Aortic Stenosis SymptomaticNCT04755426
Understanding Patient Goals and Preferences to Facilitate Shared Decision Making for Symptomatic Aortic Stenosis
An observational study of Aortic Stenosis Symptomatic, run by Shared Decision Making Resources at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis Symptomatic
- What is being tested?
- AVITA--Aortic Valve Improved Treatment Approaches
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2020to 16 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Symptomatic aortic stenosis (also known as severe aortic stenosis)
- English-speaking
- a patient of a participating HCP (for Phases 3 and 4)
Who cannot join
- 18 years of age or younger
- unable or unwilling to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shared Decision Making Resources
Georgetown, Maine, 04548
About this study
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.
Read the 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 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
- Aortic Stenosis Symptomatic
- Being tested
- AVITA--Aortic Valve Improved Treatment Approaches
- Keywords
- Shared decision making, Preference assessment, Values clarification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVITA--Aortic Valve Improved Treatment ApproachesBehavioural
Also called Values Clarification Tool, Online learning tool, Shared decision making tool
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Behavioral: AVITA--Aortic Valve Improved Treatment Approaches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shared Decision Making Process Scale
A patient-reported measure of shared decision making with their clinician.
Measured: Within a day or 2 of meeting with their valve specialist to discuss treatment options
Secondary outcomes (4)
Patient-identified preferences for treatment.
The treatment for aortic stenosis that the patient prefers (SAVR, TAVR, Medical Therapy, or undecided.
Measured: 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.
The features (attributes) of their treatment options for aortic stenosis that matter most to the patient
Measured: WIthin a few days of having an appointment with the patient who has interacted with the tool.
CollaboRATE
A short patient-reported measure of patient-provider communication
Measured: Within a day or 2 of meeting with their valve specialist to discuss treatment options
Knowledge (Subjective and objective)
Multiple choice questions that assess perceived and actual knowledge about aortic stenosis and treatment options.
Measured: At baseline, just after completing the tool, and within a day or 2 of meeting with their valve specialist.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start9 Jan 2020
- Primary completion16 Aug 2022
- Study completion16 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Aortic Stenosis SymptomaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shared Decision Making Resources
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Principal investigator, Nananda Col, Shared Decision Making Resources
- Investigators
- Nananda F Col, MD, MPH, Principal investigator, Shared Decision Making ResourcesChristina Fitzpatrick, MA, Study director, Shared Decision Making Resources
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755426
- Sponsor's protocol ID
- HCP-8243002
- Status last verified
- Nov 2022
- First submitted
- 6 Feb 2021
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All deidentified IPD. We plan to publish this information in scientific manuscripts.
Publications
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.
PubMed 28806143Col 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.
PubMed 30568563Witteman 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.
PubMed 27044883Gallagher 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.
PubMed 8477899Stacey 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.
PubMed 24470076Col 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.
PubMed 33069228Col 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.
PubMed 31667351Lytvyn 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.
PubMed 27687903Ho 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.
PubMed 27712701Valentine 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.
PubMed 33319648Coylewright 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.
PubMed 38771808Col 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.
PubMed 35951553
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Patient Goals and Preferences to Facilitate Shared Decision Making for Symptomatic Aortic Stenosis
- ClinicalTrials.gov ID
- NCT04755426
- Acronym / sponsor ID
- HCP-8243002
- Conditions
- Aortic Stenosis Symptomatic
- Keywords
- Shared decision making, Preference assessment, Values clarification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Shared Decision Making ResourcesUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 16 Aug 2022 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with severe aortic stenosis | – | Behavioral: AVITA--Aortic Valve Improved Treatment ApproachesAdults with severe aortic stenosis who either have faced or are facing a decision about valve replacement (depending on the phase of the research) |
| Health care providers | – | Behavioral: AVITA--Aortic Valve Improved Treatment ApproachesHCPs who guide decisions about managing AS, including interventional cardiologists, cardiac surgeons and advanced practice providers (APPs), including nurse practitioners and physician assistants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Symptomatic aortic stenosis (also known as severe aortic stenosis)
- English-speaking
- a patient of a participating HCP (for Phases 3 and 4)
Key exclusion criteria (2 listed)
- 18 years of age or younger
- unable or unwilling to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVITA--Aortic Valve Improved Treatment ApproachesAlso: Values Clarification Tool, Online learning tool, Shared decision making toolAVITA is an interactive shared decision making tool that helps patients clarify their treatment goals and preferences and communicate those preferences to their valve specialist. | Behavioural | Health care providers, Patients with severe aortic stenosis |
Primary outcome
Shared Decision Making Process Scale
Time frame: Within a day or 2 of meeting with their valve specialist to discuss treatment options
A patient-reported measure of shared decision making with their clinician.
4 secondary outcomes
Patient-identified preferences for treatment.
Time frame: 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.
Time frame: WIthin a few days of having an appointment with the patient who has interacted with the tool.
CollaboRATE
Time frame: Within a day or 2 of meeting with their valve specialist to discuss treatment options
Knowledge (Subjective and objective)
Time frame: At baseline, just after completing the tool, and within a day or 2 of meeting with their valve specialist.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Background: PubMed 28806143Col 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.
- Background: PubMed 30568563Col 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.
- Background: PubMed 27044883Witteman 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.
- Background: PubMed 8477899Gallagher 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.
- Background: PubMed 24470076Stacey 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.
- Background: PubMed 33069228Col 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.
- Background: PubMed 31667351Col 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.
- Background: PubMed 27687903Lytvyn 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.
- Background: PubMed 27712701Ho 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.
- Background: PubMed 33319648Valentine 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.
- Derived from this study: PubMed 38771808Coylewright 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.
- Derived from this study: PubMed 35951553Col 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.
- Individual participant dataSharing planned: Yes. All deidentified IPD. We plan to publish this information in scientific manuscripts.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nananda F Col, MD, MPH principal investigator
Shared Decision Making Resources
Christina Fitzpatrick, MA study director
Shared Decision Making Resources
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis Symptomatic, run by Shared Decision Making Resources at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shared Decision Making Process Scale (time frame: Within a day or 2 of meeting with their valve specialist to discuss treatment options). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04755426, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.