Patient DischargeNCT01091688
The Impact of Just-in-time Information on Neonatal Intensive Care Unit (NICU) Discharges
A study testing Just-in-Time information in people with Patient Discharge, run by Virginia Moyer at 1 site in United States.
Trial summary
We, the investigators, will provide "Just-in-Time" information, physician educational material, to primary care pediatricians of Neonatal Intensive Care Unit (NICU) graduates at the time of NICU discharge. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patient Discharge
- What is being tested?
- Just-in-Time information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jun 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pediatric care providers will be identified when they accept into their practices babies who are part of a related study of an enhanced discharge process in the Texas Children's Hospital (TCH) NICU (ClinicalTrials.gov Identifier: NCT01088945)
- Participating providers must be part of Texas Children's Pediatrics Associates (TCPA), or accept Texas Children's Health Plan (TCHP) insurance.
Who cannot join
- Providers who are not part of Texas Children's Pediatrics Associates (TCPA), or do not accept Texas Children's Health Plan (TCHP) insurance.
Trial locations and contacts
1 site in 1 country.
United States1 site
Newborn Center, Texas Children's Hospital
Houston, Texas, 77030
About this study
Official title: The Impact of "Just-in-time" Information on NICU Discharges
We, the investigators, will provide "Just-in-Time" information, physician educational material, to primary care pediatricians of Neonatal Intensive Care Unit (NICU) graduates at the time of NICU discharge. We will follow the rate of adverse events (deaths, re-hospitalizations, emergency room visits, and missed appointments) for 6 months after NICU discharge. We will assess levels of physician comfort in caring for NICU specific diseases, as well as physician satisfaction with the discharge process. We hypothesize that the provision of "Just-in-Time" information will decrease the rate of adverse events, and make physicians more comfortable in caring for complicated NICU graduates, and more satisfied with the discharge process.
Read the detailed description
The purpose of this protocol is to evaluate the impact of providing "Just-in-Time" information, or physician educational material at the time of discharge, to primary care pediatricians caring for Neonatal Intensive Care Unit (NICU) graduates. The material provided will be tailored to the needs of each infant. The educational material will be sent to the physicians via email and facsimile on the day of discharge, and a hard copy will be sent with the parents to bring to their first clinic appointment. Outcomes, including emergency room visits, hospital readmissions, deaths, missed appointments, and improvements in care in the areas of intervention will be assessed. Levels of physician comfort in caring for various disorders specific to NICU graduates will be assessed, and satisfaction with the discharge process will also be evaluated pre- and post- intervention.
- Conditions
- Patient Discharge
- Being tested
- Just-in-Time information
- Keywords
- neonatal, discharge planning, health transition, educational needs assessment, Intensive care, neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Just-in-Time informationBehavioural
Infants and physicians assigned to the intervention group will receive Just-in-Time information at the time of NICU discharge, by email and facsimile, and the parents will receive a copy to bring to their first clinic appointment.
| Study group | Role | What they receive |
|---|---|---|
| Just-in-Time intervention | Experimental | The infants and physicians in the experimental group will receive the "Just-in-Time" intervention sheets at the time of discharge. Receives: Behavioral: Just-in-Time information |
| Routine discharge care | No intervention | The infants and physicians in the routine discharge care arm will receive the same information and details as is per normal routine in the nursery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
The rates of death, rehospitalization, emergency room visits, and missed appointments will be calculated for infants in the first 6 months after discharge from the NICU.
Measured: 6 months from hospital discharge
Secondary outcomes (1)
Physician comfort levels
Physicians will complete pre- and post- intervention surveys that consist of 5-point Likert scales that measure comfort levels with various disorders specific to former premature infants.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient DischargeStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Moyer
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor-investigator, Virginia Moyer, Baylor College of Medicine
- Investigators
- Virginia A Moyer, MD, MPH, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091688
- Sponsor's protocol ID
- H-25701
- Status last verified
- Jul 2015
- First submitted
- 18 Mar 2010
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of "Just-in-time" Information on NICU Discharges
- ClinicalTrials.gov ID
- NCT01091688
- Acronym / sponsor ID
- H-25701
- Conditions
- Patient Discharge
- Keywords
- neonatal, discharge planning, health transition, educational needs assessment, Intensive care, neonatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Virginia MoyerUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Mar 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Mar 2010 (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.
We, the investigators, will provide "Just-in-Time" information, physician educational material, to primary care pediatricians of Neonatal Intensive Care Unit (NICU) graduates at the time of NICU discharge. We will follow the rate of adverse events (deaths, re-hospitalizations, emergency room visits, and missed appointments) for 6 months after NICU discharge. We will assess levels of physician comfort in caring for NICU specific diseases, as well as physician satisfaction with the discharge process. We hypothesize that the provision of "Just-in-Time" information will decrease the rate of adverse events, and make physicians more comfortable in caring for complicated NICU graduates, and more satisfied with the discharge process.
Detailed description
The purpose of this protocol is to evaluate the impact of providing "Just-in-Time" information, or physician educational material at the time of discharge, to primary care pediatricians caring for Neonatal Intensive Care Unit (NICU) graduates. The material provided will be tailored to the needs of each infant. The educational material will be sent to the physicians via email and facsimile on the day of discharge, and a hard copy will be sent with the parents to bring to their first clinic appointment. Outcomes, including emergency room visits, hospital readmissions, deaths, missed appointments, and improvements in care in the areas of intervention will be assessed. Levels of physician comfort in caring for various disorders specific to NICU graduates will be assessed, and satisfaction with the discharge process will also be evaluated pre- and post- intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Just-in-Time intervention | Experimental | Behavioral: Just-in-Time informationThe infants and physicians in the experimental group will receive the "Just-in-Time" intervention sheets at the time of discharge. |
| Routine discharge care | No intervention | –The infants and physicians in the routine discharge care arm will receive the same information and details as is per normal routine in the nursery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pediatric care providers will be identified when they accept into their practices babies who are part of a related study of an enhanced discharge process in the Texas Children's Hospital (TCH) NICU (ClinicalTrials.gov Identifier: NCT01088945)
- Participating providers must be part of Texas Children's Pediatrics Associates (TCPA), or accept Texas Children's Health Plan (TCHP) insurance.
Key exclusion criteria (1 listed)
- Providers who are not part of Texas Children's Pediatrics Associates (TCPA), or do not accept Texas Children's Health Plan (TCHP) insurance.
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 |
|---|---|---|
| Just-in-Time informationInfants and physicians assigned to the intervention group will receive Just-in-Time information at the time of NICU discharge, by email and facsimile, and the parents will receive a copy to bring to their first clinic appointment. | Behavioural | Just-in-Time intervention |
Primary outcome
Adverse events
Time frame: 6 months from hospital discharge
The rates of death, rehospitalization, emergency room visits, and missed appointments will be calculated for infants in the first 6 months after discharge from the NICU.
1 secondary outcome
Physician comfort levels
Time frame: 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 27 Jul 2015.
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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.
Virginia A Moyer, MD, MPH principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Just-in-Time information in people with Patient Discharge, run by Virginia Moyer 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 2 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 27 Jul 2015. 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?
Adverse events (time frame: 6 months from hospital discharge). 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 27 Jul 2015.