At-Home Skilled Nursing Care for Rehabilitation

Not currently recruiting at 4 trial locations

Overseen By David M Levine, MD, MPH, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Methadone, Intravenous controlled substances

Disqualifiers: Undomiciled, Psychiatric diagnosis, Hemodialysis, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether patients who typically require a skilled nursing facility after a hospital visit can receive equivalent care at home. The trial compares traditional facility care with home care provided by a specialized team using technology. It targets individuals who lived at home before hospitalization and are expected to return home after short-term rehabilitation. Participants should live within 10 miles of the study hospital and need ongoing care but not long-term facility placement. As an unphased study, this trial allows patients to contribute to innovative care solutions that could enhance recovery experiences at home.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on methadone or require certain specialty medications or intravenous controlled substances, you may need to discuss this with the trial team.

What prior data suggests that this method is safe for rehabilitation at home?

Research has shown that skilled nursing care at home can be safe and well-tolerated. One study found that shorter stays in nursing facilities did not affect patient safety, suggesting that effective care can also be provided at home. Although this study focused on facility stays, it implies that home care might be just as safe.

Studies have not reported major problems with skilled nursing care at home, though specific issues remain underexplored. Since this trial is not in a testing phase, the treatment has been shown to be reasonably safe in similar situations.

In summary, evidence supports that skilled nursing care at home is generally safe, with no significant safety concerns reported in related studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the at-home skilled nursing care approach because it offers a new way for patients to receive rehabilitation without leaving the comfort of their homes. Unlike traditional care where patients must stay in a skilled nursing facility, this method brings specialized care directly to the patient’s home. This can significantly enhance patient comfort, reduce the risk of hospital-acquired infections, and offer more personalized care. By allowing patients to recover in familiar surroundings, this approach may also improve mental well-being and possibly speed up recovery times.

What evidence suggests that skilled nursing facility care at home is effective for rehabilitation?

This trial will compare usual skilled nursing facility care with rehabilitation at home. Research has shown that receiving skilled nursing care at home can be as effective as facility-based care. One trial program found that patients who did their rehab at home improved in their abilities. This method also reduced costs by nearly half compared to traditional nursing facilities. Studies suggest that home care might lower the chances of hospital readmission. These findings indicate that home care could be a promising alternative to traditional settings, offering both health and financial benefits. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need skilled nursing facility care after hospitalization. It's for stroke patients not covered by insurance, those recommended for rehabilitative therapy, and surgical trauma patients able to bear weight and transfer with minimal help. Participants must have lived at home before hospitalization and be likely to return home after short-term rehab.

Inclusion Criteria

I can move with minimal help after surgery.

I had a stroke and need rehab not covered by insurance, not qualifying for long-term care.

Lives within 10 miles of any study site hospital (or per specified catchment)

Exclusion Criteria

Clinical: Requires durable medical equipment not already in place at home and excluded below

Clinical: Acute delirium noted by RAH liaison requiring more than one caregiver

My home lacks the space needed for sleep, eating, and therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Rehabilitation

Participants receive rehabilitation care either at home or in a skilled nursing facility

Up to 6 months

Follow-up

Participants are monitored for 30-day readmission or mortality after discharge from rehab

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Skilled Nursing Facility Care at Home

Trial Overview The study compares receiving skilled nursing facility care at home versus traditional in-facility care post-hospitalization. Patients are randomly placed into two groups: one receives tech-supported home care, while the other gets standard in-facility services.

How Is the Trial Designed?

Group I: Usual skilled nursing facility care Active Control 1 Intervention

Control subjects will receive care at a skilled nursing facility as per usual.

Group II: Rehab at home Active Control 1 Intervention

Intervention subjects will receive care in their home from a specialized care team.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

Cambridge Health Alliance

Collaborator

Trials

65

Recruited

22,400+

Published Research Related to This Trial

In a study of 140 patients in a skilled nursing facility (SNF), the Patient Health Questionnaire (PHQ-9) for depression was identified as the only significant predictor of improvement in gait speed during their stay.

Despite 87% of patients showing a meaningful improvement in overall physical function, a significant portion (69%) still had low SPPB scores at discharge, indicating a high risk for future disability and adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Functional Change in a Skilled Nursing Facility Population. Gustavson, AM., Falvey, JR., Forster, JE., et al.[2020]

In a study of 600 home healthcare records in Sweden, 74% of identified adverse events were classified as nursing-sensitive, indicating that registered nurses play a crucial role in preventing these incidents.

Most of the nursing-sensitive events, such as falls and pressure ulcers, were deemed preventable, highlighting the need for improved nursing care and risk assessment in home healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring nursing-sensitive events in home healthcare: A national multicenter cohort study using a trigger tool. Nilsson, L., Lindblad, M., Johansson, N., et al.[2023]

Patients who underwent rehabilitation in inpatient rehabilitation facilities (IRFs) showed better post-stroke health outcomes, such as higher rates of community discharge and lower all-cause mortality, compared to those in skilled nursing facilities (SNFs).

However, rehabilitation in IRFs was associated with higher costs than in SNFs, indicating a trade-off between improved outcomes and increased expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postacute Care Setting, Facility Characteristics, and Poststroke Outcomes: A Systematic Review. Alcusky, M., Ulbricht, CM., Lapane, KL.[2019]

Over 33% of older adults admitted to skilled nursing facilities (SNFs) experience adverse events, such as falls, within the first 35 days of their stay, highlighting a significant safety concern for this population.

Key factors contributing to these adverse events include intrinsic factors like frailty and reduced muscle strength, as well as extrinsic factors such as inappropriate medication use, environmental hazards, and poor communication among staff, indicating areas for potential intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events and Their Contributors Among Older Adults During Skilled Nursing Stays for Rehabilitation: A Scoping Review. Okpalauwaekwe, U., Tzeng, HM.[2022]

The study compares rehabilitation outcomes for stroke patients receiving care from different postacute providers, including inpatient rehabilitation facilities, skilled nursing facilities, and home health agencies.

It highlights the challenges of conducting observational studies in this area, emphasizing the complexity of evaluating the effectiveness of various rehabilitation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does postacute care site matter? A longitudinal study assessing functional recovery after a stroke. Deutsch, A.[2018]

A consensus workshop with 31 healthcare professionals identified and ranked common adverse events in community care, highlighting the need for better understanding of how these events affect care quality.

The workshop emphasized the importance of further research to establish standardized definitions of adverse events and to prioritize research questions that can improve patient safety in community care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in community care: developing a research agenda. Masotti, P., Green, M., Shortt, S., et al.[2022]

A study involving 71 stroke patients showed that home-based rehabilitation during and after hospitalization led to significantly better outcomes in disability (measured by the modified Rankin Scale) and quality of life (measured by EuroQol-5D) compared to standard care.

The home-based rehabilitation approach was not only effective in improving patient outcomes but also more cost-effective than traditional rehabilitation methods, suggesting a beneficial alternative for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stroke rehabilitation at home before and after discharge reduced disability and improved quality of life: a randomised controlled trial. Rasmussen, RS., Østergaard, A., Kjær, P., et al.[2016]

Stroke patients in Medicare skilled nursing facilities experience varying levels of rehabilitation effectiveness based on the facility's focus and resources.

Facilities that prioritize rehabilitation and community discharge, and offer more intensive therapy from a diverse range of skilled professionals, achieve better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stroke Rehabilitation in Nursing Homes. Kramer, AM., Schlenker, RE., Eilertsen, TB., et al.[2015]

Patients from post-acute and long-term care (PA/LTC) settings, while only 4.4% of the emergency department (ED) population, accounted for 21% of all adverse events (AEs), indicating they experience a higher rate of harm compared to non-PA/LTC patients.

Most AEs in PA/LTC patients were present upon arrival at the ED, primarily related to patient care (39%), medication (34%), and infections (16%), suggesting that these patients may have more severe underlying health issues that need to be addressed for quality improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-Acute and Long-Term Care Patients Account for a Disproportionately High Number of Adverse Events in the Emergency Department. Griffey, RT., Schneider, RM., Adler, L., et al.[2021]

Patients transitioning from a skilled nursing facility (SNF) back to home face significant challenges, including unmet information needs regarding medication management and therapy, which can impact their recovery and independence.

The study highlights the importance of providing individualized in-home support immediately after discharge from the SNF to enhance patient outcomes and prevent adverse effects, emphasizing that maintaining independence at home is a key goal for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex Transitions from Skilled Nursing Facility to Home: Patient and Caregiver Perspectives. Carnahan, JL., Inger, L., Rawl, SM., et al.[2022]

Enhanced Medical Rehabilitation significantly increased therapy intensity and patient engagement among 26 older adults in a skilled nursing facility, leading to improved functional outcomes such as gait speed and distance walked in 6 minutes.

Participants receiving Enhanced Medical Rehabilitation showed greater improvements in gait speed (0.38 m/s vs. 0.22 m/s) and 6-minute walk distance (266 feet vs. 94 feet) compared to those receiving standard care, suggesting that more engaging and intense rehabilitation can enhance recovery in postacute care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced medical rehabilitation increases therapy intensity and engagement and improves functional outcomes in postacute rehabilitation of older adults: a randomized-controlled trial. Lenze, EJ., Host, HH., Hildebrand, MW., et al.[2021]

Approximately 69% of rural Medicare beneficiaries who received acute care in urban hospitals returned for skilled nursing care (SNC) near their homes, indicating a strong preference for local care.

Factors influencing the likelihood of receiving SNC near home included race, gender, age, distance from the SNC facility, and the ownership status of the hospital providing acute care, suggesting that policy changes should consider these variables to improve access to local care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Characteristics Influence Whether Rural Beneficiaries Receiving Care From Urban Hospitals Return Home for Skilled Nursing Care? Hoffman, AF., Pink, GH., Kirk, DA., et al.[2021]

A new home care rehabilitation nursing team was developed at a large agency in northern Virginia, focusing on providing specialized care for patients after hospital discharge.

This innovative team offers in-service programs, consultations, and case management for various medical conditions, highlighting the growing importance of rehabilitation nursing in home care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The rehabilitation nursing team in the home healthcare setting. Neal, LJ.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8130553/

Outcomes After Shortened Skilled Nursing Facility Stays ... Reducing post-acute care in skilled nursing facilities, in favor of home-based care, is a leading cost-saving strategy in new payment models.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06547645

NCT06547645 | Skilled Nursing Facility at Home Trial The primary outcome of the trial will be the difference in hospital readmission and mortality rates from the time of enrollment to 30 days after enrollment.

3. umassmed.edu umassmed.edu/news/news-archives/2024/08/study-to-evaluate-post-hospital-skilled-nursing-care-at-home/

Study to evaluate post-hospital skilled nursing care at home The primary outcome for the SNF at Home trial will be measuring the 30-day rehospitalization rate, said Soni. Researchers will also assess ...

4. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/high-intensity-home-based-rehabilitation-offers-alternative-to-skilled-nursing-facility

High-Intensity Home-Based Rehabilitation Offers Alternative to ... A pilot program finds that postacute rehab care at home can lead to functional improvements while nearly halving costs compared with a ...

5. medpac.gov medpac.gov/wp-content/uploads/2024/03/Mar24_Ch6_MedPAC_Report_To_Congress_SEC.pdf

Skilled nursing facility services Medicare covers short-term skilled nursing and rehabilitation services for beneficiaries in skilled nursing facilities (SNFs) after an inpatient.

6. data.cms.gov data.cms.gov/provider-data/search?theme=Nursing%20homes%20including%20rehab%20services

Nursing homes including rehab services datasets Allows you to find and download quality of care data on every Medicare and Medicaid-certified nursing home in the country, including over 15,000 nationwide.

7. kff.org kff.org/medicaid/a-look-at-nursing-facility-characteristics/

A Look at Nursing Facility Characteristics Between 2015 ... This data note examines the characteristics of nursing facilities and the people living in them with data from Nursing Home Compare, ...

8. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2795935

Health Outcomes in Skilled Nursing Facilities by COVID-19 ... This study assesses health and quality of life outcomes among long-term residents of skilled nursing facilities before and during the ...

9. cdc.gov cdc.gov/nhsn/ltc/ltc-report-overview.html

Nursing Homes Data Dashboard | NHSN Nursing homes report COVID-19, influenza, and respiratory syncytial virus (RSV) data weekly to CDC's National Healthcare Safety Network (NHSN).