DementiaNCT00294307
Enhancing Care Coordination: Hospital to Home for Cognitively Impaired Older Adults and Their Caregivers
An observational study of Dementia and Dementia, Vascular, run by University of Pennsylvania at 3 sites in United States.
Trial summary
Aim 1. To compare across three hospital sites the effects on health and cost outcomes observed by the following three interventions, each designed to enhance adaptation and improve outcomes of hospitalized cognitively impaired elders and their caregivers: 1. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Dementia, Vascular, Alzheimer Disease
- What is being tested?
- Resource Nurse Care (RNC) and Advanced Practice Nurse Care (APNC)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 814 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2006to Aug 2012
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Hospitalized community dwelling older adults with cognitive impairment and a caregiver
Who may be able to join
- Age >= 65 and older
- Speaks English
- Resides within 30 miles of admitting hospital site
- Admitted from home to one of three hospital sites
- a documented history of pre-existing dementia in their medical records or pre-screen positive for cognitive impairment using our Pre-Screen Process.
- a primary caregiver (knowledgeable informant), defined as the spouse, family member, partner or friend, who will provide support following discharge to home and is reachable by telephone.
Who cannot join
- End Stage Disease
- Active untreated substance abuse or psychiatric conditions
- Primary cancer diagnosis (active treatment)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19102
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Penn-Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Hospital to Home: Cognitively Impaired Elders/Caregivers
Aim 1. To compare across three hospital sites the effects on health and cost outcomes observed by the following three interventions, each designed to enhance adaptation and improve outcomes of hospitalized cognitively impaired elders and their caregivers:
- augmented standard care (ASC) - standard hospital and, if referred, home care plus early identification of CI during the patients' hospitalization by trained registered nurses (RNs) with immediate feedback to patients' primary nurses, attending physicians and discharge planners;
- resource nurse care (RNC) - standard hospital and, if referred, home care plus early identification of CI during the patient's hospitalization by trained RNs and hospital care by RNs trained in the use of expert clinical guidelines developed to enhance the care management of hospitalized cognitively impaired elders and to facilitate their transition from hospital to home; or,
- advanced practice nurse care (APNC) - standard hospital care plus transitional (hospital to home) care substituting for standard home care and provided by APNs with advanced training in the management of CI patients using an evidence-based protocol designed specifically for this patient group and their caregivers.
Read more
[H1] We hypothesize that health and cost outcomes with APNC, a comprehensive intervention designed to meet the unique needs of cognitively impaired older adults hospitalized for an acute medical or surgical event and their caregivers will be associated, relative to health and cost outcomes with ASC and RNC, with improvement in patient, caregiver and cost outcomes.
[H2] We hypothesize that improvements in patient, caregiver and cost outcomes observed for the RNC group will be greater than those observed for the ASC group.
Aim 2. To compare within each site and over time, health and cost outcomes (identified in Aim 1) from patients treated with either ASC or RNC, both relatively lower intensity interventions, with the outcomes of patients at the same site observed after switching to APNC, a high intensity intervention.
[H3] We hypothesize that compared to patients receiving the ASC or the RNC interventions, patients at the same site will have improved patient, caregiver and cost outcomes after the site switches to APNC.
[H4] We hypothesize that patient, caregiver and cost outcomes achieved by the groups receiving APNC interventions at T1 and T2 will be similar.
Read the detailed description
Cognitive impairment (CI) is a major health problem complicating the care of increasing numbers of older adults hospitalized for an acute medical or surgical condition. Dementia and delirium, the most common causes of CI among these elders, is associated with higher mortality rates, increased morbidity and higher health care costs. A growing body of science suggests that these patients and their caregivers are particularly vulnerable to systems of care that either do not recognize or ignore their needs. The consequences are devastating for the patients and their caregivers and add tremendous burden to hospital staffs coping with a severe shortage of nurses. For these reasons, the Institute of Medicine identified improved care management of this patient group as a national priority for action. Unfortunately, little evidence is available to guide optimal care of this patient group or to address the unique needs of their caregivers. Collectively, available evidence suggests that these patients may benefit from interventions aimed at improving management of CI, comorbid conditions or both but the exact nature and intensity of intervention needed to effectively and efficiently improve their outcomes and those of their caregivers is not known. Thus, the timing is excellent for rigorous research aimed at identifying care management strategies that will result in high quality, cost-effective outcomes for this challenging patient group and their caregivers.
- Conditions
- Dementia, Dementia, Vascular, Alzheimer Disease, Delirium, Dementia, Amnestic, Cognitive Disorders, Lewy Body Disease, Mild Cognitive Impairment
- Being tested
- Augmented Standard Care (ASC), Resource Nurse Care (RNC), Advanced Practice Nurse Care (APNC)
- Keywords
- Nursing Models of Care, Collaborative Care, Care Management, Transitional Care, Advanced Practice Nurse Care Interventions, Cognitive Impairment, Dementia, Delirium
- Medical subject headings
- Dementia, Dementia, Vascular, Alzheimer Disease, Neurocognitive Disorders, Lewy Body Disease, Cognitive Dysfunction, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Standard Care (ASC)Behavioural
Standard hospital care and, if referred, home care plus early identification of CI during the patients' hospitalization by trained research assistants with immediate verbal feedback and documentation to patients' primary nurses, attending physicians and discharge planners [low intensity];
Resource Nurse Care (RNC)Behavioural
Standard hospital and, if referred, home care plus early identification of CI during the patient's hospitalization (ASC) and hospital care by RNs trained in the use of expert clinical guidelines developed to enhance the care management of hospitalized cognitively impaired elders and to facilitate their transition from hospital to home [medium intensity];.
Advanced Practice Nurse Care (APNC)Behavioural
Standard hospital care plus ASC and transitional care starting in the hospital and substituting for standard home care and provided by Advanced Practice Nurses (APNs) with advanced training in the management of CI patients using an evidence-based protocol designed specifically for this patient group and their caregivers [high intensity].
| Study group | Role | What they receive |
|---|---|---|
| Advanced Practice Nurse Care (APNC) | Hospital to Home Receives: Behavioral: Advanced Practice Nurse Care (APNC) | |
| Augmented Standard Care (ASC) | Hospital only Receives: Behavioral: Augmented Standard Care (ASC) | |
| Resource Nurse Care (RNC) | Hospital only Receives: Behavioral: Resource Nurse Care (RNC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient - Function
Basic Activities of Daily Living
Measured: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
Caregiver - Burden
Measured: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
Patient - Health Care Costs
Measured: Through 6 months
Patient - Time to first rehospitalization or death; total rehospitalization days
Time calculated from index hospital discharge to first rehospitalization or death. Total days rehospitalized through six months.
Measured: From index hospital discharge through 6 months
Secondary outcomes (8)
Patient - Total rehospitalizations
Measured: From index hospital discharge through 6 months
Patient - Cognitive Function
Measured: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
Patient - Care Management
Measured: From enrollment through 6 months
Patient - Symptoms (Physical and depressive symptoms)
Measured: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
Patient - Neuropsychiatric Behaviors
Measured: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
Patient - Quality of Life
Measured: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
Patient/Caregiver - Satisfaction with care
Measured: At 2-weeks and post APNC intervention
Caregiver - Depressive Symptoms
Measured: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionJul 2010
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- 814 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Mary D Naylor, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294307
- Sponsor's protocol ID
- R01AG023116
- Other IDs
- R01AG023116
- Status last verified
- Feb 2019
- First submitted
- 16 Feb 2006
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Naylor MD, Hirschman KB, Bowles KH, Bixby MB, Konick-McMahan J, Stephens C. Care coordination for cognitively impaired older adults and their caregivers. Home Health Care Serv Q. 2007;26(4):57-78. doi: 10.1300/j027v26n04_05.
PubMed 18032200Naylor MD, Stephens C, Bowles KH, Bixby MB. Cognitively impaired older adults: from hospital to home. Am J Nurs. 2005 Feb;105(2):52-61; quiz 61-2. doi: 10.1097/00000446-200502000-00028. No abstract available.
PubMed 15674058McCauley K, Bradway C, Hirschman KB, Naylor MD. Studying nursing interventions in acutely ill, cognitively impaired older adults. Am J Nurs. 2014 Oct;114(10):44-52. doi: 10.1097/01.NAJ.0000454851.22018.5d.
PubMed 25251126Shankar KN, Hirschman KB, Hanlon AL, Naylor MD. Burden in caregivers of cognitively impaired elderly adults at time of hospitalization: a cross-sectional analysis. J Am Geriatr Soc. 2014 Feb;62(2):276-84. doi: 10.1111/jgs.12657. Epub 2014 Feb 6.
PubMed 24502827Hirschman KB, Paik HH, Pines JM, McCusker CM, Naylor MD, Hollander JE. Cognitive Impairment among Older Adults in the Emergency Department. West J Emerg Med. 2011 Feb;12(1):56-62.
PubMed 21691473Bradway C, Trotta R, Bixby MB, McPartland E, Wollman MC, Kapustka H, McCauley K, Naylor MD. A qualitative analysis of an advanced practice nurse-directed transitional care model intervention. Gerontologist. 2012 Jun;52(3):394-407. doi: 10.1093/geront/gnr078. Epub 2011 Sep 9.
PubMed 21908805Naylor MD, Hirschman KB, Hanlon AL, Bowles KH, Bradway C, McCauley KM, Pauly MV. Comparison of evidence-based interventions on outcomes of hospitalized, cognitively impaired older adults. J Comp Eff Res. 2014 May;3(3):245-57. doi: 10.2217/cer.14.14.
PubMed 24969152Naylor MD, Hirschman KB, Hanlon AL, Bowles KH, Bradway C, McCauley KM, Pauly MV. Effects of alternative interventions among hospitalized, cognitively impaired older adults. J Comp Eff Res. 2016 May;5(3):259-72. doi: 10.2217/cer-2015-0009. Epub 2016 May 5.
PubMed 27146416Pauly MV, Hirschman KB, Hanlon AL, Huang L, Bowles KH, Bradway C, McCauley K, Naylor MD. Cost impact of the transitional care model for hospitalized cognitively impaired older adults. J Comp Eff Res. 2018 Sep;7(9):913-922. doi: 10.2217/cer-2018-0040. Epub 2018 Sep 11.
PubMed 30203668
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital to Home: Cognitively Impaired Elders/Caregivers
- ClinicalTrials.gov ID
- NCT00294307
- Acronym / sponsor ID
- R01AG023116
- Conditions
- Dementia, Dementia, Vascular, Alzheimer Disease, Delirium, Dementia, Amnestic, Cognitive Disorders, Lewy Body Disease, Mild Cognitive Impairment
- Keywords
- Nursing Models of Care, Collaborative Care, Care Management, Transitional Care, Advanced Practice Nurse Care Interventions, Cognitive Impairment, Dementia, Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 814 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Feb 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Feb 2006 (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.
Aim 1. To compare across three hospital sites the effects on health and cost outcomes observed by the following three interventions, each designed to enhance adaptation and improve outcomes of hospitalized cognitively impaired elders and their caregivers:
- augmented standard care (ASC) - standard hospital and, if referred, home care plus early identification of CI during the patients' hospitalization by trained registered nurses (RNs) with immediate feedback to patients' primary nurses, attending physicians and discharge planners;
- resource nurse care (RNC) - standard hospital and, if referred, home care plus early identification of CI during the patient's hospitalization by trained RNs and hospital care by RNs trained in the use of expert clinical guidelines developed to enhance the care management of hospitalized cognitively impaired elders and to facilitate their transition from hospital to home; or,
- advanced practice nurse care (APNC) - standard hospital care plus transitional (hospital to home) care substituting for standard home care and provided by APNs with advanced training in the management of CI patients using an evidence-based protocol designed specifically for this patient group and their caregivers.
[H1] We hypothesize that health and cost outcomes with APNC, a comprehensive intervention designed to meet the unique needs of cognitively impaired older adults hospitalized for an acute medical or surgical event and their caregivers will be associated, relative to health and cost outcomes with ASC and RNC, with improvement in patient, caregiver and cost outcomes.
[H2] We hypothesize that improvements in patient, caregiver and cost outcomes observed for the RNC group will be greater than those observed for the ASC group.
Aim 2. To compare within each site and over time, health and cost outcomes (identified in Aim 1) from patients treated with either ASC or RNC, both relatively lower intensity interventions, with the outcomes of patients at the same site observed after switching to APNC, a high intensity intervention.
[H3] We hypothesize that compared to patients receiving the ASC or the RNC interventions, patients at the same site will have improved patient, caregiver and cost outcomes after the site switches to APNC.
[H4] We hypothesize that patient, caregiver and cost outcomes achieved by the groups receiving APNC interventions at T1 and T2 will be similar.
Detailed description
Cognitive impairment (CI) is a major health problem complicating the care of increasing numbers of older adults hospitalized for an acute medical or surgical condition. Dementia and delirium, the most common causes of CI among these elders, is associated with higher mortality rates, increased morbidity and higher health care costs. A growing body of science suggests that these patients and their caregivers are particularly vulnerable to systems of care that either do not recognize or ignore their needs. The consequences are devastating for the patients and their caregivers and add tremendous burden to hospital staffs coping with a severe shortage of nurses. For these reasons, the Institute of Medicine identified improved care management of this patient group as a national priority for action. Unfortunately, little evidence is available to guide optimal care of this patient group or to address the unique needs of their caregivers. Collectively, available evidence suggests that these patients may benefit from interventions aimed at improving management of CI, comorbid conditions or both but the exact nature and intensity of intervention needed to effectively and efficiently improve their outcomes and those of their caregivers is not known. Thus, the timing is excellent for rigorous research aimed at identifying care management strategies that will result in high quality, cost-effective outcomes for this challenging patient group and their caregivers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Advanced Practice Nurse Care (APNC) | – | Behavioral: Advanced Practice Nurse Care (APNC)Hospital to Home |
| Augmented Standard Care (ASC) | – | Behavioral: Augmented Standard Care (ASC)Hospital only |
| Resource Nurse Care (RNC) | – | Behavioral: Resource Nurse Care (RNC)Hospital only |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Hospitalized community dwelling older adults with cognitive impairment and a caregiver
Key inclusion criteria (6 listed)
- Age >= 65 and older
- Speaks English
- Resides within 30 miles of admitting hospital site
- Admitted from home to one of three hospital sites
- a documented history of pre-existing dementia in their medical records or pre-screen positive for cognitive impairment using our Pre-Screen Process.
Key exclusion criteria (3 listed)
- End Stage Disease
- Active untreated substance abuse or psychiatric conditions
- Primary cancer diagnosis (active treatment)
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 |
|---|---|---|
| Augmented Standard Care (ASC)Standard hospital care and, if referred, home care plus early identification of CI during the patients' hospitalization by trained research assistants with immediate verbal feedback and documentation to patients' primary nurses, attending physicians and discharge planners [low intensity]; | Behavioural | Augmented Standard Care (ASC) |
| Resource Nurse Care (RNC)Standard hospital and, if referred, home care plus early identification of CI during the patient's hospitalization (ASC) and hospital care by RNs trained in the use of expert clinical guidelines developed to enhance the care management of hospitalized cognitively impaired elders and to facilitate their transition from hospital to home [medium intensity];. | Behavioural | Resource Nurse Care (RNC) |
| Advanced Practice Nurse Care (APNC)Standard hospital care plus ASC and transitional care starting in the hospital and substituting for standard home care and provided by Advanced Practice Nurses (APNs) with advanced training in the management of CI patients using an evidence-based protocol designed specifically for this patient group and their caregivers [high intensity]. | Behavioural | Advanced Practice Nurse Care (APNC) |
Primary outcome
Patient - Function
Time frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
Basic Activities of Daily Living
Caregiver - Burden
Time frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
Patient - Health Care Costs
Time frame: Through 6 months
Patient - Time to first rehospitalization or death; total rehospitalization days
Time frame: From index hospital discharge through 6 months
Time calculated from index hospital discharge to first rehospitalization or death. Total days rehospitalized through six months.
8 secondary outcomes
Patient - Total rehospitalizations
Time frame: From index hospital discharge through 6 months
Patient - Cognitive Function
Time frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
Patient - Care Management
Time frame: From enrollment through 6 months
Patient - Symptoms (Physical and depressive symptoms)
Time frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
Patient - Neuropsychiatric Behaviors
Time frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
Patient - Quality of Life
Time frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
Patient/Caregiver - Satisfaction with care
Time frame: At 2-weeks and post APNC intervention
Caregiver - Depressive Symptoms
Time frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
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 5 Feb 2019.
- Background: PubMed 18032200Naylor MD, Hirschman KB, Bowles KH, Bixby MB, Konick-McMahan J, Stephens C. Care coordination for cognitively impaired older adults and their caregivers. Home Health Care Serv Q. 2007;26(4):57-78. doi: 10.1300/j027v26n04_05.
- Background: PubMed 15674058Naylor MD, Stephens C, Bowles KH, Bixby MB. Cognitively impaired older adults: from hospital to home. Am J Nurs. 2005 Feb;105(2):52-61; quiz 61-2. doi: 10.1097/00000446-200502000-00028. No abstract available.
- Background: PubMed 25251126McCauley K, Bradway C, Hirschman KB, Naylor MD. Studying nursing interventions in acutely ill, cognitively impaired older adults. Am J Nurs. 2014 Oct;114(10):44-52. doi: 10.1097/01.NAJ.0000454851.22018.5d.
- Background: PubMed 24502827Shankar KN, Hirschman KB, Hanlon AL, Naylor MD. Burden in caregivers of cognitively impaired elderly adults at time of hospitalization: a cross-sectional analysis. J Am Geriatr Soc. 2014 Feb;62(2):276-84. doi: 10.1111/jgs.12657. Epub 2014 Feb 6.
- Background: PubMed 21691473Hirschman KB, Paik HH, Pines JM, McCusker CM, Naylor MD, Hollander JE. Cognitive Impairment among Older Adults in the Emergency Department. West J Emerg Med. 2011 Feb;12(1):56-62.
- Results publication: PubMed 21908805Bradway C, Trotta R, Bixby MB, McPartland E, Wollman MC, Kapustka H, McCauley K, Naylor MD. A qualitative analysis of an advanced practice nurse-directed transitional care model intervention. Gerontologist. 2012 Jun;52(3):394-407. doi: 10.1093/geront/gnr078. Epub 2011 Sep 9.
- Results publication: PubMed 24969152Naylor MD, Hirschman KB, Hanlon AL, Bowles KH, Bradway C, McCauley KM, Pauly MV. Comparison of evidence-based interventions on outcomes of hospitalized, cognitively impaired older adults. J Comp Eff Res. 2014 May;3(3):245-57. doi: 10.2217/cer.14.14.
- Results publication: PubMed 27146416Naylor MD, Hirschman KB, Hanlon AL, Bowles KH, Bradway C, McCauley KM, Pauly MV. Effects of alternative interventions among hospitalized, cognitively impaired older adults. J Comp Eff Res. 2016 May;5(3):259-72. doi: 10.2217/cer-2015-0009. Epub 2016 May 5.
- Results publication: PubMed 30203668Pauly MV, Hirschman KB, Hanlon AL, Huang L, Bowles KH, Bradway C, McCauley K, Naylor MD. Cost impact of the transitional care model for hospitalized cognitively impaired older adults. J Comp Eff Res. 2018 Sep;7(9):913-922. doi: 10.2217/cer-2018-0040. Epub 2018 Sep 11.
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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.
Mary D Naylor, PhD principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Dementia, Vascular, run by University of Pennsylvania at 3 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 6 inclusion and 3 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does the primary outcome measure?
Patient - Function (time frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge). The study lists 4 primary outcomes in all. 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 NCT00294307, which also lists 9 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 5 Feb 2019.