Conducting Clinical Research in Post-acute and Long-term Nursing Home Care Settings: Regulatory Challenges

doi:10.1016/j.jamda.2019.04.022

. 2019 Jul;20(7):798-803.

doi: 10.1016/j.jamda.2019.04.022.

Conducting Clinical Research in Post-acute and Long-term Nursing Home Care Settings: Regulatory Challenges

Affiliations

¹ Physical Therapy Program, Department of Physical Medicine and Rehabilitation, University of Colorado, Aurora, CO.
² Colorado School of Public Health, University of Colorado, Aurora, CO.
³ Colorado Multi-Institutional Review Board (COMIRB), University of Colorado School of Medicine, Aurora, CO.
⁴ Division of Geriatric Medicine, Department of Medicine, University of Colorado, Aurora, CO.
⁵ Department of Medicine, University of Colorado, Aurora, CO.
⁶ Division of Geriatric Medicine, Department of Medicine, University of Colorado, Aurora, CO; Veterans Affairs Geriatric Research, Education and Clinical Center, Aurora, CO.
⁷ Division of Hospital Medicine, University of Colorado, Aurora, CO.
⁸ Indiana University School of Medicine, Indianapolis, IN.
⁹ University of Utah, College of Nursing, Salt Lake City, UT.
¹⁰ Physical Therapy Program, Department of Physical Medicine and Rehabilitation, University of Colorado, Aurora, CO; Veterans Affairs Geriatric Research, Education and Clinical Center, Aurora, CO.
¹¹ Rocky Mountain Regional Medical Center, Aurora, CO.
¹² Division of Geriatric Medicine, Department of Medicine, University of Colorado, Aurora, CO; Veterans Affairs Geriatric Research, Education and Clinical Center, Aurora, CO. Electronic address: Rebecca.Boxer@ucdenver.edu.
¹³ Program of Post-Acute and Long-Term Care, School of Medicine, University of Colorado, Aurora, CO.

PMID: 31248598
PMCID: PMC6703170
DOI: 10.1016/j.jamda.2019.04.022

Conducting Clinical Research in Post-acute and Long-term Nursing Home Care Settings: Regulatory Challenges

Allison M Gustavson et al. J Am Med Dir Assoc. 2019 Jul.

. 2019 Jul;20(7):798-803.

doi: 10.1016/j.jamda.2019.04.022.

Authors

Affiliations

¹ Physical Therapy Program, Department of Physical Medicine and Rehabilitation, University of Colorado, Aurora, CO.
² Colorado School of Public Health, University of Colorado, Aurora, CO.
³ Colorado Multi-Institutional Review Board (COMIRB), University of Colorado School of Medicine, Aurora, CO.
⁴ Division of Geriatric Medicine, Department of Medicine, University of Colorado, Aurora, CO.
⁵ Department of Medicine, University of Colorado, Aurora, CO.
⁶ Division of Geriatric Medicine, Department of Medicine, University of Colorado, Aurora, CO; Veterans Affairs Geriatric Research, Education and Clinical Center, Aurora, CO.
⁷ Division of Hospital Medicine, University of Colorado, Aurora, CO.
⁸ Indiana University School of Medicine, Indianapolis, IN.
⁹ University of Utah, College of Nursing, Salt Lake City, UT.
¹⁰ Physical Therapy Program, Department of Physical Medicine and Rehabilitation, University of Colorado, Aurora, CO; Veterans Affairs Geriatric Research, Education and Clinical Center, Aurora, CO.
¹¹ Rocky Mountain Regional Medical Center, Aurora, CO.
¹² Division of Geriatric Medicine, Department of Medicine, University of Colorado, Aurora, CO; Veterans Affairs Geriatric Research, Education and Clinical Center, Aurora, CO. Electronic address: Rebecca.Boxer@ucdenver.edu.
¹³ Program of Post-Acute and Long-Term Care, School of Medicine, University of Colorado, Aurora, CO.

