Pilot Evaluation of Hospice Decision Support Tools

August 8, 2022 updated by: University of Colorado, Denver
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
OTHER: Intervention
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.
Other: Hospice Decision Aids
Paper and video hospice decision aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospice Knowledge Scale
Time Frame: 1 month follow-up
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.
1 month follow-up
Hospice Beliefs and Attitudes Scale
Time Frame: 1-Month follow up
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. .
1-Month follow up
Decision Self Efficacy Scale
Time Frame: 1 month Follow up
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.
1 month Follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Daniel Matlock, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 15, 2018

Primary Completion (ACTUAL)

March 4, 2020

Study Completion (ACTUAL)

March 4, 2020

Study Registration Dates

First Submitted

December 21, 2018

First Submitted That Met QC Criteria

January 2, 2019

First Posted (ACTUAL)

January 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 30, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-1138
  • 1R21AG059114-01 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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