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.
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
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.
- First posted17 Jun 2009 (estimated)
- Study start3 Apr 2009
- Primary completion1 Mar 2010
- Study completion1 Aug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Valleley, PhD, Principal investigator, University of Nebraska
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration and Direct Cost of Behavioral Health Concerns in Pediatric Primary Care
- ClinicalTrials.gov ID
- NCT00922922
- Acronym / sponsor ID
- EI / 0136-09-EP
- Conditions
- Mental Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 3 Apr 2009 (actual)
- Primary completion
- 1 Mar 2010 (actual)
- Study completion
- 1 Aug 2010 (actual)
- First posted
- 17 Jun 2009 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Approximately 500 patients from a pediatrician office will be reviewed.
Key inclusion criteria (1 listed)
- Patients who attend a local pediatrician clinic between between March 2009 and March 2010
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.
Primary outcome
Not reported in the source record.
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 6 Sep 2023.
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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.
Rachel Valleley, PhD principal investigator
University of Nebraska
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 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.