Shared Decision Making Aid for Prosthetic Design (D-MAP)

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.

Study Overview

• Status: Completed
• Conditions: Amputation; Prosthesis User
• Intervention / Treatment: Other: Qualitative focus group interviews; Other: Qualitative semi-structured interviews

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 Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	Other: 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.	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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Preferences for Personal Preference Towards Control in a Health Decision, as Measured by the Control Preferences Scale Survey	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.	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	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.	Data collection occurred at the baseline time point only, lasting an average of 1 hour during 1 day.

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Orthotic and Prosthetic Education and Research Foundation (OPERF)
• Investigators: Principal Investigator: Cory L Christiansen, PT, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2020
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): September 2, 2020

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Decision Making; Lower Limb Amputation
• Other Study ID Numbers: 20-1070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No