Shared Decision Making Aid for Prosthetic Design

Amputation Clinical Trial

— D-MAP  

Official title:

Shared Decision Making Aid for Prosthetic Design

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04536025
• Other study ID #: 20-1070
• Status: Active, not recruiting
• Start date: June 6, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: February 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Group 1 Prosthetist Inclusion Criteria:

• At least 18 years of age

• Prosthetists actively providing prosthetic care to people with lower limb amputation

Group 1 Prosthetist 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

Related Conditions & MeSH terms

• Amputation
• Prosthesis User

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Orthotic and Prosthetic Education and Research Foundation (OPERF)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitatively identified decisional needs of patients and prosthetists for Prosthetic Design Decisions, to be used as content in the development of a decision aid for prosthetic design	Qualitatively collected content and themes will be identified from focus group and semi structured interviews, via direct content analysis using the Ottawa Decision Support Framework, and the Elwyn Shared Decision Making Model.	Data collection at baseline time point only
Primary	Accuracy of the decision aid prototype, as measured in percentage.	Accuracy of the Decision Aid will be determined by the percentage (ranging 0% to 100%, with a higher percentage representing greater accuracy) of expert working group members who perceive the presented risks and benefits in the Decision Aid to align with the scientific evidence available on the prosthetic design decision outcomes.	Data collection at baseline time point only
Primary	Comprehensibility of the decision aid prototype, as measured by a Likert Scale	Comprehensibility of the Decision Aid will be classified as the degree to which the Decision Aid content covers information necessary for making an informed decision about prosthetic design, and will be evaluated using a Likert scale (ranging 1-10, with a higher score representing greater comprehensibility) for each component of the Decision Aid.	Data collection at baseline time point only
Primary	Usability of the decision decision aid prototype, as measured by a Likert scale	Usability will be qualified as the extent to which the information presented in the Decision Aid is clear, understandable, and effective, and will be evaluated using a Likert scale (ranging 1-10, with a higher score representing greater usability) for each component of the Decision Aid Prototype.	Data collection at baseline time point only
Secondary	Participant preferences for personal preference towards control in a health decision, as measured by the Control Preferences Scale Survey	A survey measurement of patient or prosthetist preferences regarding participation in healthcare decisions. The survey has 5 questions about separate parts of a prosthesis, rated on a Likert scale (Scores ranging 5-25, with lower scores representing greater control preference). Answers to each question will range from 1) I prefer to make the final decision about the prosthesis to 5) I prefer to leave all decisions about the prosthesis to my patient/prosthetist.	Data collection at baseline time point only
Secondary	Perceived ability to find and use health information, via the eHealth Literacy Scale Survey	A survey measurement of patient or prosthetist perceived ability to find and use traditional, scientific, media, and computer health information. The survey has ten questions about finding and using health information online, rated on a Likert scale (Scores ranging 10-50, with a higher score indicating more agreement). Responses to each question range from 1) strongly disagree to 5) strongly agree.	Data collection at baseline time point only