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

Study Overview
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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.

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

Conditions
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Reproductive Behavior

Intervention / Treatment
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* Behavioral: An electronic self-administered pre-visit planning tool.
* Behavioral: Control group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This project will utilize a sequential explanatory research design, with an embedded randomized controlled trial (RCT) intervention .
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |