Use of an Educational Multimedia Tool Versus Routine Care for the Uptake of Postpartum LARC in High-Risk Pregnancies

Study Overview
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Brief Summary
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The purpose of the study is to evaluate if the implementation of a multimedia based educational tool and regular reminders with shared decision-making will increase the rate of LARC uptake and retention in high risk pregnancy patients within 12 weeks of delivery and to study the rates of retention of LARC at 12 and 24 months and short-interval pregnancy rates.

Detailed Description
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This study will include 380 women aged 18-50 enrolled between 28 weeks gestation and postpartum day #1 who have a pregnancy that is considered high-risk. After consent, participants will be randomized to either routine care or multimedia based intervention. The intervention will include an investigator created decision aid presented at the time of randomization and reminder texts until 12 weeks postpartum. The primary objective is to evaluate the rate of LARC uptake and retention within 12 weeks of delivery. Secondary objectives include i) the retention of LARC at 12 and 24 months and ii) short-interval pregnancy rates.

Official Title
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Use of an Educational Multimedia Tool Versus Routine Care for the Uptake of Postpartum LARC in High-Risk Pregnancies (SUSTAIN): A Randomized Clinical Trial

Conditions
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Pregnancy, High Risk, Contraception

Intervention / Treatment
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* Behavioral: Decision Aid
* Behavioral: Routine Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 13-50 years old High risk pregnancy due to either maternal medical conditions or obstetric/neonatal complications Exclusion Criteria: Planned cesarean hysterectomy Unable to provide informed consent in either English or Spanish Unable to provide reliable cell phone access for the study duration Not willing to provide follow-up for two years

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decision Aid<br> | Behavioral: Decision Aid<br>* Following randomization, participants will independently view the multimedia based decision aid on a provided tablet. They will also receive provider counseling. For the remainder of the pregnancy, they will receive a text message with a link to the multimedia based presentation. This will occur every 4 weeks until 12 weeks postpartum.<br>|
| Active Comparator: Routine Care<br> | Behavioral: Routine Care<br>* The control arm will receive routine prenatal care including provider counselling on postpartum contraceptive options.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of initial LARC utilization | Number of subjects who elect to have LARC procedure between the 2 arms | 12 weeks postpartum (12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who keep the LARC after placement |  | 12 months | 
| Number of patients who keep the LARC after placement |  | 24 months | 
| rates of short interval pregnancy | Number of patients who become pregnant after enrollment pregnancy | 24 months |