Palliative Care For Me (PCforMe)

Palliative Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03874195
• Other study ID #: Pro00075906
• Status: Completed
• Phase: N/A
• Start date: January 11, 2017
• Est. completion date: February 26, 2018

Study information

• Verified date: March 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 26, 2018
• Est. primary completion date: February 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Palliative Care

Intervention

Behavioral:
• Access to PCforMe for review
Intervention Arm subjects will receive access to PCforMe.
• 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

Locations

Country	Name	City	State
United States	Duke University Cancer Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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