Informed Consent: Doula Services Pilot Program
TN Department of Health
TITLE OF STUDY
Doula Services Pilot Program
PRINCIPAL INVESTIGATOR
Mariah Phillips, Doula Services Program Director
TN Department of Health
710 James Robertson Parkway, Nashville, TN 37243
615-635-9499 | mariah.phillips@tn.gov
PURPOSE OF STUDY
You are being asked to take part in a research study. Before you decide to participate in this study, it is important that you understand why the research is being done and what it will involve. Please read the following information carefully. Please ask the researcher if there is anything that is not clear or if you need more information.
The purpose of this study is to remove the financial barriers of doula support for Medicaid-eligible patients. We expect that doula support will decrease the rates of primary cesarean sections, increase the postpartum attendance adherence and increase breastfeeding initiation. We also anticipate that doula support will decrease interracial and ethnic disparities. If the outcomes are as we expect, this intervention has promise in reducing maternal morbidity and disparities in this patient population.
STUDY PROCEDURES
Doulas will visit study subjects at their place of choice, usually their home or medical visit, at up to 3 prenatal visits, continuous labor support, and up to 3 postpartum visits. Each visit will last between 30-60 minutes and is entirely dependent on how long the study subject would like support. Doulas will provide all-encompassing support which can include discussing the following topics:
Prenatal and Labor Care
1. Role of Doula in
Labor
2. Birth Plan/Labor
planning
3. Stages of Labor
4. Pushing techniques
and positions
5. Comfort Measures
6. Navigating medical
questions/providers
7. Physical and
emotional impact of
labor
8. Birth recovery
Postpartum Care
1. Community
resources for
postpartum period
2. Processing/
discussing labor
3. Education/support
for mental and
emotional health in
postpartum period
4. Social support plan
after birth
5. Discuss postpartum
visits and wellness
Baby Care
1. Education/support
for breastfeeding
initiation
2. Education/
support for breastfee
ding maintenance
3. Safe sleep education
and support
4. Resources for baby
items
5. Discuss infant well-
baby visits
Data Collection
Doulas will collect information from study participants for the purpose of this research. This data includes personal information from birth certificate data (e.g. child’s name and date of birth, delivery and labor information), and surveying participants with the Pregnancy Risk Assessment Monitoring System (PRAMS) dataset (includes information on your experience, behaviors, and attitudes during the pregnancy and postpartum period).
You may decline to give information at any point throughout the study. You may revoke your consent for your information to be used in this study at any point. There will be no repercussions to your care if you choose to not share your information. If you would like any information or would like to see this data before you give consent, please ask your doula.
RISKS
There are no foreseeable risks to this study. You may decline to answer any or all questions and you may terminate your involvement at any time if you choose.
BENEFITS
The direct benefit to the participant is doula services throughout pregnancy provided free of cost. We hope that information obtained from this study will serve future Medicaid populations throughout pregnancy and postpartum.
CONFIDENTIALITY
For the purposes of this research study, your comments and responses will not be anonymous. Every effort will be made by the researcher to preserve your confidentiality
including the following:
• Assigning a study number for participants that will be used on all research
documents.
• All study documents and identifying participant information will be stored in an online, HIPAA-compliant password-secured database. If downloaded, identifying information will be removed. No paper files will ever be kept.
• All identifying information will be destroyed after the research study is
concluded.
Participant data will be kept confidential except in cases where the researcher is legally obligated to report specific incidents. These incidents include, but may not be limited to, incidents of abuse and suicide risk.
CONTACT INFORMATION
If you have questions at any time about this study, or you experience adverse effects as the result of participating in this study, you may contact the researcher whose contact information is provided on the first page. If you have questions regarding your rights as a research participant, or if problems arise which you do not feel you can discuss with the Primary Investigator, please contact the Institutional Review Board at 615-253-2557 or TDH-IRB.Health@tn.gov.
VOLUNTARY PARTICIPATION
Your participation in this study is voluntary. It is up to you to decide whether to take part in this study. If you decide to take part in this study, you will be asked to sign a consent form. After you sign the consent form, you are still free to withdraw at any time and without giving a reason. Withdrawing from this study will not affect the relationship you have, if any, with the researcher. If you withdraw from the study before data collection is completed, your data will be destroyed.
CONSENT
I have read and I understand the provided information and have had the opportunity to ask questions. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving a reason and without cost. I understand that I will be given a copy of this consent form. I voluntarily agree to take part in this study.