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

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).

Study Overview

• Status: Terminated
• Conditions: Reproductive Behavior
• Intervention / Treatment: Behavioral: An electronic self-administered pre-visit planning tool.; Behavioral: Control group

Detailed Description

Aim 1: Through qualitative data collection, characterize perspectives of adolescent girls and providers regarding the feasibility and acceptability 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. Interviews will also explore approaches to implement and evaluate such a tool.

Aim 2: Determine the effectiveness of the tool through a randomized controlled trial (RCT).

Aim 3: Synthesize outcomes, identify opportunities for improvement and plan next steps in both research, and if the tool works well, implementation.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06516
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Inclusion criteria for adolescent girls: between the ages of 14-18 years old, English-speaking, and a patient of a provider affiliated with the Yale New Haven Hospital.
• Inclusion criteria for healthcare providers are: a provider the Yale New Haven Hospital who regularly sees adolescent patients.

Exclusion Criteria:

• Exclusion criteria for adolescent girls: currently pregnant, or who have an impairment that would prevent them from completing the tool and survey.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-visit Planning Tool; 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.; An electronic self-administered pre-visit planning tool allowing adolescents to list areas of concern to support shared decision-making during an office visit.
Active Comparator: control group; Will not be receiving an electronic self-administered pre-visit planning tool.	Behavioral: Control group; No planning tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sources of sexual and reproductive health knowledge	An increase in score in the self-administered survey questions concerning sources of sexual and reproductive health knowledge from baseline to testing 2 weeks after initial appointment. Questions adapted from the World Health Organization's Illustrative Questionnaire for Surveys with Young People	up to 2 weeks after appointment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use and perceptions of healthcare services	An increase in score of the self-administered survey questions concerning other services used and perceptions of those services provided at their appointment to scores tested 2 weeks after. Questions adapted from the World Health Organization's Illustrative Questionnaire for Surveys with Young People	up to 2 weeks after appointment

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Marie Brault, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2020
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 18, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2000023279

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No