NCT01565642

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

August 10, 2018

Completed
Last Updated

August 10, 2018

Status Verified

March 1, 2016

Enrollment Period

3.2 years

First QC Date

March 26, 2012

Results QC Date

May 25, 2018

Last Update Submit

July 9, 2018

Conditions

Dementia

Keywords

Dementia, decision making

Outcome Measures

Primary Outcomes (1)

  • Quality of Communication and Decision-making

    The Quality of Communication (QOC) score with its End of Life (EOL) subscale score. Scores range 0-10 on QOC and its subscales, with higher scores indicating better communication quality.

    3 months

Secondary Outcomes (8)

  • Number of Palliative Care Domains in Care Plan

    9 months

  • Satisfaction With Care

    9 months

  • Comfort in Dying

    9 months

  • Alzheimer Disease Related Quality of Life

    9 months

  • Quality of Dying

    9 months

  • +3 more secondary outcomes

Study Arms (2)

Decision support intervention

EXPERIMENTAL

Decision aid and care plan meeting

Behavioral: Goals of care decision support

Control

NO INTERVENTION

Attention control information on dementia care

Interventions

Goals of care decision supportBEHAVIORAL

Decision aid and care plan meeting

Decision support intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Non-related legal surrogate without personal knowledge of resident

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (3)

  • 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.

    PMID: 29957095DERIVED

  • 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.

    PMID: 27893884DERIVED

  • 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.

    PMID: 27271683DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Laura C. Hanson, MD, MPH
Organization
University of North Carolina at Chapel Hill
lhanson@med.unc.edu
919-843-4096

Study Officials

  • Laura C Hanson, MD, MPH

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2012

First Posted

March 28, 2012

Study Start

May 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 10, 2018

Results First Posted

August 10, 2018

Record last verified: 2016-03

Locations

US(1)