Pilot Evaluation of Hospice Decision Support Tools

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT03794700
Collaborator
National Institute on Aging (NIA) (NIH)
131
1
2
32.5
4

Study Details

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 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Hospice Decision Aids
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
131 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Pilot Evaluation of Hospice Decision Support Tools
Actual Study Start Date :
Jul 15, 2018
Actual Primary Completion Date :
Mar 31, 2021
Actual Study Completion Date :
Mar 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Ottawa Acceptability Scale (OAS) [Baseline, 1 month follow-up]

    Acceptability will be measured using the Ottawa Acceptability Scale (OAS). PtDA acceptability evaluates the comprehensibility of components of a PtDA including: its length, pace, amount of information, balance in presentation of information about options, and overall suitability for decision making. The OAS scale consists of 8 questions on a 5-point Likert scale (ranging from poor to excellent) with additional yes/no questions. The OAS will be assessed at 2 time points.

  2. Decision Aid Feasibility Survey [1 week FU Only]

    This survey will evaluate how the patients used the PtDAs, including when they used the PtDA and whether they used of the video, paper or both. These are opened questions: After you received the decision aids, when did you view them? Did you view the paper version, the video version or both? Which did you prefer? Why? Do you have any suggestions on how to improve the decision aids?

Secondary Outcome Measures

  1. Change in Hospice Knowledge Scale [Baseline and 1 month follow-up]

    Hospice Knowledge Scale is a 23-item true/false scale. Each question is worth 1 point with 23 being the highest score. Hospice Knowledge will be assessed at 2 time points.

  2. Change in Decision Conflict Scale [Baseline, 1 month follow-up]

    The Decision Conflict Scale is a 16-item with statements answered on a 5-point likert scale (ranging from not at all confident to very confident). DCS will be measured at 2 time points

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Colorado Denver Aurora Colorado United States 80045

Sponsors and Collaborators

  • University of Colorado, Denver
  • National Institute on Aging (NIA)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT03794700
Other Study ID Numbers:
  • 18-1138
  • 1R21AG059114-01
First Posted:
Jan 7, 2019
Last Update Posted:
Jul 9, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Colorado, Denver
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 9, 2021