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Conjoint Analysis of Patient Preferences in Joint Interventions

Primary Purpose

Arthritis, Femoroacetabular Impingement, Osteochondritis Dissecans

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision tool
Standard treatment information
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Arthritis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Decision tool

Standard treatment information

Arm Description

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.

"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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 22, 2016
Last Updated
June 6, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02664337
Brief Title
Conjoint Analysis of Patient Preferences in Joint Interventions
Official Title
Conjoint Analysis of Patient Preferences in Joint Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Suspended
Why Stopped
Suspended currently as we plan for the next musculoskeletal condition to collect data on.
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Femoroacetabular Impingement, Osteochondritis Dissecans, Hip Fractures, Ankle Fractures, Tibial Fractures

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Decision tool
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard treatment information
Arm Type
Active Comparator
Arm Description
"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.
Intervention Type
Other
Intervention Name(s)
Decision tool
Intervention Description
A survey will be created for each condition that reflects the most important aspects of the corresponding treatment process.
Intervention Type
Other
Intervention Name(s)
Standard treatment information
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient preferences survey - Hip Arthritis
Description
Patient-voiced preferences regarding treatment for hip arthritis based on questionnaires
Time Frame
3-5 years
Title
Patient preferences survey - Knee Arthritis
Description
Patient-voiced preferences regarding treatment for knee arthritis based on questionnaires
Time Frame
2 years
Title
Patient preferences survey - hip labral tears and FAI
Description
Patient-voiced preferences regarding treatment for hip labral tears and femoroacetabular impingement (FAI) based on questionnaires
Time Frame
3-5 years
Title
Patient preferences survey - Osteochondritis dissecans
Description
Patient-voiced preferences regarding treatment for osteochondritis dissecans based on questionnaires
Time Frame
3-5 years
Title
Patient preferences survey - Achilles tendon rupture
Description
Patient-voiced preferences regarding treatment for Achilles tendon rupture based on questionnaires
Time Frame
2 years
Title
Patient preferences survey - patellofemoral dislocation
Description
Patient-voiced preferences regarding treatment for patellofemoral dislocation based on questionnaires
Time Frame
2 years
Title
Patient preferences survey - distal radius fracture
Description
Patient-voiced preferences regarding treatment for distal radius fracture based on questionnaires
Time Frame
3-5 years
Title
Patient preferences survey - hip fracture
Description
Patient-voiced preferences regarding treatment for hip fracture based on questionnaires
Time Frame
3-5 years
Title
Patient preferences survey - ankle fracture
Description
Patient-voiced preferences regarding treatment for ankle fracture based on questionnaires
Time Frame
3-5 years
Title
Patient preferences survey - tibia fracture
Description
Patient-voiced preferences regarding treatment for tibia fracture based on questionnaires
Time Frame
3-5 years
Title
Patient preferences survey - proximal humerus fracture
Description
Patient-voiced preferences regarding treatment for proximal humerus fracture based on questionnaires
Time Frame
3-5 years
Title
Patient preferences survey - Ankle Arthritis
Description
Patient-voiced preferences regarding treatment for ankle arthritis based on questionnaires
Time Frame
3-5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient age criteria for each condition is listed below: Hip arthritis: 50-80 years Knee arthritis: 50-80 years Hip labral tears and FAI: 18-65 Osteochondritis dissecans: parents with children between the ages of 8-18 Achilles tendon rupture: 25-60 years Patellofemoral dislocation: parents with children between the ages of 8-18 and adults between 18-50 years of age Distal radius fracture: 18-80 years Hip fracture: 50-85 years Ankle fracture: 18-80 years Tibia fracture: 18-80 years Proximal humerus fracture: 18-80 years Ankle Arthritis: 40-80 years Exclusion Criteria: Inability to read, understand and give effective English consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard C. Mather III, MD, MBA
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Conjoint Analysis of Patient Preferences in Joint Interventions

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