Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03579680 |
| Other study ID # |
HUM00133932-1 |
| Secondary ID |
1R37CA222885-01 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 22, 2018 |
| Est. completion date |
April 6, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
University of Michigan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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 comparing two tailored deimplementation strategies
to reduce chemical castration as localized prostate cancer treatment and treatment for
non-metastatic biochemical recurrence with low PSA levels.
Description:
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, of which Aim 3 is represented
in this registration.
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 deimplementation 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 deimplementation 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 deimplementation strategies in
preparation for Aim 3 piloting.
Aim 3: To pilot two tailored de-implementation strategies to reduce castration as localized
prostate cancer treatment and treatment for non-metastatic biochemical recurrence with low
PSA levels. Building on findings from Aims 1 and 2, two de-implementation strategies will be
piloted. One strategy will focus on formulary restriction/ order check attestation at the
organizational level and the other on physician/ patient informed decision-making at
different facilities. Pilot outcomes will include feasibility at the site level, feasibility
at the clinic level, reach, and penetration 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 and nonmetastatic biochemical recurrence with low PSA levels
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.
