A Program Evaluation to Measure the Feasibility of the Team Birth Project
Phase: NA
Conditions: Pregnancy Complications, Cesarean Section Complications, Maternal Complication of Pregnancy, Communication, Multidisciplinary
Sponsor: Harvard School of Public Health (HSPH)

 
Team Birth Project - Study Protocol 20 August 2019  
 
1 
 
 
 
 
 
 
 
 
 
A Program Evaluation to Measure the Feasibility 
of the Team Birth Project 
 
NCT03529214 
 
August 20, 2019 
 
 

 
Team Birth Project - Study Protocol 20 August 2019  
 
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STUDY PROTOCOL 
 
Team Birth Project 
 
A Partnership to Improve Vaginal Delivery Rates while 
Enhancing the Safety and Experience of Care 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Team Birth Project - Study Protocol 20 August 2019  
 
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TABLE OF CONTENTS 
1. BACKGROUND AND SIGNIFICANCE 
5 
2. STATEMENT OF THE PROBLEM 
5 
I. Timing of Key Decisions 
5 
II. Shared Information and Decision Making 
6 
III. Conflation of risk 
6 
3. PROCESS IMPROVEMENT PROGRAM 
7 
I. Program Description 
7 
II. Tools 
8 
III. Implementation Plan 
11 
IV. Local Quality Assurance 
14 
4. RESEARCH PROJECT: PROGRAM EVALUATION 
16 
I. Aims and Endpoints 
16 
II. Research Eligibility Criteria 
20 
III. Data Collection 
20 
IV. Analysis 
26 
V. Outputs 
26 
5. BENEFITS 
27 
6. RISKS 
28 
7. DATA MONITORING AND ADVERSE EVENTS 
29 
I. Data and Outcomes Monitoring 
29 
II. Adverse Events Reporting Guidelines 
29 
8. DATA SECURITY & PRIVACY 
30 

 
Team Birth Project - Study Protocol 20 August 2019  
 
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I. Data Security 
30 
II. Data Privacy 
30 
9. REFERENCES 
31 
10. APPENDICES 
32 
Appendix 1: Tools 
32 
Appendix 1a: Shared Labor and Planning Delivery Board 
32 
Appendix 1b: Admission Decision Aid 
33 
Appendix 1c: Delivery Decision Aid 
34 
Appendix 2: Tool Development and Adaptation 
36 
Tool Development 
36 
Tool Adaptation 
36 
Appendix 3: Patient Record Data Measures 
38 
 
 
 
 

 
Team Birth Project - Study Protocol 20 August 2019  
 
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1. Background and Significance  
Supporting and caring for women in labor often requires making difficult decisions with 
imperfect information. Among the most challenging decisions is when to deliver via cesarean. 
Modern maternal healthcare systems have the capacity to save lives by performing cesarean 
deliveries but we sometimes overuse this capacity in ways that can be harmful.1,2 The 
national cesarean delivery rate in the United States has increased by 500% since the early 
1970s without proportional benefit to mothers or term infants.3 This shift is not well 
explained by demographic changes, women’s preferences, reimbursement or malpractice 
policies.2,4–7 Furthermore, cesarean delivery rates vary 10-fold, from 7% to 70% at the 
hospital-level, suggesting a significant opportunity for improvement with hospital-based 
quality improvement programs.8–10 The WHO has recently advocated for programs that move 
away from rigid adherence to labor progress protocols towards enhanced models of team 
communication.11  
This project will evaluate and support the implementation of a process improvement program 
that is designed to improve vaginal delivery rates to enhance the safety and experience of 
care. The program was developed through a one-year design effort at Ariadne Labs that 
included literature review, expert validation, workflow mapping, feature selection, 
prototyping and rapid cycle testing.  
2. Statement of the Problem 
The goal is to improve vaginal delivery rates to enhance the safety and experience of care. 
Cesarean delivery rates have been selected as the primary patient safety indicator because 
overuse of cesarean deliveries is a national concern and cesarean reduction is a top priority 
among the American College of Obstetricians and Gynecologists, Society for Maternal Fetal 
Medicine, and American College of Nurse Midwives.  
To date, professional efforts to safely reduce cesarean rates focus on improving clinical 
knowledge. Policymakers, payers and purchasers tackle addressing misaligned incentives 
through payment and malpractice reforms. However, emerging research at Ariadne Labs 
suggest a third, previously unaddressed root cause -- unintentional errors due to system 
complexity.12  
This project aims to mitigate errors rooted in system complexity by addressing three types of 
challenges that can influence team performance:  
I. Timing of Key Decisions 
Optimizing the timing of when to admit patients to a labor and delivery room or when to 
deliver operatively has a substantial impact on the likelihood of cesarean delivery 
independent of other risks and preferences. Guidelines on when to do a cesarean delivery are 
imprecise. In emergent situations, obstetric clinicians (nurses, midwives and doctors) agree 
about when to perform a cesarean delivery, but reasonably disagree about when to act to 
prevent an emergency. In the absence of a communication process to ensure appropriate 
decision makers are considering all of the pertinent information and using a common decision 

 
Team Birth Project - Study Protocol 20 August 2019  
 
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framework, disagreements can go unrecognized or unresolved. As a result, even well-
intended, well-trained and board-certified clinicians perform surgeries that appear to be 
potentially avoidable, and even harmful, in retrospect.  
II. Shared Information and Decision Making 
When deciding which actions should be taken to ensure the safety of the mother and baby, 
obstetric clinicians are often presented with disconnected pieces of information, uncertainty 
and time pressures when synthesizing large volumes of data. Women have a unique insight 
into their preferences, symptoms, energy, mood, and motivation during labor. Labor nurses 
often spend the most time with the laboring woman collecting objective and subjective data, 
and tracking labor progress. Obstetricians and midwives typically have the most technical 
proficiency at intervening during labor. Nonetheless, each person often evaluates the status 
of labor tacitly and clinicians make decisions with limited accountability to each other or to 
the laboring woman.  
Clinical decisions are generally based on trend data. The present is analyzed in the context of 
the past to predict the future. There is no reliable process to ensure all members of the team 
are reviewing the same information together with a shared mental model of how this data 
should inform their actions. These factors can lead to inaccurate decision making since it is 
difficult to keep track of timelines and activities in a clinician’s working memory, particularly 
as they may also be responsible for other patients simultaneously. 
III. Conflation of risk 
Labeling risk in obstetrics (e.g. hypertension, advanced maternal age, gestational diabetes 
etc.) is important to identify those pregnancies that have an increased risk of poor outcome 
for either the mother or the baby. However, these labels can be used sub-optimally during 
labor where “high risk pregnancy” is often conflated with “high risk labor”. For example, a 
pregnant woman with hypertension may be at high risk during her pregnancy but can still be 
expected to have a routine and labor deliver vaginally. Moreover, clinicians can sometimes 
conflate maternal, fetal and labor progress status when making decisions, meaning that care 
plans may not always be specific to the concern identified, leading to inaccurate decision 
making. 
 
