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

Reproductive Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03670745
• Other study ID #: 2000023279
• Status: Terminated
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: October 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Reproductive Behavior

Intervention

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.
• Control group
No planning tool

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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	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