NCT02917603

Brief Summary

Twenty-eight percent of Americans over the age of 65 die in a nursing home. Research has found the quality of care of end-of-life care in nursing homes to have many challenges. It has also been documented that family members, especially those living at a distance, want to be involved in the care of their resident and family support can be beneficial to residents. Family members' involvement in decision-making in the nursing home setting improves outcomes for residents with life-limiting illnesses. Shared decision-making (SDM) is a process wherein a healthcare choice is jointly made by a healthcare provider and a resident or resident's proxy, often a family member. This proposal seeks to facilitate SDM among family members, residents with life-limiting illnesses (who are not enrolled in hospice), and the nursing home care team. The overall research question (RQ) asks: To what extent are outcomes for family member and residents with life limiting illnesses associated with SDM via web-conferencing in the nursing home? The overall hypothesis (H) is that SDM among family members, residents (when possible), and skilled nursing home staff via web-conferencing will improve outcomes for family members and residents with life-limiting illnesses. This is an exploratory mixed methods randomized clinical trial pilot to test the effect of shared decision making using web-based conferencing on the depression and burden of family members and the pain of nursing home residents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable pain

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

Study Start

First participant enrolled

September 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

February 5, 2020

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2020

Enrollment Period

1.6 years

First QC Date

September 23, 2016

Results QC Date

October 1, 2019

Last Update Submit

January 15, 2021

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Difference in Mean Patient Health Questionaire 9 Score From Baseline

    9 questions that indicate depression- taken at 30 days-Scale is 0-27 with higher values representing more depression. Measure collected every 30 days. Analysis is a comparison of means between the last measure taken and the baseline scores- with an overall average then computed.

    30 days

Secondary Outcomes (3)

  • Zarit Burden Interview

    30 days

  • Generalized Anxiety- 7

    30 days

  • Caregiver Quality of Life

    30 days

Study Arms (2)

Intervention

EXPERIMENTAL

These family members and residents will use web conferencing technology to attend their quarterly care conferences

Behavioral: Web Conferencing

Control

NO INTERVENTION

These family and residents will receive usual care

Interventions

Web ConferencingBEHAVIORAL

Individuals will communicate with the nursing home team via web conferencing during quarterly care conference

Intervention

Eligibility Criteria

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

You may qualify if:

  • Residents: Residents of The Bluffs nursing home, Columbia Missouri, over the age of 65, have at least one family member who agrees to participate, and have a serious life limiting illness. Residents enrolled in hospice or admitted to post hospital short term nursing home stay are excluded from participation.
  • Family Members: Identified family member by a resident or nursing home staff at The Bluffs, over the age of 18, without cognitive impairment, and with access to a computer, tablet, or smartphone device.

You may not qualify if:

  • Residents enrolled in hospice can not participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Bluffs

Columbia, Missouri, 65203, United States

Location

Related Publications (1)

  • Oliver DP, Rolbiecki AJ, Washington K, Kruse RL, Popejoy L, Smith JB, Demiris G. A Pilot Study of An Intervention to Increase Family Member Involvement in Nursing Home Care Plan Meetings. J Appl Gerontol. 2021 Sep;40(9):1080-1086. doi: 10.1177/0733464820946927. Epub 2020 Aug 13.

    PMID: 32787506DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Debra Parker Oliver; PI
Organization
UMissouri
oliverdr@missouri.edu
573-356-6719

Study Officials

  • Debra Oliver, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 23, 2016

First Posted

September 28, 2016

Study Start

September 1, 2016

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

January 20, 2021

Results First Posted

February 5, 2020

Record last verified: 2020-01

Locations

US(1)