The STRIDE Study: A pragmatic cluster randomized trial

The STRIDE Study: A pragmatic cluster randomized trial

The STRIDE Study: A pragmatic cluster randomized trial Nancy Latham PhD PT Siobhan McMahon PhD GNP-BC Nancy Latham, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018 STRIDE Study Design Outline STRIDE Intervention Preliminary Intervention Implementation Data Next Steps and New Questions Nancy Latham, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018 The Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) Study Funders: Patient-Centered Outcomes Research Institute (PCORI) and

National Institute on Aging Pragmatic trial designed to answer: Can redesigning health care practices and engaging patients to improve quality reduce serious falls-related injuries and improve other outcomes? Nancy Latham, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018 Cluster-randomized, parallel group superiority trial with practices stratified by healthcare system and patients nested within practices Unit of randomization is the practice (clinics) Design 86 clinics and 5451 patients recruited from across 10 research sites over 20 months with 24 months of follow-up (maximum follow up =44 months) Clinics randomized to 1 of 2 conditions STRIDE Intervention Enhanced practice (education about falls prevention and increased access to CDC published fall prevention resources)

Primary Outcome: Serious fall-related injuries Nancy Latham, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018 STRIDE Clinical Trial Sites Mercy Health System University of Iowa Des Moines, IA HealthCare Partners El Segundo, CA Essentia Health Duluth, MN Michigan Medicine University of Michigan Ann Arbor, MI

Partners HealthCare Boston, MA Reliant Medical Group Worcester, MA Mt. Sinai Health System New York, NY Johns Hopkins Medicine Baltimore, MD University of Pittsburgh Medical Center Pittsburgh, PA University of Texas Medical Branch at Galveston Galveston, TX Nancy Latham, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018 STRIDE Patients

Community dwelling persons 70 years of age or older One or more risk factors for falls Fallen and hurt self in the past year Fallen 2 or more times in the past year Fear of falling because of balance or gait Nancy Latham, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018 The STRIDE Intervention Evidence based fall risk assessment and treatment

Chronic care model Self-management Patient centered Motivational interviewing spirit and basic tactics Empirical and Theoretical Foundation Falls Care Management (FCM) Processes Protocol guided Nurse delivered in primary care settings Assessment (7 primary fall risks) Elicit Patient preferences Provide counseling/ information about fall reducing behaviors Co-create, individualized fallreducing plan of care

Co-evaluation and refinement of individualized care plan annually (minimum) Nancy Latham, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018 Primary providers and clinic staff Co-create and approve how FCM processes will be operationalized locally Approve and/ or contribute to individualized care plans Co-manage fall risk Clinical and community resources Referral sources for specific risks (e.g., physical therapy, medication therapy management ) Community based resources for specific risks (e.g., group exercise program that includes balancechallenging and leg-strengthening movements) Interdisciplinar

y Collaboration 1. Medication risks 1, 2 2. Postural hypotension1,2 STRIDE Intervention Risk Factors Reducing most of these risks requires behavior change among patients at 1 risk and, often, health care provider/ prescriber.2 3. Visual impairment11,2 4. Feet and footwear problems

1 5. Osteoporosis, calcium and vitamin D1,2 6. Strength, gait, and balance disorders 7. Home safety risks Nancy Latham, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018 1,2 1,2 Risk factor Which fall risk factors are common among STRIDE patients ? Strength gait balance problems Osteoporosis Visual impairment

Foot and footwear problems Medication risks Home safety risks Postural hypotension % STRIDE patients with this risk* 100 92 64 51 24 17 12 *percent of patients in the intervention arm of STRIDE whose assessments revealed the presence of these risks Nancy Latham, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018 Which fall risk factors do STRIDE patients prioritize

(e.g., choose to learn about and consider treatment options)? Risk factor % STRIDE patients with risk that also prioritized risk* Strength gait balance problems 89 Osteoporosis Visual impairment 66 84

Foot and footwear problems 73 Medication risks 34 65 92 Home safety risks Postural hypotension *percent of patients in the intervention arm of STRIDE, with this positive risk factor who prioritized it Nancy Latham, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018 Risk factor Which fall risk factors do STRIDE patients agree to act on?

% STRIDE patients acted on this risk Strength gait balance problems 70 Osteoporosis 43 40 22 6 9 7 Visual impairment Foot and footwear problems Medication risks Home safety risks

Postural hypotension *percent of patients in the intervention arm of STRIDE who self-reported action(s) to reduce risk Nancy Latham, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018 Next Steps Intervention ends November 30, 2018 Main study results April 2020 Analyze effects of 2 STRIDE conditions on primary outcome of serious fall related injuries Analyze intervention processes Ancillary study to examine contextual and cultural factors influencing intervention implementation Secondary analysis to describe patient risks, priorities and actions over time Secondary analyses to explore intervention effects among sub-groups of patients Nancy Latham, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018 New Questions (e.g., future

research) What behavior strategies/techniques will most efficiently& effectively lead to changes in fallreducing behavior. at what doses and for whom? What are the linkages between behavior change strategies, psychosocial mechanisms of change, and behavioral outcomes? Role of technology in supporting behavior change? STRIDE References STRIDE website: http://www.stride-study.org/ Bhasin, S., Gill, T. M., Reuben, D. B., Latham, N. K., Gurwitz, J. H., Dykes, P., ... & Basaria, S. (2017). Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE): a cluster-randomized pragmatic trial of a multifactorial fall injury prevention strategy: design and methods. The Journals of Gerontology: Series A. Reuben, D. B., Gazarian, P., Alexander, N., Araujo, K., Baker, D., Bean, J. F., ... & Leipzig, R. M. (2017). The Strategies to Reduce Injuries and Develop Confidence in Elders Intervention: Falls Risk Factor Assessment and Management, Patient Engagement, and Nurse Comanagement. Journal of the American Geriatrics Society, 65(12), 2733-2739

Nancy Latham, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018 Questions? [email protected] @Nancy_K_Latham Nancy Latham, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018 The Chronic Care Model Extra Nancy Latham, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018 Extra Self-Management: Definition The day to day management of a health condition Practice of activities regarding health Interactions with healthcare system Monitoring the status of a condition Making adjustments to plans over time

Everyone practices self management! Nancy Latham, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018 Extra Key concepts in Self-Management Individualized assessment Collaborative goal setting Enhancing skills Follow up and support Overcoming barriers in the healthcare system and elsewhere Access to community resources Nancy Latham, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

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