NCT03427645

Brief Summary

The trial is testing an investigator-developed decision support tool for surrogate decision makers for stroke patients that are unable to make medical decisions for themselves. A historical usual care control group will be enrolled during tool development. The tool will then be tested in surrogates of hospitalized stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Feb 2018

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

January 29, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

February 8, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2019

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

January 29, 2018

Last Update Submit

February 3, 2020

Conditions

Stroke

Keywords

surrogate decision maker

Outcome Measures

Primary Outcomes (1)

  • Acceptability of the decision tool intervention

    The proportion of cases where the surrogate completes use of the tool with high acceptability using the Acceptability E-Scale. The Acceptability E-Scale is a 6-item scale. A score of 1 indicates a negative evaluation and 5 indicates a positive evaluation. A score of 3 indicates a neutral evaluation. An individual will be considered to have high acceptability if the average response across the 6 items is 4 or higher)

    Immediately post-intervention

Secondary Outcomes (2)

  • Accuracy of the surrogate's prognostic estimate for functional recovery

    Within approximately 5 days of admission

  • Decisional Self Efficacy scale

    Within approximately 5 days of admission

Study Arms (2)

Control Surrogate Arm

NO INTERVENTION

Usual care control group will complete baseline and follow-up questionnaires with standard decision making techniques. This group will not be asked to use the decision making tool.

Surrogate Decision Tool Arm

EXPERIMENTAL

This group will complete a baseline questionnaire, then use the tool and complete follow up questionnaires.

Behavioral: Decision tool

Interventions

Decision toolBEHAVIORAL

A tailored web-based stroke decision support intervention. This web-based tool will be developed for use by the surrogate decision maker during the acute stroke hospitalization and will be designed to facilitate high quality patient-centered decisions and minimize adverse effects on the surrogate.

Also known as: tailored decision support intervention
Surrogate Decision Tool Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identify as the surrogate decision maker for eligible patient
  • Able to read and communicate in English without an interpreter
  • Limited to one surrogate per patient

You may not qualify if:

  • No prior relationship with patient
  • Dementia or other cognitive or health condition that would impair their ability to participate
  • Patients:
  • Ischemic stroke or spontaneous intracerebral hemorrhage
  • Impaired decisional capacity (per treating team)
  • Enrolled on or before full hospital day 5
  • Minimum illness severity (either):
  • National Institutes of Health Stroke Scale ≥ 10
  • Glasgow coma scale ≤12
  • No surrogate available for study procedures
  • Already on comfort measures only
  • Physician refuses to allow approach for consent
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Chen EP, Arslanian-Engoren C, Newhouse W, Egleston D, Sahgal S, Yande A, Fagerlin A, Zahuranec DB. Development and usability testing of Understanding Stroke, a tailored life-sustaining treatment decision support tool for stroke surrogate decision makers. BMC Palliat Care. 2020 Jul 20;19(1):110. doi: 10.1186/s12904-020-00617-x.

    PMID: 32689982DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Darin Zahuranec

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

January 29, 2018

First Posted

February 9, 2018

Study Start

February 8, 2018

Primary Completion

November 22, 2019

Study Completion

November 22, 2019

Last Updated

February 5, 2020

Record last verified: 2020-02

Locations

US(1)