PMID: 31248598
PMCID: PMC6703170
DOI: 10.1016/j.jamda.2019.04.022

Abstract

Despite multiple initiatives in post-acute and long-term nursing home care settings (NHs) to improve the quality of care while reducing health care costs, research in NHs can prove challenging. Extensive regulation for both research and NHs is designed to protect a highly vulnerable population but can be a deterrent to conducting research. This article outlines regulatory challenges faced by NHs and researchers, such as protecting resident privacy as well as health information and obtaining informed consent. The article provides lessons learned to help form mutually beneficial partnerships between researchers and NHs to conduct studies that grow and advance NH research initiatives and clinical care.

Keywords: Post-acute care; long-term care; nursing homes; research regulation.

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Conflict of interest statement

Conflicts of Interest

The authors have no conflicts of interest.

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References

1. Maas ML, Kelley LS, Park M, Specht JP. Issues in conducting research in nursing homes. West J Nurs Res 2002;24(4):373–389. - PubMed
1. Daddato A, Wald HL, Horney C, et al. A randomized trial of heart failure disease management in skilled nursing facilities (SNF Connect): Lessons learned. Clinical Trials 2017;14(3):308–313. - PMC - PubMed
1. Hall S, Longhurst S, Higginson IJ. Challenges to conducting research with older people living in nursing homes. BMC Geriatrics 2009;9(1):38. - PMC - PubMed
1. Gustavson A, Boxer R, Nordon-Craft A, Marcus R, Stevens-Lapsley JE. Advancing innovation in skilled nursing facilities through research collaborations. Physical Therapy Journal of Policy, Administration, and Leadership 2018;18(3):5–16. - PMC - PubMed
1. Jenkins C, Smythe A, Galant-Miecznikowska M, Bentham P, Oyebode J. Overcoming challenges of conducting research in nursing homes. Nurs Older People 2016;28(5):16–23. - PubMed

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[1] Maas ML, Kelley LS, Park M, Specht JP. Issues in conducting research in nursing homes. West J Nurs Res 2002;24(4):373–389. - PubMed

[2] Maas ML, Kelley LS, Park M, Specht JP. Issues in conducting research in nursing homes. West J Nurs Res 2002;24(4):373–389. - PubMed

[3] Daddato A, Wald HL, Horney C, et al. A randomized trial of heart failure disease management in skilled nursing facilities (SNF Connect): Lessons learned. Clinical Trials 2017;14(3):308–313. - PMC - PubMed

[4] Daddato A, Wald HL, Horney C, et al. A randomized trial of heart failure disease management in skilled nursing facilities (SNF Connect): Lessons learned. Clinical Trials 2017;14(3):308–313. - PMC - PubMed

[5] Hall S, Longhurst S, Higginson IJ. Challenges to conducting research with older people living in nursing homes. BMC Geriatrics 2009;9(1):38. - PMC - PubMed

[6] Hall S, Longhurst S, Higginson IJ. Challenges to conducting research with older people living in nursing homes. BMC Geriatrics 2009;9(1):38. - PMC - PubMed

[7] Gustavson A, Boxer R, Nordon-Craft A, Marcus R, Stevens-Lapsley JE. Advancing innovation in skilled nursing facilities through research collaborations. Physical Therapy Journal of Policy, Administration, and Leadership 2018;18(3):5–16. - PMC - PubMed

[8] Gustavson A, Boxer R, Nordon-Craft A, Marcus R, Stevens-Lapsley JE. Advancing innovation in skilled nursing facilities through research collaborations. Physical Therapy Journal of Policy, Administration, and Leadership 2018;18(3):5–16. - PMC - PubMed

[9] Jenkins C, Smythe A, Galant-Miecznikowska M, Bentham P, Oyebode J. Overcoming challenges of conducting research in nursing homes. Nurs Older People 2016;28(5):16–23. - PubMed

[10] Jenkins C, Smythe A, Galant-Miecznikowska M, Bentham P, Oyebode J. Overcoming challenges of conducting research in nursing homes. Nurs Older People 2016;28(5):16–23. - PubMed

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Conducting Clinical Research in Post-acute and Long-term Nursing Home Care Settings: Regulatory Challenges

Affiliations

Conducting Clinical Research in Post-acute and Long-term Nursing Home Care Settings: Regulatory Challenges

Authors

Affiliations

Abstract

Conflict of interest statement

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Cited by

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical