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OpenTrials
Completed

NCT Number: NCT04160442

Use of a Patient Preferences Shared Decision-Making Encounter Tool in Clinical Practice for Patients With DLBCL and FL

The goal of this project is to test the feasibility of a Patient Preferences in Shared Decision-Making encounter tool (PPSDM) in the clinical context of Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL). This project will evaluate the feasibility of a shared decision-making (SDM) model that employs an "encounter tool"1 to facilitate SDM at the point of a treatment decision for patients with DLBCL and FL.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

About this study

This project is a single-arm pilot project conducted with 90 patients with newly diagnosed or recurrent DLBCL or FL and their providers at three medical oncology practices. Utilizing the PPSDM tool in the Carevive electronic platform, patients will report their needs, preferences, values and goal prior to the treatment decision-making focused clinical encounter. The treating provider will receive the patient results prior to the visit and can use these to facilitate SDM in treatment selection during the clinical encounter. Post-encounter, patients and providers will complete measures designed to assess feasibility and utility of SDM intervention. Patients will also complete measures to assess patient satisfaction with the treatment decision, patient activation, and patient perceived achievement of desired role in shared decision making and satisfaction with care.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All participants must be 18 years of age or older.
  • Patient participants must have a diagnosis of new or recurrent DLBCL or FL
  • All participants must be able to understand English.

Exclusion criteria

  • Any patient who cannot understand written or spoken English.
  • Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).

Treatment and study plan

Carevive CarePlanning System

Behavioral

Subject will complete brief survey prior to seeing provider in clinic. Utilizing the CarePlanning System, the provider will review the subject's responses directing the conversation and treatment decision will be made. A treatment careplan will be developed and given to the subject.

Primary outcomes

  1. Satisfaction of using the Carevive treatment planning system in shared decision making will be collected from both patient and provider perspectives: questionnaires

    Time frame: 3 months

    patient and providers will complete questionnaires at each clinic visit. These questions will determine their satisfaction with the treatment care planning system.

Secondary outcomes

  1. Evaluation of patient satisfaction and perceived shared decision making utilizing surveys at each clinic visit

    Time frame: 3 months

    Questionnaires answering questions regarding patient satisfaction with the treatment decision, patient activation, and patient perceived achievement of desired role in shared decision making following the technology-facilitated SDM intervention and compare differences in scores between the enrolled subjects. These surveys are part of the Carevive treatment planning platform and collect the information at each clinic visit.

Sponsors and collaborators

Lead sponsor

Carevive Systems, Inc.

Industry

Registry information

Important dates

Study start
2009
Primary completion
2020
Study completion
2020
First posted
Nov 13, 2019
Registry last updated
Dec 11, 2020

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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