CClinicalTrials.gg
TerminatedNCT03670745Updated Oct 26, 2021

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

An interventional study of An electronic self-administered pre-visit planning tool. and Control group in Reproductive Behavior, sponsored by Yale University. Terminated at 1 site in United States. Open to female participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-26.

Sponsored by Yale University · Not applicable, Interventional, and Supportive care

Why this study was terminated
The COVID pandemic and issues with the APT platform hindered recruitment and participant completion of intervention surveys.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
14 Years to 18 Years
Sex
Female
01

Study 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).

Read the 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.

02

Conditions studied

  • Reproductive Behavior
03

In context

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 18 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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:

  • Exclusion criteria for adolescent girls: currently pregnant, or who have an impairment that would prevent them from completing the tool and survey.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
10 participants (actual)

Study arms

  • 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.

  • Active comparator
    control group

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

    Behavioral: Control group

Interventions

  • BehavioralAn 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.

  • BehavioralControl group

    No planning tool

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 2 weeks after appointment

  2. 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

    Time frame: up to 2 weeks after appointment

  3. 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

    Time frame: up to 2 weeks after appointment

Secondary outcomes

  1. 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

    Time frame: up to 2 weeks after appointment

Other outcomes

  1. 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

    Time frame: up to 2 weeks after appointment

07

Study locations

1 site
  • Yale New Haven Hospital
    New Haven, Connecticut 06516, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03670745
Lead sponsor
Yale University
Responsible party
Sponsor
First posted
Sep 14, 2018
Start date
May 15, 2020
Primary completion
Aug 1, 2021
Completion
Aug 1, 2021
Last update
Oct 26, 2021

Study contacts

Marie Brault, PhD
principal investigator · Yale University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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