Clinical trial NCT05974865: Amelioration of Literacy Deficits in Prenatal Care
Official title: Amelioration of Literacy Deficits in Prenatal Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prenatal Care
Health Literacy
Numeracy
Keywords: patient-physician communication
patient activation intervention
RIAS
health literacy
spoken literacy
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-08-03
Enrollment: 355
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: patient-centered communication
timeFrame: Baseline
Secondary outcomes:
measure: depression as assessed by the Edinburgh Depression Scale
timeFrame: post medical visit up to 8 months
Other outcomes:
measure: patient satisfaction as assessed by a questionnaire developed by the study team
timeFrame: post medical visit up to 8 months
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Debra Roter, PhD
role: PRINCIPAL_INVESTIGATOR
References: