Trial Outcomes & Findings for Shared Decision Making Aid for Prosthetic Design (NCT NCT04536025)
NCT ID: NCT04536025
Last Updated: 2024-09-26
Results Overview
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.
COMPLETED
66 participants
Data collection of the semi structured qualitative interview occurred at the baseline time point only, lasting an average of 1 hour during 1 day.
2024-09-26
Participant Flow
Participant milestones
| Measure |
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.
Qualitative focus group interviews: Prosthetists and/or expert working group members will participate in qualitative focus group interviews up to 120 minutes in length.
|
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.
Qualitative semi-structured interviews: 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
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.
Qualitative focus group interviews: Prosthetists and/or expert working group members will participate in qualitative focus group interviews up to 120 minutes in length.
Qualitative semi-structured interviews: People with lower limb amputation and/or expert working group members will participate in qualitative individual, semi-structured interviews approximately 60 minutes in length.
|
|---|---|---|---|
|
Overall Study
STARTED
|
38
|
17
|
11
|
|
Overall Study
COMPLETED
|
38
|
17
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Shared Decision Making Aid for Prosthetic Design
Baseline characteristics by cohort
| Measure |
Prosthetists
n=38 Participants
Qualitative Focus Groups
|
People With Lower Limb Amputation
n=17 Participants
Qualitative Individual Interviews
|
Expert Working Group
n=11 Participants
Qualitative Focus Groups, Individual Interviews, Quantitative Surveys
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Qualitative Focus Groups
|
38 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Data collection of the semi structured qualitative interview occurred at the baseline time point only, lasting an average of 1 hour during 1 day.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.
Outcome measures
| Measure |
Prosthetists
n=38 Participants
38 prosthetists who are actively providing prosthetic care to people with lower limb amputation were recruited for participating in focus groups to describe their decisional needs for providing prostheses to people with lower limb amputation.
Qualitative focus group interviews: Prosthetists and/or expert working group members will participate in qualitative focus group interviews up to 120 minutes in length.
|
People With Lower Limb Amputation
n=17 Participants
17 people within 1 year from lower limb amputation, receiving their first prosthesis were recruited for individual semi-structured interviews to describe their decisional needs for provision of a prosthesis.
Qualitative semi-structured interviews: 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
n=11 Participants
The expert working group consisted of 6 people with LLA actively receiving prosthetic care, and 5 prosthetic care providers with greater than 5 years of experience. Individuals were invited to join the expert working group based on expertise, and representation of key stakeholders relevant to the prosthetic design process.
Qualitative focus group interviews: Prosthetists and/or expert working group members participated in qualitative focus group interviews up to 120 minutes in length.
Qualitative semi-structured interviews: People with lower limb amputation and/or expert working group members participated in qualitative individual, semi-structured interviews approximately 60 minutes in length.
|
|---|---|---|---|
|
Number of Participants Who Participated in and Completed 1 Hour Qualitative Interview Data Collection Via a Semi Structured Interview Guides
|
38 Participants
|
17 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Data collection occurred at the baseline time point only, lasting an average of 1 hour during 1 day.Population: Accuracy was only evaluated in the Expert Working Group
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).
Outcome measures
| Measure |
Prosthetists
38 prosthetists who are actively providing prosthetic care to people with lower limb amputation were recruited for participating in focus groups to describe their decisional needs for providing prostheses to people with lower limb amputation.
Qualitative focus group interviews: Prosthetists and/or expert working group members will participate in qualitative focus group interviews up to 120 minutes in length.
|
People With Lower Limb Amputation
17 people within 1 year from lower limb amputation, receiving their first prosthesis were recruited for individual semi-structured interviews to describe their decisional needs for provision of a prosthesis.
Qualitative semi-structured interviews: 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
n=10 Participants
The expert working group consisted of 6 people with LLA actively receiving prosthetic care, and 5 prosthetic care providers with greater than 5 years of experience. Individuals were invited to join the expert working group based on expertise, and representation of key stakeholders relevant to the prosthetic design process.
