Pediatric HospitalizationNCT03153722
Pediatric Ward Discharge Quality Improvement
A study testing Pediatric discharge process interventions in people with Pediatric Hospitalization, run by University of California, Davis at 1 site in United States.
Trial summary
This study will utilize an iterative quality improvement process to identify and address delays in the pediatric hospital discharge process. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Pediatric Hospitalization
- What is being tested?
- Pediatric discharge process interventions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,478 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2017to 31 Dec 2020
- Phase
- Interventional
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children or young adults less than 21 years of age admitted to the University of California Davis Children's Hospital Pediatric Hospitalist Service on the general pediatric inpatient ward
Who cannot join
- Adults greater than 21 years of age, including those unable to consent
- Pregnant women
- Prisoners
- Children admitted to other services (i.e. Ear, Nose and Throat Surgery, Pediatric Surgery, Pediatric Gastroenterology, Trauma, Pediatric Nephrology, Pediatric Hematology/Oncology, Pediatric Intensive Care Unit, Neonatal Intensive Care Unit, Newborn Nursery, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis
Sacramento, California, 95817
About this study
This study will utilize an iterative quality improvement process to identify and address delays in the pediatric hospital discharge process.
Read the detailed description
Hospital crowding has been associated with increased hospital length of stay in pediatric populations and adverse outcomes in adult populations. This study focuses on a 36-bed general pediatric inpatient care unit whose occupancy has seen exponential growth over the past several years. With the growth in patient population, the study hospital is experiencing increasing difficulty with hospital crowding, particularly during key times of year, such as the winter viral respiratory season. During these times, pediatric patients may experience high emergency room wait times, and admitted patients may be required to board in the emergency room or post-anesthesia care unit while they await an inpatient bed. Lack of inpatient bed availability has also, at times, required cancellation of surgical cases and denial of outside hospital patient transfers to the institution, resulting in inconvenience to patients and delays in care.
The pediatric hospital discharge process has come under particular scrutiny as an area in which both the efficiency and the effectiveness of patient care can be improved. Currently, around 10% of patients ready for discharge in a given day from the general pediatric hospitalist service are discharged prior to noon, freeing up this bed space for a new patient. While for some patients, discharge is postponed for medical reasons, others must remain in the hospital for non-medical delays. For example, they may remain hospitalized because they have not yet been seen by a physician, their medications are not available for pick-up from the pharmacy, or they do not have transportation from hospital to home. Several studies in pediatric populations have shown that quality improvement processes can improve discharge efficiency without compromising care quality or patient/family satisfaction. The investigators aim to determine if an iterative quality improvement process can reduce barriers to discharge and therefore decrease pediatric patients' length of stay. They will simultaneously analyze several secondary outcomes to evaluate patient flow, patient/family satisfaction, and subsequent hospital utilization to evaluate for unintended consequences of the interventions.
- Conditions
- Pediatric Hospitalization
- Being tested
- Pediatric discharge process interventions
- Keywords
- pediatric, hospital discharge, quality improvement, transition of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric discharge process interventionsProcedure or surgery
As this is an iterative quality improvement process, interventions will be evidence-based and chosen to test effectiveness for addressing areas of discharge bottlenecks or inefficiency within our specific hospital's context. Examples of possible interventions may include implementation of a discharge risk assessment (as in Statile et al, Pediatrics 2016), institution of a "medications-in-hand" policy on hospital discharge (as in Sauers-Ford et al, Pediatrics 2016), or initiation of a ward discharge coordinator who will help coordinate outpatient follow-up for patients. Interventions will be implemented in a stepwise fashion, utilizing successive plan-do-study-act cycles, with a minimum 2 month period between interventions to monitor outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric discharge process intervention | Experimental | All patients hospitalized on the pediatric ward under the pediatric hospitalist service will participate in pediatric discharge process interventions. Receives: Procedure: Pediatric discharge process interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay index
Length of stay index is a metric that is calculated by Vizient and compares a patient's hospital length of stay to national averages, taking into account the patient's diagnosis, severity of illness, and disease complexity.
