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Completed

NCT Number: NCT03874195

Palliative Care For Me (PCforMe)

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Cancer Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Access to PCforMe for review

Behavioral

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

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

Other names: Knowledge of Palliative Care, Prepartion for Palliative Care appointment, Confidence in Palliative Care discussion with provider

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 14, 2019
Registry last updated
Mar 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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