Sexually Transmitted DiseasesAdolCHICANCT02244138
Improving Adolescent Health Outcomes Through Preventive Care Transformation
An observational study of Sexually Transmitted Diseases and Depression Diagnosis, run by Indiana University at 1 site in United States.
Trial summary
Preventive care for adolescents is vitally important for maximizing their health and well-being. Unfortunately, pediatric primary care frequently fails to meet the preventive needs of adolescents as demonstrated by poor health outcomes for this population. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Sexually Transmitted Diseases, Depression Diagnosis, Substance Use Disorders
- What is being tested?
- Adolescent CDSS
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,831 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2014to 30 Sep 2017
- Phase
- Observational
- 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 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescent from primary care clinics will be studied
Who may be able to join
- 11-21 years
- attending primary care clinic
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Preventive care for adolescents is vitally important for maximizing their health and well-being. Unfortunately, pediatric primary care frequently fails to meet the preventive needs of adolescents as demonstrated by poor health outcomes for this population.
In this grant application, the investigators propose to expand an existing computer decision support system (CDSS) into the investigators adolescent primary care practices for the purpose of implementing a comprehensive, and developmentally appropriate, screening and physician decision support process. Prior work completed by the investigators research group has demonstrated the feasibility of using CDSS to implement and evaluate clinical guidelines. The investigators seek to positively impact the effectiveness of preventative primary care visits by applying this previous success to the investigators adolescent practice. The investigators hypothesize that the implementation of developmentally appropriate universal screening practices, using tablet technology, and enhanced physician decision support regarding clinically relevant guidelines for all annual adolescent preventive care visits will result in better health outcomes, including higher rates of adherence to physician recommendations and improved patient functioning.
Read more
The specific research aims of this proposal are:
Aim 1: Expand and modify an existing CDSS to include an Adolescent Preventive Care Module comprised of developmentally appropriate screening tools for adolescents aged 11 to 21 years and tailored evidence-based clinical decision support for physicians.
Aim 2: Evaluate the impact of the Adolescent Preventive Care Module on the identification of specific mental and physical health problems and treatment outcomes in an adolescent primary health care setting.
Adolescent primary care issues of interest for this project include sexually transmitted infection (STI), depression, substance use and Human Papillomavirus (HPV) immunization. The investigators expect this project to improve the health outcomes of adolescents, guide future efforts to implement universal screening and CDSS in a variety of primary care settings, and provide additional evidence to support broad-based electronic screening and computerized decision support for use in preventive care as a method for improving adolescent health.
- Being tested
- Adolescent CDSS
- Keywords
- Adolescent, Screening, Primary Care, Computer Decision Support Systems
- Medical subject headings
- Sexually Transmitted Diseases, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adolescent CDSSBehavioural
computer decision support system (CDSS) for health care providers of adolescents in primary care
| Study group | Role | What they receive |
|---|---|---|
| Adolescent CDSS | Implementation clinic site for CDDS Receives: Behavioral: Adolescent CDSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
sexually transmitted infection
diagnosis of sexually transmitted infection by physician as indicated in electronic health record for patient
Measured: 12 months
Secondary outcomes (1)
depression
diagnosis of depression by physician as indicated in electronic health record for patient
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study start1 Sep 2014
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,831 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Matthew Aalsma, Indiana University
- Investigators
- matthew c aalsma, phd, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244138
- Sponsor's protocol ID
- 1308038999
- Other IDs
- R01HS022681
- Acronym
- AdolCHICA
- Status last verified
- Aug 2018
- First submitted
- 12 Sep 2014
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Aalsma M, Keys J, Ferrin S, Shan M, Garbuz T, Scott T, Adams Z, Hulvershorn L, Downs S. Adolescent suicide assessment and management in primary care. BMC Pediatr. 2022 Jul 2;22(1):389. doi: 10.1186/s12887-022-03454-4.
PubMed 35780090Etter DJ, McCord A, Ouyang F, Gilbert AL, Williams RL, Hall JA, Tu W, Downs SM, Aalsma MC. Suicide Screening in Primary Care: Use of an Electronic Screener to Assess Suicidality and Improve Provider Follow-Up for Adolescents. J Adolesc Health. 2018 Feb;62(2):191-197. doi: 10.1016/j.jadohealth.2017.08.026. Epub 2017 Nov 28.
