Clinical trial NCT04536025: Shared Decision Making Aid for Prosthetic Design
Official title: Shared Decision Making Aid for Prosthetic Design
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation
Prosthesis User
Keywords: Lower Limb Amputation
Decision Making
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Orthotic and Prosthetic Education and Research Foundation (OPERF)
First posted: 2020-09-02
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Participated in and Completed 1 Hour Qualitative Interview Data Collection Via a Semi Structured Interview Guides
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.
measure: Accuracy of the Decision Aid Prototype, as Measured in Percentage.
timeFrame: Data collection occurred at the baseline time point only, lasting an average of 1 hour during 1 day.
measure: Comprehensibility of the Decision Aid Prototype, as Measured by a Likert Scale
timeFrame: Data collection occurred at the baseline time point only, lasting an average of 1 hour during 1 day.
measure: Usability of the Decision Decision Aid Prototype, as Measured by a Likert Scale
timeFrame: Data collection occurred at the baseline time point only, lasting an average of 1 hour during 1 day.
Secondary outcomes:
measure: Participant Preferences for Personal Preference Towards Control in a Health Decision, as Measured by the Control Preferences Scale Survey
timeFrame: Data collection occurred at the baseline time point only, lasting an average of 1 hour during 1 day.
measure: Perceived Ability to Find and Use Health Information, Via the eHealth Literacy Scale Survey
timeFrame: Data collection occurred at the baseline time point only, lasting an average of 1 hour during 1 day.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Cory L Christiansen, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: