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Mental HealthEINCT00922922

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

An observational study of Mental Health, run by University of Nebraska at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Mental Health
How many people
228 participants
Where
1 siteUnited States
Study dates
3 Apr 2009to 1 Aug 2010
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Approximately 500 patients from a pediatrician office will be reviewed.

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Nebraska Medical Center, Munroe Meyer Institute

    Omaha, Nebraska, 68198-7830

Other trials in United States

About this study

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.

Read the 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).

Conditions
Mental Health
Medical subject headings
Psychological Well-Being

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2009 (estimated)
  2. Study start3 Apr 2009
  3. Primary completion1 Mar 2010
  4. Study completion1 Aug 2010

Resources

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 only
Time perspective
Cross-sectional
Enrolment
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00922922
Sponsor's protocol ID
0136-09-EP
Acronym
EI
Status last verified
Sep 2023
First submitted
15 Jun 2009
Last updated
6 Sep 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Mental Health, run by University of Nebraska 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 1 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 6 Sep 2023. 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.

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 6 Sep 2023.

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