Shared Decision Making Aid for Prosthetic Design

• Conditions: Amputation; Prosthesis User
• Interventions: Other: Qualitative focus group interviews; Other: Qualitative semi-structured interviews

• Registration Number: NCT04536025
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

The overarching hypothesis of this work is that the lack of shared decision making (SDM) for prosthetic design and failure to match patient expectations with a prosthetic design plan result in poor health outcomes for patients with LLA. Shared decision making (SDM) is where clinicians and patients share the best available evidence for comparing options in order to achieve informed preferences for making health decisions. A patient's involvement in their health care process is known to affect their satisfaction, adherence to care programs, and health outcomes. Clinical decision aids (DAs) support patients in SDM and making informed health decisions, by providing information on the available options and associated outcomes. DAs are intended to help patients clarify their values associated with the options and potential outcomes, to create a platform for communication with healthcare providers. DAs have been shown to improve patient knowledge and realistic expectations for given health options. This project aims to examine how to better align patient and clinician values and expectations by developing a DA for prosthetic design decision options, to support SDM between patients receiving their first prosthesis and prosthetic care providers. This proposal will be guided by the International Patient Decision Aids Standards (IPDAS).

Aim 1: Qualitatively define the key determinants and decisional needs of new prosthetic patients (n=14) and prosthetic care providers (n=20- 24) during prosthetic design, via semi structured interviews with patient participants and focus groups with prosthetist participants.

Expected Result 1.1: Key determinants and decisional needs for prosthetic design will be defined using content analysis guided by the Ottawa Decision Support framework9 for patients making health decisions, and the Model for Shared Decision Making in Clinical Practice.

Expected Result 1.2: Key stakeholders who contribute directly to prosthetic design decisions (e.g., patients with LLA, prosthetists, physicians, caregivers, close friends or family members) will be identified via purposive sampling, to inform the target end users of a DA prototype.

Aim 2: Synthesize the evidence for prosthetic design decision options to develop a DA prototype.

Expected Result 2.1: Via systematic literature review, a DA prototype will be developed from the evidence on prosthetic design decision options associated with decisional needs identified in Aim 1.

Aim 3: Assess the DA prototype's accuracy, comprehensibility, and usability through alpha testing with an expert working group of patients with LLA and prosthetic care providers.

Expected Result 3.1: Quantitative results from a Likert scale measurement of the DA prototype's accuracy, comprehensibility and usability will inform revisions to the DA prior to use in a pilot clinical trial.

Expected Result 3.2: Qualitative feedback on the DA prototype's accuracy, comprehensibility, and usability will inform directed iterative revision for the DA prototype and implementation methods for use in a pilot clinical trial.

Study Timeline

• Study Start: 2020-06-06
• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-09-02
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-02-24
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

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

Group 1 Prosthetist

Read More

Exclusion Criteria

• Unable to participate in a 1 hour phone or video conference
• Non-English speaking

Group 2 Patient Inclusion Criteria:

• 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

Group 2 Patient Exclusion Criteria:

• Unable to participate in a 1 hour phone or video conference
• Non-English speaking

Group 3 Expert Working Group Inclusion Criteria:

• 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.

Group Expert Working Group Exclusion Criteria:

• Unable to participate in a 1 hour phone or video conference
• Non-English speaking

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Expert working group	Qualitative focus group interviews	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.
Prosthetists	Qualitative focus group interviews	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.
People with lower limb amputation	Qualitative semi-structured interviews	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.
Expert working group	Qualitative semi-structured interviews	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Participated in and Completed 1 Hour Qualitative Interview Data Collection Via a Semi Structured Interview Guides	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.
Accuracy of the Decision Aid Prototype, as Measured in Percentage.	Data collection occurred at the baseline time point only, lasting an average of 1 hour during 1 day.	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).
Comprehensibility of the Decision Aid Prototype, as Measured by a Likert Scale	Data collection occurred at the baseline time point only, lasting an average of 1 hour during 1 day.	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.
Usability of the Decision Decision Aid Prototype, as Measured by a Likert Scale	Data collection occurred at the baseline time point only, lasting an average of 1 hour during 1 day.	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).

Secondary Outcome Measures

Name	Time	Method
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.	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.
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.	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.

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States