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

Not Applicable

Terminated

• Conditions: Reproductive Behavior
• Interventions: Behavioral: An electronic self-administered pre-visit planning tool.; Behavioral: Control group

• Registration Number: NCT03670745
• Lead Sponsor: Yale University

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).

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 Timeline

• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-14
• Study Start: 2020-05-15
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-18
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 10

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-visit Planning Tool	An electronic self-administered 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.
control group	Control group	Will not be receiving an electronic self-administered pre-visit planning tool.

Primary Outcome Measures

Name	Time	Method
Sexual and Reproductive Health Knowledge Scale	up to 2 weeks after appointment	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.
Communication with provider	up to 2 weeks after appointment	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
Contraceptive intentions	up to 2 weeks after appointment	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

Secondary Outcome Measures

Name	Time	Method
Sources of sexual and reproductive health knowledge	up to 2 weeks after appointment	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

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States