Palliative Care For Me (PCforMe)

NCT03874195 | Completed

• 1 other identifier: Pro00075906
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the usability of PCforMe, a web-based preparation and engagement tool about palliative care, during a pre-visit pilot trial in outpatient palliative care at the Duke Cancer Institute Palliative Care Clinic.

Conditions

Palliative Care

Outcome Measures

Primary Outcomes (1)

• System usability as measured by the system usability scale

  To determine usability, the System Usability Scale will be administered to each participate. 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 the participant's results involves "normalizing" the scores to produce a percentile ranking." The original scale is a 10-item, 5-point Likert scale.

  1 hour

Secondary Outcomes (3)

• Change in Palliative Care knowledge

  Baseline, up to 1 hour

• Change in Perceived Efficacy for the Patient-Physician Interaction (PEPPI)

  Baseline, up to 1 hour

• Change in single-item Prepared item

  Baseline, up to 1 hour

Study Arms (2)

Control

ACTIVE COMPARATOR

Subjects in the Active Control arm will receive a list of three nationally-recognized websites to receive information on palliative care - www.palliativedoctors.org; getpalliativecare.org; and Wikipedia "Palliative Care" https://en.wikipedia.org/wiki/Palliative care).

Behavioral: Access to three nationally-recognized Palliative Care websites for review

Intervention

EXPERIMENTAL

Intervention Arm subjects will receive access to PCforMe.

Behavioral: Access to PCforMe for review

Interventions

Access to PCforMe for review BEHAVIORAL

Intervention Arm subjects will receive access to PCforMe.

Also known as: Knowledge of Palliative Care, Prepartion for Palliative Care appointment, Confidence in Palliative Care discussion with provider

Intervention

Access to three nationally-recognized Palliative Care websites for review BEHAVIORAL

Subjects in the Active Control arm will receive a list of three nationally-recognized websites to receive information on palliative care

Also known as: Knowledge of Palliative Care, Prepartion for Palliative Care appointment, Confidence in Palliative Care discussion with provider

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential participants will be identified by reviewing clinic appointment listings in EPIC (e.g., diagnosis, date of diagnosis, date of clinic appointment, physician), and deemed eligible by the RA by meeting the following criteria:
• Age \>18
• capacity to give consent
• has a scheduled outpatient visit (initial consult) with a palliative care provider
• ability to speak and understand English

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Cancer Center

Durham, North Carolina, 27705, United States

Location

Study Officials

• Arif Kamal, MD

  Duke University Health Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The Investigator will 1:1 randomize patients to an Active Control arm or Intervention arm. Both arms will receive a tablet computer (iPad or Galaxy Tab based on preference) connected to the internet with disposable headphones to use for up to 30 minutes. Subjects in the Active Control arm will receive a list of three nationally-recognized websites to receive information on palliative care - www.palliativedoctors.org; getpalliativecare.org; and Wikipedia "Palliative Care" https://en.wikipedia.org/wiki/Palliative\_care). Intervention Arm subjects will receive access to PCforMe.

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 14, 2019
• Study Start: January 11, 2017
• Primary Completion: February 26, 2018
• Study Completion: February 26, 2018
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)