Amelioration of Literacy Deficits in Prenatal Care

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.

Study Overview

• Status: Completed
• Conditions: Health Literacy; Prenatal Care; Numeracy
• Intervention / Treatment: Behavioral: Healthy Babies and Healthy Moms; Behavioral: Baby Basics Prenatal Guide

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 355
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Pregnant women attending study prenatal clinics with consenting clinicians. English speaking

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Babies and Health Moms; 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
Active Comparator: Baby Basics Prenatal Guide; 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction as assessed by a questionnaire developed by the study team	Patient satisfaction with medical visit as assessed by a questionnaire developed by the study team. The measure consisted of 8 items on a 5-point scale ranging from poor (1) to excellent (5). Scale scores range from 8- 40.	post medical visit up to 8 months

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Debra Roter, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: July 22, 2014
• First Submitted That Met QC Criteria: July 26, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: health literacy; RIAS; patient-physician communication; patient activation intervention; spoken literacy
• Other Study ID Numbers: HD050437; R01HD050437 (U.S. NIH Grant/Contract)