 

 
Team Birth Project - Study Protocol 20 August 2019  
 
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3. Process Improvement Program 
I. Program Description 
Ariadne Labs has developed a process improvement program called the “Team Birth Project” 
that consists of 1) a set of three tools to designed to improve team communication and 
decision making during labor, 2) training and coaching to support sustained implementation of 
these tools and 3) data collection for assurance of implementation fidelity. 
Our program is designed to achieve four behaviors that support team performance. We 
identified these behaviors and designed tools to support them through a one-year human-
centered design process that included expert validation and rapid cycle testing.  
The team behaviors are as follows: 
Behavior 1: Promote the roles of the laboring woman, nurse, and delivering provider as 
members of the care team with equally valuable input for decision-making 
Behavior 2: Elicit laboring woman’s preferences, symptoms, and subjective 
experiences to inform care plans 
Behavior 3: Distinguish between maternal, fetal, and labor progress statuses and care 
plans 
Behavior 4: Set shared expectations for next planned evaluation 
These behaviors will be carried out by the “minimum care team,” which consists of three 
individuals: the laboring woman, the labor nurse, and the provider (obstetrician or midwife).  
The minimum care team will come together during a team huddle (structured conversation 
about care and corresponding plans) to carry out these behaviors. Other individuals may also 
be involved in these huddles depending on the circumstance (e.g. anesthesiologist, labor 
support individuals, doula, neonatologist), but at least the minimum care team must be 
physically present to be considered a complete huddle. 
Huddles should ideally take place during the following key moments: 
1) Before or soon after a laboring woman is admitted to a labor and delivery room 
2) At any time during the active phase of labor (when cervical dilatation is >4-6cm) 
3) When the laboring woman commences pushing (cervical dilation = 10cm) 
4) When clinicians are considering operative delivery (cesarean or instrumental) 
5) When any member of the care team has concerns that may require a change of plan 
 
The care team may also wish to come together as a team huddle at other times, including 
when there are changes in shift of either the labor nurse, provider, or should any member of 
the care team request a team huddle. These are not prescribed and not mandatory in this 
process improvement program. 

 
Team Birth Project - Study Protocol 20 August 2019  
 
8 
II. Tools 
The four team behaviors are the basis of the tools that have been designed for 
implementation in labor and delivery units across the country to increase vaginal delivery 
rates. The development of these tools is described in Appendix 2. These tools act in concert 
during the childbirth encounter to promote optimal timing of admission to the labor and 
delivery unit, generate reliability during clinical assessments in labor and precision when 
distinguishing concerns in labor and to foster accuracy when making decisions to deliver 
operatively.  
i) Shared Labor and Delivery Planning Board (Appendix 1a) 
The Shared Labor and Delivery Planning Board is a patient facing whiteboard which will be 
located all labor and delivery rooms in the hospital. Components of the board include: 
designated spaces for names of the care team (behavior 1), preferences (behavior 2), plans 
across the maternal, fetal, and progress categories (behavior 3), and next steps in care 
(behavior 4).  
The care team will be constructed uniquely each time, but at a minimum the names of the 
laboring woman, the labor nurse and provider should be documented on the whiteboard. The 
purpose of the board is to act as a fulcrum for the care team to come together and huddle at 
defined key moments. The huddles will involve collating shared information, clearly 
distinguishing between maternal, fetal, and progress statuses, developing corresponding care 
plans, and setting expectations for future evaluations.  
ii) Admission Decision Aid (Appendix 1b)  
The Admission Decision Aid is a one-page tool intended to be used primarily by the triaging 
clinician to prevent premature admission of laboring women to a labor and delivery bed. The 
triaging clinician may choose to involve the laboring woman or other clinicians in using the 
tool, but how this is done will not be prescribed by Ariadne Labs Project Team. The tool 
defines a new category of indication, deferred admission for women in early labor, for 
clinicians to identify those women who are unable to return home but can be supported with 
care options which do not require admission to a labor and delivery room.  
Specifically, the Admission Decision Aid 1) improves precision by separating the reasons for 
admission into three distinct categories: maternal, fetal, and progress, 2) improves accuracy 
by distinguishing between patients who need to be admitted versus those whose admission 
can be deferred and 3) organizes the care options which can be reviewed with other 
members of the care team when constructing care plans to manage the care of laboring 
women.  
iii) Delivery Decision Aid (Appendix 1c)  
The Delivery Decision Aid is a one-page tool intended to improve the accuracy of decisions to 
intentionally deliver a baby (via cesarean or operative vaginal delivery) instead of allowing 
labor and delivery to proceed. The tool is to be used by the labor nurse and delivering 
provider in front of the laboring woman during a team huddle when clinicians are considering 

 
Team Birth Project - Study Protocol 20 August 2019  
 
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whether an operative delivery is indicated or when any member of the care team would like 
to review the care options. 
The Delivery Decision Aid 1) improves precision by separating the reasons for performing an 
operative delivery into three distinct categories: maternal, fetal, and progress), 2) requires 
reliability and accountability (ensuring the minimum criteria to deliver have been confirmed 
each time this decision is made, and requiring that this confirmation and decision process 
occurs verbally with the nurse, delivering provider, and woman all present), and 3) organizes 
the care options which can be reviewed with other members of the care team when 
constructing care plans to manage the care of laboring women. 
 
 

 
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III. Sites 
Four sites have been selected to partner with Ariadne Labs to trial this process improvement 
program. We have aimed for diversity in the choice of site which includes the following 
variables: geography, rural/urban mix, facility type (academic health canter, community 
hospital, critical access hospital etc.) delivery volume, provider mix and patient 
demographics. Overlying these parameters, we have used four criteria -- specifically high 
need (facility cesarean rates have room for improvement), willingness to engage in the 
improvement program with capacity to support the implementation of the program and 
broader relationships that can lead to spread of the program regionally and nationally. 
 
The criteria are described in more detail below. 
NEED: Hospitals with NTSV 1 cesarean rates above the HealthyPeople 2020 target of 
23.9% 
WILL: Site leadership commitment at the executive, service line, and front-line levels 
CAPACITY: Site infrastructure to support quality improvement activity, including 
oversight responsibility for quality, data tracking for quality assurance, and standing 
quality assurance committees 
RELATIONSHIPS: Site has relationships with state perinatal quality collaborative 
department of public health, or other stakeholders to facilitate spread. 
SITE 
SPECIFICS 
LAUNCH 
CONFIRMED 
South Shore Hospital, South 
Weymouth, Massachusetts 
Community hospital, annual delivery 
volume ~3000, 40% NTSV rate 
April 2018 
Saint Francis Hospital, Tulsa, 
Oklahoma 
Catholic, not-for-profit health system, 
annual delivery volume ~4000, NTSV rate 
36% 
September 
2018 
Eastside Health Alliance – 
Overlake Medical Center and 
Evergreen Health, Puget 
Sound, Washington 
Alliance between a regional non-profit 
hospital and a public district hospital  
January 2019 
 

Team Birth Project - Study Protocol 26 March 2019 
 
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IV. Implementation Plan  
Table 1: Study activities 
Activity 
Lead team 
QI or 
research 
 
Pre-
implementation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Ongoing
 
Implementation period 
 
Identify super-users and champions 
Site 
QI 
✓ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Small scale implementation 
Both 
QI 
✓ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Training the trainers 
Ariadne 
QI 
✓ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Training the observers 
Ariadne 
QI 
✓ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Installation of tools 
Site 
QI 
✓ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Widespread training 
Site 
QI 
✓ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Ongoing coaching & support 
Both 
QI 
 
✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ 
 
Training evaluation 
Site 
QI 
✓ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Observations  
Site 
QI 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Four 12-hour shifts per week 
 
 
 
✓ ✓ ✓  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Three 6-hour shifts per week 
 
 
 
 
 
 ✓ ✓ ✓ ✓ ✓  
 
 
 
 
 
 
 
 
 
 
Three 4-hour shifts every other week 
Ad hoc as needed for sustainability 
 
 
 
 
 
 
 
 
 
 
 ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ 
 
✓ 
Patient record data extraction 
Both 
Both 
 
✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ 
✓ 
Management Surveys 
Site 
Research 
✓ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 ✓ 
 
Clinician Practice Surveys 
Site 
Research 
 
✓  
 
 
 
 
 ✓  
 
 ✓  
 
 
 
 
 
 
Clinician Acceptability and Feasibility 
Surveys 
Site 
Research 
 
 
 ✓  
 
 
 ✓  
 
 ✓  
 
 
 
 
 
 
Clinician in-depth interviews 
Ariadne 
Research 
 
 
 
 
 
 
 
 ✓  
 
 ✓  
 
 
 
 
 
 
Focus Group Discussions 
Ariadne 
Research 
 
✓  
 
 
 
 
 ✓  
 
 ✓  
 
 
 
 
 
 
Patient Postpartum Surveys (daily) 
Site 
Research 
 
✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ 
 
Data use agreement  
Both 
Both 
✓ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Collect and store data for analysis 
Both 
Both 
 
✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ 
 
Monitor data for quality and changes 
in outcomes 
Both 
Both 
 
✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ 
 
Data analysis  
Ariadne 
Research 
 
 
 
 
 
 
 
 
 
 
 
 
 ✓ ✓ ✓ ✓  
 
 
Publications 
Both 
Research 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 ✓ ✓ ✓ ✓ 
 

Team Birth Project - Study Protocol 26 March 2019 
 
12
The implementation plan will be co-developed by the local site and the Ariadne Labs Project 
Teams (see Appendix 4 for a list of project team members). All clinicians (labor nurses, and 
obstetricians and midwives) in the unit will participate in the initiative as a component of the 
hospital process  improvement effort.  
The tools will be used for all women other than those who have 1) a scheduled cesarean 
delivery or 2) are being induced for fetal loss.  
i) Local Site Implementation Team 
A core local team will be identified to embed the program and socialize the tools to generate 
buy-in from frontline staff. Key site leaders include: 1) local leaders (e.g. chair of obstetrics 
and gynecology, nurse manager, head of midwifery) to champion the project in the labor and 
delivery unit, 2) executive sponsor (e.g. chief medical officer) to support implementation at 
the administrative and board level, and 3) day to day clinical champions among physicians, 
midwives, and nurses to troubleshoot and propel the program forward. This implementation 
team will direct local implementation processes with support from the Ariadne Labs Project 
Team. 
ii) Ariadne Labs Implementation Team 
The Ariadne Labs Team will support each local site implementation team with initial clinician 
training to introduce the behaviors and tools and subsequently ongoing coaching. The team 
will include implementation specialists, clinical coaches and trainers.  
iii) Implementation Schedule 
1. Small scale implementation: Preceding widespread training, the Ariadne Labs Project 
Team will train a small group of clinician champions and “super-users” in the program 
and tool use. These clinicians will be identified by the local site implementation team 
and will include labor nurses, obstetricians and midwives as appropriate for the 
context. They will trial the tools and behaviors to identify ideas for site-specific 
adaptations and build a library of local testimonials to help generate buy-in among 
their peers during socialization and widespread training.  
 
2. Training the trainers: super-users will be trained to train and coach their peers to help 
build their capacity to deliver widespread training to all frontline clinical staff at each 
site with assistance from the Ariadne Labs Implementation Team. Super-users will 
become “experts’ in the use of the tools and provide technical assistance and support 
to other clinicians using the tools. Both champions and super-users will help to 
troubleshoot any challenges in implementing the tools.  
 
3. Training the observers: Each local site will allocate local staff to be observers in both 
triage and labor and delivery unit. Observers will be trained to use a structured 
observation form by the Ariadne Labs Project Team to ensure consistency of data 

 
Team Birth Project - Study Protocol 20 August 2019  
 
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collection. The observers may also be trained as coaches to be able to provide 
feedback to the clinicians they are observing about areas for improvement. 
 
4. Installation of tools: The Ariadne Labs Project Team will share the most updated 
versions of the tools via a shared folder. Each local site implementation team will be 
responsible for printing and distributing materials and positioning the labor and 
delivery planning board to ensure accessibility, visibility and ease of use in labor and 
delivery rooms. The Ariadne Labs Project Team and local site implementation team 
will work together to determine location and accessibility of the decision aids. Should 
versions of the decisions aids change during implementation, the Ariadne Labs Project 
Team will be responsible for incorporating the changes into the tool and distributing 
updated tools to each local site implementation team in an organized and timely 
manner.  
 
5. Widespread training: Each local site will expect all of the clinicians involved in 
childbirth care with hospital practice privileges (nurses, midwives, and obstetricians) 
to participate in the training, but the format will be dependent on their availability. 
The training will be conducted by the local site implementation team with support 
from the Ariadne Labs Implementation Team and will include a combination of 
didactic and interactive sessions. The didactic sessions will aim to generate buy in for 
the initiative and introduce the key behaviors and tools. Learning objectives will 
include understanding the conceptual framework of dividing statuses and care plans 
into maternal, fetal, and labor progress categories and the categorization of delivery 
indications based on clinical urgency. Interactive sessions will include reflections, 
discussions, and roleplays to allow clinicians to react to the behaviors and tools and 
begin to practice implementing them in hypothetical, simulated scenarios. 
 
6. Ongoing coaching & support: Once all local staff have been trained in the use of the 
tools and the quality improvement program has gone “live” across the site, the 
Ariadne Labs Implementation Team will support local implementers, champions and 
super-users through weekly calls. The Ariadne Labs Project Team may also conduct 
site visits to identify any contextual or mitigating factors that are affecting the 
implementation of the tools with the intent to co-produce solutions. 
 
 
 
 
 
 
 

 
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V. Local Quality Assurance 
Each local site team, with support from the Ariadne Labs Project Team, will conduct routine 
quality assurance to assess the fidelity of program implementation using a mixed methods 
approach. These data will help identify potential adaptations to improve the implementation 
of the behaviors and tools. Quality assurance data collection methods will include the 
following components: training evaluations, observations, patient record data, and weekly 
coaching calls.  
1. Training evaluations will assess the experience and quality of the training.  
a) Training evaluations will be administered by trainers following the initial 
training as an electronic survey.  
b) The local site will administer the electronic survey to all clinicians’ email 
addresses. 
c) All clinicians involved in the training will be invited to participate in the 
evaluations. 
d) All surveys will be anonymous. 
e) Only data that defines the clinician role of respondents will be collected. No 
individual identifiers will be collected.  
f) Participation will be voluntary and uncompensated. 
 
2. Observations will document the use of the three tools (admission decision aid, delivery 
decision aid, planning whiteboard) as well as the nature of the interactions and 
conversations that occur during huddles.  
a) Observations will be conducted by trained members of the local teams, 
including nurse managers, nurse educators and other individuals involved in 
quality administrative roles. Local observers will receive training from the 
Ariadne Labs Project Team to support reliable and actionable observations.  
b) Local staff will use a paper observation checklist to capture quantitative and 
qualitative data about the huddles.  
c) No identifiable information about the patient or the participating clinicians will 
be collected by the observers. 
d) Observers will transfer data from the paper observation checklist into an 
electronic format. Local site observers will decide how to store or dispose of 
paper checklists. 
e) Observer shifts frequency will be as follows: 
i. 
Month 1-3: four 12-hour shifts (2 weekday, 1 night and 1 weekend) 
ii. 
Month 4-8: three 6-hour shifts (1 weekday, 1 weekend, 1 night) 
iii. 
Month 9-18: three 4-hour shifts on alternate weeks (1 weekday, 1 
weekend, 1 night) 
iv. 
Ongoing: ad hoc as needed for sustainability and training new staff 
f) Observers will be alerted to when a key moment is occurring by the care team 
or by the charge nurse on the labor and delivery unit. If two key moments are 
happening simultaneously for two patients, observers may use their discretion 

 
Team Birth Project - Study Protocol 20 August 2019  
 
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about which observation to make to capture a range of key moments and types 
of laboring women.  
g) The clinicians will introduce the observer and explain the purpose of the 
observation to the laboring woman and her family and ask the laboring woman 
if she agrees to the observation or wishes to opt out. 
 
3. Patient record data collected by each local site for tracking quality and reporting 
including cesarean delivery rates and adverse outcomes will be used to assess if the 
project is having any impact on these measures. 
a) Patient record data will be extracted from the medical record system by the 
data and quality team at each local site. 
b) The indicators that will be collected and analyzed for the project have been 
identified based on the measures used for other cesarean birth reduction 
projects and the measures of greatest interest to site leadership (see Appendix 
3 for more details).  
c) The Ariadne Labs Project Team will support each local site team with designing 
a system to extract any data required for the project that is not currently 
being regularly collected. 
d) The Ariadne Labs Project Team will analyze the data and produce reports to 
share with the local site implementation team and frontline clinicians to track 
progress with project implementation and key outcomes of interest. 
 