PubMed 29195764Aalsma MC, Zerr AM, Etter DJ, Ouyang F, Gilbert AL, Williams RL, Hall JA, Downs SM. Physician Intervention to Positive Depression Screens Among Adolescents in Primary Care. J Adolesc Health. 2018 Feb;62(2):212-218. doi: 10.1016/j.jadohealth.2017.08.023. Epub 2017 Nov 23.
PubMed 29174939
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adolescent Health Outcomes Through Preventive Care Transformation
- ClinicalTrials.gov ID
- NCT02244138
- Acronym / sponsor ID
- AdolCHICA / 1308038999
- Keywords
- Adolescent, Screening, Primary Care, Computer Decision Support Systems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,831 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 18 Sep 2014 (estimated)
- 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.
Preventive care for adolescents is vitally important for maximizing their health and well-being. Unfortunately, pediatric primary care frequently fails to meet the preventive needs of adolescents as demonstrated by poor health outcomes for this population.
In this grant application, the investigators propose to expand an existing computer decision support system (CDSS) into the investigators adolescent primary care practices for the purpose of implementing a comprehensive, and developmentally appropriate, screening and physician decision support process. Prior work completed by the investigators research group has demonstrated the feasibility of using CDSS to implement and evaluate clinical guidelines. The investigators seek to positively impact the effectiveness of preventative primary care visits by applying this previous success to the investigators adolescent practice. The investigators hypothesize that the implementation of developmentally appropriate universal screening practices, using tablet technology, and enhanced physician decision support regarding clinically relevant guidelines for all annual adolescent preventive care visits will result in better health outcomes, including higher rates of adherence to physician recommendations and improved patient functioning.
The specific research aims of this proposal are:
Aim 1: Expand and modify an existing CDSS to include an Adolescent Preventive Care Module comprised of developmentally appropriate screening tools for adolescents aged 11 to 21 years and tailored evidence-based clinical decision support for physicians.
Aim 2: Evaluate the impact of the Adolescent Preventive Care Module on the identification of specific mental and physical health problems and treatment outcomes in an adolescent primary health care setting.
Adolescent primary care issues of interest for this project include sexually transmitted infection (STI), depression, substance use and Human Papillomavirus (HPV) immunization. The investigators expect this project to improve the health outcomes of adolescents, guide future efforts to implement universal screening and CDSS in a variety of primary care settings, and provide additional evidence to support broad-based electronic screening and computerized decision support for use in preventive care as a method for improving adolescent health.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescent CDSS | – | Behavioral: Adolescent CDSSImplementation clinic site for CDDS |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescent from primary care clinics will be studied
Key inclusion criteria (2 listed)
- 11-21 years
- attending primary care clinic
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Adolescent CDSScomputer decision support system (CDSS) for health care providers of adolescents in primary care | Behavioural | Adolescent CDSS |
Primary outcome
sexually transmitted infection
Time frame: 12 months
diagnosis of sexually transmitted infection by physician as indicated in electronic health record for patient
1 secondary outcome
depression
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Derived from this study: PubMed 35780090Aalsma M, Keys J, Ferrin S, Shan M, Garbuz T, Scott T, Adams Z, Hulvershorn L, Downs S. Adolescent suicide assessment and management in primary care. BMC Pediatr. 2022 Jul 2;22(1):389. doi: 10.1186/s12887-022-03454-4.
- Derived from this study: PubMed 29195764Etter DJ, McCord A, Ouyang F, Gilbert AL, Williams RL, Hall JA, Tu W, Downs SM, Aalsma MC. Suicide Screening in Primary Care: Use of an Electronic Screener to Assess Suicidality and Improve Provider Follow-Up for Adolescents. J Adolesc Health. 2018 Feb;62(2):191-197. doi: 10.1016/j.jadohealth.2017.08.026. Epub 2017 Nov 28.
- Derived from this study: PubMed 29174939Aalsma MC, Zerr AM, Etter DJ, Ouyang F, Gilbert AL, Williams RL, Hall JA, Downs SM. Physician Intervention to Positive Depression Screens Among Adolescents in Primary Care. J Adolesc Health. 2018 Feb;62(2):212-218. doi: 10.1016/j.jadohealth.2017.08.023. Epub 2017 Nov 23.
Related trials for Sexually Transmitted Diseases
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
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.
matthew c aalsma, phd principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexually Transmitted Diseases and Depression Diagnosis, run by Indiana 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: finished, as of the sponsor's last update on 9 Aug 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
sexually transmitted infection (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02244138, which also lists 3 linked publications.
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 9 Aug 2018.