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

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ClinicalTrials.gov Identifier: NCT03579680
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ted Skolarus, University of Michigan

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.

Condition or disease
Cancer of Prostate

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
Estimated Enrollment : 35 participants
Observational Model: Other
Time Perspective: Other
Official Title: De-implementation of Low Value Castration for Men With Prostate Cancer
Actual Study Start Date : August 22, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579680


Contacts
Contact: Tabitha Metreger, MA 734-845-3624 tabitha.metreger@va.gov

Locations
United States, Michigan
VA Ann Arbor Healthcare System Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Tabitha Metreger, MA    734-845-3624    tabitha.metreger@va.gov   
Sponsors and Collaborators
University of Michigan
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ted Skolarus, MD University of Michigan/Department of Veterans Affairs

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ted Skolarus, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03579680     History of Changes
Other Study ID Numbers: HUM00133932-1
1R37CA222885-01 ( U.S. NIH Grant/Contract )
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ted Skolarus, University of Michigan:
Prostatic Neoplasms
De-implementation
androgen deprivation therapy
Provider Preferences

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases