TOGETHER: Structured Shared Decision Making for Patients Undergoing SAVR or TAVR

Sponsor

University Hospital Inselspital, Berne (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05711186

Collaborator

(none)

140

Enrollment

Location

Arms

37.9

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Transcatheter aortic valve replacement (TAVR) is a well-established alternative to surgical aortic valve replacement (SAVR) for the treatment of patients with severe aortic stenosis regardless of surgical risk. While TAVR and SAVR share some of the benefits and risks, they importantly differ with regards to invasiveness, time to recovery, hemodynamics, as well as options for re-intervention and possibly valve durability. An early benefit of TAVR may be offset by late risks. Therefore, current guidelines of the European Society of Cardiology recommend an integration of patient values and preferences for the selection of the treatment modality.

The objective of the TOGETHER trial is to investigate the efficacy of a structured shared decision making approach (SDM) to improve patient-centered outcomes for the choice between SAVR and TAVR.

TOGETHER is an investigator-initiated, randomized, open-label, single-center clinical trial. A total of 140 patients referred for treatment of symptomatic severe aortic stenosis and deemed to undergo TAVR or SAVR according to heart team decision will be randomized in a 1:1 ratio to structured SDM or usual care.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis Symptomatic Aortic Stenosis	Other: Structured SDM Other: Usual Care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Structured Shared Decision Making for Patients Undergoing Elective Surgical or Transcatheter Aortic Valve Replacement (TOGETHER): A Randomized-controlled Trial

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

May 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Structured SDM Structured shared decision making for the choice between SAVR and TAVR	Other: Structured SDM The conversation between the heart team member and the patient will be structured according the adapted three-talk model for patients with symptomatic aortic stenosis and using the American College of Cardiology's decision aid for patients deciding between TAVR and SAVR
Other: Usual Care Usual care for the choice between SAVR and TAVR	Other: Usual Care Usual care will include baseline visits without a structured SDM approach. Usual care includes at least one decision making talk with a heart team member discussing information about the disease, treatment options as well as benefits and risks of each procedure.

Arm

Intervention/Treatment

Other: Structured SDM

Structured shared decision making for the choice between SAVR and TAVR

Other: Structured SDM

The conversation between the heart team member and the patient will be structured according the adapted three-talk model for patients with symptomatic aortic stenosis and using the American College of Cardiology's decision aid for patients deciding between TAVR and SAVR

Other: Usual Care

Usual care for the choice between SAVR and TAVR

Other: Usual Care

Usual care will include baseline visits without a structured SDM approach. Usual care includes at least one decision making talk with a heart team member discussing information about the disease, treatment options as well as benefits and risks of each procedure.

Outcome Measures

Primary Outcome Measures

Patient decisional conflict [3 days post baseline visit]
Assessed by decisional conflict scale
Patient decisional regret [30 days post TAVR/SAVR]
Assessed by the decision regret scale

Secondary Outcome Measures

Patient-centered communication [3 days post baseline visit]
Assessed by CollaboRATE scale
Patient knowledge about the treatment options and outcomes [3 days post baseline visit]
Assessed by 6 multiple-choice items
Patient procedural satisfaction [3 days post baseline visit]
Assessed by Likert Scale
Patient decisional satisfaction [3 days post baseline visit; 30 days and 1 year post TAVR/SAVR]
Assessed by Likert Scale
Incorporation of patient values [3 days post baseline visit]
Assessed by values clarity subscore of the decisional conflict scale
Patient feeling of not being informed [3 days post baseline visit]
Assessed by informed subscore of the decisional conflict scale
Quality of choice [3 days post baseline visit]
Assessed by effective decision subscore of the decisional conflict scale
Patient decisional regret [1 year post TAVR/SAVR]
Assessed by the decision regret scale
Patient health-related quality of life [30 days post TAVR/SAVR]
Assessed by KCCQ 12
The proportion of patients choosing TAVR/SAVR [Baseline]
Number of participants choosing valve replacement by TAVR or SAVR
The incidences of major clinical adverse events [30 days and 1 year post TAVR/SAVR]
All-cause mortality, stroke, transient ischemic attack, bleeding event, kidney injury, systemic embolism, myocardial infarction, new onset atrial fibrillation, permanent pacemaker implantation and intervention related to the device

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 70 years
Symptomatic severe aortic stenosis defined by an aortic valve area ≤1.0 cm2 or an aortic valve area indexed to body surface area <0.6cm2/m2
Both SAVR and transfemoral TAVR as reasonable treatment options based on heart team decision

Exclusion Criteria:

Life expectancy <1 year irrespective of valvular heart disease
Inability to provide informed consent
Participation in another clinical trial with an active intervention

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bern University Hospital, Dep. of Cardiology	Bern		Switzerland	3010

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators

Principal Investigator: Thomas Pilgrim, Prof., Department of Cardiology, University Hospital Bern, Inselspital, Bern
Principal Investigator: Christoph Ryffel, Dr. med., Department of Cardiology, University Hospital Bern, Inselspital, Bern