Understanding Patient Goals and Preferences to Facilitate Shared Decision Making for Symptomatic Aortic Stenosis

NCT04755426 | Completed

• 1 other identifier: HCP-8243002
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis Symptomatic

Keywords

Shared decision making; Preference assessment; Values clarification

Outcome Measures

Primary Outcomes (1)

• Shared Decision Making Process Scale

  A patient-reported measure of shared decision making with their clinician.

  Within a day or 2 of meeting with their valve specialist to discuss treatment options

Secondary Outcomes (4)

• Patient-identified preferences for treatment.

  At baseline, while using the tool, and within a day or 2 of meeting with their valve specialist to discuss treatment options

• Healthcare providers' perceptions of their patient's preferences.

  WIthin a few days of having an appointment with the patient who has interacted with the tool.

• CollaboRATE

  Within a day or 2 of meeting with their valve specialist to discuss treatment options

• Knowledge (Subjective and objective)

  At baseline, just after completing the tool, and within a day or 2 of meeting with their valve specialist.

Study Arms (2)

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)

Behavioral: AVITA--Aortic Valve Improved Treatment Approaches

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.

Behavioral: AVITA--Aortic Valve Improved Treatment Approaches

Interventions

AVITA--Aortic Valve Improved Treatment Approaches BEHAVIORAL

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.

Also known as: Values Clarification Tool, Online learning tool, Shared decision making tool

Health care providers; Patients with severe aortic stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient participants are identified through HCP advisers and patient advisers with access to a AS patient networks (Heart Valve Voice US), Women in Cardiology (private Facebook Group) using a purposive sampling design.

You may qualify if:

• Symptomatic aortic stenosis (also known as severe aortic stenosis)
• English-speaking
• a patient of a participating HCP (for Phases 3 and 4)

You may not qualify if:

• years of age or younger
• unable or unwilling to give informed consent.

Sponsors & Collaborators

• Shared Decision Making Resources: lead
• Edwards Lifesciences: collaborator

Study Sites (1)

Shared Decision Making Resources

Georgetown, Maine, 04548, United States

Location

Related Publications (12)

• 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.

  PMID: 28806143 BACKGROUND

• 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.

  PMID: 30568563 BACKGROUND

• 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.

  PMID: 27044883 BACKGROUND

• 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.

  PMID: 8477899 BACKGROUND

• 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.

  PMID: 24470076 BACKGROUND

• 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.

  PMID: 33069228 BACKGROUND

• 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.

  PMID: 31667351 BACKGROUND

• 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.

  PMID: 27687903 BACKGROUND

• 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.

  PMID: 27712701 BACKGROUND

• 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.

  PMID: 33319648 BACKGROUND

• 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.

  PMID: 38771808 DERIVED

• 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.

  PMID: 35951553 DERIVED

Study Officials

• Nananda F Col, MD, MPH

  Shared Decision Making Resources

  PRINCIPAL INVESTIGATOR

• Christina Fitzpatrick, MA

  Shared Decision Making Resources

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founder

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: February 16, 2021
• Study Start: January 9, 2020
• Primary Completion: August 16, 2022
• Study Completion: August 16, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: At the time of publication of our findings and for the following 2 years.
• Access Criteria: Contact the study investigators.

Locations

US (1)