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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.IS

Abstract

BACKGROUND

The primary prevention of cardiovascular (CV) events is often less intense in persons at higher CV risk and vice versa. Clinical practice guidelines recommend that clinicians and patients use shared decision making (SDM) to arrive at an effective and feasible prevention plan that is congruent with each person's CV risk and informed preferences. However, SDM does not routinely happen in practice. This study aims to integrate into routine care an SDM decision tool (CV PREVENTION CHOICE) at three diverse healthcare systems in the USA and study strategies that foster its adoption and routine use.

METHODS

This is a mixed method, hybrid type III stepped wedge cluster randomized study to estimate (a) the effectiveness of implementation strategies on SDM uptake and utilization and (b) the extent to which SDM results in prevention plans that are risk-congruent. Formative evaluation methods, including clinician and stakeholder interviews and surveys, will identify factors likely to impact feasibility, acceptability, and adoption of CV PREVENTION CHOICE as well as normalization of CV PREVENTION CHOICE in routine care. Implementation facilitation will be used to tailor implementation strategies to local needs, and implementation strategies will be systematically adjusted and tracked for assessment and refinement. Electronic health record data will be used to assess implementation and effectiveness outcomes, including CV PREVENTION CHOICE reach, adoption, implementation, maintenance, and effectiveness (measured as risk-concordant care plans). A sample of video-recorded clinical encounters and patient surveys will be used to assess fidelity. The study employs three theoretical approaches: a determinant framework that calls attention to categories of factors that may foster or inhibit implementation outcomes (the Consolidated Framework for Implementation Research), an implementation theory that guides explanation or understanding of causal influences on implementation outcomes (Normalization Process Theory), and an evaluation framework (RE-AIM).

DISCUSSION

By the project's end, we 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.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT04450914 . Posted June 30, 2020 TRIAL STATUS: This study received ethics approval on April 17, 2020. The current trial protocol is version 2 (approved February 17, 2021). The first subject had not yet been enrolled at the time of submission.

Authors+Show Affiliations

Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. Ridgeway.Jennifer@mayo.edu. Knowledge and Evaluation Research Unit, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. Ridgeway.Jennifer@mayo.edu.Knowledge and Evaluation Research Unit, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado-Denver Anschutz Medical Campus, 13001 East 17th Place, 3rd Floor, Mail Stop B119, Aurora, CO, 80045, USA.Knowledge and Evaluation Research Unit, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.Knowledge and Evaluation Research Unit, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. Division of Diabetes, Endocrinology, Metabolism, and Nutrition, Department of Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.Knowledge and Evaluation Research Unit, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.Knowledge and Evaluation Research Unit, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. Knowledge and Evaluation Research Unit, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.Altru Health System, 1380 S. Columbia Road, Grand Forks, ND, 58206, USA.Department of Population Health, NYU Grossman School of Medicine, 530 1st Avenue, New York, NY, 10016, USA.Wellstar Cardiovascular Medicine, 55 Whitcher Street, NE, Suite 350, Marietta, GA, 30060, USA.Division of Preventive Cardiology, Department of Cardiovascular Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.Knowledge and Evaluation Research Unit, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.Knowledge and Evaluation Research Unit, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.Virginia Hospital Center Physician Group-Cardiology, 1715 North George Mason Drive, Arlington, VA, 22205, USA.Knowledge and Evaluation Research Unit, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. Division of Diabetes, Endocrinology, Metabolism, and Nutrition, Department of Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

