NCT04410627

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
2 years until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

May 26, 2020

Last Update Submit

March 4, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Technology usability as measured by System Usability Scale

    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 Outcomes (3)

  • Study Feasibility as measured by enrollment efficiency

    At study completion, up to 4 months

  • Study Feasibility as measured by intervention completion

    At study completion, up to 4 months

  • User Accessibility as measured by Net Promoter score

    At study completion, up to 4 months

Study Arms (2)

Standard of Care

NO INTERVENTION

Standard of Care + HoPE

EXPERIMENTAL
Other: HoPE Website

Interventions

Educational website focused on hospice care

Standard of Care + HoPE

Eligibility Criteria

Age21 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

WakeMed Health & Hospitals

Raleigh, North Carolina, 27610, United States

Location

Study Officials

  • Arif Kamal, MD

    Duke University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2020

First Posted

June 1, 2020

Study Start

June 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 18, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations