Amelioration of Literacy Deficits in Prenatal Care

Study Overview
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Brief Summary
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The purpose of the study was to develop and evaluate a skill-based, computer intervention designed to facilitate effective prenatal visit communication for women with restricted literacy.

Detailed Description
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The primary aim of the study is to develop and evaluate a skills-based, interactive computer intervention designed to enhance the communication skills of pregnant women with restricted literacy. To this end, a randomized trial compared a skill-based computer intervention to a facilitated review of pertinent print-based educational material on communication processes and its consequences. Intervention impact was evaluated through medical visit recordings and post-visit assessments by patients and clinicians. We hypothesized that women assigned to the skills-based, computer intervention would demonstrate greater use of targeted skills, be more actively engaged in the communication process, and experience more patient-centered visits than women assigned to the print-based intervention. We also hypothesized that computer use would result in greater visit satisfaction and closer patient and clinician alignment in their assessment of the patient's physical and emotional health status.. Study Design included 84 women seeing 19 obstetrical clinicians were randomized to use an interactive, skill-based, computer program or to a personalized review of a prenatal guide. Prenatal visits were recorded and coded using the Roter Interaction Analysis System (RIAS). Post-visit satisfaction and perceptions of physical and emotional health were reported. Analysis adjusted for the nesting of patients within physicians, gestation, literacy and visit length.

Official Title
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Amelioration of Literacy Deficits in Prenatal Care

Conditions
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Prenatal Care, Health Literacy, Numeracy

Intervention / Treatment
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* Behavioral: Healthy Babies and Healthy Moms
* Behavioral: Baby Basics Prenatal Guide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women attending study prenatal clinics with consenting clinicians. English speaking Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Babies and Health Moms<br>Healthy Babies and Healthy Moms was designed as a 20-minute communication skills-based computer program based on key social learning principles designed to empower women to more actively and productively use targetted skills to improve the medical dialogue of their prenatal visits. | Behavioral: Healthy Babies and Healthy Moms<br> <br> |
| Active Comparator: Baby Basics Prenatal Guide<br>The Baby Basics Prenatal Guide, published by the What to Expect Foundation, was used in a face-to-face educational session with a study research assistant during which pregnancy related information was personalized by reviewing relevant sections of the Baby Basics prenatal guide. | Behavioral: Baby Basics Prenatal Guide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient-centered communication | Audio recordings of the prenatal visits are coded using the Roter Interaction Analysis System (RIAS). The communication outcome measure is derived from this coding. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depression as assessed by the Edinburgh Depression Scale | The correlation between patient score on the The Edinburgh Depression Scale and the clinician's rating of signs of emotional state. The Edinburgh has 10 items items on a 4 point scale with score range 10-40. Higher scores indicating more symptoms of depression. Clinician completed a novel post visit assessment of the participant's emotional state asking to indicate signs of anxiety and depression observed during the recorded visit. 1 (no signs), 2 (some symptoms, but no illness), ), 3 (mild case), 4 (moderate case), 5 (severe case). Higher ratings indicated more significant anxiety and depression. | post medical visit up to 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient-physician communication, patient activation intervention, RIAS, health literacy, spoken literacy