AdenotonsillectomyNCT02501122
Retrospective Analysis in Quality of Care Measures in Pediatric Adenotonsillectomy Patients
An observational study of Adenotonsillectomy, run by Vidya Raman.
Trial summary
The purpose of this study is to interrogate the Partners for Kids (PFK) and the pediatric health information (PHIS) databases in addition to our own perioperative Nationwide Children's data base to look at outcomes, resource utilization, and cost trends for adenotonsillectomy in the nationally versus locally. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adenotonsillectomy
- What is being tested?
- Pediatric Health Information System (PHIS), Partners for Kids (PFK) and Nationwide Children's Hospital Perioperative Database
- How many people
- 1,000,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have undergone anesthesia for adenotonsillectomy, tonsillectomy or adenoidectomy during 2013-2015 at Nationwide Children's Hospital.
Who may be able to join
- Patients who undergone an adenotonsillectomy, tonsillectomy or adenoidectomy during the past 2 years (2013-2015) who have ICD-9 codes (International Classification of Diseases) in the databases
Who cannot join
- Non-adenotonsillectomy patients
About this study
Official title: Cost Savings From Non-pharmacological Interventions for Pediatric Patients Undergoing Diagnostic Imaging at Nationwide Children's Hospital
The purpose of this study is to interrogate the Partners for Kids (PFK) and the pediatric health information (PHIS) databases in addition to our own perioperative Nationwide Children's data base to look at outcomes, resource utilization, and cost trends for adenotonsillectomy in the nationally versus locally. The investigators also want compare Nationwide Children's to other regional and national tertiary pediatric institutions.
- Conditions
- Adenotonsillectomy
- Being tested
- Pediatric Health Information System (PHIS), Partners for Kids (PFK) and Nationwide Children's Hospital Perioperative Database
- Keywords
- Quality, hospital care, adenotonsillectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Health Information System (PHIS), Partners for Kids (PFK) and Nationwide Children's Hospital Perioperative DatabaseOther
Utilizing these databases to assess standards for quality of care measures in adenotonsillectomy patients.
| Study group | Role | What they receive |
|---|---|---|
| Adenotonsillectomy | Measuring quality of care in patients undergoing adenotonsillectomy. Receives: Other: Pediatric Health Information System (PHIS), Partners for Kids (PFK) and Nationwide Children's Hospital Perioperative Database |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gather data from PHIS and contrast local databases (PFK versus Nationwide Children's)
The significance is to identify outcome measures, resource utilization, and cost of adenotonsillectomy nationally as well as locally.
Measured: after patient's discharge, an expected average between 6 months to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenotonsillectomyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vidya Raman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vidya Raman, Nationwide Children's Hospital
- Investigators
- Vidya Raman, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501122
- Sponsor's protocol ID
- IRB 15-00264
- Status last verified
- Jan 2017
- First submitted
- 20 May 2015
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Savings From Non-pharmacological Interventions for Pediatric Patients Undergoing Diagnostic Imaging at Nationwide Children's Hospital
- ClinicalTrials.gov ID
- NCT02501122
- Acronym / sponsor ID
- IRB 15-00264
- Conditions
- Adenotonsillectomy
- Keywords
- Quality, hospital care, adenotonsillectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000,000 participants (actual)
- Lead sponsor
- Vidya RamanUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 17 Jul 2015 (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 interrogate the Partners for Kids (PFK) and the pediatric health information (PHIS) databases in addition to our own perioperative Nationwide Children's data base to look at outcomes, resource utilization, and cost trends for adenotonsillectomy in the nationally versus locally. The investigators also want compare Nationwide Children's to other regional and national tertiary pediatric institutions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adenotonsillectomy | – | Other: Pediatric Health Information System (PHIS), Partners for Kids (PFK) and Nationwide Children's Hospital Perioperative DatabaseMeasuring quality of care in patients undergoing adenotonsillectomy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have undergone anesthesia for adenotonsillectomy, tonsillectomy or adenoidectomy during 2013-2015 at Nationwide Children's Hospital.
Key inclusion criteria (1 listed)
- Patients who undergone an adenotonsillectomy, tonsillectomy or adenoidectomy during the past 2 years (2013-2015) who have ICD-9 codes (International Classification of Diseases) in the databases
Key exclusion criteria (1 listed)
- Non-adenotonsillectomy patients
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 |
|---|---|---|
| Pediatric Health Information System (PHIS), Partners for Kids (PFK) and Nationwide Children's Hospital Perioperative DatabaseUtilizing these databases to assess standards for quality of care measures in adenotonsillectomy patients. | Other | Adenotonsillectomy |
Primary outcome
Gather data from PHIS and contrast local databases (PFK versus Nationwide Children's)
Time frame: after patient's discharge, an expected average between 6 months to 2 years
The significance is to identify outcome measures, resource utilization, and cost of adenotonsillectomy nationally as well as locally.
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 31 Jan 2017.
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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.
Vidya Raman, MD principal investigator
Nationwide Children's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Adenotonsillectomy, run by Vidya Raman.
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 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Gather data from PHIS and contrast local databases (PFK versus Nationwide Children's) (time frame: after patient's discharge, an expected average between 6 months to 2 years). It is what the study was designed to measure, not a finding.
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 31 Jan 2017.