Proactive Care for Osteoarthritis

Overseen By Marielena De Araujo-Greecher, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Dual enrollment, Hospice, Institutional care

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

1454 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The aim of this pragmatic randomized controlled trial is to test the effects of a brief proactive care intervention involving mailed material and two phone calls on: (1) increasing participation in SilverSneakers exercise programs among older adults with osteoarthritis; (2) improving physical, social and psychological outcomes identified as important to older adults with osteoarthritis; and (3) reducing costly osteoarthritis-related health service use. Approximately 1,454 older adults with osteoarthritis who have SilverSneakers access through their Medicare Advantage plan, but no prior SilverSneakers use, will be recruited to participate across the United States. Key outcome measures will be assessed over a two-year follow-up period.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on exercise participation, so it's likely you can continue your medications, but please confirm with the trial organizers.

What safety data exists for Proactive Care for Osteoarthritis?

The available research does not provide specific safety data for Proactive Care for Osteoarthritis. However, it highlights the importance of patient-reported outcomes in understanding adverse events, which can help improve safety monitoring in treatments. ^{1 2 3 4 5}

How is the Proactive Care treatment for osteoarthritis different from other treatments?

Proactive Care for osteoarthritis is unique because it emphasizes being proactive rather than reactive, focusing on preparing patients for potential joint replacement surgery to prevent complications and improve outcomes. It integrates wellness care and structured educational strategies to enhance patient understanding and management of the condition. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Proactive Care for osteoarthritis?

Research shows that nonoperative treatments, like those in Proactive Care, are crucial for managing osteoarthritis symptoms and improving function. Programs that include information, exercise, and weight control have been effective in enhancing care quality for osteoarthritis patients. ^{11 12 13 14 15}

Who Is on the Research Team?

Liza S. Rovniak, PhD, MPH

Principal Investigator

Penn State College of Medicine

Are You a Good Fit for This Trial?

This trial is for older adults with osteoarthritis who have access to SilverSneakers through Medicare Advantage but haven't used it. The study aims to engage these individuals in exercise programs to improve their physical, social, and psychological well-being while reducing healthcare costs related to osteoarthritis.

Inclusion Criteria

I have been diagnosed with osteoarthritis in my hip, knee, or another joint.

I understand the consent form and do not have dementia.

I am 65 years old or older.

Exclusion Criteria

Medicare/Medicaid dual enrollment due to limited data accessibility for this group

Receiving hospice care or under long-term institutional care (Part C) due to limited data accessibility for this group

I have not had major surgery in the last month and do not plan any that will limit my physical activity in the next year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Proactive Care Intervention

Participants receive mailed material and two phone calls to activate SilverSneakers benefits

6 months

2 phone calls

Follow-up

Participants are monitored for SilverSneakers participation and health outcomes

24 months

Assessments at baseline, 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Proactive Care

Trial Overview The trial is testing a proactive care intervention that includes sending materials by mail and making two phone calls, aiming to increase participation in SilverSneakers exercise programs among seniors with osteoarthritis.

How Is the Trial Designed?

Group I: Proactive Care Experimental Treatment 1 Intervention

The Proactive Care condition will consist of one mailing to alert older adults to the existence of their SilverSneakers benefit, followed by two action-planning phone calls to prompt activation and use of the SilverSneakers exercise benefit. The action-planning calls will guide older adults through an action plan to enroll in SilverSneakers, and choose convenient joint-friendly SilverSneakers exercise options appropriate for their fitness level. Exercise options are available both in-person and online. Older adults will also be given the option to have an information sheet about SilverSneakers sent to their primary care providers to encourage further discussion about SilverSneakers.

Group II: Usual Care Active Control 1 Intervention

The Usual Care condition will include the standard information provided to Medicare Advantage beneficiaries about SilverSneakers.

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

Humana Healthcare Research

Collaborator

Trials

1

Recruited

1,500+

Global Healthy Living Foundation

Collaborator

Trials

6

Recruited

46,600+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

CVS Healthspire Life Sciences Solutions

Collaborator

Trials

1

Recruited

1,500+

Tivity Health

Collaborator

Trials

1

Recruited

1,500+

Published Research Related to This Trial

Patients with osteoarthritis who participated in a new integrated multidisciplinary outpatient program reported significantly higher satisfaction with their healthcare compared to those receiving usual care, with a mean difference of -1.05 on a satisfaction scale after 4 months.

