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Grant Details

Grant Number: 5R37CA222885-03 Interpret this number
Primary Investigator: Skolarus, Ted
Organization: University Of Michigan At Ann Arbor
Project Title: DE-Implementation of Low Value Castration for Men with Prostate Cancer
Fiscal Year: 2020


Project Background: Prostate cancer is the leading male cancer. One in three men with prostate cancer is chemically castrated at some point with long-acting injectable drugs (i.e., androgen deprivation therapy or ADT). This impacts the well-being of thousands of men annually. Although some patients benefit in terms of survival and symptom improvement, chemical castration with ADT is also commonly performed when there are little to no health benefits to patients raising questions of low value care. A growing awareness of castration harms (e.g., heart attack, osteoporosis, loss of sexual function) creates patient safety concerns. Despite this, ADT use in low value cases, such as for localized prostate cancer treatment persists. Ineffective and harmful practices such as chemical castration of prostate cancer patients with ADT outside of the evidence base are ideal targets for de-implementation. De-implementation, or stopping low value practices, has the potential to improve patient outcomes and decrease healthcare costs. However, provider preferences regarding de-implementation are not well understood, and possible de-implementation interventions range from blunt formulary restriction policies to shared decision-making. Both intervention strategies need tailoring based on provider input for acceptability and feasibility in clinical practice, including piloting prior to trialing. As many medical practices lack evidence and cause harm, robust, behavioral theory-based methods for incorporating provider preferences into deimplementation strategy development will advance both implementation research and practice. Project Objectives: This study will use a theory-based, mixed methods approach to identify, tailor and pilot two different de-implementation strategies that vary widely in delivery, impact, and expected results for reducing low value ADT use, in preparation for a randomized comparative effectiveness trial. Project Methods: This innovative mixed-methods research program has three aims. Aim 1: To assess preferences and barriers for de-implementation of chemical castration in prostate cancer. Guided by the Theoretical Domains Framework, urologists from facilities with the highest castration rates across an integrated delivery system will be interviewed to identify key preferences and de-implementation barriers for reducing castration as prostate cancer treatment. This qualitative work will inform Aim 2 while gathering rich information for two proposed pilot intervention strategies. Aim 2: To use a discrete choice experiment, a novel barrier prioritization approach, for de-implementation strategy tailoring. A national survey of urologists will prioritize key barriers identified in Aim 1 for stopping castration as localized prostate cancer treatment using a discrete choice experiment design. These quantitative results will identify the most important barriers to be addressed through tailoring of two pilot de-implementation strategies in preparation for Aim 3 piloting. Aim 3: To pilot two tailored de-implementation strategies to reduce castration as localized prostate cancer treatment. Building on findings from Aims 1 and 2, two de-implementation strategies will be piloted. One strategy will focus on formulary restriction at the organizational level and the other on physician/patient decision-making. Outcomes will include acceptability, feasibility, and scalability in preparation for an effectiveness trial comparing these two widely varying de-implementation strategies. This innovative approach to de-implementation strategy development will transform how and why castration is performed for localized prostate cancer through combining provider preferences and strategy tailoring. This work will advance de-implementation science for low value cancer care and foster participation in a subsequent de- implementation evaluation trial by addressing preferences and concerns through pilot tailoring.


Development and Validation of a Short Version of the Metric for the Observation of Decision-Making in Multidisciplinary Tumor Boards: MODe-Lite.
Authors: Lamb B.W. , Miah S. , Skolarus T.A. , Stewart G.D. , Green J.S.A. , Sevdalis N. , Soukup T. .
Source: Annals of surgical oncology, 2021 Nov; 28(12), p. 7577-7588.
EPub date: 2021-05-11.
PMID: 33974197
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Learning from the "tail end" of de-implementation: the case of chemical castration for localized prostate cancer.
Authors: Skolarus T.A. , Forman J. , Sparks J.B. , Metreger T. , Hawley S.T. , Caram M.V. , Dossett L. , Paniagua-Cruz A. , Makarov D.V. , Leppert J.T. , et al. .
Source: Implementation science communications, 2021-10-28; 2(1), p. 124.
EPub date: 2021-10-28.
PMID: 34711274
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Designing lean, efficient clinical trials is an ethical imperative: the fragility index should not be used in the design of randomized clinical trials.
Authors: Stensland K.D. , Daignault-Newton S. , Skolarus T.A. .
Source: Urologic oncology, 2021 10; 39(10), p. 738-739.
EPub date: 2021-08-13.
PMID: 34400067
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Using an Automated Electronic Health Record Score To Estimate Life Expectancy In Men Diagnosed With Prostate Cancer In The Veterans Health Administration.
Authors: Soerensen S.J.C. , Thomas I.C. , Schmidt B. , Daskivich T.J. , Skolarus T.A. , Jackson C. , Osborne T.F. , Chertow G.M. , Brooks J.D. , Rehkopf D.H. , et al. .
Source: Urology, 2021 Sep; 155, p. 70-76.
EPub date: 2021-06-15.
PMID: 34139251
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Urology Workforce Changes and Implications for Prostate Cancer Care Among Medicare Enrollees.
Authors: Marchetti K.A. , Oerline M. , Hollenbeck B.K. , Kaufman S.R. , Skolarus T.A. , Shahinian V.B. , Caram M.E.V. , Modi P.K. .
Source: Urology, 2021 Sep; 155, p. 77-82.
EPub date: 2021-02-19.
PMID: 33610652
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Factors influencing treatment of veterans with advanced prostate cancer.
Authors: Caram M.E.V. , Burns J. , Kumbier K. , Sparks J.B. , Tsao P.A. , Chapman C.H. , Bauman J. , Hollenbeck B.K. , Shahinian V.B. , Skolarus T.A. .
Source: Cancer, 2021-07-01; 127(13), p. 2311-2318.
EPub date: 2021-03-25.
PMID: 33764537
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Adherence and out-of-pocket costs among Medicare beneficiaries who are prescribed oral targeted therapies for advanced prostate cancer.
Authors: Caram M.E.V. , Oerline M.K. , Dusetzina S. , Herrel L.A. , Modi P.K. , Kaufman S.R. , Skolarus T.A. , Hollenbeck B.K. , Shahinian V. .
Source: Cancer, 2020-12-01; 126(23), p. 5050-5059.
EPub date: 2020-09-14.
PMID: 32926427
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The Impact of the COVID-19 Pandemic on Genitourinary Cancer Care: Re-envisioning the Future.
Authors: Wallis C.J.D. , Catto J.W.F. , Finelli A. , Glaser A.W. , Gore J.L. , Loeb S. , Morgan T.M. , Morgans A.K. , Mottet N. , Neal R. , et al. .
Source: European urology, 2020 11; 78(5), p. 731-742.
EPub date: 2020-09-04.
PMID: 32893062
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Urologist practice structure and quality of prostate cancer care.
Authors: Modi P.K. , Yan P. , Hollenbeck B.K. , Kaufman S.R. , Borza T. , Skolarus T.A. , Schroeck F.R. , Ryan A.M. , Shahinian V.B. , Herrel L.A. .
Source: Urology practice, 2020 Sep; 7(5), p. 419-424.
EPub date: 2020-09-01.
PMID: 34541260
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Life expectancy estimates for patients diagnosed with prostate cancer in the Veterans Health Administration.
Authors: Sohlberg E.M. , Thomas I.C. , Yang J. , Kapphahn K. , Daskivich T.J. , Skolarus T.A. , Shelton J.B. , Makarov D.V. , Bergman J. , Bang C.K. , et al. .
Source: Urologic oncology, 2020 09; 38(9), p. 734.e1-734.e10.
EPub date: 2020-07-13.
PMID: 32674954
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Too Much Surgery: Overcoming Barriers to Deimplementation of Low-value Surgery.
Authors: Berlin N.L. , Skolarus T.A. , Kerr E.A. , Dossett L.A. .
Source: Annals of surgery, 2020 06; 271(6), p. 1020-1022.
PMID: 32209904
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Association between PSA values and surveillance quality after prostate cancer surgery.
Authors: Chapman C.H. , Caram M.E.V. , Radhakrishnan A. , Tsodikov A. , Deville C. , Burns J. , Zaslavsky A. , Chang M. , Leppert J.T. , Hofer T. , et al. .
Source: Cancer medicine, 2019 12; 8(18), p. 7903-7912.
EPub date: 2019-11-05.
PMID: 31691526
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Characterising potential bone scan overuse amongst men treated with radical prostatectomy.
Authors: Kirk P.S. , Borza T. , Caram M.E.V. , Shumway D.A. , Makarov D.V. , Burns J.A. , Shelton J.B. , Leppert J.T. , Chapman C. , Chang M. , et al. .
Source: BJU international, 2019 07; 124(1), p. 55-61.
EPub date: 2018-11-12.
PMID: 30246937
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Self-Management in Long-Term Prostate Cancer Survivors: A Randomized, Controlled Trial.
Authors: Skolarus T.A. , Metreger T. , Wittmann D. , Hwang S. , Kim H.M. , Grubb R.L. , Gingrich J.R. , Zhu H. , Piette J.D. , Hawley S.T. .
Source: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019-05-20; 37(15), p. 1326-1335.
EPub date: 2019-03-29.
PMID: 30925126
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Determinants of quality prostate cancer survivorship care across the primary and specialty care interface: Lessons from the Veterans Health Administration.
Authors: Radhakrishnan A. , Henry J. , Zhu K. , Hawley S.T. , Hollenbeck B.K. , Hofer T. , Wittmann D.A. , Sales A.E. , Skolarus T.A. .
Source: Cancer medicine, 2019 05; 8(5), p. 2686-2702.
EPub date: 2019-04-05.
PMID: 30950216
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De-implementation of low value castration for men with prostate cancer: protocol for a theory-based, mixed methods approach to minimizing low value androgen deprivation therapy (DeADT).
Authors: Skolarus T.A. , Hawley S.T. , Wittmann D.A. , Forman J. , Metreger T. , Sparks J.B. , Zhu K. , Caram M.E.V. , Hollenbeck B.K. , Makarov D.V. , et al. .
Source: Implementation science : IS, 2018-11-29; 13(1), p. 144.
EPub date: 2018-11-29.
PMID: 30486836
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Castration remains despite decreasing definitive treatment of localized prostate cancer in the elderly: A case for de-implementation.
Authors: Skolarus T.A. , Caram M.E. , Chapman C.H. , Smith D.C. , Hollenbeck B.K. , Hawley S. , Tsodikov A. , Sales A. , Wittmann D. , Zaslavsky A. .
Source: Cancer, 2018-10-15; 124(20), p. 3971-3974.
EPub date: 2018-09-07.
PMID: 30192374
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Introduction to a Seminar on implementation and de-implementation to improve urologic cancer care.
Authors: Skolarus T.A. .
Source: Urologic oncology, 2018 05; 36(5), p. 244-245.
EPub date: 2018-02-16.
PMID: 29455907
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