NCT02244138

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,831

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

3.1 years

First QC Date

September 12, 2014

Last Update Submit

August 8, 2018

Conditions

Keywords

AdolescentScreeningPrimary CareComputer Decision Support Systems

Outcome Measures

Primary Outcomes (1)

  • sexually transmitted infection

    diagnosis of sexually transmitted infection by physician as indicated in electronic health record for patient

    12 months

Secondary Outcomes (1)

  • depression

    12 months

Other Outcomes (1)

  • substance use

    12 months

Study Arms (1)

Adolescent CDSS

Implementation clinic site for CDDS

Behavioral: Adolescent CDSS

Interventions

Adolescent CDSSBEHAVIORAL

computer decision support system (CDSS) for health care providers of adolescents in primary care

Adolescent CDSS

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adolescent from primary care clinics will be studied

You may qualify if:

  • years
  • attending primary care clinic

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskenazi Medical Group

Indianapolis, Indiana, 46203, United States

Location

Related Publications (3)

  • 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.

  • Etter 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.

  • Aalsma 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.

MeSH Terms

Conditions

Sexually Transmitted DiseasesSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsChemically-Induced DisordersMental Disorders

Study Officials

  • matthew c aalsma, phd

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 12, 2014

First Posted

September 18, 2014

Study Start

September 1, 2014

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

August 9, 2018

Record last verified: 2018-08

Locations