Reproductive BehaviorNCT03670745
Patient-centered Approaches to Provider and Adolescent Reproductive Health Communication and Shared Decision-making
A study testing An electronic self-administered pre-visit planning tool. in people with Reproductive Behavior, run by Yale University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reproductive Behavior
- What is being tested?
- An electronic self-administered pre-visit planning tool.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2020to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Exclusion criteria for adolescent girls: currently pregnant, or who have an impairment that would prevent them from completing the tool and survey.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06516
About this study
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.
- Conditions
- Reproductive Behavior
- Being tested
- An electronic self-administered pre-visit planning tool., Control group
- Medical subject headings
- Reproductive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An electronic self-administered pre-visit planning tool.Behavioural
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 groupBehavioural
No planning tool
| Study group | Role | What they receive |
|---|---|---|
| Pre-visit Planning Tool | Experimental | 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. Receives: Behavioral: An electronic self-administered pre-visit planning tool. |
| control group | Active comparator | Will not be receiving an electronic self-administered pre-visit planning tool. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: up to 2 weeks after appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start15 May 2020
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Why it stopped: The COVID pandemic and issues with the APT platform hindered recruitment and participant completion of intervention surveys.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive BehaviorStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This project will utilize a sequential explanatory research design, with an embedded randomized controlled trial (RCT) intervention .
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Brault, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670745
- Sponsor's protocol ID
- 2000023279
- Status last verified
- Oct 2021
- First submitted
- 10 Sep 2018
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-centered Approaches to Provider and Adolescent Reproductive Health Communication and Shared Decision-making
- ClinicalTrials.gov ID
- NCT03670745
- Acronym / sponsor ID
- 2000023279
- Conditions
- Reproductive Behavior
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The COVID pandemic and issues with the APT platform hindered recruitment and participant completion of intervention surveys.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This project will utilize a sequential explanatory research design, with an embedded randomized controlled trial (RCT) intervention .
| Arm | Type | Receives |
|---|---|---|
| Pre-visit Planning Tool | Experimental | Behavioral: 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 | Active comparator | Behavioral: Control groupWill not be receiving an electronic self-administered pre-visit planning tool. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Exclusion criteria for adolescent girls: currently pregnant, or who have an impairment that would prevent them from completing the tool and survey.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Pre-visit Planning Tool |
| Control groupNo planning tool | Behavioural | control group |
Primary outcome
Sexual and Reproductive Health Knowledge Scale
Time frame: 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.
Contraceptive intentions
Time frame: 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
Communication with provider
Time frame: 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
1 secondary outcome
Sources of sexual and reproductive health knowledge
Time frame: up to 2 weeks after appointment
Results and safety
The study was stopped early (reason given: The COVID pandemic and issues with the APT platform hindered recruitment and participant completion of intervention surveys.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Brault, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An electronic self-administered pre-visit planning tool. in people with Reproductive Behavior, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The COVID pandemic and issues with the APT platform hindered recruitment and participant completion of intervention surveys.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual and Reproductive Health Knowledge Scale (time frame: up to 2 weeks after appointment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.