Palliative Care For Me (PCforMe)

Usability Testing of a Web-based Tool to Prepare Patients for Palliative Care

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.

Study Overview

• Status: Completed
• Conditions: Palliative Care
• Intervention / Treatment: Behavioral: Access to three nationally-recognized Palliative Care websites for review; Behavioral: Access to PCforMe for review

Detailed Description

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.

PCforMe is an online, web-based, interactive tool to prepare patients for a clinical palliative care encounter. PCforMe is accessible through www.pcforme.org. It does not collect any patient information, including identifiers (e.g. name, email address, disease, location) or health information (e.g. disease, symptom severity or location). The system uses a combination of animated videos and user-answered questions to generate a "Palliative Care Passport", which is a summary of information entered into the system. Research staff will print out the Passport for patients and hand it to them prior to the appointment.

Queries for users include standard-of-care questions asked by palliative care clinicians, including areas that patients want to more learn about. No diagnoses, medication advice, or clinical assessments are made or given.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Not meeting the inclusion requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; 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; Subjects in the Active Control arm will receive a list of three nationally-recognized websites to receive information on palliative care; Other Names: Knowledge of Palliative Care; Prepartion for Palliative Care appointment; Confidence in Palliative Care discussion with provider
Experimental: Intervention; Intervention Arm subjects will receive access to PCforMe.	Behavioral: Access to PCforMe for review; Intervention Arm subjects will receive access to PCforMe.; Other Names: Knowledge of Palliative Care; Prepartion for Palliative Care appointment; Confidence in Palliative Care discussion with provider

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Palliative Care knowledge	Regarding the change in knowledge outcome, Two-side P value of <0.05 will infer significance. The Palliative Care Knowledge instrument is a 4-item, multiple choice assessment of palliative care knowledge. Only one answer is correct. A change in knowledge of Palliative Care will be determined based on the answer provided in the follow-up assessment	Baseline, up to 1 hour
Change in Perceived Efficacy for the Patient-Physician Interaction (PEPPI)	Change in PEPPI will be determined using 5-point Likert response - 1 being Not at all Confident and 5 being Very Confident	Baseline, up to 1 hour
Change in single-item Prepared item	"I feel prepared for my palliative care appointment" (5-point Likert response - Strongly Disagree, Disagree, Neither Agree or Disagree, Agree, Strongly Agree)	Baseline, up to 1 hour

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Arif Kamal, MD, Duke University Health Systems

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2017
• Primary Completion (Actual): February 26, 2018
• Study Completion (Actual): February 26, 2018

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Pro00075906

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