Duration and Direct Cost of Behavioral Health Concerns in Pediatric Primary Care (EI)

September 1, 2023 updated by: University of Nebraska
The purpose of this study is to compare the duration and direct cost of pediatric primary care visits consisting of medical concerns only, behavioral concerns only, and medical and behavioral concerns.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Behavioral, emotional, and psychosocial issues of children and adolescents are often brought to the attention of primary care physicians by parents (Smith, Rost, & Kashner, 1995). In fact, behavioral health concerns are the primary reason for visits to physicians in 15% to 21% of cases (Kelleher, Childs, Wasserman, McInerny, Nutting, & Gardner, 1997; Lavigne, Gibbons, Arend, Rosenbaum, Binns, & Christoffel, 1999; Williams, Klinepeter, Palmes, Pulley, & Foy, 2004). During 50% to 80% of child health care visits, parents or physicians raise concerns of behavioral or psychosocial issues (Cassidy & Jellinek 1998; Fries, Koop, Beadle, Cooper, England, Greaves, et al., 1993; Sharp, Pantell, Murphy, & Lewis, 1992).

Several concerns have been raised when patients seek mental health services from primary care physicians, including an increase in the number of medical visits, an increase in the time spent with the physician, lost revenue if a patient takes more time than scheduled, a lower reimbursement rate for mental health issues, limited training in mental health treatment, a decrease in the number of patients seen, an increase in the risk of physician burnout, unsatisfied patients, an increase in impairment in patient health and functioning, and an increase in the use of acute and emergency care (Connor, McLaughlin, Jeffers-Terry, O'Brien, Stille, Young, & Antonelli, 2006; deGruy, 1997; Leaf, Owens, Levelthal, Forsyth, Vaden-Kiernan, Epstein, et al., 2004; Strosahl, 2002; Young, Klap, Sherbourne, & Wells, 2001).

There are limited studies examining the time and cost incurred by physicians for treating patients with behavioral, emotional, and psychosocial issues. Average primary care visits last between 13 and 17 minutes (Blumenthal, Causino, Chang, Culpepper, Marder, Saglam, et al., 1999; Bryant & Shimizu, 1988) A more recent study conducted in rural communities found that physicians spent an average of 5 to 7 minutes longer on visits where behavioral issues were raised (Cooper, Valleley, Polaha, Begeny, & Evans, 2006). Primary care physicians see four or five patients per hour (deGruy, 1997), which is an insufficient amount of time for a detailed psychological assessment or management of mental health symptoms. Therefore, frequent or longer visits are scheduled. Additionally, physicians are reimbursed for medical diagnosis but not mental diagnoses (deGruy).

This study is based on previous work documenting that pediatric primary care visits increased in duration when behavioral concerns were identified prior to the visit and spontaneously raised during the visit (Cooper, et al., 2006). Additionally, this study calculates the reimbursement rate associated with those visits in addition to the duration of the visit. Finally, this study is a replication of a study previously approved through the University of Nebraska Medical Center Institutional Review Board (i.e., IRB # 449-07-EP).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
228

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198-7830
        • University of Nebraska Medical Center, Munroe Meyer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Approximately 500 patients from a pediatrician office will be reviewed.

Description

Inclusion Criteria:

  • Patients who attend a local pediatrician clinic between between March 2009 and March 2010

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nebraska

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rachel Valleley, PhD, University Of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2009

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0136-09-EP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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