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

NCT ID: NCT03670745

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-15

Study Completion Date

2021-08-01

Brief Summary

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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

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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.

Conditions

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Reproductive Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This project will utilize a sequential explanatory research design, with an embedded randomized controlled trial (RCT) intervention .
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

An electronic self-administered pre-visit planning tool.

Intervention Type 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.

control group

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

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type BEHAVIORAL

No planning tool

Interventions

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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.

Intervention Type BEHAVIORAL

Control group

No planning tool

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie Brault, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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2000023279

Identifier Type: -

Identifier Source: org_study_id