Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03579680
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : October 18, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ted Skolarus, University of Michigan

Tracking Information
First Submitted Date June 25, 2018
First Posted Date July 6, 2018
Last Update Posted Date October 18, 2019
Actual Study Start Date August 22, 2018
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 25, 2018)
Provider Interviews [ Time Frame: 30-45 minutes ]
Guided by the Theoretical Domains Framework, urologists from facilities with the highest and lowest 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 10, 2018)
Patient Interviews [ Time Frame: 30-45 minutes ]
To better understand patient perspectives into not initiating or stopping castration with ADT, the investigators also plan to conduct up to 15 patient interviews from high outlier sites. The investigators will use the VA Corporate Data Warehouse (CDW)Oncology data to identify these patients.
Original Secondary Outcome Measures
 (submitted: June 25, 2018)
Patient Interviews [ Time Frame: 30-45 minutes ]
To better understand patient perspectives into not initiating or stopping castration with ADT, we also plan to conduct up to 15 patient interviews from high outlier sites. We will use the CDW-Oncology data to identify these patients.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title De-implementation of Low Value Castration for Men With Prostate Cancer
Official Title De-implementation of Low Value Castration for Men With Prostate Cancer
Brief 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.
Detailed 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. 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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Urologists from facilities with the highest and lowest use of castration as primary treatment who have experience caring for more than 10 prostate cancer patients on androgen deprivation therapy (ADT) and expresses interest in prostate cancer (PC) care will be eligible to participate in an interview. Patients from high outlier sites identified as receiving ADT as primary prostate cancer treatment will be eligible to participate in an interview.
Condition Cancer of Prostate
Intervention Not Provided
Study Groups/Cohorts
  • Providers
    Urologists and other providers who have experience caring for more than 10 prostate cancer patients on ADT and express interest in prostate cancer care for prostate cancer will be eligible to participate. Providers will engage in a 30-45 minute interview to identify key preferences and de-implementation barriers, as well as facilitators, for reducing low value ADT as prostate cancer (PC) treatment.
  • Patients
    Patients receiving ADT as primary prostate cancer treatment will engage in a 30-45 minute interview regarding to better understand patient perspectives into not initiating or stopping castration with ADT
Publications * Skolarus TA, Hawley ST, Wittmann DA, Forman J, Metreger T, Sparks JB, Zhu K, Caram MEV, Hollenbeck BK, Makarov DV, Leppert JT, Shelton JB, Shahinian V, Srinivasaraghavan S, Sales AE. 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). Implement Sci. 2018 Nov 29;13(1):144. doi: 10.1186/s13012-018-0833-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 25, 2018)
35
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Tabitha Metreger, MA 734-845-3624 tabitha.metreger@va.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03579680
Other Study ID Numbers HUM00133932-1
1R37CA222885-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Ted Skolarus, University of Michigan
Study Sponsor University of Michigan
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Ted Skolarus, MD University of Michigan/Department of Veterans Affairs
PRS Account University of Michigan
Verification Date October 2019