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Pilot Evaluation of Hospice Decision Support Tools

Primary Purpose

Hospice, End-of-life Decision Making, Hospice Decision Making

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hospice Decision Aids
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hospice focused on measuring Hospice, End-of-life, Patient decision aid, Shared decision making

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 65 or older.
  • At least one life-limiting illness or syndrome.

Exclusion Criteria:

  • Non-English speakers.
  • Patients with cognitive Impairments preventing ability to provide informed consent.
  • Patients on isolation precautions due to resistant bacteria or impaired immune function.

Sites / Locations

  • University of Colorado Denver

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Control

Intervention

Arm Description

Participants will receive hospice decisional support materials and be asked to review them. Participants will provide feedback on tools and complete feasibility, efficacy and knowledge assessments.

Outcomes

Primary Outcome Measures

Hospice Knowledge Scale
Hospice Knowledge Scale is a 23-item true/false scale that measures patient knowledge about hospice care. Each question is worth 1 point with possible scores ranging from 0 to 23. Higher scores indicate more knowledge.
Hospice Beliefs and Attitudes Scale
8-item scale developed to measure beliefs and attitudes towards hospice care. It has a Cronbach's α = .74 for the scale, indicating a good degree of internal reliability. Scores from 8 to 40. Higher scores indicate better opinions of hospice. .
Decision Self Efficacy Scale
Is an 11-item instrument that one's self-confidence in decision making. This scale is a validated scale with a Cronbach's alpha of 0.92 and correlates with DCS subscale of being informed (r=0.47). Scored from 0-100 with higher scores indicating more decision self efficacy.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2018
Last Updated
August 8, 2022
Sponsor
University of Colorado, Denver
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03794700
Brief Title
Pilot Evaluation of Hospice Decision Support Tools
Official Title
Pilot Evaluation of Hospice Decision Support Tools
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
March 4, 2020 (Actual)
Study Completion Date
March 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this project is to determine the feasibility and acceptability of a hospice decision aid among a diverse population of older adults at multiple stages of illness (Aim 1) and to determine the preliminary efficacy of the hospice decision aid on decision quality, hospice knowledge, and values-concordance (Aim 2). By testing the feasibility, acceptability, and preliminary efficacy of a novel hospice Patient Decision Aid (PTDa) in a diverse population of older adults, additionally the study will simultaneously explore barriers to PtDA implementation in both an outpatient primary care and inpatient palliative care setting. The study will also gather sufficient pilot data to support a subsequent effectiveness/implementation trial and thus address the absence of quality of SDM interventions for end-of-life care decision-making.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hospice, End-of-life Decision Making, Hospice Decision Making
Keywords
Hospice, End-of-life, Patient decision aid, Shared decision making

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Intervention
Arm Type
Other
Arm Description
Participants will receive hospice decisional support materials and be asked to review them. Participants will provide feedback on tools and complete feasibility, efficacy and knowledge assessments.
Intervention Type
Other
Intervention Name(s)
Hospice Decision Aids
Intervention Description
Paper and video hospice decision aid
Primary Outcome Measure Information:
Title
Hospice Knowledge Scale
Description
Hospice Knowledge Scale is a 23-item true/false scale that measures patient knowledge about hospice care. Each question is worth 1 point with possible scores ranging from 0 to 23. Higher scores indicate more knowledge.
Time Frame
1 month follow-up
Title
Hospice Beliefs and Attitudes Scale
Description
8-item scale developed to measure beliefs and attitudes towards hospice care. It has a Cronbach's α = .74 for the scale, indicating a good degree of internal reliability. Scores from 8 to 40. Higher scores indicate better opinions of hospice. .
Time Frame
1-Month follow up
Title
Decision Self Efficacy Scale
Description
Is an 11-item instrument that one's self-confidence in decision making. This scale is a validated scale with a Cronbach's alpha of 0.92 and correlates with DCS subscale of being informed (r=0.47). Scored from 0-100 with higher scores indicating more decision self efficacy.
Time Frame
1 month Follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 65 or older. At least one life-limiting illness or syndrome. Exclusion Criteria: Non-English speakers. Patients with cognitive Impairments preventing ability to provide informed consent. Patients on isolation precautions due to resistant bacteria or impaired immune function.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Matlock, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35944273
Citation
Brereton E, Harger G, Matlock DD, Dorsey Holliman B, Tate CE. How Do Patients Describe Hospice Care? A Qualitative Analysis of the Language Used by Older Adults to Describe Hospice Care. J Palliat Med. 2022 Nov;25(11):1692-1696. doi: 10.1089/jpm.2022.0011. Epub 2022 Aug 9.
Results Reference
derived
PubMed Identifier
33439075
Citation
Tate CE, Venechuk G, Pierce K, Khazanie P, Ingle MP, Morris MA, Allen LA, Matlock DD. Development of a Decision Aid for Patients and Families Considering Hospice. J Palliat Med. 2021 Apr;24(4):505-513. doi: 10.1089/jpm.2020.0250. Epub 2021 Jan 13.
Results Reference
derived

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Pilot Evaluation of Hospice Decision Support Tools

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