HoPE (Hospice Preparation and Education)

March 4, 2022 updated by: Duke University

Pilot Trial Evaluating Usability, Acceptability, and Feasibility of the HoPE (Hospice Preparation and Education) Web-Based Tool

The investigator will conduct a two-site, randomized, controlled study of the HoPE (Hospice Preparation and Education) web-based tool versus usual care to assess: Technology usability (primary), study feasibility (secondary), user acceptability (secondary), and hospice service conversion rate (exploratory). Technology usability will be assessed through a one-time quantitative survey using established instruments. Study feasibility and user accessibility will be assessed through trial enrollment and retention alongside analytics assessing tool usage (e.g. time spent on each page of the website). Conversion rate is the percent of patients introduced to hospice who eventually enroll. The investigators will evaluate in an exploratory manner the differential effect of HoPE versus usual care.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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

    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Raleigh, North Carolina, United States, 27610
        • WakeMed Health & Hospitals

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

21 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eligible for and referral made for home hospice services (Note: this excludes home palliative care, home infusion, home nursing, home physical therapy, and bridge services)
  • Aged between 21 and 89
  • Capacity to give consent
  • Ability to speak and understand English

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
Experimental: Standard of Care + HoPE
Educational website focused on hospice care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technology usability as measured by System Usability Scale
Time Frame: At study completion, up to 4 months.
To determine usability, the System Usability Scale will be administered to each participant in the intervention arm. As described by usability.gov: "The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average, however the best way to interpret your results involves "normalizing" the scores to produce a percentile ranking."
At study completion, up to 4 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study Feasibility as measured by enrollment efficiency
Time Frame: At study completion, up to 4 months
Enrollment efficiency will be measured by the percentage of patients approached who enroll in the study, with the goal of >50% enrollment.
At study completion, up to 4 months
Study Feasibility as measured by intervention completion
Time Frame: At study completion, up to 4 months
Intervention completion will be measured by the percentage of participants on the intervention arm who complete at least 50% of the modules within the intervention website, with a goal of >50% of the participants.
At study completion, up to 4 months
User Accessibility as measured by Net Promoter score
Time Frame: At study completion, up to 4 months
The Net Promoter scale is administered to participants in the intervention arm of the study only. This scale is an eleven-item likert scale assessing likelihood to recommend the intervention to a family member or friend. The percentage of participants who give a score of 0 through 6 is subtracted by the percentage of participants who give a score of 9 or 10 to give the overall Net Promoter score. This score is then compared to other scores of similar technologies.
At study completion, up to 4 months

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Arif Kamal, MD, Duke University

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 (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 4, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00105058

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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