveries as well as providers who attend vaginal deliveries at Providence St Peter Hospital Family Birth Center in Olympia Washington (WA).
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal Delivery Debrief ChecklistParticipating team members will utilize Vaginal Delivery Debrief checklist | Other | vaginal delivery debrief checklist |
Primary outcome
Determine if there is a change in satisfaction with team communication following the use of a structured debrief checklist after vaginal deliveries.
Time frame: Within 6 months of data collection
An electronic opinion survey will be administered to participants both pre and post checklist utilization. The survey was derived from communication literature on medical teams such as the collaboration items and 3 subscales from the labour and delivery version of the Safety Attitudes Questionnaire (SAQ) and the Agency for Healthcare Research and Quality (AHRQ) TeamSTEPPS training program for high functioning medical teams.
1 secondary outcome
Determine if the use of a vaginal delivery debrief checklist will reduce documentation of conflicting data in the electronic medical record.
Time frame: Within 6 months of data collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daren B Sachet, RN, BSN, MPA principal investigator
Providence Health & Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal Delivery Debrief Checklist in people with Other Specified Complications of Labor and Delivery, run by Providence Health & Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if there is a change in satisfaction with team communication following the use of a structured debrief checklist after vaginal deliveries. (time frame: Within 6 months of data collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.