While the multidisciplinary program improved self-efficacy regarding symptoms, it did not lead to clinically relevant improvements in health outcomes, and some pain and fatigue scores worsened at 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an Integrated Multidisciplinary Osteoarthritis Outpatient Program versus Outpatient Clinic as Usual: A Randomized Controlled Trial. Moe, RH., Grotle, M., Kjeken, I., et al.[2016]

The intervention involving workshops for general practitioners and physiotherapists led to a small, non-significant increase in the quality of care for patients with hip and knee osteoarthritis, particularly in providing information about treatment options and self-management strategies.

Patients reported higher odds of receiving information on treatment alternatives and self-management after the intervention, indicating improved communication and education, although there were minimal changes in referral practices and imaging use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving osteoarthritis management in primary healthcare: results from a quasi-experimental study. Østerås, N., Blaker, IB., Hjortland, T., et al.[2021]

In a study of 2,146 patients undergoing elective knee, hip, and spine surgeries for degenerative conditions, the overall adverse event rate was 27%, with spinal surgeries having the highest rate of severe adverse events.

Key risk factors for adverse events included increasing age, male sex, longer operative duration, longer hospital stays, and undergoing revision surgery, highlighting the need for careful patient assessment and procedural efficiency improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated with Adverse Events in Inpatient Elective Spine, Knee, and Hip Orthopaedic Surgery. Millstone, DB., Perruccio, AV., Badley, EM., et al.[2017]

In a study of 143 patients with rheumatoid arthritis (RA) and osteoarthritis (OA), 35.7% experienced adverse drug events (ADEs), highlighting the commonality of these events in patients taking medications for these conditions.

Most ADEs were linked to disease-modifying anti-rheumatic drugs (59.4%) and non-steroidal anti-inflammatory drugs (14.5%), with 44.1% of the ADEs deemed preventable, indicating a need for better monitoring and management of drug safety in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events in rheumatoid arthritis and osteoarthritis ambulatory patients. Tragulpiankit, P., Chulavatnatol, S., Rerkpattanapipat, T., et al.[2012]

The PROSPER Consortium aims to enhance safety reporting in healthcare by integrating patient-reported outcomes (PROs) into the assessment of adverse events, recognizing the importance of the patient's perspective in understanding treatment effects.

Despite advancements in technology and increased focus on patient involvement, current safety reporting still heavily relies on healthcare professionals, which can lead to under-reporting and discrepancies between patient experiences and clinician perceptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance. Banerjee, AK., Okun, S., Edwards, IR., et al.[2022]

In a 10-week study involving 164 patients undergoing elective orthopedic procedures, independent clinical reviewers identified significantly more adverse events (99) compared to surgeons (14), highlighting a gap in surgeons' reporting practices.

While surgeons effectively captured major adverse events, they missed many minor events that were documented by reviewers, suggesting that using standardized assessment tools like SAVES V2 and OrthoSAVES could enhance overall adverse-event reporting in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Surgeons Adequately Capture Adverse Events Using the Spinal Adverse Events Severity System (SAVES) and OrthoSAVES? Chen, BP., Garland, K., Roffey, DM., et al.[2018]

The implementation of the SAMBA model for integrated osteoarthritis care in primary care settings significantly improved patient-reported quality of care and satisfaction, with scores rising from 41 to 60 on a quality indicator scale among 393 patients studied.

Patients receiving the intervention were more likely to be referred to physiotherapy and meet physical activity recommendations, while fewer were referred to orthopedic surgeons, indicating a more effective management of osteoarthritis compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a structured model for osteoarthritis care in primary healthcare: A stepped-wedge cluster-randomised trial. Østerås, N., Moseng, T., van Bodegom-Vos, L., et al.[2021]

Citations

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Effectiveness of an Integrated Multidisciplinary Osteoarthritis Outpatient Program versus Outpatient Clinic as Usual: A Randomized Controlled Trial. [2016]

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Improving osteoarthritis management in primary healthcare: results from a quasi-experimental study. [2021]

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Factors Associated with Adverse Events in Inpatient Elective Spine, Knee, and Hip Orthopaedic Surgery. [2017]

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Adverse drug events in rheumatoid arthritis and osteoarthritis ambulatory patients. [2012]

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Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance. [2022]

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Timing of Adverse Events Following Geriatric Hip Fracture Surgery: A Study of 19,873 Patients in the American College of Surgeons National Surgical Quality Improvement Program. [2019]

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Can Surgeons Adequately Capture Adverse Events Using the Spinal Adverse Events Severity System (SAVES) and OrthoSAVES? [2018]

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Implementing a structured model for osteoarthritis care in primary healthcare: A stepped-wedge cluster-randomised trial. [2021]

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