Shared Decision Making Aid for Prosthetic Design

NCT04536025 | Completed Results

• 1 other identifier: 20-1070
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to learn more about decision making for prosthetic design, with the goal of producing a decision making aid for prosthetic design decisions.

Conditions

Amputation; Prosthesis User

Keywords

Lower Limb Amputation; Decision Making

Outcome Measures

Primary Outcomes (4)

• Number of Participants Who Participated in and Completed 1 Hour Qualitative Interview Data Collection Via a Semi Structured Interview Guides

  During 1 hour semi structured interviews with participants, questions about the decisional needs of patients and prosthetists for Prosthetic Design Decisions were asked. Because qualitative data is not numerical, the transcripts of each interview were analyzed using directed content analysis using the Ottawa Decision Support Framework, and the Elwyn Shared Decision Making Model, and resulting final qualitative themes were used to guide the content in the development of a decision aid for prosthetic design. Qualitative data is not numerical, and only the number of participants who complete the semi structured interviews was able to be numerically recorded and analyzed.

  Data collection of the semi structured qualitative interview occurred at the baseline time point only, lasting an average of 1 hour during 1 day.

• Accuracy of the Decision Aid Prototype, as Measured in Percentage.

  The Accuracy of the Decision Aid is a single item Likert scale measure of the degree to which the decision aid's revised content, advantages, and disadvantages in the decision aid aligns with the scientific evidence available on the prosthesis design decision outcomes. This scale includes 1 question, with a range of response scoring from 1 to 5. 1 represents low accuracy of the decision aid, while 5 represents high accuracy of the decision aid. The final score is converted to a percentage for all respondents (ranging 0% to 100%, with a higher percentage representing greater accuracy).

  Data collection occurred at the baseline time point only, lasting an average of 1 hour during 1 day.

• Comprehensibility of the Decision Aid Prototype, as Measured by a Likert Scale

  The Comprehensibility of the Decision Aid is a single item Likert scale measure of the degree to which the information in the Decision Aid was understandable and covers information necessary for making an informed decision about prosthesis design. This scale includes 1 question, with a range of response scoring from 1 to 5. 1 represents low comprehensibility of the decision aid, while 5 represents high comprehensibility of the decision aid. The final score is calculated as a percentage (ranging 0% to 100%, with a higher percentage representing greater comprehensibility) for all participants.

  Data collection occurred at the baseline time point only, lasting an average of 1 hour during 1 day.

• Usability of the Decision Decision Aid Prototype, as Measured by a Likert Scale

  The Usability of the Decision Aid is a single item Likert scale measure of the degree to which the Decision Aid prototype was acceptable, clear, understandable, and effective in use. This scale includes 1 question, with a range of response scoring from 1 to 5. 1 represents low usability of the decision aid, while 5 represents high usability of the decision aid. The final score is calculated as a percentage for all respondents (ranging 0% to 100%, with a higher percentage representing greater usability).

  Data collection occurred at the baseline time point only, lasting an average of 1 hour during 1 day.

Secondary Outcomes (2)

• Participant Preferences for Personal Preference Towards Control in a Health Decision, as Measured by the Control Preferences Scale Survey

  Data collection occurred at the baseline time point only, lasting an average of 1 hour during 1 day.

• Perceived Ability to Find and Use Health Information, Via the eHealth Literacy Scale Survey

  Data collection occurred at the baseline time point only, lasting an average of 1 hour during 1 day.

Study Arms (3)

Prosthetists

Up to 24 prosthetists who are actively providing prosthetic care to people with lower limb amputation will be recruited for participating in focus groups to describe their decisional needs for providing prostheses to people with lower limb amputation.

Other: Qualitative focus group interviews

People with lower limb amputation

An estimated 14 people within 1 year from lower limb amputation, receiving their first prosthesis will be recruited for individual semi-structured interviews to describe their decisional needs for provision of a prosthesis.

Other: Qualitative semi-structured interviews

Expert working group

The expert working group will consist of at least 5 and up to 12 people with LLA actively receiving prosthetic care, and at least 5 and up to 12 prosthetic care providers with greater than 5 years of experience. Individuals will be invited to join the expert working group based on expertise, and representation of key stakeholders relevant to the prosthetic design process.

Other: Qualitative focus group interviews; Other: Qualitative semi-structured interviews

Interventions

Qualitative focus group interviews OTHER

Prosthetists and/or expert working group members will participate in qualitative focus group interviews up to 120 minutes in length.

Expert working group; Prosthetists

Qualitative semi-structured interviews OTHER

People with lower limb amputation and/or expert working group members will participate in qualitative individual, semi-structured interviews approximately 60 minutes in length.

Expert working group; People with lower limb amputation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited for three groups: 1. Prosthetists who actively provide prosthetic care, for focus group qualitative interviews to determine decisional needs for prosthetic decisions. 2. People with lower limb amputation who are within their first year after amputation and using their first prosthesis, for individual semi-structured qualitative interviews to determine decisional needs for prosthetic decisions. 3. An Expert Working Group of patients with lower limb amputation and prosthetists, for collecting data on the comprehensibility, usability, and acceptability of the Decision Aid Prototype. Prosthetists will have at least 5 years of experience providing prosthetic care, and patients with lower limb amputation will be actively receiving prosthetic care.

You may qualify if:

• At least 18 years of age
• Prosthetists actively providing prosthetic care to people with lower limb amputation

You may not qualify if:

• Unable to participate in a 1 hour phone or video conference
• Non-English speaking
• At least 18 years of age
• People who have a lower limb amputation
• People within 1 year since their first amputation
• Amputation levels ranging between above the ankle and below the hip
• Unable to participate in a 1 hour phone or video conference
• Non-English speaking
• At least 18 years of age
• People who have a lower limb amputation ranging between above the ankle and below the hip \*OR\* Prosthetists with at least 5 years experience providing prosthetic care to people with lower limb amputation.
• Unable to participate in a 1 hour phone or video conference
• Non-English speaking

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Orthotic and Prosthetic Education and Research Foundation (OPERF): collaborator

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Results Point of Contact

• Title: Dr. Chelsey Anderson
• Organization: University of Colorado

chelsey.anderson@cuanschutz.edu

12069926861

Study Officials

• Cory L Christiansen, PT, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 2, 2020
• Study Start: June 6, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: September 26, 2024
• Results First Posted: September 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)