Functional DeclineNCT00182962
GRACE: Geriatric Resources for Assessment and Care of Elders
A study testing Geriatric Resources for Assessment & Care of Elders (GRACE) in people with Functional Decline and Aging, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of a collaborative model of team care as compared to usual care in improving functional outcomes among community-dwelling low-income older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Functional Decline, Aging
- What is being tested?
- Geriatric Resources for Assessment & Care of Elders (GRACE)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,270 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Oct 2006
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years old or older
- Annual income less than 200% of the federal poverty level
- Have had one or more primary care visits in the past 12 months
- Reside in the community (non-institutionalized)
Who cannot join
- Non-English speaking
- No regular access to a telephone
- Currently undergoing kidney dialysis treatments
- Residing with a patient already participating in the GRACE clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
Official title: Geriatric Resources for Assessment and Care of Elders
The purpose of this study is to test the effectiveness of a collaborative model of team care as compared to usual care in improving functional outcomes among community-dwelling low-income older adults.
Read the detailed description
This collaborative model of care, Geriatric Resources for Assessment and Care of Elders (GRACE), involves a geriatric nurse practitioner and a geriatric social worker caring for the vulnerable older adult in collaboration with the patient's primary care physician to improve coordination and quality of care. The specific components of GRACE mirror those recommended in recent reviews: a) specific targeting of elders at risk; b) availability of collaborative expertise in geriatrics; c) integration of the program into primary care; d) coordination of care across all sites of care; e) integration of data systems that support physician's practice and facilitate monitoring of pertinent clinical parameters; and f) institutionally endorsed clinical practice guidelines. To our knowledge, there are no prior studies investigating the effectiveness of such a comprehensive approach among vulnerable older adults.
We are hypothesizing that, compared to usual care, patients enrolled in the intervention will have:
- greater independence in activities of daily living over 2 years of follow-up;
- better health status scores as assessed by the HEDIS® 2000 Health Outcomes Survey
- fewer nursing home days over 2 years of follow-up; and
- fewer hospitalizations over the 2 years of follow-up.
- Conditions
- Functional Decline, Aging
- Being tested
- Geriatric Resources for Assessment & Care of Elders (GRACE)
- Keywords
- Activities of Daily Living, Low-income, geriatric medicine, computer assisted patient care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric Resources for Assessment & Care of Elders (GRACE)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional status
health status
hospitalization and nursing home placement
Secondary outcomes (1)
Patient satisfaction and quality of care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMar 2002
- Study completionOct 2006
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 Functional DeclineStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 1,270 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Nina Mason Pulliam Charitable Trust, Wishard Health Services
- Investigators
- Steven R. Counsell, MD, Principal investigator, Indiana University Geriatrics Program, Indiana University Center for Aging Research, Indiana University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182962
- Sponsor's protocol ID
- AG0042
- Other IDs
- R01AG020175
- Status last verified
- Nov 2006
- First submitted
- 13 Sep 2005
- Last updated
- 20 Nov 2006
- Results posted
- No
Publications
Bernabei R, Landi F, Gambassi G, Sgadari A, Zuccala G, Mor V, Rubenstein LZ, Carbonin P. Randomised trial of impact of model of integrated care and case management for older people living in the community. BMJ. 1998 May 2;316(7141):1348-51. doi: 10.1136/bmj.316.7141.1348.
PubMed 9563983Callahan CM, Stump TE, Stroupe KT, Tierney WM. Cost of health care for a community of older adults in an urban academic healthcare system. J Am Geriatr Soc. 1998 Nov;46(11):1371-7. doi: 10.1111/j.1532-5415.1998.tb06003.x.
PubMed 9809758Counsell SR, Holder CM, Liebenauer LL, Palmer RM, Fortinsky RH, Kresevic DM, Quinn LM, Allen KR, Covinsky KE, Landefeld CS. Effects of a multicomponent intervention on functional outcomes and process of care in hospitalized older patients: a randomized controlled trial of Acute Care for Elders (ACE) in a community hospital. J Am Geriatr Soc. 2000 Dec;48(12):1572-81. doi: 10.1111/j.1532-5415.2000.tb03866.x.
PubMed 11129745Stuck AE, Minder CE, Peter-Wuest I, Gillmann G, Egli C, Kesselring A, Leu RE, Beck JC. A randomized trial of in-home visits for disability prevention in community-dwelling older people at low and high risk for nursing home admission. Arch Intern Med. 2000 Apr 10;160(7):977-86. doi: 10.1001/archinte.160.7.977.
PubMed 10761963Chen A, Brown R, Archibald N, Aliotta S, Fox PD. Best practice in coordinated care. Health Care Financing Administration. 2000. Contract No. HCFA 500-95-0048 (04).
Counsell SR, Callahan CM, Buttar AB, Clark DO, Frank KI. Geriatric Resources for Assessment and Care of Elders (GRACE): a new model of primary care for low-income seniors. J Am Geriatr Soc. 2006 Jul;54(7):1136-41. doi: 10.1111/j.1532-5415.2006.00791.x.
PubMed 16866688Clark DO, Callahan CM, Counsell SR. Reliability and validity of a steadiness score. J Am Geriatr Soc. 2005 Sep;53(9):1582-6. doi: 10.1111/j.1532-5415.2005.53485.x.
PubMed 16137291Counsell SR, Callahan CM, Tu W, Stump TE, Arling GW. Cost analysis of the Geriatric Resources for Assessment and Care of Elders care management intervention. J Am Geriatr Soc. 2009 Aug;57(8):1420-6. doi: 10.1111/j.1532-5415.2009.02383.x.
PubMed 19691149Counsell SR, Callahan CM, Clark DO, Tu W, Buttar AB, Stump TE, Ricketts GD. Geriatric care management for low-income seniors: a randomized controlled trial. JAMA. 2007 Dec 12;298(22):2623-33. doi: 10.1001/jama.298.22.2623.
PubMed 18073358
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatric Resources for Assessment and Care of Elders
- ClinicalTrials.gov ID
- NCT00182962
- Acronym / sponsor ID
- AG0042
- Conditions
- Functional Decline, Aging
- Keywords
- Activities of Daily Living, Low-income, geriatric medicine, computer assisted patient care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,270 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Collaborators
- Nina Mason Pulliam Charitable Trust, Wishard Health Services
- Study start
- Mar 2002
- Study completion
- Oct 2006
- First posted
- 16 Sep 2005 (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.
The purpose of this study is to test the effectiveness of a collaborative model of team care as compared to usual care in improving functional outcomes among community-dwelling low-income older adults.
Detailed description
This collaborative model of care, Geriatric Resources for Assessment and Care of Elders (GRACE), involves a geriatric nurse practitioner and a geriatric social worker caring for the vulnerable older adult in collaboration with the patient's primary care physician to improve coordination and quality of care. The specific components of GRACE mirror those recommended in recent reviews: a) specific targeting of elders at risk; b) availability of collaborative expertise in geriatrics; c) integration of the program into primary care; d) coordination of care across all sites of care; e) integration of data systems that support physician's practice and facilitate monitoring of pertinent clinical parameters; and f) institutionally endorsed clinical practice guidelines. To our knowledge, there are no prior studies investigating the effectiveness of such a comprehensive approach among vulnerable older adults.
We are hypothesizing that, compared to usual care, patients enrolled in the intervention will have:
- greater independence in activities of daily living over 2 years of follow-up;
- better health status scores as assessed by the HEDIS® 2000 Health Outcomes Survey
- fewer nursing home days over 2 years of follow-up; and
- fewer hospitalizations over the 2 years of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 65 years old or older
- Annual income less than 200% of the federal poverty level
- Have had one or more primary care visits in the past 12 months
- Reside in the community (non-institutionalized)
Key exclusion criteria (4 listed)
- Non-English speaking
- No regular access to a telephone
- Currently undergoing kidney dialysis treatments
- Residing with a patient already participating in the GRACE clinical trial
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 |
|---|---|---|
| Geriatric Resources for Assessment & Care of Elders (GRACE) | Behavioural | – |
Primary outcome
Functional status
health status
hospitalization and nursing home placement
1 secondary outcome
Patient satisfaction and quality of care
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 20 Nov 2006.
- Background: PubMed 9563983Bernabei R, Landi F, Gambassi G, Sgadari A, Zuccala G, Mor V, Rubenstein LZ, Carbonin P. Randomised trial of impact of model of integrated care and case management for older people living in the community. BMJ. 1998 May 2;316(7141):1348-51. doi: 10.1136/bmj.316.7141.1348.
- Background: PubMed 9809758Callahan CM, Stump TE, Stroupe KT, Tierney WM. Cost of health care for a community of older adults in an urban academic healthcare system. J Am Geriatr Soc. 1998 Nov;46(11):1371-7. doi: 10.1111/j.1532-5415.1998.tb06003.x.
- Background: PubMed 11129745Counsell SR, Holder CM, Liebenauer LL, Palmer RM, Fortinsky RH, Kresevic DM, Quinn LM, Allen KR, Covinsky KE, Landefeld CS. Effects of a multicomponent intervention on functional outcomes and process of care in hospitalized older patients: a randomized controlled trial of Acute Care for Elders (ACE) in a community hospital. J Am Geriatr Soc. 2000 Dec;48(12):1572-81. doi: 10.1111/j.1532-5415.2000.tb03866.x.
- Background: PubMed 10761963Stuck AE, Minder CE, Peter-Wuest I, Gillmann G, Egli C, Kesselring A, Leu RE, Beck JC. A randomized trial of in-home visits for disability prevention in community-dwelling older people at low and high risk for nursing home admission. Arch Intern Med. 2000 Apr 10;160(7):977-86. doi: 10.1001/archinte.160.7.977.
- BackgroundChen A, Brown R, Archibald N, Aliotta S, Fox PD. Best practice in coordinated care. Health Care Financing Administration. 2000. Contract No. HCFA 500-95-0048 (04).
- Results publication: PubMed 16866688Counsell SR, Callahan CM, Buttar AB, Clark DO, Frank KI. Geriatric Resources for Assessment and Care of Elders (GRACE): a new model of primary care for low-income seniors. J Am Geriatr Soc. 2006 Jul;54(7):1136-41. doi: 10.1111/j.1532-5415.2006.00791.x.
- Results publication: PubMed 16137291Clark DO, Callahan CM, Counsell SR. Reliability and validity of a steadiness score. J Am Geriatr Soc. 2005 Sep;53(9):1582-6. doi: 10.1111/j.1532-5415.2005.53485.x.
- Derived from this study: PubMed 19691149Counsell SR, Callahan CM, Tu W, Stump TE, Arling GW. Cost analysis of the Geriatric Resources for Assessment and Care of Elders care management intervention. J Am Geriatr Soc. 2009 Aug;57(8):1420-6. doi: 10.1111/j.1532-5415.2009.02383.x.
- Derived from this study: PubMed 18073358Counsell SR, Callahan CM, Clark DO, Tu W, Buttar AB, Stump TE, Ricketts GD. Geriatric care management for low-income seniors: a randomized controlled trial. JAMA. 2007 Dec 12;298(22):2623-33. doi: 10.1001/jama.298.22.2623.
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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.
Steven R. Counsell, MD principal investigator
Indiana University Geriatrics Program, Indiana University Center for Aging Research, Indiana University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatric Resources for Assessment & Care of Elders (GRACE) in people with Functional Decline and Aging, run by National Institute on Aging (NIA) 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 4 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 20 Nov 2006. 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?
Functional status. The study lists 3 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 NCT00182962, 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 20 Nov 2006.