Perspectives on End-of-Life Care for Medically-Fragile Ch... | NCT00724646

Studies
Perspectives on End-of-Life Care for Medically-Fragile Children and Young Adults

NCT00724646

Sponsor

Akron Children's Hospital

Status

Completed

Last Update Posted

Sep 15, 2009Estimated

Enrollment

125Estimated

Phase

Not provided

Conditions

Death

Interventions

Survey
Focus group

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

Sep 2009

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

Feb 2009

Primary Completion Date

Apr 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Jul 25, 2008

First Submission Date that Met QC Criteria

Jul 28, 2008

First Posted Date

Jul 29, 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

Sep 14, 2009

Last Update Posted Date

Sep 15, 2009Estimated

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

Hattie Larlham is a specialized long-term care facility for pediatric and young adult residents who are medically fragile and intellectually disabled, whose daily care is provided by direct care staff, Habilitation Assistants (HA), in conjunction with nurses and other direct care providers. The purpose of this study is to assess the perspectives of HA and parents/legal guardians on end-of-life care in a long-term care facility for pediatric and young adult residents who are medically fragile and intellectually disabled.

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

125Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Habilitation assistants	Other: Survey Other: Focus group
2		Parents/ legal guardians	Other: Survey Other: Focus group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Survey	Other	3 individual surveys	1 2
Focus group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participants' responses to survey questions.		Start of Study

Secondary Outcomes

Measure	Description	Time Frame
Participants' responses to focus group discussions.		End of study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HA at Hattie Larlham between January 1, 2006 to present
HA provided care to > 1 resident whose death occurred between January 1, 2006 through the end of the study period
HA provided ongoing care to the resident for at least 5 days in the last 30 days at Hattie Larlham before the resident's death
Parent/legal guardian of a Hattie Larlham resident whose death occurred between January 1, 2006 through the end of the study

Exclusion Criteria:

HA employed < 30 days at Hattie Larlham or cared for resident <5 days in last 30 days prior to the resident's death
HA or parent/legal guardian who has not experienced a Hattie Larlham resident's death since December 31, 2005

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Parents/ legal guardians and habilitation assistants

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Grossberg, MD	Hattie Larlham Center for Disabled Children	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hattie Larlham Center for Disabled Children		Mantua	Ohio	44255	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15332472	Background	Brazil K, McAiney C, Caron-O'Brien M, Kelley ML, O'Krafka P, Sturdy-Smith C. Quality end-of-life care in long-term care facilities: service providers' perspective. J Palliat Care. 2004 Summer;20(2):85-92.
11772185	Background	Contro N, Larson J, Scofield S, Sourkes B, Cohen H. Family perspectives on the quality of pediatric palliative care. Arch Pediatr Adolesc Med. 2002 Jan;156(1):14-9. doi: 10.1001/archpedi.156.1.14.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D011795	Surveys and Questionnaires
D017144	Focus Groups

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms