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Palliative Care For Me (PCforMe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03874195
Recruitment Status : Completed
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Palliative Care Behavioral: Access to PCforMe for review Behavioral: Access to three nationally-recognized Palliative Care websites for review Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model 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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Usability Testing of a Web-based Tool to Prepare Patients for Palliative Care
Actual Study Start Date : January 11, 2017
Actual Primary Completion Date : February 26, 2018
Actual Study Completion Date : February 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. System usability as measured by the system usability scale [ Time Frame: 1 hour ]
    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.


Secondary Outcome Measures :
  1. Change in Palliative Care knowledge [ Time Frame: Baseline, up to 1 hour ]
    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

  2. Change in Perceived Efficacy for the Patient-Physician Interaction (PEPPI) [ Time Frame: Baseline, up to 1 hour ]
    Change in PEPPI will be determined using 5-point Likert response - 1 being Not at all Confident and 5 being Very Confident

  3. Change in single-item Prepared item [ Time Frame: Baseline, up to 1 hour ]
    "I feel prepared for my palliative care appointment" (5-point Likert response - Strongly Disagree, Disagree, Neither Agree or Disagree, Agree, Strongly Agree)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874195


Locations
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United States, North Carolina
Duke University Cancer Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Arif Kamal, MD Duke University Health Systems
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03874195    
Other Study ID Numbers: Pro00075906
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No