De-implementation of Low Value Castration for Men With Prostate Cancer



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:10/13/2018
Start Date:August 22, 2018
End Date:June 30, 2021
Contact:Tabitha Metreger, MA
Email:tabitha.metreger@va.gov
Phone:734-845-3624

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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 androgen deprivation therapy (ADT) use in preparation for a
randomized comparative effectiveness trial.

Prostate cancer is the leading cancer among Veterans. One in three Veterans 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 Veterans
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 in the Veterans Health Administration (VHA) with five-fold variation
across its facilities. 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 informed 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 de-implementation strategy development will advance
both implementation research and practice.

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.

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 (TDF), urologists and patients from facilities with the highest
and lowest castration rates across VHA 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 (DCE), a novel barrier
prioritization approach, for de-implementation strategy tailoring. The investigators will
conduct national surveys of US Government urologists to prioritize key barriers identified in
Aim 1 for stopping incident 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
informed decision-making at different facilities. 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 and patient preferences and strategy tailoring.
This work will advance de-implementation science for low value care and foster participation
in a subsequent de-implementation evaluation trial by addressing barriers, facilitators and
concerns through pilot tailoring.

Inclusion Criteria:

- Any urologist who has experience caring for more than 10 prostate cancer patients on
ADT and expresses interest in prostate cancer care

- Will consider non-physician providers (e.g., nurse practitioners) if they prescribe a
significant amount of ADT

- Patients from high outlier site receiving ADT as primary prostate cancer treatment

Exclusion Criteria:

- Providers caring for 10 or fewer prostate cancer patients on ADT

- Patients with dementia or other significant mental impairment noted in their medical
record
We found this trial at
1
site
Ann Arbor, Michigan 48113
Phone: 734-845-3624
?
mi
from
Ann Arbor, MI
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