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Maximizing Patient Goal Attainment (mGAME)

Primary Purpose

Knee Osteoarthritis, Knee Injuries, Knee Pain Chronic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Goal Attainment
Goal Development
Goal Tracking
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Knee Osteoarthritis focused on measuring Orthopaedic, Knee, Patient Goals

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Individuals 21 years of age or older New patients or existing patients with a new problem that are scheduled to see an orthopaedic surgeon in the Hip and Knee Arthroplasty service for a knee consult. Exclusion Criteria: Individuals who are unable to consent or complete surveys without assistance Non-English speaking Patients who are less than 12 months from surgery on the knee they are being evaluated for, less than 6 months from surgery on the spine, or less than 3 months from another knee/hip surgery

Sites / Locations

  • Dartmouth Hitchcock Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Goal Attainment Intervention

Goal Development Intervention

Goal Development and Tracking Intervention

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the effectiveness of the goal development intervention using the Goal Attainment Outcome Measure
To evaluate the effectiveness of the goal development intervention in guiding individual patients through the identification of high quality, specific, measurable, relevant and time-bound goal for treatment.

Secondary Outcome Measures

To assess the intervention's ability to improve shared decision making using the collaboRATE measure
To assess the acceptability, usability, as well as qualitatively the appropriateness, feasibility, and scalability of integrating the brief patient goal development intervention into standard clinical care. To assess the intervention's ability to improve shared decision making.

Full Information

First Posted
December 7, 2022
Last Updated
August 10, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Medacta USA
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1. Study Identification

Unique Protocol Identification Number
NCT05652270
Brief Title
Maximizing Patient Goal Attainment
Acronym
mGAME
Official Title
Maximizing Patient Goal Attainment, Motivations and Expectations (mGAME) in Elective Musculoskeletal Care
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2023 (Actual)
Primary Completion Date
April 21, 2024 (Anticipated)
Study Completion Date
April 21, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Medacta USA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the effectiveness of the goal development intervention in guiding individual patients through the identification of high quality, specific, measurable, relevant and time-bound goal for treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Knee Injuries, Knee Pain Chronic, Knee Injuries and Disorders
Keywords
Orthopaedic, Knee, Patient Goals

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
245 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Goal Attainment Intervention
Arm Type
Active Comparator
Arm Title
Goal Development Intervention
Arm Type
Active Comparator
Arm Title
Goal Development and Tracking Intervention
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Goal Attainment
Intervention Description
Development of an attainable goal
Intervention Type
Behavioral
Intervention Name(s)
Goal Development
Intervention Description
A Systematic process to help patients create "SMaRT " goals
Intervention Type
Behavioral
Intervention Name(s)
Goal Tracking
Intervention Description
Setting milestones to allow patients to track their progress towards their developed goal
Primary Outcome Measure Information:
Title
To evaluate the effectiveness of the goal development intervention using the Goal Attainment Outcome Measure
Description
To evaluate the effectiveness of the goal development intervention in guiding individual patients through the identification of high quality, specific, measurable, relevant and time-bound goal for treatment.
Time Frame
8 Months
Secondary Outcome Measure Information:
Title
To assess the intervention's ability to improve shared decision making using the collaboRATE measure
Description
To assess the acceptability, usability, as well as qualitatively the appropriateness, feasibility, and scalability of integrating the brief patient goal development intervention into standard clinical care. To assess the intervention's ability to improve shared decision making.
Time Frame
8 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals 21 years of age or older New patients or existing patients with a new problem that are scheduled to see an orthopaedic surgeon in the Hip and Knee Arthroplasty service for a knee consult. Exclusion Criteria: Individuals who are unable to consent or complete surveys without assistance Non-English speaking Patients who are less than 12 months from surgery on the knee they are being evaluated for, less than 6 months from surgery on the spine, or less than 3 months from another knee/hip surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiaoyuan Elisabeth Diallo
Phone
603-653-9496
Email
jiaoyuan.elisabeth.diallo@hitchcock.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jon Mikael Anderson
Phone
603-653-3306
Email
Jon.Mikael.Anderson@hitchcock.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Werth, PhD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiaoyuan Elisabeth Diallo
Phone
603-653-9496
Email
jiaoyuan.elisabeth.diallo@hitchcock.org
First Name & Middle Initial & Last Name & Degree
Jon Mikael Anderson
Phone
603-653-3306
Email
Jon.Mikael.Anderson@hitchcock.org
First Name & Middle Initial & Last Name & Degree
Paul Werth, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Maximizing Patient Goal Attainment

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