DeathNCT00724646
Perspectives on End-of-Life Care for Medically-Fragile Children and Young Adults
An observational study of Death, run by Akron Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Death
- What is being tested?
- Survey and Focus group
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Parents/ legal guardians and habilitation assistants
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hattie Larlham Center for Disabled Children
Mantua, Ohio, 44255
About this study
Official title: Direct Care Staff and Parents'/Legal Guardians' Perspectives on End-of-Life Care in a Long-Term Care Facility for Medically Fragile and Intellectually Disabled Pediatric and Young Adult Residents
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.
- Conditions
- Death
- Being tested
- Survey, Focus group
- Keywords
- parents, medically fragile, death, end-of-life care, surveys
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
3 individual surveys
Focus groupOther
Focus group discussions facilitated by a psychologist
| Study group | Role | What they receive |
|---|---|---|
| 1 | Habilitation assistants Receives: Other: Survey; Other: Focus group | |
| 2 | Parents/ legal guardians Receives: Other: Survey; Other: Focus group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' responses to survey questions.
Measured: Start of Study
Secondary outcomes (1)
Participants' responses to focus group discussions.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startFeb 2009
- Primary completionApr 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DeathStudies 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
- Retrospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akron Children's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Richard Grossberg, MD, Principal investigator, Hattie Larlham Center for Disabled Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724646
- Sponsor's protocol ID
- End-of-Life Care
- Status last verified
- Sep 2009
- First submitted
- 25 Jul 2008
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15332472Contro 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.
PubMed 11772185Vohra JU, Brazil K, Szala-Meneok K. The last word: family members' descriptions of end-of-life care in long-term care facilities. J Palliat Care. 2006 Spring;22(1):33-9.
PubMed 16689413
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Care Staff and Parents'/Legal Guardians' Perspectives on End-of-Life Care in a Long-Term Care Facility for Medically Fragile and Intellectually Disabled Pediatric and Young Adult Residents
- ClinicalTrials.gov ID
- NCT00724646
- Acronym / sponsor ID
- End-of-Life Care
- Conditions
- Death
- Keywords
- parents, medically fragile, death, end-of-life care, surveys
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Akron Children's HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 29 Jul 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Survey, Other: Focus groupHabilitation assistants |
| 2 | – | Other: Survey, Other: Focus groupParents/ legal guardians |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parents/ legal guardians and habilitation assistants
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Survey3 individual surveys | Other | 1, 2 |
| Focus groupFocus group discussions facilitated by a psychologist | Other | 1, 2 |
Primary outcome
Participants' responses to survey questions.
Time frame: Start of Study
1 secondary outcome
Participants' responses to focus group discussions.
Time frame: End of study
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 15 Sep 2009.
- Background: PubMed 15332472Brazil 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.
- Background: PubMed 11772185Contro 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.
- Background: PubMed 16689413Vohra JU, Brazil K, Szala-Meneok K. The last word: family members' descriptions of end-of-life care in long-term care facilities. J Palliat Care. 2006 Spring;22(1):33-9.
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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.
Richard Grossberg, MD principal investigator
Hattie Larlham Center for Disabled Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Death, run by Akron Children's Hospital 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 4 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 15 Sep 2009. 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?
Participants' responses to survey questions. (time frame: Start of Study). 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 NCT00724646, which also lists 3 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 15 Sep 2009.