Amelioration of Literacy Deficits in Prenatal Care

Sponsor
Johns Hopkins Bloomberg School of Public Health (Other)
Overall Status
Completed
CT.gov ID
NCT05974865
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
355
1
2
57
6.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Healthy Babies and Healthy Moms
  • Behavioral: Baby Basics Prenatal Guide
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
355 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Amelioration of Literacy Deficits in Prenatal Care
Study Start Date :
Sep 1, 2006
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. patient-centered communication [Baseline]

    Audio recordings of the prenatal visits are coded using the Roter Interaction Analysis System (RIAS). The communication outcome measure is derived from this coding.

Secondary Outcome Measures

  1. depression as assessed by the Edinburgh Depression Scale [post medical visit up to 8 months]

    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.

Other Outcome Measures

  1. patient satisfaction as assessed by a questionnaire developed by the study team [post medical visit up to 8 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Pregnant women attending study prenatal clinics with consenting clinicians. English speaking
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins Hospital Baltimore Maryland United States 21205

Sponsors and Collaborators

  • Johns Hopkins Bloomberg School of Public Health
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT05974865
Other Study ID Numbers:
  • HD050437
  • R01HD050437
First Posted:
Aug 3, 2023
Last Update Posted:
Aug 3, 2023
Last Verified:
Jul 1, 2023
Keywords provided by Johns Hopkins Bloomberg School of Public Health

Study Results

No Results Posted as of Aug 3, 2023