- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04410627
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
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
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Raleigh, North Carolina, United States, 27610
- WakeMed Health & Hospitals
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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
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Experimental: Standard of Care + HoPE
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Educational website focused on hospice care
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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."
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At study completion, up to 4 months.
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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.
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At study completion, up to 4 months
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Study Feasibility as measured by intervention completion
Time Frame: At study completion, up to 4 months
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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.
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At study completion, up to 4 months
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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.
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At study completion, up to 4 months
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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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