Measured: Time from admission to discharge through study completion in 1 year.
Percentage of patients discharged before 1200
Percentage of pediatric hospitalist patients who are discharged before noon on the day they are eligible for discharge.
Measured: Discharge time for each patient within a 24 hour period on day of discharge.
Secondary outcomes (3)
Readmission
Same hospital 30 day readmission rate
Measured: 30 days
Emergency department re-visit
Same hospital 7- and 30-day emergency room revisit rate
Measured: 7 and 30 days
Patient satisfaction
Patient/family hospital discharge satisfaction scores, as measured on the Child Hospital Consumer Assessment of Healthcare Providers and Systems (CHCAHPS), which is sent to each family after their child is discharged from the hospital.
Measured: Mailed to families following hospital discharge through study completion in 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start15 May 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pediatric HospitalizationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,478 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153722
- Sponsor's protocol ID
- 1016479
- Status last verified
- Apr 2021
- First submitted
- 2 May 2017
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lorch SA, Millman AM, Zhang X, Even-Shoshan O, Silber JH. Impact of admission-day crowding on the length of stay of pediatric hospitalizations. Pediatrics. 2008 Apr;121(4):e718-30. doi: 10.1542/peds.2007-1280.
PubMed 18381501Kostis WJ, Demissie K, Marcella SW, Shao YH, Wilson AC, Moreyra AE; Myocardial Infarction Data Acquisition System (MIDAS 10) Study Group. Weekend versus weekday admission and mortality from myocardial infarction. N Engl J Med. 2007 Mar 15;356(11):1099-109. doi: 10.1056/NEJMoa063355.
PubMed 17360988Bell CM, Redelmeier DA. Mortality among patients admitted to hospitals on weekends as compared with weekdays. N Engl J Med. 2001 Aug 30;345(9):663-8. doi: 10.1056/NEJMsa003376.
PubMed 11547721Beck MJ, Gosik K. Redesigning an inpatient pediatric service using Lean to improve throughput efficiency. J Hosp Med. 2015 Apr;10(4):220-7. doi: 10.1002/jhm.2300. Epub 2014 Dec 8.
PubMed 25483409Statile AM, Schondelmeyer AC, Thomson JE, Brower LH, Davis B, Redel J, Hausfeld J, Tucker K, White DL, White CM. Improving Discharge Efficiency in Medically Complex Pediatric Patients. Pediatrics. 2016 Aug;138(2):e20153832. doi: 10.1542/peds.2015-3832. Epub 2016 Jul 13.
PubMed 27412640White CM, Statile AM, White DL, Elkeeb D, Tucker K, Herzog D, Warrick SD, Warrick DM, Hausfeld J, Schondelmeyer A, Schoettker PJ, Kiessling P, Farrell M, Kotagal U, Ryckman FC. Using quality improvement to optimise paediatric discharge efficiency. BMJ Qual Saf. 2014 May;23(5):428-36. doi: 10.1136/bmjqs-2013-002556. Epub 2014 Jan 27.
PubMed 24470173Sauers-Ford HS, Moore JL, Guiot AB, Simpson BE, Clohessy CR, Yost D, Mayhaus DC, Simmons JM, Gosdin CH. Local Pharmacy Partnership to Prevent Pediatric Asthma Reutilization in a Satellite Hospital. Pediatrics. 2016 Apr;137(4):e20150039. doi: 10.1542/peds.2015-0039. Epub 2016 Mar 16.
PubMed 26983469Hamline MY, Rutman L, Tancredi DJ, Rosenthal JL; UNIVERSITY OF CALIFORNIA DAVIS CHILDREN'S HOSPITAL DISCHARGE QUALITY IMPROVEMENT WORKING GROUP. An Iterative Quality Improvement Process Improves Pediatric Ward Discharge Efficiency. Hosp Pediatr. 2020 Mar;10(3):214-221. doi: 10.1542/hpeds.2019-0158. Epub 2020 Feb 12.
