Developing an Online Clinical Trial Specific Question Prompt List

July 6, 2015 updated by: Virginia Commonwealth University
The investigators will leverage e-technologies to provide an online version of the Question Prompt LIst (QPL-CT), that patients access via available iPads, enabling both the real-time prioritizing of patient questions as well as the seamless delivery of these questions to their treating physician (and other members of their clinical team) via the VCU Health System (VCUHS) patient portal, and the electronic medical record (EMR) prior to a consultation to discuss a clinical trial

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The investigators propose to conduct pilot work to inform our knowledge of optimal methods of utilizing QPLs and will use the QPL-CT as an example. The investigators will leverage e-technologies to provide an online version of the QPL-CT, that patients access via available iPads, enabling both the real-time prioritizing of patient questions as well as the seamless delivery of these questions to their treating physician (and other members of their clinical team) via the VCU Health System (VCUHS) patient portal, and the EMR prior to a consultation to discuss a clinical trial. The investigators will use a pilot randomized clinical trial design to demonstrate the efficacy of the online QPL-CT versus a paper and pencil QPL-CT to increase question asking, patient understanding of trial information and reduce patients conflict over their upcoming decision to join a trial

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Cancer diagnosis
  • Fluent in English
  • eligible for a therapeutic clinical trial
  • Patients of recruited oncologists

Exclusion Criteria:

  • Healthy subjects
  • Not eligible for a therapeutic clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online QPL-CT to Oncologist
Use the online QPL-CT to prioritize their questions and the prioritized list will be conveyed to their oncologist
Behavioral: QPL-CT
Use the QPL-CT to prioritize questions
Experimental: Online QPL-CT
Use the online QPL-CT to prioritize their questions.
Behavioral: QPL-CT
Use the QPL-CT to prioritize questions
Experimental: Pencil and Paper QPL-CT
Use pencil and paper QPL-CT to prioritize their questions
Behavioral: QPL-CT
Use the QPL-CT to prioritize questions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Online QPL-CT to Oncologist
Time Frame: 30 days
Use online QPL-CT to prioritize their questions and the prioritized list will be conveyed to their oncologist. Investigators will evaluate the efficacy of the online QPL-CT to increase question asking, patient understanding of trial information and reduce patients conflict over their upcoming decision to join a trial.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of providing physicians patient's QPL-CT
Time Frame: 30 days
Examine the impact of providing physicians their patient's prioritized QPL-CT on information provision and decision making process as measured by the Decision Analysis System for Oncology
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test the feasibility of using the online QPL-CT for patients and physicians
Time Frame: 30 days
Patients will complete an exit interview at the completion of patient's consultation asking about the patient's impressions of the online QPL-CT including its ease of use and the patient's perceptions of its influence on consultation communication. Physicians will complete a brief interview on one occasion at the completion of patient recruitment asking about the impact of the prioritized QPL-CT on consultation communication.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Richard Brown, PhD, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimate)

January 8, 2014

Study Record Updates

Last Update Posted (Estimate)

July 7, 2015

Last Update Submitted That Met QC Criteria

July 6, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MCC-14970
  • HM14970 (Other Identifier: VCU Institutional Review Board)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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