Clinical trial NCT04450914: Implementing Shared Decision Making (SDM) For Individualized CV Prevention (SDM4IP)
Official title: Implementing Shared Decision Making (SDM) For Individualized CV Prevention (SDM4IP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk
Cardiovascular Prevention
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 112127
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Mixed method, hybrid implementation-effectiveness (Type III) step-wedge clustered randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Cardiovascular (CV) disease is the #1 cause of premature mortality and substantial morbidity in the U.S. Despite clinical guidelines, most clinical interventions are implemented in people at relatively lower CV risk, and few among people at the highest risk. Shared decision making (SDM) can mitigate the risk-treatment paradox by reducing risk blindness and lack of fit of the preventive regimen, but the adoption of SDM in routine clinical care is incomplete. This study addresses SDM adoption of a CV prevention SDM tool in three health systems.

Detailed description: The primary prevention of cardiovascular (CV) events is often more intense in individuals at lower risk and vice versa (the so called "risk-treatment paradox") in part due to unawareness of each person's CV risk, of their preferences for prevention interventions, and of their feasibility in each person's daily life. Clinical practice guidelines recommend that clinicians and patients work together to arrive at an effective and feasible prevention plan that is congruent with each person's CV risk and informed preferences, a process called shared decision making (SDM). Despite the availability of an innovative and effective tool that estimates CV risk, shows the impact and features of available lifestyle and pharmacological preventive interventions, and thus can facilitate CV treatment discussions between clinicians and patients, this type of SDM does not routinely happen in practice.

The challenge therefore is to identify strategies to increase adoption of this type of SDM in real-world clinical practices. This 4-year study - proposed by a multidisciplinary team with expertise in preventive cardiology, SDM, and implementation science - aims to integrate an SDM tool (the CV Prevention Choice tool) in the primary care practices of three diverse health care systems in the U.S. and study both the tool and tailored strategies that foster its adoption and routine use. The study will use a mixed method, hybrid implementation-effectiveness (Type III) step-wedge clustered randomized trial design to determine:

* Implementation effectiveness (Aim 1) by evaluating the settings (including local workflow and policies) in which the CV Prevention Choice tool is implemented and the engagement of users in implementation strategies; implementation outcomes (e.g., reach, adoption) associated with these strategies; and how implementation fosters routine adoption of SDM and the CV Prevention Choice tool in primary care practices, and
* SDM effectiveness (Aim 2) estimated by the extent to which individual CV prevention plans are feasible and congruent with each person's estimated CV risk and preferences.

The investigators hypothesize that efforts to assess local needs and use them to develop tailored implementation approaches will foster greater adoption of SDM in practice. They further hypothesize that individual preventive care plans will be congruent with estimated risk when clinicians adopt the SDM tool. The broad goal is to promote patient-centered care that effectively reduces the substantial burden of CV disease among Americans. By the project's end, the investigators expect to have (a) identified the most effective implementation strategies to embed SDM in routine practice and (b) estimated the effectiveness of SDM to achieve feasible and risk-concordant CV prevention in primary care.

Eligibility criteria: Inclusion Criteria:

* Clinician Participants: All clinicians who are affiliated with a participating primary care practice and care for adult patients eligible for CV prevention will be invited to participate.
* Patient Participants: Adult patients (ages 40-75 years) with or without diabetes who have not experienced an atherothrombotic clinical event and receive preventive care at a participating primary care practice will be eligible to participate.

Exclusion Criteria:

- Individuals who do not speak English or have any sort of cognitive deficit that would impact their ability to consent to participate in the study will not be invited to participate.

Primary outcomes:
measure: Reach metrics
timeFrame: Q1/Year 2 through Q3/Year 4
measure: Effectiveness perceptions
timeFrame: Q1/Year 2 through Q3/Year 4
measure: Adoption metrics
timeFrame: Q1/Year 2 through Q3/Year 4
measure: Adoption perceptions
timeFrame: Q1/Year 2 through Q3/Year 4
measure: Implementation fidelity
timeFrame: Q1/Year 4 through Q3/Year 4
measure: Implementation SDM quality
timeFrame: Q1/Year 4 through Q3/Year 4
measure: Implementation care quality
timeFrame: Q1/Year 4 through Q3/Year 4
measure: Maintenance metrics
timeFrame: Q1/Year 4 through Q3/Year 4
measure: Maintenance self-report
timeFrame: Q1/Year 4 through Q3/Year 4
Secondary outcomes:
measure: SDM Effectiveness
timeFrame: Q1/Year 2 through Q3/Year 4
Other outcomes:
Locations:
city: Marietta
country: United States
facility: Wellstar Health System
state: Georgia
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Grand Forks
country: United States
facility: Altru Health System
state: North Dakota
city: Arlington
country: United States
facility: VHC Health
state: Virginia
Study officials:
affiliation: Mayo Clinic
name: Jennifer Ridgeway, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Victor Montori, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ridgeway JL, Branda ME, Gravholt D, Brito JP, Hargraves IG, Hartasanchez SA, Leppin AL, Gomez YL, Mann DM, Nautiyal V, Thomas RJ, Behnken EM, Torres Roldan VD, Shah ND, Khurana CS, Montori VM. Increasing risk-concordant cardiovascular care in diverse health systems: a mixed methods pragmatic stepped wedge cluster randomized implementation trial of shared decision making (SDM4IP). Implement Sci Commun. 2021 Apr 21;2(1):43. doi: 10.1186/s43058-021-00145-6.