NCT02568475

Brief Summary

This study addresses the Patient-Centered Outcomes Research Institute (PCORI) area of interest related to development of decision support tools that bring patients, families and clinicians together to decide, in this instance, whether or not transfer from the nursing home (NH) to acute care is necessary and appropriate. The purposes of this study were 1) to develop an evidence-based decision aid addressing potentially avoidable transfers of residents from nursing homes to hospitals (preceded this protocol), and 2) to evaluate this decision aid in terms of acceptability to residents and families and its effect on the quality of transfer decisions. The primary hypotheses to be tested are: Hypothesis 1: Resident and family members in the intervention group will report greater preparation for decision making and less decisional conflict than those in the no treatment control group. Hypothesis 2: Residents and family members in the intervention group will demonstrate increased knowledge related to acute care transfer and less preference for acute care transfer than those in the no treatment control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 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

Study Start

First participant enrolled

October 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 2, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

August 31, 2020

Completed
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

2.9 years

First QC Date

October 2, 2015

Results QC Date

April 25, 2017

Last Update Submit

August 14, 2020

Conditions

Keywords

nursing home residents, decision aid, acute care transfers

Outcome Measures

Primary Outcomes (2)

  • Preparation for Decision Making

    Range of possible raw scores: 10 - 50. Items can be summed and scored (sum the 10 items and divide by 10). There are no subscales. A higher score is positive indicating perception of being better prepared to make the decision identified when test is administered.

    Decision Aid group only: Post test (2-3 weeks after pretest) and at 3 month follow-up (after post test)

  • Decisional Conflict Scale

    Scale Range of possible raw scores: 0 - 64. A lower score indicates less decisional conflict related to making the identified decision. Decisional conflict is a state of uncertainty about a course of action. Decision supporting interventions are thought to be effective in

    Decision aid: Pretest (baseline) and Post test (2-3 weeks after pretest); No decision aid: Post test only

Secondary Outcomes (3)

  • Knowledge Test

    Pretest (baseline) and Post test (2-3 weeks after pretest)

  • Treatment Preference/Decisional Conflict Scale

    Post test (2-3 weeks after pretest)

  • 30 Day Hospital Readmission

    Length of stay ≤30 days at Post test

Study Arms (2)

Decision aid

EXPERIMENTAL

Provision of "Go to the Hospital or Stay Here?"

Behavioral: Provision of "Go to the Hospital or Stay Here?"

No decision aid

NO INTERVENTION

Does not receive the decision aid.

Interventions

Residents and families randomly assigned to the intervention group (one half of the residents and one half of the families enrolled) are given the new Decision Aid to review with an RA trained for this purpose by the investigators. The Decision Aid provides information on risks and benefits of acute care transfer and information on advance care planning, resident and families' right to be involved in the decision. Resident or family member is also asked to re-read it and think about it over the subsequent 14 days.

Also known as: Transfer Decision Guide
Decision aid

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult nursing home resident and/or family member or identified significant other of a nursing home resident. Cognitively unimpaired individuals. Long or short term residents of nursing home or rehabilitation center.

You may not qualify if:

  • Dementia as indicated by score on Mini-Cog. Inability to respond to questions due to physical disability or illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Atlantic University, Christine E. Lynn College of Nursing

Boca Raton, Florida, 33431, United States

Location

Related Publications (1)

  • Tappen RM, Worch SM, Elkins D, Hain DJ, Moffa CM, Sullivan G. Remaining in the nursing home versus transfer to acute care: resident, family, and staff preferences. J Gerontol Nurs. 2014 Oct;40(10):48-57. doi: 10.3928/00989134-20140807-01.

MeSH Terms

Conditions

Chronic DiseaseAcute Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Ruth M. Tappen, Principal Investigator
Organization
Florida Atlantic University

Study Officials

  • Ruth M. Tappen, EdD, RN, FAAN

    Christine E. Lynn College of Nursing, Florida Atlantic University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Christine E. Lynn Eminent Scholar and Professor

Study Record Dates

First Submitted

October 2, 2015

First Posted

October 6, 2015

Study Start

October 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

August 31, 2020

Results First Posted

August 31, 2020

Record last verified: 2020-08

Locations