Discharge Planning Assessment of Family Needs | NCT00759213

Studies
Discharge Planning Assessment of Family Needs

NCT00759213

Sponsor

Christiana Care Health Services

Status

Completed

Last Update Posted

Feb 17, 2012Estimated

Enrollment

250Actual

Phase

Not provided

Conditions

Family Needs / Concerns

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Nov 2008Actual

Completion Date

Sep 2009Actual

First Submitted Date

Sep 24, 2008

First Submission Date that Met QC Criteria

Sep 24, 2008

First Posted Date

Sep 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2012

Last Update Posted Date

Feb 17, 2012Estimated

Name	Class
Alfred I. duPont Hospital for Children	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Any infant with a length of stay in the NICU of at least 7 days.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infants admitted to the NICU
Length of stay > 6 days
Discharge to home

Exclusion Criteria:

Length of stay \

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

12 Months

Standard Ages

Child

Study Population

Infants in the NICU

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert G. Locke, DO	Christiana Care Health Services	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Christiana Care Health Systems		Newark	Delaware	19711	United States
Alfred I. duPont Hospital for Children