Conjoint Analysis of Patient Preferences in Joint Interventions

June 6, 2023 updated by: Duke University
This study is an observational study to test and validate a questionnaire and statistical model used to determine patient preferences regarding treatment for any one of 11 musculoskeletal conditions: hip arthritis, knee arthritis, hip labral tears and femoroacetabular impingement (FAI), osteochondritis dissecans, Achilles tendon rupture, patellofemoral dislocation, distal radius fracture, and fractures of the hip, ankle, tibia, and proximal humerus. This study aims to understand how multiple treatment variables, including pain, rehabilitation time, cost, and choice of surgical versus non-surgical intervention, impact patients' decision-making processes and ultimate choice of treatment.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2310

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
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Health System

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient age criteria for each condition is listed below:

    1. Hip arthritis: 50-80 years
    2. Knee arthritis: 50-80 years
    3. Hip labral tears and FAI: 18-65
    4. Osteochondritis dissecans: parents with children between the ages of 8-18
    5. Achilles tendon rupture: 25-60 years
    6. Patellofemoral dislocation: parents with children between the ages of 8-18 and adults between 18-50 years of age
    7. Distal radius fracture: 18-80 years
    8. Hip fracture: 50-85 years
    9. Ankle fracture: 18-80 years
    10. Tibia fracture: 18-80 years
    11. Proximal humerus fracture: 18-80 years

    12. Ankle Arthritis: 40-80 years

      Exclusion Criteria:

  • Inability to read, understand and give effective English consent

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: Decision tool
A "decision tool" will be provided to participants who currently or previously have had one of the following 12 musculoskeletal conditions: hip arthritis, knee arthritis, ankle arthritis, hip labral tears and femoroacetabular impingement (FAI), osteochondritis dissecans, Achilles tendon rupture, patellofemoral dislocation, distal radius fracture, and fractures of the hip, ankle, tibia, and proximal humerus.
Other: Decision tool
A survey will be created for each condition that reflects the most important aspects of the corresponding treatment process.
Active Comparator: Standard treatment information
"Standard treatment information" will be provided to participants who currently or previously have had one of the following 12 musculoskeletal conditions: hip arthritis, knee arthritis, ankle arthritis, hip labral tears and femoroacetabular impingement (FAI), osteochondritis dissecans, Achilles tendon rupture, patellofemoral dislocation, distal radius fracture, and fractures of the hip, ankle, tibia, and proximal humerus.
Other: Standard treatment information
Participants will receive information pertaining to one of the 12 specified musculoskeletal conditions. This information will reflect information commonly distributed to patients seeking to make a decision concerning treatment for their condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient preferences survey - Hip Arthritis
Time Frame: 3-5 years
Patient-voiced preferences regarding treatment for hip arthritis based on questionnaires
3-5 years
Patient preferences survey - Knee Arthritis
Time Frame: 2 years
Patient-voiced preferences regarding treatment for knee arthritis based on questionnaires
2 years
Patient preferences survey - hip labral tears and FAI
Time Frame: 3-5 years
Patient-voiced preferences regarding treatment for hip labral tears and femoroacetabular impingement (FAI) based on questionnaires
3-5 years
Patient preferences survey - Osteochondritis dissecans
Time Frame: 3-5 years
Patient-voiced preferences regarding treatment for osteochondritis dissecans based on questionnaires
3-5 years
Patient preferences survey - Achilles tendon rupture
Time Frame: 2 years
Patient-voiced preferences regarding treatment for Achilles tendon rupture based on questionnaires
2 years
Patient preferences survey - patellofemoral dislocation
Time Frame: 2 years
Patient-voiced preferences regarding treatment for patellofemoral dislocation based on questionnaires
2 years
Patient preferences survey - distal radius fracture
Time Frame: 3-5 years
Patient-voiced preferences regarding treatment for distal radius fracture based on questionnaires
3-5 years
Patient preferences survey - hip fracture
Time Frame: 3-5 years
Patient-voiced preferences regarding treatment for hip fracture based on questionnaires
3-5 years
Patient preferences survey - ankle fracture
Time Frame: 3-5 years
Patient-voiced preferences regarding treatment for ankle fracture based on questionnaires
3-5 years
Patient preferences survey - tibia fracture
Time Frame: 3-5 years
Patient-voiced preferences regarding treatment for tibia fracture based on questionnaires
3-5 years
Patient preferences survey - proximal humerus fracture
Time Frame: 3-5 years
Patient-voiced preferences regarding treatment for proximal humerus fracture based on questionnaires
3-5 years
Patient preferences survey - Ankle Arthritis
Time Frame: 3-5 years
Patient-voiced preferences regarding treatment for ankle arthritis based on questionnaires
3-5 years

Collaborators and Investigators

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

Sponsor

Duke University

Investigators

  • Principal Investigator: Richard C. Mather III, MD, MBA, Duke 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

February 1, 2016

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

January 22, 2016

First Submitted That Met QC Criteria

January 22, 2016

First Posted (Estimated)

January 27, 2016

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00067150

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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