Understanding Patient Goals and Preferences to Facilitate Shared Decision Making for Symptomatic Aortic Stenosis
NCT ID: NCT04755426
Last Updated: 2022-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
99 participants
OBSERVATIONAL
2020-01-09
2022-08-16
Brief Summary
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Detailed Description
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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 NGT's 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: https://tinyurl.com/WhatMattersMS
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 patient's 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 his/her inferred patient treatment goals, he/she will be shown the patient's 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with severe aortic stenosis
Adults with severe aortic stenosis who either have faced or are facing a decision about valve replacement (depending on the phase of the research)
AVITA--Aortic Valve Improved Treatment Approaches
AVITA is an interactive shared decision making tool that helps patients clarify their treatment goals and preferences and communicate those preferences to their valve specialist.
Health care providers
HCPs who guide decisions about managing AS, including interventional cardiologists, cardiac surgeons and advanced practice providers (APPs), including nurse practitioners and physician assistants.
AVITA--Aortic Valve Improved Treatment Approaches
AVITA is an interactive shared decision making tool that helps patients clarify their treatment goals and preferences and communicate those preferences to their valve specialist.
Interventions
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AVITA--Aortic Valve Improved Treatment Approaches
AVITA is an interactive shared decision making tool that helps patients clarify their treatment goals and preferences and communicate those preferences to their valve specialist.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* English-speaking
* a patient of a participating HCP (for Phases 3 and 4)
Exclusion Criteria
* unable or unwilling to give informed consent.
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Shared Decision Making Resources
OTHER
Responsible Party
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Nananda Col
Founder
Principal Investigators
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Nananda F Col, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Shared Decision Making Resources
Christina Fitzpatrick, MA
Role: STUDY_DIRECTOR
Shared Decision Making Resources
Locations
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Shared Decision Making Resources
Georgetown, Maine, United States
Countries
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References
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Col NF, Solomon AJ, Springmann V, Garbin CP, Ionete C, Pbert L, Alvarez E, Tierman B, Hopson A, Kutz C, Berrios Morales I, Griffin C, Phillips G, Ngo LH. Whose Preferences Matter? A Patient-Centered Approach for Eliciting Treatment Goals. Med Decis Making. 2018 Jan;38(1):44-55. doi: 10.1177/0272989X17724434. Epub 2017 Aug 14.
Col NF, Solomon AJ, Springmann V, Ionete C, Alvarez E, Tierman B, Kutz C, Morales IB, Griffin C, Ngo LH, Jones DE, Phillips G, Hopson A, Pbert L. Evaluation of a Novel Preference Assessment Tool for Patients with Multiple Sclerosis. Int J MS Care. 2018 Nov-Dec;20(6):260-267. doi: 10.7224/1537-2073.2017-021.
Witteman HO, Gavaruzzi T, Scherer LD, Pieterse AH, Fuhrel-Forbis A, Chipenda Dansokho S, Exe N, Kahn VC, Feldman-Stewart D, Col NF, Turgeon AF, Fagerlin A. Effects of Design Features of Explicit Values Clarification Methods: A Systematic Review. Med Decis Making. 2016 Aug;36(6):760-76. doi: 10.1177/0272989X16634085. Epub 2016 Apr 4.
Gallagher M, Hares T, Spencer J, Bradshaw C, Webb I. The nominal group technique: a research tool for general practice? Fam Pract. 1993 Mar;10(1):76-81. doi: 10.1093/fampra/10.1.76.
Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4.
Col N, Hull S, Springmann V, Ngo L, Merritt E, Gold S, Sprintz M, Genova N, Nesin N, Tierman B, Sanfilippo F, Entel R, Pbert L. Improving patient-provider communication about chronic pain: development and feasibility testing of a shared decision-making tool. BMC Med Inform Decis Mak. 2020 Oct 17;20(1):267. doi: 10.1186/s12911-020-01279-8.
Col N, Alvarez E, Springmann V, Ionete C, Berrios Morales I, Solomon A, Kutz C, Griffin C, Tierman B, Livingston T, Patel M, van Leeuwen D, Ngo L, Pbert L. A Novel Tool to Improve Shared Decision Making and Adherence in Multiple Sclerosis: Development and Preliminary Testing. MDM Policy Pract. 2019 Oct 16;4(2):2381468319879134. doi: 10.1177/2381468319879134. eCollection 2019 Jul-Dec.
Lytvyn L, Guyatt GH, Manja V, Siemieniuk RA, Zhang Y, Agoritsas T, Vandvik PO. Patient values and preferences on transcatheter or surgical aortic valve replacement therapy for aortic stenosis: a systematic review. BMJ Open. 2016 Sep 29;6(9):e014327. doi: 10.1136/bmjopen-2016-014327.
Ho M, Saha A, McCleary KK, Levitan B, Christopher S, Zandlo K, Braithwaite RS, Hauber AB; Medical Device Innovation Consortium's Patient Centered Benefit-Risk Steering Committee. A Framework for Incorporating Patient Preferences Regarding Benefits and Risks into Regulatory Assessment of Medical Technologies. Value Health. 2016 Sep-Oct;19(6):746-750. doi: 10.1016/j.jval.2016.02.019.
Valentine KD, Vo H, Fowler FJ Jr, Brodney S, Barry MJ, Sepucha KR. Development and Evaluation of the Shared Decision Making Process Scale: A Short Patient-Reported Measure. Med Decis Making. 2021 Feb;41(2):108-119. doi: 10.1177/0272989X20977878. Epub 2020 Dec 15.
Coylewright M, Otero D, Lindman BR, Levack MM, Horne A Jr, Ngo LH, Beaudry M, Col HV, Col NF. An interactive, online decision aid assessing patient goals and preferences for treatment of aortic stenosis to support physician-led shared decision-making: Early feasibility pilot study. PLoS One. 2024 May 21;19(5):e0302378. doi: 10.1371/journal.pone.0302378. eCollection 2024.
Col NF, Otero D, Lindman BR, Horne A, Levack MM, Ngo L, Goodloe K, Strong S, Kaplan E, Beaudry M, Coylewright M. What matters most to patients with severe aortic stenosis when choosing treatment? Framing the conversation for shared decision making. PLoS One. 2022 Aug 11;17(8):e0270209. doi: 10.1371/journal.pone.0270209. eCollection 2022.
Other Identifiers
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HCP-8243002
Identifier Type: -
Identifier Source: org_study_id
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