PubMed 32051222
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Ward Discharge Quality Improvement
- ClinicalTrials.gov ID
- NCT03153722
- Acronym / sponsor ID
- 1016479
- Conditions
- Pediatric Hospitalization
- Keywords
- pediatric, hospital discharge, quality improvement, transition of care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,478 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 15 May 2017 (actual)
- 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.
This study will utilize an iterative quality improvement process to identify and address delays in the pediatric hospital discharge process.
Detailed description
Hospital crowding has been associated with increased hospital length of stay in pediatric populations and adverse outcomes in adult populations. This study focuses on a 36-bed general pediatric inpatient care unit whose occupancy has seen exponential growth over the past several years. With the growth in patient population, the study hospital is experiencing increasing difficulty with hospital crowding, particularly during key times of year, such as the winter viral respiratory season. During these times, pediatric patients may experience high emergency room wait times, and admitted patients may be required to board in the emergency room or post-anesthesia care unit while they await an inpatient bed. Lack of inpatient bed availability has also, at times, required cancellation of surgical cases and denial of outside hospital patient transfers to the institution, resulting in inconvenience to patients and delays in care.
The pediatric hospital discharge process has come under particular scrutiny as an area in which both the efficiency and the effectiveness of patient care can be improved. Currently, around 10% of patients ready for discharge in a given day from the general pediatric hospitalist service are discharged prior to noon, freeing up this bed space for a new patient. While for some patients, discharge is postponed for medical reasons, others must remain in the hospital for non-medical delays. For example, they may remain hospitalized because they have not yet been seen by a physician, their medications are not available for pick-up from the pharmacy, or they do not have transportation from hospital to home. Several studies in pediatric populations have shown that quality improvement processes can improve discharge efficiency without compromising care quality or patient/family satisfaction. The investigators aim to determine if an iterative quality improvement process can reduce barriers to discharge and therefore decrease pediatric patients' length of stay. They will simultaneously analyze several secondary outcomes to evaluate patient flow, patient/family satisfaction, and subsequent hospital utilization to evaluate for unintended consequences of the interventions.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric discharge process intervention | Experimental | Procedure: Pediatric discharge process interventionsAll patients hospitalized on the pediatric ward under the pediatric hospitalist service will participate in pediatric discharge process interventions. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children or young adults less than 21 years of age admitted to the University of California Davis Children's Hospital Pediatric Hospitalist Service on the general pediatric inpatient ward
Key exclusion criteria (4 listed)
- Adults greater than 21 years of age, including those unable to consent
- Pregnant women
- Prisoners
- Children admitted to other services (i.e. Ear, Nose and Throat Surgery, Pediatric Surgery, Pediatric Gastroenterology, Trauma, Pediatric Nephrology, Pediatric Hematology/Oncology, Pediatric Intensive Care Unit, Neonatal Intensive Care Unit, Newborn Nursery, etc.)
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 discharge process interventionsAs this is an iterative quality improvement process, interventions will be evidence-based and chosen to test effectiveness for addressing areas of discharge bottlenecks or inefficiency within our specific hospital's context. Examples of possible interventions may include implementation of a discharge risk assessment (as in Statile et al, Pediatrics 2016), institution of a "medications-in-hand" policy on hospital discharge (as in Sauers-Ford et al, Pediatrics 2016), or initiation of a ward discharge coordinator who will help coordinate outpatient follow-up for patients. Interventions will be implemented in a stepwise fashion, utilizing successive plan-do-study-act cycles, with a minimum 2 month period between interventions to monitor outcomes. | Procedure or surgery | Pediatric discharge process intervention |
Primary outcome
Length of stay index
Time frame: Time from admission to discharge through study completion in 1 year.
Length of stay index is a metric that is calculated by Vizient and compares a patient's hospital length of stay to national averages, taking into account the patient's diagnosis, severity of illness, and disease complexity.
Percentage of patients discharged before 1200
Time frame: Discharge time for each patient within a 24 hour period on day of discharge.
Percentage of pediatric hospitalist patients who are discharged before noon on the day they are eligible for discharge.
3 secondary outcomes
Readmission
Time frame: 30 days
Emergency department re-visit
Time frame: 7 and 30 days
Patient satisfaction
Time frame: Mailed to families following hospital discharge through study completion in 1 year.
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 20 Apr 2021.
- Background: PubMed 18381501Lorch SA, Millman AM, Zhang X, Even-Shoshan O, Silber JH. Impact of admission-day crowding on the length of stay of pediatric hospitalizations. Pediatrics. 2008 Apr;121(4):e718-30. doi: 10.1542/peds.2007-1280.
- Background: PubMed 17360988Kostis WJ, Demissie K, Marcella SW, Shao YH, Wilson AC, Moreyra AE; Myocardial Infarction Data Acquisition System (MIDAS 10) Study Group. Weekend versus weekday admission and mortality from myocardial infarction. N Engl J Med. 2007 Mar 15;356(11):1099-109. doi: 10.1056/NEJMoa063355.
- Background: PubMed 11547721Bell CM, Redelmeier DA. Mortality among patients admitted to hospitals on weekends as compared with weekdays. N Engl J Med. 2001 Aug 30;345(9):663-8. doi: 10.1056/NEJMsa003376.
- Background: PubMed 25483409Beck MJ, Gosik K. Redesigning an inpatient pediatric service using Lean to improve throughput efficiency. J Hosp Med. 2015 Apr;10(4):220-7. doi: 10.1002/jhm.2300. Epub 2014 Dec 8.
- Background: PubMed 27412640Statile AM, Schondelmeyer AC, Thomson JE, Brower LH, Davis B, Redel J, Hausfeld J, Tucker K, White DL, White CM. Improving Discharge Efficiency in Medically Complex Pediatric Patients. Pediatrics. 2016 Aug;138(2):e20153832. doi: 10.1542/peds.2015-3832. Epub 2016 Jul 13.
- Background: PubMed 24470173White CM, Statile AM, White DL, Elkeeb D, Tucker K, Herzog D, Warrick SD, Warrick DM, Hausfeld J, Schondelmeyer A, Schoettker PJ, Kiessling P, Farrell M, Kotagal U, Ryckman FC. Using quality improvement to optimise paediatric discharge efficiency. BMJ Qual Saf. 2014 May;23(5):428-36. doi: 10.1136/bmjqs-2013-002556. Epub 2014 Jan 27.
- Background: PubMed 26983469Sauers-Ford HS, Moore JL, Guiot AB, Simpson BE, Clohessy CR, Yost D, Mayhaus DC, Simmons JM, Gosdin CH. Local Pharmacy Partnership to Prevent Pediatric Asthma Reutilization in a Satellite Hospital. Pediatrics. 2016 Apr;137(4):e20150039. doi: 10.1542/peds.2015-0039. Epub 2016 Mar 16.
- Derived from this study: PubMed 32051222Hamline MY, Rutman L, Tancredi DJ, Rosenthal JL; UNIVERSITY OF CALIFORNIA DAVIS CHILDREN'S HOSPITAL DISCHARGE QUALITY IMPROVEMENT WORKING GROUP. An Iterative Quality Improvement Process Improves Pediatric Ward Discharge Efficiency. Hosp Pediatr. 2020 Mar;10(3):214-221. doi: 10.1542/hpeds.2019-0158. Epub 2020 Feb 12.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric discharge process interventions in people with Pediatric Hospitalization, run by University of California, Davis 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 4 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 20 Apr 2021. 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.
What does the primary outcome measure?
Length of stay index (time frame: Time from admission to discharge through study completion in 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03153722, which also lists 8 linked publications.
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 20 Apr 2021.