LaPPS: Labor Podcast for Patient Satisfaction
Condition: Labor Onset and Length Abnormalities; Pregnancy Related
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      Patients will be enrolled at 28w0d-36w0d. Randomized to one of two arms:

        1. Labor podcasts - Seven labor podcasts that can be downloaded for any podcast app

        2. Usual care
    

Detailed description: 
      Objectives Overall objectives To assess the effect of listening to physician-created podcasts
      of common labor topics on patient satisfaction and perception of their birth experience
      Primary outcome variable(s) Patient satisfaction as measured by LAS + 2 satisfaction
      questions Secondary outcome variable(s) Edinburgh Postpartum Depression Scale (EPDS) scores
      Logistic regression for multivariate analysis with regards to demographics and other birth
      outcomes

      Background Recently, podcasts have been used for both undergraduate and graduate medical
      education, with studies showing that they are feasible, acceptable, and effective. Learners
      appear to enjoy podcast learning because they increased efficiency by allowing listeners to
      multitask, made listeners keep up to date with medical literature, and increased overall
      knowledge. However, podcast learning has not been as widespread for patient education. There
      have been some studies that showed that podcast patient education is feasible, and one small
      study showed increased knowledge scores after listening to podcasts.

      To our knowledge, podcast learning has never been studied in the obstetric population. Labor
      and delivery is usually a time that is fraught with questions from first time mothers, and
      more education may increase these women's perception of control and satisfaction overall with
      birth and the postpartum period. The Labor Agentry Scale (LAS)-10 is a validated instrument
      measuring expectancies and experiences of personal control during childbirth. The Edinburgh
      Postnatal Depression Scale (EPDS) is also a validated scale that measures levels of
      postpartum depression that is commonly used at our institution both immediately postpartum
      and at the postpartum visit 4-6 weeks after delivery.

      Study Design Design Pregnant patients between 28w0d - 36w0d will be randomized to one of the
      following study arms upon enrollment. Patients will be approached after 20 weeks for consent
      and randomized after they reach 28 weeks. The study will be done in an intent-to-treat
      fashion. Due to the nature of the study, blinding will not be possible.

      Study Arms 1) Labor Podcast Group - Women randomized to this arm will receive access to a
      link to download seven HUP physician created labor podcasts in addition to usual care during
      labor, delivery, and postpartum

      o Podcast topics: Labor Anesthesia, Induction of Labor, Second Stage of Labor, Reasons for
      Cesarean Section, Postpartum Recovery, Complications of Labor and Birth, Normal Labor

        -  LAS-10 and Birth Satisfaction survey - Women will be sent these surveys on postpartum
           day 2 via method they indicated they desire (either email or text message)

        -  EPDS - Women will receive this survey on postpartum day 7 via method they desire

           2. Usual care Women randomized to this arm will receive usual care during labor,
           delivery, and postpartum with the following exceptions:

        -  LAS-10 and Birth Satisfaction survey Women will be sent these surveys on postpartum day
           2 via method they indicated they desire (either email or text message)

        -  EPDS Women will receive this survey on postpartum day 7 via method they desire

      Study duration Estimated length of time to enroll all subjects and complete the study Length
      of a subject's participation time in study Project date of the proposed study

      Estimated length of time to enroll all subjects and complete study:

      Based on previous studies using the LAS-10, average score ranged between 45-53/70, with
      standard deviations ranging from 6-12. Therefore, we would estimate that the LAS score in the
      usual care group to be approximately 50. To be able to detect an effect size of 4, with a
      standard deviation of 9, and to achieve a power of 0.8 and alpha of 0.05, we would need a
      sample size of approximately 79 subjects per group. Calculating for a 20% loss to follow-up
      rate, we would anticipate recruiting 95 subjects per group.

      Our city has an average of 16% preterm birth rate. Our hospital averages 1400 nulliparous
      deliveries/year. We would conservatively estimate approaching 50% of these women in the
      prenatal period for enrollment. If we assume a 75% consent rate for the RCT, which is
      standard for our center, we anticipate enrolling 30-36 women per month in our study. We would
      therefore anticipate it taking 6 months before we reach our target sample size.

      We would then require an additional 6 months to compile and analyze the data.

      Length of subject's participation:

      Women will be followed from time of consent until 7 days postpartum Women will be followed
      from time of consent until 7 days postpartum.

      Project date of the proposed study:

      Proposed to start April 2021 for recruitment and enrollment. We anticipate enrolling all
      patients by end of September 2021. We would likely be able to conclude the study by April
      2022.

      Resources necessary for human research protection Subjects will be recruited from looking at
      antepartum clinic charts and messaged via MPM once they are deemed eligible. This can be one
      by Dr. Cai and Dr. Srinivas. Both will be trained in the study protocol prior to enrolling
      subjects.

      The research staff will also distribute information regarding the study to the aforementioned
      prenatal clinics so that written information can be handed out by providers to patients. This
      will allow for patients to be aware of the study. However, only study personnel will be able
      to consent and enroll patients.
    

Intervention name(s): Labor Podcast
Intervention type(s): Behavioral
Intervention description(s): Listening to podcasts.
Topics include:
Labor Anesthesia, Induction of Labor, Second Stage of Labor, Reasons for Cesarean Section, Postpartum Recovery, Complications of Labor and Birth
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pregnant patients between 28w0d - 36w0d will be randomized to one of the following study arms upon enrollment. Patients will be approached after 20 weeks for consent and randomized after they reach 28 weeks. The study will be done in an intent-to-treat fashion. Due to the nature of the study, blinding will not be possible.
Study Arms
Labor Podcast Group
Usual Teaching
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Nulliparity; Podcast; Labor