Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04755426
Status:
COMPLETED
Last Update Posted:
2022-11-30
First Post:
2021-02-06
Brief Title:
Understanding Patient Goals and Preferences to Facilitate Shared Decision Making for Symptomatic Aortic Stenosis
Sponsor:
Shared Decision Making Resources
Organization:
Shared Decision Making Resources
Study Overview
Official Title:
Understanding Patient Goals and Preferences to Facilitate Shared Decision Making for Symptomatic Aortic Stenosis
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall goal of this study is to develop and validate a preference assessment tool for patients who have severe aortic stenosis and are contemplating their treatment options The first part of the study focuses on understanding the treatment goals and treatment features that matter most to patients who have already made the decision The investigators use mixed methods nominal group technique card sorting to elicit prioritize and organize these patient preferences into a cognitive map Based on those findings the investigators design a preference tool and then pre-test the tool with patients and healthcare providers
Detailed Description:
The investigators are conducting a 4-phase phase mixed methods study involving nominal group technique NGT with patients driving the identification and categorization of preferences regarding treatment options for symptomatic AS Participants include adults with a history of symptomatic AS and HCPs who guide decisions about managing AS including interventional cardiologists cardiac surgeons and advanced practice providers APPs including nurse practitioners and physician assistants
The initial phases of the study generating patient goals and preferences through NGTs targets diverse patients with a history of severe Aortic Stenosis AS who have previously made the decision regarding treatment choices This will include patients who have undergone Surgical aortic valve replacement SAVR Transcatheter aortic valve replacement TAVR or who elected palliative care with or without balloon valvuloplasty The subsequent phases will include patients with AS who are currently facing a decision with regard to treatment
Phase 1 Identify and prioritize patient a goals and b preferences for treatment The nominal group technique NGT will be used to identify and prioritize patient-centered outcomes related to treatment goals and treatment features Both in-person and online NGT groups with 5-9 patients each will be conducted to maximize the representativeness of the sample 6-8 NGTs Planning for 4 NGTs per question 8 total including a minimum of 2 in-person NGTs and the remaining conducted either in-person or online depending on which approach better enables recruitment needs Each NGT has between 5 and 9 patients A separate parallel process will be done for each NGT question including a goals and b preferences for treatment attributes to limit patient burden for each portion of the study
Phase 2 Categorize patient a goals and b preferences for treatment through cognitive mapping Following identification and prioritization of patient-generated goals and preferences 25-50 patients across the three sites will participate online in card sorting activities that will be used to organize these prioritized lists into clusters domains using Multidimensional Scaling MDS and Hierarchical Cluster Analysis HCA to analyze the data A parallel process will be done for each cognitive map including a goals and b preferences for treatment
Phase 3 Based on patient-defined goals and preferences for the treatment of AS develop the preference assessment tool The patient-identified goals and preferences will serve as the core of the preference tool The investigators will draw from a validated SDM template to summarize and communicate patient preferences to their HCPs An early prototype will be developed and subsequent usability testing with patients with a history of severe AS will refine the tool The prototype that will be used is available at httpstinyurlcomWhatMattersMS
Phase 4 Pilot test the preference assessment tool using 20-25 patient-HCP pairs to compare HCPs prediction of patient preferences to actual patient preferences among those patients who have not yet received treatment for their AS Before each clinical encounter each HCP will be asked to infer their patients top 1-3 treatment goals and preferences Patients will have interacted with the preference assessment tool independently before the clinical appointment which will have assessed and summarized their goals and preferences After the HCP has entered hisher inferred patient treatment goals heshe will be shown the patients actual treatment goals and preferences Analyses will compare the correspondence between the patient and HCP preferences using Kappa statistic Additionally the outcomes below will be assessed in preparation for the subsequent national validation study
The initial phases of the study generating patient goals and preferences through NGTs targets diverse patients with a history of severe Aortic Stenosis AS who have previously made the decision regarding treatment choices This will include patients who have undergone Surgical aortic valve replacement SAVR Transcatheter aortic valve replacement TAVR or who elected palliative care with or without balloon valvuloplasty The subsequent phases will include patients with AS who are currently facing a decision with regard to treatment
Phase 1 Identify and prioritize patient a goals and b preferences for treatment The nominal group technique NGT will be used to identify and prioritize patient-centered outcomes related to treatment goals and treatment features Both in-person and online NGT groups with 5-9 patients each will be conducted to maximize the representativeness of the sample 6-8 NGTs Planning for 4 NGTs per question 8 total including a minimum of 2 in-person NGTs and the remaining conducted either in-person or online depending on which approach better enables recruitment needs Each NGT has between 5 and 9 patients A separate parallel process will be done for each NGT question including a goals and b preferences for treatment attributes to limit patient burden for each portion of the study
Phase 2 Categorize patient a goals and b preferences for treatment through cognitive mapping Following identification and prioritization of patient-generated goals and preferences 25-50 patients across the three sites will participate online in card sorting activities that will be used to organize these prioritized lists into clusters domains using Multidimensional Scaling MDS and Hierarchical Cluster Analysis HCA to analyze the data A parallel process will be done for each cognitive map including a goals and b preferences for treatment
Phase 3 Based on patient-defined goals and preferences for the treatment of AS develop the preference assessment tool The patient-identified goals and preferences will serve as the core of the preference tool The investigators will draw from a validated SDM template to summarize and communicate patient preferences to their HCPs An early prototype will be developed and subsequent usability testing with patients with a history of severe AS will refine the tool The prototype that will be used is available at httpstinyurlcomWhatMattersMS
Phase 4 Pilot test the preference assessment tool using 20-25 patient-HCP pairs to compare HCPs prediction of patient preferences to actual patient preferences among those patients who have not yet received treatment for their AS Before each clinical encounter each HCP will be asked to infer their patients top 1-3 treatment goals and preferences Patients will have interacted with the preference assessment tool independently before the clinical appointment which will have assessed and summarized their goals and preferences After the HCP has entered hisher inferred patient treatment goals heshe will be shown the patients actual treatment goals and preferences Analyses will compare the correspondence between the patient and HCP preferences using Kappa statistic Additionally the outcomes below will be assessed in preparation for the subsequent national validation study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None