4. Weekly coaching calls will include conversations on the facilitators, barriers, and 
adaptations the local teams are encountering throughout the implementation process. 
a) The Ariadne Labs Project Team will take detailed notes on the coaching calls to 
capture the lessons and challenges experienced by the local site teams.  
b) The Ariadne Lab Project Team will qualitatively analyze the notes within and 
across calls to identify common themes to inform future coaching and 
implementation problem solving. 
 
Monitoring and analyses for implementation fidelity will be conducted by the local site team 
and Ariadne Labs Project Team. These analyses will include quantitative analyses of the 
training evaluations, observations, and patient record data and qualitative analyses of the 
observations and weekly coaching calls. The analyses will be shared with each local site 
implementation team and frontline clinicians through regular reports. 
 
 
 
 
 

 
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4. Research Project: South Shore Program Evaluation 
The Ariadne Labs Project Team will evaluate the feasibility and acceptability of implementing 
the process improvement program at each local site, as well as the potential benefits and 
harms of the program, for generalizable lessons for broader implementation.  
I. Aims and Endpoints 
This study has four aims: 
1. Adaptation of the tools and implementation strategy to optimize practice of the four 
core behaviors  
2. Documentation of the feasibility and acceptability of tools and implementation 
strategy to clinician and patient participants 
3. Detection of any unintended consequences associated with the tools or 
implementation of the tools 
4. Collection of preliminary data on the relationship between the tools and subsequent 
implementation on patient outcomes between the use of the tools and corresponding 
implementation with cesarean delivery rates 
 
As the Quality Improvement Program progresses at each local site, we will collect additional 
data toward the above aims (Table 4). The three primary endpoints relate to the 
implementation of the intervention (Primary 1), its acceptability to various groups (Primary 
2), and any unintended consequences, including adverse events that could impact patient 
safety (Primary 3). Additionally, cesarean delivery rates will be monitored at each site to 
identify any decline as a secondary endpoint. Since this is not an effectiveness trial, the study 
is not intentionally powered or designed to detect this reduction. The two exploratory 
endpoints will measure the specific adaptations of the program and any information on how 
the program succeeds or struggles in various contexts. 
 
 
 
 
 
 
 

 
Team Birth Project - Study Protocol 20 August 2019  
 
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Table 4: Endpoints 
Primary 
1 
High fidelity Implementation of the program 
2 
Acceptability and feasibility of the program 
3 
Patient safety 
Secondary 
  
Patient benefit, including program effectiveness at 
improving vaginal delivery rates 
Exploratory 
1 
Adaptation of the program for improvement 
2 
Determinants of how program successes and failures 
  
The aims and endpoints will be measured with a variety of outcome measures, as shown in 
Table 5. Each aim maps to an endpoint, which is paired with a specific research question. The 
table also lists the specific measures and data sources we will use to address each question 
and the domains covered in each data source.  

Team Birth Project - Study Protocol 26 March 2019 
 
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Table 5: Aims, endpoints, outcomes, data sources, and domains 
Aim 
Endpoint 
Implementation question 
Outcome measures 
Data sources 
Domains 
1. Adaptation of the tools 
and implementation 
strategy to optimize 
practice of the four 
behaviors 
  
  
Primary 1 
How are the four core behaviors 
implemented? 
Quantity and quality 
of core 
behaviors 
performed 
Observations  
Clinician Practice Surveys 
Clinician Knowledge and 
Attitudes Survey 
Clinician Interviews 
Patient Surveys 
Involvement of minimum team 
Incorporation of woman’s input 
Precision of MFP distinction 
Shared expectations 
Primary 1 
Are the tools implemented? 
Quantity of tool use Observations  
Clinician Practice Surveys 
Patient Surveys 
Team huddle occurrence 
Whiteboard use 
Admission decision aid use 
Delivery decision aid use 
Exploratory 1 What adaptations are made to the 
intervention? 
Adaptations 
Clinician Interviews 
Implementation Focus 
Groups Discussions 
Site-specific adaptations 
Generalizable adaptations 
2. Documentation of the 
feasibility and 
acceptability of the tools 
and implementation 
strategy to clinician and 
patient participants 
  
  
Primary 2 
Do clinicians find the tools acceptable 
and feasible to implement? 
Clinician reports 
Clinician Acceptability and 
Feasibility Surveys 
Clinician Interviews 
Implementation Focus 
Group Discussions 
Perceived value of behaviors, 
including collaboration 
Ease of integration in workflow 
Adaptations and suggestions for 
improvement 
Primary 2 
Are the tool and implementation 
strategy acceptable to patients? 
Patient reports 
Patient Surveys 
Role in care 
Communication with team 
Timing of care 
Primary 2 
Do site teams find the tools acceptable 
and feasible to implement? 
Site team reports 
Implementation Focus 
Group Discussions 
Facilitators 
Barriers 

 
Team Birth Project - Study Protocol 20 August 2019  
 
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Table 5: Aims, endpoints, outcomes, data sources, and domains 
Aim 
Endpoint 
Implementation question 
Outcome measures 
Data sources 
Domains 
Adaptations 
Coaching and support 
3. Detection of any harms 
to associated with the 
tools or implementation 
of the tools 
Primary 3 
  
 
Has there been any harm to 
patients as a result of the tools 
and implementation strategy?  
Patient outcomes 
and care 
processes 
Patient Level Data 
Intervention rates 
Maternal morbidity and mortality 
Neonatal morbidity and mortality 
Patient experience 
  
Patient Postpartum Surveys 
  
Role in care 
Communication with team 
Disempowerment 
Timing of care 
4. Collection of preliminary 
data on the relationship 
between the tools and 
subsequent 
implementation on 
patient outcomes 
between the use of the 
tools and corresponding 
implementation with 
cesarean delivery rates 
  
  
Secondary 
  
  
Have there been any benefits to 
patients as a result of the tools 
and implementation strategy? 
  
Patient outcomes & 
care processes 
Patient Level Data 
Intervention rates 
Delivery indications 
Admission timing 
Admission indications 
Patient experience 
Patient Postpartum Surveys 
 
Role in care 
Communication with team 
Empowerment 
Timing of care  
Exploratory 2 What contextual factors may be 
related to cesarean delivery? 
Contextual factors 
Management Surveys 
Site Implementation Team 
focus group discussions 
Other contextual factors 

Team Birth Project - Study Protocol 26 March 2019 
 
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II. Research Eligibility Criteria 
The following participants are eligible for this research project. 
1. Clinician participants 
i. 
Inclusion criteria 
a) All clinicians (nurses, obstetricians and midwives as appropriate) who 
have practice privileges at each local site 
ii. 
Exclusion criteria 
a) None 
2. Implementation Team participants 
i. 
Inclusion criteria 
a) Each local site implementation team which includes site champions, 
super-users and others who have been involved in the implementation of 
the process improvement program at each of the local sites 
ii. 
Exclusion criteria 
     a) None 
3. Patient participants 
i. 
Inclusion criteria 
a) 18 years or older (15 years or older at St. Francis Hospital only) 
b) Live birth (spontaneous or induction of labor)  
- Vaginally or 
- With an instrument (forceps/vacuum) or 
- Unscheduled cesarean delivery 
ii. 
Exclusion criteria 
a) Scheduled cesarean delivery 
b) Experienced intrapartum, stillbirth, or neonatal death 
 
At no time during the course of the study will the Ariadne Labs Project Team directly interact 
with patient participants for the purpose of data collection. All patient participant 
interaction will be the responsibility of local site staff.  
III. Data Collection 
We will use the data we collect to assess how the tools have been implemented, any 
adaptations that have been made to the tools for greater acceptability and feasibility of the 
program in order to deriver generalizable lessons for future implementation efforts. Data will 
be used to assess any unintended consequences and benefits of using the tools in clinical 
practice. The data collection approach is based upon the logic model we developed (Appendix 
2) and Consolidated Framework for Implementation Research (CFIR). 
 
All data collected will not include any identifiers for the participating clinicians or patients. 
Clinicians, the implementation team and patients will be invited to participate in surveys, 
interviews and focus group discussion as relevant. All participation will be voluntary. There 
will be no penalty for not choosing not to complete surveys or interviews. 

 
Team Birth Project - Study Protocol 20 August 2019  
 
21
1. Management Surveys will provide background information about contextual factors, 
including delivery volume, bed occupancy rates, nurse staffing levels and other 
organizational information.  
a) This survey will be administered digitally using either a Word document or the 
online survey service Qualtrics. 
b) Data will be collected at baseline and at the end of the project through an 
electronic form designed by the Ariadne Labs Project Team.  
c) The local site Implementation Team will fill out this survey at each data 
collection point to ensure consistency of data collection. 
2. Clinician Practice Surveys will provide insight into current practices of team decision 
making and their frequency of occurrence. This survey will be administered at 
baseline, midpoint and endpoint to assess any longitudinal change in practices related 
to the key behaviors. 
a) The local site team will administer the survey three times to all clinicians’ 
email addresses.  
b) All clinicians with practicing privileges in the unit will be invited to participate 
and will be sent a hyperlink which will direct them to the Qualtrics survey. 
c) All surveys will be confidential   
d) Consent text is available in the consent language attachments. 
e) Consent will be affirmed with an agreed statement, stating that moving 
forward with the survey, the participant is providing consent to participate. 
f) Participation will be voluntary and uncompensated for completion of multiple 
surveys. 
g) The survey will take no more than 15 minutes to complete. 
3. Clinician Acceptability and Feasibility Surveys will provide insight into feasibility and 
acceptability of use of the tools for clinicians and leading indicators of issues to 
investigate further through in-depth interviews. Surveys will be conducted at month, 
3, 8 and 12 of the project.  
a) The local site team will administer the survey to all clinicians’ email addresses.  
b) All clinicians with practicing privileges in the unit will be invited to participate 
and will be sent a hyperlink which will direct them to the Qualtrics survey. 
c) All surveys will be confidential. 
d) Consent text is available in the consent language attachments. 
e) Consent will be affirmed with an agreed statement, stating that moving 
forward with the survey, the participant is providing consent to participate. 
f) Participation will be voluntary and uncompensated for completion of multiple 
surveys. 
g) The survey will take no more than 15 minutes to complete. 
4. Clinician Interviews will be used to provide deeper insights related to the Team Birth 
project including implementation. Interviews will be conducted at the project midline 

 
Team Birth Project - Study Protocol 20 August 2019  
 
22
and end line leading to a total of 15-35 interviews per site. Interviews will no longer 
be conducted monthly. Additional interviews may also be conducted ad hoc if key 
issues are raised in the surveys and further information is needed to inform 
adaptations to the tools or implementation Each interview is expected to last about 
45-60 minutes. 
 
a) Maximum variation purposive sampling will be used to identify a subset of 
clinicians who have a range of receptiveness to the project and the tools. 
b) The local site implementation team will identify clinicians in-depth interviews, 
using selection criteria such as responsiveness to the intervention (i.e. positive, 
neutral, negative), clinician type (doctor, midwife, nurse), and potentially other 
criteria to be identified. The Ariadne Labs Team will select interviewees based 
upon this list. 
c) Local sites will invite the selected participants via their email address or site 
teams will utilize a interview sign up sheet. The sheet will be kept securely on site 
by the implementation team. Participation will be voluntary and uncompensated 
for completion of multiple surveys. 
d) The Ariadne Labs Team will be responsible for scheduling of interviewees with 
participants. 
e) One-to-one semi-structured interviews will be conducted by the Ariadne Labs 
Project Team and will be audio recorded.  
f) Interviews will be conducted using a combination of methods (in person, over the 
telephone or both) depending on preference of the interviewees. In person 
interviews will be conducted at a designated location which will be guided by the 
local site. 
g) Consent text is available in the consent language attachments. 
h) Verbal consent will be obtained by the Ariadne Labs interviewer either in person or 
by telephone prior to conducting the interview. 
i) The audio files will originate with Ariadne Labs Project Team and the audio files 
will be transcribed.  
j) These interviews will not be anonymous, but no identifying information about the 
participants will be noted or recorded and all audio-recordings and transcripts will 
be kept confidential. 
k) General themes from the interviews will be shared with local site implementation 
teams.  
 
5. Clinician Knowledge and Attitudes Survey will be conducted to evaluate knowledge 
and skills related to the core behaviors, use of the tools and attitudes toward reducing 
cesarean delivery rates and implementing the intervention. This survey will no longer 
be administered.  
a) The local site team will administer the survey to all clinicians’ email addresses.  
b) All clinicians with practicing privileges in the unit will be invited to participate 
and will be sent a hyperlink which will direct them to the Qualtrics survey. 

 
Team Birth Project - Study Protocol 20 August 2019  
 
23
c) All surveys will be confidential.  
d) Consent text is available in the consent language attachments. 
e) Consent will be affirmed with an agreed statement, stating that moving 
forward with the survey, the participant is providing consent to participate. 
f) Participation will be voluntary and uncompensated for completion of multiple 
surveys. 
g) The survey will take no more than 15 minutes to complete. 
 
6. Focus Group Discussions will be conducted to identify successes, challenges and other 
contextual factors that are impacting the implementation of the tools, identify 
adaptations that have been made, why they have been made and how to improve the 
tools or the implementation program. The majority of focus group participants will fill 
all three roles (i.e. super-users, champions and implementers). Consequently, focus 
group discussions will address issues relevant to all three roles. In the event that some 
individuals only have one role, separate role-specific focus groups will be conducted 
with these individuals (e.g. some individuals may be super-users but not champions or 
implementers). Focus group discussions will be held at beginning of project, project 
midline and end line at each study site leading to 3-5 focus groups per site.  
a) Ariadne Labs Team will invite local site implementation teams to participate in 
focus group discussions. 
b) Four to six members of the implementation team, champions and super users 
will be invited to participate in each focus group discussion.  
c) A fact sheet, with all elements of informed consent, will be provided to 
participants during the scheduling process and at the time of the focus group. 
d) Participants will be given the opportunity to ask questions and asked to confirm 
their consent to participate in the focus groups. 
e) A semi-structured guide will be used. Focus groups that only include one role, 
will use a subset of questions from that guide. 
f) These discussions will audiotaped.  
g) Discussions will happen either in-person, at a location designated by the local 
site, or by video conference.   
h) Participation will be voluntary and uncompensated for completion of multiple 
focus group discussions. 
i) The audio files will originate with Ariadne Labs Project Team and the audio 
files will be transcribed.  
j) These focus groups will not be anonymous, but no identifying information about 
the participants will be noted or recorded and all audio-recordings and 
transcripts will be kept confidential. 
k) General themes from the interviews will be shared with each local site 
implementation team.   
7. Patient Postpartum Surveys will be conducted by the local site team on the 
postpartum ward to provide an insight into patient experience of the tools.  

 
Team Birth Project - Study Protocol 20 August 2019  
 
24
a. Convenience sampling will be used. 
b. Members of local staff will offer the survey electronically using an online 
survey service, Qualtrics, to all women who meet inclusion criteria while 
recovering from their delivery on the postpartum ward. 
c. The survey will be administered daily on a tablet device which will be offered 
to postpartum women by local staff. 
d. Any women who have experienced an intrapartum, stillbirth or neonatal death 
will not be asked to complete this survey. 
e. The survey will be completed once per eligible postpartum woman. 
f. There will be no incentives presented to postpartum women or surveys 
administered after discharge form the postpartum ward. 
g. Consent text is detailed in the consent language attachments and postpartum 
women will have the opportunity to ask questions to local staff prior to 
proceeding with completion of the survey. 
h. Consent will be affirmed with an agreed statement, stating that moving 
forward with the survey, the participant is providing consent to participate. 
i. Participation is voluntary and uncompensated, and women may stop taking the 
survey at any time.  
j. The survey will last no longer than ten minutes. 
k. Survey data will be analyzed and reported in aggregate on a monthly basis. 
l. Demographic data will be collected to assess the impact of the tools on 
different groups of women.  
m. Demographics that will be collected include: age, race/ethnicity, education, 
and parity.  
n. Any demographic data that is collected will not be shared unless there are at 
least five individuals in that category.  
  