33883035

Citation

Ridgeway, Jennifer L., et al. "Increasing Risk-concordant Cardiovascular Care in Diverse Health Systems: a Mixed Methods Pragmatic Stepped Wedge Cluster Randomized Implementation Trial of Shared Decision Making (SDM4IP)." Implementation Science Communications, vol. 2, no. 1, 2021, p. 43.
Ridgeway JL, Branda ME, Gravholt D, et al. 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;2(1):43.
Ridgeway, J. L., Branda, M. E., Gravholt, D., Brito, J. P., Hargraves, I. G., Hartasanchez, S. A., Leppin, A. L., Gomez, Y. L., Mann, D. M., Nautiyal, V., Thomas, R. J., Behnken, E. M., Torres Roldan, V. D., Shah, N. D., Khurana, C. S., & Montori, V. M. (2021). Increasing risk-concordant cardiovascular care in diverse health systems: a mixed methods pragmatic stepped wedge cluster randomized implementation trial of shared decision making (SDM4IP). Implementation Science Communications, 2(1), 43. https://doi.org/10.1186/s43058-021-00145-6
Ridgeway JL, et al. 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. PubMed PMID: 33883035.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Increasing risk-concordant cardiovascular care in diverse health systems: a mixed methods pragmatic stepped wedge cluster randomized implementation trial of shared decision making (SDM4IP). AU - Ridgeway,Jennifer L, AU - Branda,Megan E, AU - Gravholt,Derek, AU - Brito,Juan P, AU - Hargraves,Ian G, AU - Hartasanchez,Sandra A, AU - Leppin,Aaron L, AU - Gomez,Yvonne L, AU - Mann,Devin M, AU - Nautiyal,Vivek, AU - Thomas,Randal J, AU - Behnken,Emma M, AU - Torres Roldan,Victor D, AU - Shah,Nilay D, AU - Khurana,Charanjit S, AU - Montori,Victor M, Y1 - 2021/04/21/ PY - 2021/03/02/received PY - 2021/04/05/accepted PY - 2021/4/22/entrez PY - 2021/4/23/pubmed PY - 2021/4/23/medline KW - Cardiovascular treatment KW - Implementation facilitation KW - Implementation science KW - Mixed methods KW - Risk-treatment paradox KW - Shared decision making SP - 43 EP - 43 JF - Implementation science communications JO - Implement Sci Commun VL - 2 IS - 1 N2 - BACKGROUND: The primary prevention of cardiovascular (CV) events is often less intense in persons at higher CV risk and vice versa. Clinical practice guidelines recommend that clinicians and patients use shared decision making (SDM) to arrive at an effective and feasible prevention plan that is congruent with each person's CV risk and informed preferences. However, SDM does not routinely happen in practice. This study aims to integrate into routine care an SDM decision tool (CV PREVENTION CHOICE) at three diverse healthcare systems in the USA and study strategies that foster its adoption and routine use. METHODS: This is a mixed method, hybrid type III stepped wedge cluster randomized study to estimate (a) the effectiveness of implementation strategies on SDM uptake and utilization and (b) the extent to which SDM results in prevention plans that are risk-congruent. Formative evaluation methods, including clinician and stakeholder interviews and surveys, will identify factors likely to impact feasibility, acceptability, and adoption of CV PREVENTION CHOICE as well as normalization of CV PREVENTION CHOICE in routine care. Implementation facilitation will be used to tailor implementation strategies to local needs, and implementation strategies will be systematically adjusted and tracked for assessment and refinement. Electronic health record data will be used to assess implementation and effectiveness outcomes, including CV PREVENTION CHOICE reach, adoption, implementation, maintenance, and effectiveness (measured as risk-concordant care plans). A sample of video-recorded clinical encounters and patient surveys will be used to assess fidelity. The study employs three theoretical approaches: a determinant framework that calls attention to categories of factors that may foster or inhibit implementation outcomes (the Consolidated Framework for Implementation Research), an implementation theory that guides explanation or understanding of causal influences on implementation outcomes (Normalization Process Theory), and an evaluation framework (RE-AIM). DISCUSSION: By the project's end, we 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. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04450914 . Posted June 30, 2020 TRIAL STATUS: This study received ethics approval on April 17, 2020. The current trial protocol is version 2 (approved February 17, 2021). The first subject had not yet been enrolled at the time of submission. SN - 2662-2211 UR - https://www.unboundmedicine.com/medline/citation/33883035/Increasing_risk_concordant_cardiovascular_care_in_diverse_health_systems:_a_mixed_methods_pragmatic_stepped_wedge_cluster_randomized_implementation_trial_of_shared_decision_making__SDM4IP__ L2 - https://implementationsciencecomms.biomedcentral.com/articles10.1186/s43058-021-00145-6 DB - PRIME DP - Unbound Medicine ER -