Family Needs / ConcernsNCT00759213
Discharge Planning Assessment of Family Needs
An observational study of Family Needs / Concerns, run by Christiana Care Health Services at 2 sites in United States.
Trial summary
It is well established within pediatric and neonatal medicine that social and traditionally "non-medical" aspects of the home environment and conditions after discharge influence neonatal health both in the acute and long-term setting. Read more about this study
- Who is it for?
- Ages Up to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Family Needs / Concerns
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2007to Sep 2009
- 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 Up to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants in the NICU
Who may be able to join
- Infants admitted to the NICU
- Length of stay > 6 days
- Discharge to home
Who cannot join
- Length of stay </= 6 days
- Discharge to another hospital
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Christiana Care Health Systems
Newark, Delaware, 19711
Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19808
About this study
Official title: Discharge Planning Assessment of Family Needs and Concerns at the Time of Infant's Discharge in the NICU
It is well established within pediatric and neonatal medicine that social and traditionally "non-medical" aspects of the home environment and conditions after discharge influence neonatal health both in the acute and long-term setting. Government programs and laws exist that are designed for the provision of basic pediatric health needs. Unfortunately, deficits in obtaining those services lead to preventable poor health outcomes. Hospital social workers and discharge planners are able to identify appropriate services, while lawyers are experts in ensuring those rights and services are actually obtained and delivered.
West Side Health of CCHS has implemented a medical-legal partnership along the pathways advocated by the Medical Legal Partnership for Children as part of their clinical care services. Before implementing a similar system in the NICU, a needs assessment will be performed first.
The purpose of this study is to determine what the health care team (physicians, nurses, social workers, discharge planners, etc) through our discharge planning practice establishes as the legal needs. We will collect information which is normally collected by the health care team as a part of their usual care and assessment for discharge planning. The families will not be approached directly by study staff.
- Conditions
- Family Needs / Concerns
- Keywords
- Discharge planning, Family needs, Family concerns, NICU, Infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Any infant with a length of stay in the NICU of at least 7 days. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startDec 2007
- Primary completionNov 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family Needs / ConcernsStudies 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
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Alfred I. duPont Hospital for Children
- Responsible party
- Sponsor
- Investigators
- Robert G. Locke, DO, Principal investigator, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759213
- Sponsor's protocol ID
- 27215
- Status last verified
- Feb 2012
- First submitted
- 24 Sep 2008
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discharge Planning Assessment of Family Needs and Concerns at the Time of Infant's Discharge in the NICU
- ClinicalTrials.gov ID
- NCT00759213
- Acronym / sponsor ID
- 27215
- Conditions
- Family Needs / Concerns
- Keywords
- Discharge planning, Family needs, Family concerns, NICU, Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Collaborators
- Alfred I. duPont Hospital for Children
- Study start
- Dec 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 25 Sep 2008 (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.
It is well established within pediatric and neonatal medicine that social and traditionally "non-medical" aspects of the home environment and conditions after discharge influence neonatal health both in the acute and long-term setting. Government programs and laws exist that are designed for the provision of basic pediatric health needs. Unfortunately, deficits in obtaining those services lead to preventable poor health outcomes. Hospital social workers and discharge planners are able to identify appropriate services, while lawyers are experts in ensuring those rights and services are actually obtained and delivered.
West Side Health of CCHS has implemented a medical-legal partnership along the pathways advocated by the Medical Legal Partnership for Children as part of their clinical care services. Before implementing a similar system in the NICU, a needs assessment will be performed first.
The purpose of this study is to determine what the health care team (physicians, nurses, social workers, discharge planners, etc) through our discharge planning practice establishes as the legal needs. We will collect information which is normally collected by the health care team as a part of their usual care and assessment for discharge planning. The families will not be approached directly by study staff.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Any infant with a length of stay in the NICU of at least 7 days. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants in the NICU
Key inclusion criteria (3 listed)
- Infants admitted to the NICU
- Length of stay > 6 days
- Discharge to home
Key exclusion criteria (2 listed)
- Length of stay </= 6 days
- Discharge to another hospital
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 17 Feb 2012.
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.
Robert G. Locke, DO principal investigator
Christiana Care Health Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Family Needs / Concerns, run by Christiana Care Health Services at 2 sites 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 3 inclusion and 2 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 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 17 Feb 2012; AzTrials last refreshed its copy on 7 Nov 2026.