8. Patient Postpartum Interviews will be conducted by study team on the postpartum 
ward to provide an insight into the patient’s care experience. Interviews will be 
conducted during the final month of data collection. Patients will also be screened to 
participate in interviews during the final month of data collection. 
a. Convenience sampling will be used. 
b. Members of the study team will offer patients the option to complete an 
interview and/or survey to all women who meet inclusion criteria while 
recovering in the postpartum ward. This is a one-time interview. There will be 
no invitations presented to patients after the patient has been discharged from 
the postpartum care unit.     
c. Any women who have experienced an intrapartum, stillbirth or neonatal death 
will not be asked to complete this interview. 
d. Participation is voluntary and uncompensated, and women may stop the 
interview at any time.  
e. The interview will last no longer than fifteen minutes and collectively no more 
than 30 minutes if completed with a survey. 

 
Team Birth Project - Study Protocol 20 August 2019  
 
25
f. One-to-one semi-structured interviews will be conducted by the Ariadne Labs 
Study Team and will be audio recorded. 
g. The audio files will originate with Ariadne Labs Study Team and the audio files 
will be transcribed. 
h. No identifying information about the participants will be noted or recorded and 
all audio-recordings and transcripts will be kept confidential. 
i. Interview will be analyzed and reported in aggregate by the Ariadne Labs Study 
Team. 
j. Demographic data will be collected to assess the impact of the care on 
different groups of women.  
k. Demographics that will be collected include: age, race/ethnicity, education, 
and parity.  
l. Any demographic data that is collected will not be shared unless there are at 
least five individuals in that category.  
m. If a patient participant completes both the survey and the interview, a code 
will be place on the interviewer’s questions sheet and the survey which will 
link the demographic information. This is to avoid the participant having to 
complete this section twice. Demographic questions will mirror those presented 
in the patient survey.  
 
9. Patient Level Data will be collected from patient records through a partnership 
between the Ariadne Labs and each local site team.  
a) Patient record data will be extracted from the medical record system by the 
data and quality team at each local site. 
b) The indicators that will be collected and analyzed for the project have been 
identified based on the measures used for other cesarean birth reduction 
projects and the measures of greatest interest to site leadership (see Appendix 
3 for more details).  
c) The Ariadne Labs Project Team will support each local site team to design a 
system to extract any data required for the project that is not currently being 
regularly collected. 
d) All data will adhere to data protection agreements as described in Section 8. 
 
10. Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey 
data will be shared with Ariadne Labs by site’s study teams.  
a) HCAHPS is a standardized, publicly reported survey of patients' perspectives of 
their hospital care and experience. All sites / hospitals are required to collect 
HCAHPS by the Centers of Medicare and Medicaid Services (CMS). The data from 
the survey will be used to allow study staff to better understand the patient 
experience in aggregate and compare with the patient surveys. 
b) HCAHPS survey report will be shared securely with Ariadne Labs via email.  
c) The survey reports will be sent on a quarterly basis including the quarter 
before launch as baseline data.  

 
Team Birth Project - Study Protocol 20 August 2019  
 
26
d) This information does not contain any protected health information and 
displays quantitative data in aggregate.  
e) The survey is a standardized, publicly reported survey of patients' perspectives 
of their hospital care and experience. All sites / hospitals are required to 
collect HCAHPS by the Centers of Medicare and Medicaid Services (CMS). 
However, Ariadne Labs will only be sent HCAHPS reports specific to the 
Obstetrical unit.  
f) The HCAHPS reports are a general hospital quality metric captures that Ariadne 
Labs will use to compare to the results of the patient postpartum surveys. 
IV. Analysis 
The Ariadne Labs Project Team will analyze all data with the goal of addressing the specific 
aims and endpoints associated with each data source. A thorough statistical analysis plan and 
table shells will be drawn up before the final data analysis, but at a minimum it will include 
both quantitative and qualitative approaches, as well as specific attention to longitudinal 
changes in endpoints over time. 
Quantitative approaches will include basic descriptive statistics such as means, percentages, 
and standard deviations over time. Because this study is not designed as a test of 
effectiveness and because our study populations will not be representative, no statistical 
tests for causal inference are anticipated. Analyses will be performed in SAS 9.4 or equivalent 
platform. 
Qualitative approaches will include rapid thematic analysis of the qualitative sections of the 
observation form, the weekly coaching calls, clinician interview transcripts and focus group 
transcripts. Thereafter, all interviews will be transcribed and could be used for secondary 
analysis with data from other sites. This secondary analysis would be coded thematically using 
QSR NVivo or equivalent program qualitative analysis software to identify commonalities and 
differences. Secondary analysis of the qualitative fields from observation forms used in the 
quality improvement program at South Shore may be conducted at a later date to identify 
lessons for key implementation lessons for South Shore and future sites.  
V. Outputs 
The research evaluation will create the three key outputs: 
1. Improved versions of the tools and implementation package that could be applied to 
successfully implement the program more broadly in the future. 
 
2. Peer-reviewed publications co-authored with local site teams describing the feasibility 
and acceptability of the intervention and qualitative experiences of implementation. 
 
3. White paper on generalizable lessons for implementation of solutions to address 
clinical complexity in childbirth. 
 
 

 
Team Birth Project - Study Protocol 20 August 2019  
 
27
5. Benefits 
Possible benefits of participating in the quality improvement program are described as below: 
1. Clinician Participants 
As a result of participation in the quality improvement program, clinician-participants 
may experience improved team communication, greater reliability and accuracy for 
decisions making at key moments related to either admission or labor and delivery at 
their site. 
 
2. Patient Participants 
As a result of participation, laboring women may feel their preferences were reflected 
in the care they received, they were involved in key decisions and have a better 
experience of childbirth.  
There are no benefits of the research project to either the clinician participants or the 
patient participants. However, insights gained from this program evaluation may contribute 
to the development of new improved methods of clinician-patient communication and 
scalable implementation lessons to support the spread of the program to other sites. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Team Birth Project - Study Protocol 20 August 2019  
 
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6. Risks 
The quality improvement program focuses on processes of care and does not specify care 
plans and does not include any treatment-decision directives. All guidance conforms with 
evidence-based and nationally endorsed guidelines from obstetrics professional organizations, 
including the American College of Obstetricians and Gynecologists, the Society for Maternal-
Fetal Medicine, the American College of Nurse-Midwives, and the Association of Women's 
Health, Obstetric and Neonatal Nurses.  
For clinician participants, attending trainings, using the tools and being observed are part of 
the hospital’s quality improvement process, so any risks would be associated with that effort 
and not the research. For patient participants, it is possible that the quality improvement 
program could be associated with a rise in complications associated with vaginal delivery, 
including 3rd/4th degree perineal lacerations and postpartum hemorrhage. Patients may also 
feel uncomfortable with having their care observed or with being explicitly included in the 
care team, especially during labor.  
For clinician participants, the research components, voluntary participation in surveys, 
individual interviews and focus groups, carry very low risk of criminal or civil liability, 
financial standing, employability, insurability or reputation discomfort because the surveys, 
interviews, and focus groups do not contain sensitive topics. For patient surveys, there are no 
anticipated any risks to patients’ criminal or civil liability, financial standing, employability, 
insurability, or reputation from taking the survey because the surveys do not contain sensitive 
topics. 
 
 
 
 
 
 
 
 
 
 

 
Team Birth Project - Study Protocol 20 August 2019  
 
29
7. Data Monitoring and Adverse Events 
I. Data and Outcomes Monitoring 
The principal investigator will assess the quality and completeness of patient level data 
regularly over the course of the study, and consistent problems will be identified and 
corrected as needed. Safety of subjects will be discussed actively and longitudinally as 
required during the period that the study is active, both with the participating site and also 
as an Ariadne Labs Project Team. Progress and potential safety or other concerns for subject 
will be discussed at protocol meetings to be held as needed during the duration of the 
protocol activity.  
II. Adverse Events Reporting Guidelines 
The proposed research will comply with the regulations set forth in 45 CFR Part 46, Protection 
of Human Subjects. The Ariadne Labs Project Team are educated on the protection of human 
research participants. They have been educated regarding HIPAA regulations and fully 
understand their responsibility to safeguard the personal health information of every 
participant involved in the research. 
A communication plan has been developed to report adverse events for either patient-
participants or clinician-participants (see Appendix 3 for a list of possible adverse events). All 
events will be reported to the site investigator, who will then report all events to the 
Principal Investigator. The site investigator will be responsible for notifying their local IRB, 
and the principal investigator will promptly notify the HMS IRB in necessary instances, as 
determined by the Principal Investigator, within 5 business days. The Ariadne Labs Project 
Team will then meet, in conjunction with the site investigator, to discuss the adverse event 
and decide on strategies to avoid such events from recurring. 
 
 
 
 
 
 
 
 

 
Team Birth Project - Study Protocol 20 August 2019  
 
30
8. Data Security & Privacy 
I. Data Security 
All data will be stored on an Amazon Web Services server in a secure environment approved 
by Harvard University Information Technology (HUIT).  
The following measures will be taken to ensure the data is stored securely: 1) all data will be 
encrypted in transit and at rest, 2) servers containing sensitive data will not be exposed to 
the internet and 3) access only to authorized personnel by role via proxy servers using AWS 
security groups and private subnets. 
Users will be required to login and passwords will be a minimum of 8 characters and be 
alphanumeric. Vulnerability scanning will be performed daily and all user activity will be 
logged.  
Additionally, data may be stored on the secure Harvard shared drive. Only the Ariadne Labs 
Project Team will have access to data and will remain up to date on Human Subjects 
Protection training.   
II. Data Privacy  
Prior to data collection, a data use agreement will be executed between Harvard TH Chan 
School of Public Health and each local site. The data use agreement will include 1) the 
purpose, 2) a description of the data and data parameters, and 3) key Ariadne Labs and site 
contacts. The signed data use agreement will be uploaded to the IRB systems as soon as it is 
available. 
Surveys will not be linked to any names or personal information. Interview data will be kept 
confidential. Observation data will not include any names or protected health information. 
Electronic medical record data that will be provided will include identifiable elements but no 
names or dates of birth will be included. 
 
 
 
 
 
 
  
 
 

 
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9. References 
1.  
Witt WP, Wisk LE, Cheng ER, et al. Determinants of Cesarean Delivery in the US: A 
Lifecourse Approach. Matern Child Health J. 2014:84-93. doi:10.1007/s10995-014-1498-
8. 
2.  
Declercq ER, Sakala C, Corry MP, Applebaum S, Herrlich A. Major Survey Findings of 
Listening to MothersSM III: Pregnancy and Birth. J Perinat Educ. 2014;23(1):9-16. 
doi:10.1891/1058-1243.23.1.9. 
3.  
Hamilton BE, Hoyert DL. Annual Summary of Vital Statistics: 2010-2011. Pediatrics. 
2013;131:548-558. doi:10.1542/peds.2012-3769. 
4.  
Declercq E, Menacker F, MacDorman M. Rise in &quot;no indicated risk&quot; primary 
caesareans in the United States, 1991-2001: cross sectional analysis. BMJ. 
2005;330(7482):71-72. doi:10.1136/bmj.38279.705336.0B. 
5.  
Ecker J. Elective cesarean delivery on maternal request. JAMA. 2013;309(18):1930-
1936. doi:10.1001/jama.2013.3982. 
6.  
Yang YT, Mello MM, Subramanian S V., Studdert DM. Relationship Between Malpractice 
Litigation Pressure and Rates of Cesarean Section and Vaginal Birth After Cesarean 
Section. Med Care. 2009;47(2):234-242. doi:10.1097/MLR.0b013e31818475de. 
7.  
Gimm GW. The impact of malpractice liability claims on obstetrical practice patterns. 
Health Serv Res. 2010;45(1):195-211. doi:10.1111/j.1475-6773.2009.01062.x. 
8.  
Kozhimannil KB, Law MR, Virnig BA. Cesarean delivery rates vary tenfold among US 
hospitals; reducing variation may address quality and cost issues. Health Aff 
(Millwood). 2013;32(3):527-535. doi:10.1377/hlthaff.2012.1030. 
9.  
Kozhimannil KB, Arcaya MC, Subramanian S V., et al. Maternal Clinical Diagnoses and 
Hospital Variation in the Risk of Cesarean Delivery: Analyses of a National US Hospital 
Discharge Database. Smith GC, ed. PLoS Med. 2014;11(10):e1001745. 
doi:10.1371/journal.pmed.1001745. 
10.  
Cáceres IA, Arcaya M, Declercq E, et al. Hospital Differences in Cesarean Deliveries in 
Massachusetts (US) 2004–2006: The Case against Case-Mix Artifact. Young RC, ed. PLoS 
One. 2013;8(3):e57817. doi:10.1371/journal.pone.0057817. 
11.  
WHO | WHO recommendations: intrapartum care for a positive childbirth experience. 
WHO. 2018. 
12.  
Plough AC, Galvin G, Li Z, et al. Relationship Between Labor and Delivery Unit 
Management Practices and Maternal Outcomes. Obstet Gynecol. 2017;130(2):358-365. 
doi:10.1097/AOG.0000000000002128. 
 

 
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10. Appendices 
Appendix 1: Tools 
 
Appendix 1a: Shared Labor and Planning Delivery Board 
 
 

 
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33
Appendix 1b: Admission Decision Aid 
 

 
Team Birth Project - Study Protocol 20 August 2019  
 
34
Appendix 1c: Delivery Decision Aid 
 

 
Team Birth Project - Study Protocol 20 August 2019  
 
35
 
 
 

 
Team Birth Project - Study Protocol 20 August 2019  
 
36
Appendix 2: Tool Development and Adaptation 
 
Tool Development 
This program was developed using a year-long, rigorous human-centered design process that 
included expert validation and rapid cycle testing. Through a comprehensive review of the 
peer-reviewed literature, gray literature, and professional organization guidelines evidence-
based strategies were identified to reduce harm from overuse of cesarean deliveries. Using 
expert consultation with approximately fifty key leaders from clinical obstetrics (nurses, 
midwives, obstetricians, anesthesiologists), patient advocacy, health services research, and 
implementation science, we prioritized the strategies based on their strength of evidence, 
impact, ability to be operationalized through simple tools, and sensitivity to context. As a 
result of this process, strategies that preserved labor progress and minimize preemptive 
cesareans for inadequate labor progress in the absence of other concerns were prioritized.  
Clinical workflow process maps and logic models were developed to identify opportunities to 
operationalize these strategies, including the specific opportunity to improve team decision-
making. A second expert consultation session surfaced four previously described behaviors. 
Using interviews with clinicians, and rapid cycle testing in simulation, a set of care planning 
and decision aids to support these behaviors at admission, during labor, and at delivery were 
developed.  
The tools organize available pertinent data and care management options using a patient 
facing shared planning board that can create accountability between the laboring woman, 
nurse and delivering provider and two decision aids to support the decisions to admit a 
woman to a labor and delivery room and to deliver her baby operatively. The decision aids 
embed guidelines for labor management from national professional organizations, but do not 
direct specific care management options. In addition to use of these aids by the care teams, 
an implementation model has been developed which will be evaluated for implementation 
fidelity and track progress towards patient safety goals. 
Tool Adaptation 
Throughout the implementation process, the local site implementation team will make 
adaptations to the tools and implementation processes based upon their context, resources, 
and early experiences with training on, coaching about, and using the tools. There are three 
categories of adaptations that can be made while maintaining implementation fidelity: 
1. No Adaptation: Features that are essential to the four behaviors that constitute the 
program objectives and therefore cannot be adapted without altering the program 
objectives. 
2. Ariadne Labs-Guided Adaptation: Features that have major impact on core behaviors 
but can be adapted by local sites with Ariadne Labs support to ensure adequate 
implementation, tracking, and measurement of the changes. 

 
Team Birth Project - Study Protocol 20 August 2019  
 
37
3. Site Guided Adaptation: Features that are not essential to the core behaviors and will 
be best adapted to local contexts and preferences. 
Tool 
No Adaptation 
Ariadne Labs-Guided 
Adaptation 
Site Guided Adaptation 
Labor and 
Delivery 
Planning 
Board 
Conversations between 
laboring woman, 
nurse, and provider 
 
Conversations in MFP 
format 
 
Updating of 
whiteboard at each 
key moment 
conversation  
In person vs. phone 
conversations 
 
Identifying critical 
moments for conversations 
 
Modifying elements of the 
labor and delivery 
planning board 
Lead roles for different 
elements of conversations 
 
Location of whiteboard in the 
labor room 
Admission 
Decision Aid 
 
Indications for admission 
may vary with site and 
context 
Plan options may vary 
according to availability at 
sites 
Delivery 
Decision Aid 
Indications for delivery 
 
Lead roles for different 
elements of verification 
 
Team members present for 
verification 
 
Plan options if do not meet 
verification indications 
 
Ariadne Labs-Guided Adaptations will be discussed with the Ariadne Labs Project Team and 
local site teams before implementation and will be rolled out at set points in time to 
facilitate measurement of the changes and acceptability. Site Guided Adaptations will be 
allowed to happen organically based on the preferences of the local champions, super-users, 
and frontline staff. All adaptations will be tracked by the Ariadne Labs Project Team along 
with the justifications for each adaptation as part of our program evaluation. 
 

 
Team Birth Project - Study Protocol 20 August 2019  
 
38
Appendix 3: Patient Record Data Measures  
Patient level data and/or calculated measures may come from ICD-10 codes or from other 
fields in the clinical record, depending on the variable and the existing data infrastructure 
and analysis processes at the hospital. The Ariadne Labs Project Team will request that the 
hospital team provides these data on a monthly basis.  
 
The Ariadne Labs Project Team will use these data to calculate indicators, such as rates and 
counts, to include in reports for the study team, managers, clinicians, and any other people 
at the hospital involved in the project. The reports will focus on primary outcomes for impact 
of the quality improvement initiative, including cesarean delivery rates and other related 
indicators (i.e. operative delivery rates). We will also monitor selected maternal and neonatal 
adverse events and co-morbidities in order to identify other potential benefits or harms and 
provide context to interpret the primary outcome results. 
 
Below are examples of the types of indicators we will report based on the patient level data 
the hospital team provides. Further below is a full list of the patient level data elements we 
will request to calculate these indicators. 
Procedures 
Maternal Adverse Events 
Neonatal Adverse Events 
− Cesarean delivery rate 
− Operative delivery rate 
− Vaginal delivery rate 
− Induction rate 
− Episiotomy rate 
− 3rd/4th degree 
laceration rate 
− Hemorrhage rate 
− Infection rate 
− ICU admission 
− Maternal death 
− Birth trauma rate 
− Rate of Apgar ≤ 7 at 
5 minutes 
− Intubation rate 
− NICU admission rate 
− Neonatal death 
Patient Comorbidities 
Other 
− Rate of diabetes 
− Rate of hypertension 
− Cholestasis of pregnancy 
− Placenta previa 
− Placenta accreta 
− Indications for cesarean 
or operative deliveries 
− Indications for admission 
− Length of labor 
 
 
 
 
 
 
 
 

Team Birth Project - Study Protocol 26 March 2019 
 
39
Maternal Variables 
Maternal ID 
Month of delivery 
Year of delivery 
Maternal age 
Gestational age 
Parity 
Prior cesarean delivery 
Scheduled cesarean delivery 
TOLAC 
Cesarean indication 
Induction 
Scheduled induction 
Admission indication 
Dilation at admission 
Labor length 
First stage of labor length 
Postpartum stay length 
Episiotomy 
Third/fourth degree laceration 
Maternal death 
Maternal ICU admission 
Postpartum hemorrhage 
Massive obstetric hemorrhage 
Blood transfusion 
Placenta accreta 
Placenta previa 
Unplanned hysterectomy 
Infection 
Sepsis 
Cholestasis 
Chorioamnionitis 
Uterine rupture 
Abruption 
Acute fatty liver of pregnancy 
Acute renal failure 
Amniotic fluid embolism 
Cardiac arrest 
Ventricular fibrillation 
Disseminated intravascular coagulation 
Deep vein thrombosis 
Ileus 
Acute heart failure 
Pulmonary edema 
Pulmonary embolism 
Substance misuse 
Pre-gestational diabetes 
Gestational diabetes 
Chronis hypertension 
Gestational hypertension 
Preeclampsia 
Eclampsia 
Sickle cell disease 
Epidural 
 
 
 
Neonatal Variables 
Baby ID 
Maternal ID 
Mode of delivery 
Presentation 
Ventilation resuscitation within the first 72 
hours 
Cardiopulmonary resuscitation within the 
first 72 hours 
Cardiac arrest 
Cephalohematoma 
Hypoglycemia 
Stillbirth 
Neonatal death 
NICU admission 
Neonatal transfer 
Unexpected newborn complications 
Apgar at 1 min 
Apgar at 5 min 
Meconium aspiration syndrome 
Birth trauma 
Intracranial hemorrhage 
Encephalopathy 
Hypotension 
Pneumonia 
Seizures 
Sepsis 
Transfusion 
Preexisting condition 
Intubation 
Continuous positive airway pressure (CPAP)

Team Birth Project - Study Protocol 26 March 2019 
 
40
Appendix 4: Local Site Teams and Ariadne Labs Project Team 
 
1. Site 1: South Shore Hospital Team 
South Shore Team Role 
Named individual 
Executive Sponsor   
Kimberly Dever, MD, President of the Medical Executive 
Committee and Associate CMO  
 
Co-Directors of Project 
Kimberly Dever, MD Chair of the Department of Obstetrics and 
Gynecology 
Julie Paul, CNM, Co-Director of Midwifery  
 
Day-to-Day Champions   
Rachel Ballester, Certified Nurse Midwife 
Judy Berk, Certified Nurse Midwife 
Faye Weir, MSN, cDNP, RN and Director Child Parent Services  
Luke Poppish, Senior Service Line Manager 
Kathleen Bruce, Labor and Delivery Nurse Manager 
Kathleen Cahill, Parent/Child Services 
Hospital Quality 
Improvement Team 
Karen Baxter, JD, RN, Director, Risk Management  
Brett Corrigan, Performance Management Specialist  
Noreen MacLean, MSN, RN Administrative Clinical Coordinator  
Christine Just, MSN, RN, CNM Director of Provider Council  
Data Analyst 
Pamela Patterson, BSN, RN Perinatal Outcomes Nurse   
Research Coordinator 
Maureen DeMenna, MSN, RN, Clinical Research Program 
Manager 
 
 
 

 
Team Birth Project - Study Protocol 20 August 2019  
 
41
2. Site 2: Saint Francis Hospital Team 
South Shore Team Role 
Named individual 
Executive Sponsor   
Shannon Filosa, RN, PhD, Executive Director of Women’s and 
Children’s Services  
Director(s) of Project 
Donald Loveless, MD, Section Chief of Obstetrics and 
Gynecology 
Karen Duncan, BSN, RNC-OB, Clinical Manager of Labor and 
Delivery 
Day-to-Day Champions   
Lisa Early, APRN-CNS, MS, C-OB, Clinical Educator  
 
Trisha Short, BSN, RN, Perinatal Safety Nurse  
Hospital Quality 
Improvement Team 
Brenda Nance, RN, Executive Director for the Quality 
Department 
 
Bonnie Parks, Manager of Outcomes Measurement 
Data Analyst 
Maggie Smith,  IT representative for Stork  
Research Coordinator 
Amber Hood, IRB and Compliance Manager