Patient-centered Approaches to Provider and Adolescent Reproductive Health Communication and Shared Decision-making

NCT03670745 | Terminated DMC

• 1 other identifier: 2000023279
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Determine the effectiveness of an electronic self-administered pre-visit planning tool allowing adolescents to list areas of concern to support shared decision-making and communication during an office visit through a randomized controlled trial (RCT).

Conditions

Reproductive Behavior

Outcome Measures

Primary Outcomes (3)

• Sexual and Reproductive Health Knowledge Scale

  An increase in score in the self-administered survey scale measuring knowledge adapted from the World Health Organization's Illustrative Questionnaire for Surveys with Young People from baseline to testing 2 weeks after appointment.

  up to 2 weeks after appointment

• Contraceptive intentions

  An increase in score in the self-administered survey questions concerning intentions to use contraceptives from baseline test to test 2 weeks after appointment. Questions adapted from the World Health Organization's Illustrative Questionnaire for Surveys with Young People

  up to 2 weeks after appointment

• Communication with provider

  An increased score in the self-administered survey scale measuring communication with health provider on topics of concern from baseline score to testing 2 weeks after initial appointment. Scale is adapted from the World Health Organization's Illustrative Questionnaire for Surveys with Young People

  up to 2 weeks after appointment

Secondary Outcomes (1)

• Sources of sexual and reproductive health knowledge

  up to 2 weeks after appointment

Other Outcomes (1)

• Use and perceptions of healthcare services

  up to 2 weeks after appointment

Study Arms (2)

Pre-visit Planning Tool

EXPERIMENTAL

To determine the effectiveness an electronic self-administered pre-visit planning tool allowing adolescents to list areas of concern to support shared decision-making during an office visit. Interviews will also explore approaches to implement and evaluate such a tool.

Behavioral: An electronic self-administered pre-visit planning tool.

control group

ACTIVE COMPARATOR

Will not be receiving an electronic self-administered pre-visit planning tool.

Behavioral: Control group

Interventions

An electronic self-administered pre-visit planning tool. BEHAVIORAL

An electronic self-administered pre-visit planning tool allowing adolescents to list areas of concern to support shared decision-making during an office visit.

Pre-visit Planning Tool

Control group BEHAVIORAL

No planning tool

control group

Eligibility Criteria

• Age: 14 Years - 18 Years
• Gender Eligibility Details: Adolescent girls between the ages of 14-18 years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Reproductive Behavior

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Marie Brault, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This project will utilize a sequential explanatory research design, with an embedded randomized controlled trial (RCT) intervention .

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 14, 2018
• Study Start: May 15, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Locations

US (1)