Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia

NCT ID: NCT01565642

Last Updated: 2018-08-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-07-31

Brief Summary

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This cluster randomized controlled trial is to examine whether decision support for goals of care can improve quality of communication and decision-making and improve the quality of palliative care for nursing home residents with advanced dementia.

Detailed Description

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Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Decision support intervention

Decision aid and care plan meeting

Group Type EXPERIMENTAL

Goals of care decision support

Intervention Type BEHAVIORAL

Decision aid and care plan meeting

Control

Attention control information on dementia care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Goals of care decision support

Decision aid and care plan meeting

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Surrogate for nursing home resident with advanced dementia, paired with resident with advanced dementia

Exclusion Criteria

* Non-related legal surrogate without personal knowledge of resident
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura C Hanson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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Ernecoff NC, Zimmerman S, Mitchell SL, Song MK, Lin FC, Wessell KL, Hanson LC. Concordance between Goals of Care and Treatment Decisions for Persons with Dementia. J Palliat Med. 2018 Oct;21(10):1442-1447. doi: 10.1089/jpm.2018.0103. Epub 2018 Jun 29.

Reference Type DERIVED
PMID: 29957095 (View on PubMed)

Hanson LC, Zimmerman S, Song MK, Lin FC, Rosemond C, Carey TS, Mitchell SL. Effect of the Goals of Care Intervention for Advanced Dementia: A Randomized Clinical Trial. JAMA Intern Med. 2017 Jan 1;177(1):24-31. doi: 10.1001/jamainternmed.2016.7031.

Reference Type DERIVED
PMID: 27893884 (View on PubMed)

Hanson LC, Song MK, Zimmerman S, Gilliam R, Rosemond C, Chisholm L, Lin FC. Fidelity to a behavioral intervention to improve goals of care decisions for nursing home residents with advanced dementia. Clin Trials. 2016 Dec;13(6):599-604. doi: 10.1177/1740774516650863. Epub 2016 Jun 7.

Reference Type DERIVED
PMID: 27271683 (View on PubMed)

Other Identifiers

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R01AG037483

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10-0699

Identifier Type: -

Identifier Source: org_study_id

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