Qualitative focus group interviews: Prosthetists and/or expert working group members participated in qualitative focus group interviews up to 120 minutes in length.
Qualitative semi-structured interviews: People with lower limb amputation and/or expert working group members participated in qualitative individual, semi-structured interviews approximately 60 minutes in length.
|
|---|---|---|---|
|
Accuracy of the Decision Aid Prototype, as Measured in Percentage.
|
—
|
—
|
96.0 percentage
Standard Deviation 5.2
|
PRIMARY outcome
Timeframe: Data collection occurred at the baseline time point only, lasting an average of 1 hour during 1 day.Population: Only the Expert Working Group participated in Comprehensibility survey data collection.
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.
Outcome measures
| Measure |
Prosthetists
38 prosthetists who are actively providing prosthetic care to people with lower limb amputation were recruited for participating in focus groups to describe their decisional needs for providing prostheses to people with lower limb amputation.
Qualitative focus group interviews: Prosthetists and/or expert working group members will participate in qualitative focus group interviews up to 120 minutes in length.
|
People With Lower Limb Amputation
17 people within 1 year from lower limb amputation, receiving their first prosthesis were recruited for individual semi-structured interviews to describe their decisional needs for provision of a prosthesis.
Qualitative semi-structured interviews: 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
n=10 Participants
The expert working group consisted of 6 people with LLA actively receiving prosthetic care, and 5 prosthetic care providers with greater than 5 years of experience. Individuals were invited to join the expert working group based on expertise, and representation of key stakeholders relevant to the prosthetic design process.
Qualitative focus group interviews: Prosthetists and/or expert working group members participated in qualitative focus group interviews up to 120 minutes in length.
Qualitative semi-structured interviews: People with lower limb amputation and/or expert working group members participated in qualitative individual, semi-structured interviews approximately 60 minutes in length.
|
|---|---|---|---|
|
Comprehensibility of the Decision Aid Prototype, as Measured by a Likert Scale
|
—
|
—
|
96.0 percentage
Standard Deviation 7.0
|
PRIMARY outcome
Timeframe: Data collection occurred at the baseline time point only, lasting an average of 1 hour during 1 day.Population: Only Expert Working Group Members participated in Usability Survey Data collection.
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).
Outcome measures
| Measure |
Prosthetists
38 prosthetists who are actively providing prosthetic care to people with lower limb amputation were recruited for participating in focus groups to describe their decisional needs for providing prostheses to people with lower limb amputation.
Qualitative focus group interviews: Prosthetists and/or expert working group members will participate in qualitative focus group interviews up to 120 minutes in length.
|
People With Lower Limb Amputation
17 people within 1 year from lower limb amputation, receiving their first prosthesis were recruited for individual semi-structured interviews to describe their decisional needs for provision of a prosthesis.
Qualitative semi-structured interviews: 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
n=10 Participants
The expert working group consisted of 6 people with LLA actively receiving prosthetic care, and 5 prosthetic care providers with greater than 5 years of experience. Individuals were invited to join the expert working group based on expertise, and representation of key stakeholders relevant to the prosthetic design process.
Qualitative focus group interviews: Prosthetists and/or expert working group members participated in qualitative focus group interviews up to 120 minutes in length.
Qualitative semi-structured interviews: People with lower limb amputation and/or expert working group members participated in qualitative individual, semi-structured interviews approximately 60 minutes in length.
|
|---|---|---|---|
|
Usability of the Decision Decision Aid Prototype, as Measured by a Likert Scale
|
—
|
—
|
93.0 percentage
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: Data collection occurred at the baseline time point only, lasting an average of 1 hour during 1 day.Population: Data from the Control Preference Scale was only collected and analyzed in the Prosthetists group and the People with Lower Limb Amputation Group, not the Expert Working Group.
The control preference scale is a measure of the degree of control an individual wants to assume when decisions are being made about medical treatment. This scale was adapted to this study, to include 5 questions with a range of response scores from 1 to 5 for each question (totaling a final score ranging from 5 to 25). 1 the degree of control an individual wants to assume when decisions are being made about medical treatment represents a more passive provider controlled preference for making a decision, while 5 represents a more active patient controlled preference for making a decision.
Outcome measures
| Measure |
Prosthetists
n=38 Participants
38 prosthetists who are actively providing prosthetic care to people with lower limb amputation were recruited for participating in focus groups to describe their decisional needs for providing prostheses to people with lower limb amputation.
Qualitative focus group interviews: Prosthetists and/or expert working group members will participate in qualitative focus group interviews up to 120 minutes in length.
|
People With Lower Limb Amputation
n=17 Participants
17 people within 1 year from lower limb amputation, receiving their first prosthesis were recruited for individual semi-structured interviews to describe their decisional needs for provision of a prosthesis.
Qualitative semi-structured interviews: 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
The expert working group consisted of 6 people with LLA actively receiving prosthetic care, and 5 prosthetic care providers with greater than 5 years of experience. Individuals were invited to join the expert working group based on expertise, and representation of key stakeholders relevant to the prosthetic design process.
Qualitative focus group interviews: Prosthetists and/or expert working group members participated in qualitative focus group interviews up to 120 minutes in length.
Qualitative semi-structured interviews: People with lower limb amputation and/or expert working group members participated in qualitative individual, semi-structured interviews approximately 60 minutes in length.
|
|---|---|---|---|
|
Participant Preferences for Personal Preference Towards Control in a Health Decision, as Measured by the Control Preferences Scale Survey
|
15.5 units on a scale, range 5-25
Standard Deviation 2.1
|
15.4 units on a scale, range 5-25
Standard Deviation 4.5
|
—
|
SECONDARY outcome
Timeframe: Data collection occurred at the baseline time point only, lasting an average of 1 hour during 1 day.Population: Data from the eHealth Literacy Scale Survey was only collected from the Prosthetists group and the People with Lower Limb Amputation group, and was not collected from the Expert Working group
The eHealth Literacy scale survey is a 10-item measure of electronic Health literacy developed to measure patient's combined knowledge, comfort, and perceived skills at finding, evaluating, and applying electronic health information to health problems. This scale includes 10 questions with a range of response scores from 1 to 5 for each question (totaling a final score ranging from 10 to 50). 1 represents low electronic health literacy, while 5 represents higher electronic health literacy.
Outcome measures
| Measure |
Prosthetists
n=38 Participants
38 prosthetists who are actively providing prosthetic care to people with lower limb amputation were recruited for participating in focus groups to describe their decisional needs for providing prostheses to people with lower limb amputation.
Qualitative focus group interviews: Prosthetists and/or expert working group members will participate in qualitative focus group interviews up to 120 minutes in length.
|
People With Lower Limb Amputation
n=17 Participants
17 people within 1 year from lower limb amputation, receiving their first prosthesis were recruited for individual semi-structured interviews to describe their decisional needs for provision of a prosthesis.
Qualitative semi-structured interviews: 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
The expert working group consisted of 6 people with LLA actively receiving prosthetic care, and 5 prosthetic care providers with greater than 5 years of experience. Individuals were invited to join the expert working group based on expertise, and representation of key stakeholders relevant to the prosthetic design process.
Qualitative focus group interviews: Prosthetists and/or expert working group members participated in qualitative focus group interviews up to 120 minutes in length.
Qualitative semi-structured interviews: People with lower limb amputation and/or expert working group members participated in qualitative individual, semi-structured interviews approximately 60 minutes in length.
|
|---|---|---|---|
|
Perceived Ability to Find and Use Health Information, Via the eHealth Literacy Scale Survey
|
41.7 units on a scale, range 10-50
Standard Deviation 4.1
|
36.3 units on a scale, range 10-50
Standard Deviation 6.7
|
—
|
Adverse Events
Prosthetists
People With Lower Limb Amputation
Expert Working Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place