Cancer of ProstateDeADTNCT03579680
De-implementation of Low Value Castration for Men With Prostate Cancer
A study testing ADT ORDER CHECK ATTESTATION (OR) and PROVIDER SCRIPT (SC) in people with Cancer of Prostate, run by University of Michigan at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cancer of Prostate
- What is being tested?
- ADT ORDER CHECK ATTESTATION (OR) and PROVIDER SCRIPT (SC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2018to 6 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Any provider at participating sites who prescribes ADT for prostate cancer patients
Who cannot join
- Providers opting out of study
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105
About this study
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.
Read the 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, 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.
- Conditions
- Cancer of Prostate
- Being tested
- ADT ORDER CHECK ATTESTATION (OR), PROVIDER SCRIPT (SC)
- Keywords
- Prostatic Neoplasms, De-implementation, androgen deprivation therapy, Provider Preferences
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADT ORDER CHECK ATTESTATION (OR)Behavioural
Order restrictions (Or) operate as an organizational constraint, widely perceived as a forcing function giving providers little leeway to exercise judgment but have a strong evidence-base for changing provider behavior.
PROVIDER SCRIPT (SC)Behavioural
The provider script (Sc) is a communication aid to be used and documented as an accountable justification in the electronic medical record. This strategy also has a strong evidence-base for changing provider behavior.
| Study group | Role | What they receive |
|---|---|---|
| ADT ORDER CHECK ATTESTATION (OR) | Experimental | Experimental: ADT ORDER CHECK ATTESTATION (OR) Order restrictions (Or) operate as an organizational constraint, widely perceived as a forcing function giving providers little leeway to exercise judgment but have a strong evidence-base for changing provider behavior. Study staff will place a "health factor" structured data element in the EMR of patients whose clinic visits study staff have confirmed to be targets for ADT de-implementation. This health factor combined with a low PSA level will trigger the ADT Order Check Attestation Intervention (Or) when the provider places an order for ADT. Receives: Behavioral: ADT ORDER CHECK ATTESTATION (OR) |
| PROVIDER SCRIPT (SC) | Experimental | Experimental: PROVIDER SCRIPT (SC) The provider script (Sc) is a communication aid to be used and documented as an accountable justification in the electronic medical record. This strategy also has a strong evidence-base for changing provider behavior. Study staff will enter a pre-populated CPRS EMR progress note 1 business day prior to a target clinic visit. The note includes talking points for the provider to help with a discussion. It can be edited and cosigned by the provider, giving a quick and simple way to document the discussion. The progress note template asks providers to indicate whether patient prefers to continue or discontinue low-value ADT. Appropriate documentation of the decision will be tracked for fidelity. We will also have a patient handout entitled: "Living well with prostate cancer: Is hormone therapy still right for you?" as a patient engagement and information resource. Receives: Behavioral: PROVIDER SCRIPT (SC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Site Level: Medical Center Director (MCD) Approval
The percentage of pilot sites asked to participate that received MCD approval to implement the intervention (Order Check or Progress Note/Patient Handout)
Measured: Within 1 month
Feasibility - Site Level: Fully Operationalized Intervention
The percentage of approved pilot sites with fully operationalized intervention, i.e. intervention successfully programmed into site Electronic Health Records and ready to be implemented. Depending on randomization arm, this includes either health factor placement or script assignment prior to at least one patient visit.
Measured: Within 6 months of approval
Feasibility - Clinic Level: Clinics With Intervention Implementation
The percentage of clinics at approved pilot sites with at least 1 intervention implemented, i.e. at least 1 health factor assigned and/or at least 1 progress note assigned to a provider. Clinics may include Urology, Medical Oncology, and Radiation Oncology.
Measured: Within 6 months of intervention implementation
Secondary outcomes (3)
Reach
The percentage of providers prescribing ADT for prostate cancer sent an information sheet who did not opt out of the study.
Measured: Within 6 months of intervention
Penetration - Provider Script (SC)
Percentage of SC intervention clinic notes assigned to providers that were signed.
Measured: Within 6 months of intervention
Penetration - OR
Percentage of OR intervention order checks justified.
Measured: Within 6 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start22 Aug 2018
- Primary completion8 Nov 2022
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cancer of ProstateStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ted Skolarus, University of Michigan
- Investigators
- Ted Skolarus, MD, Principal investigator, University of Michigan/Department of Veterans Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579680
- Sponsor's protocol ID
- HUM00133932-1
- Other IDs
- 1R37CA222885-01
- Acronym
- DeADT
- Status last verified
- Aug 2024
- First submitted
- 25 Jun 2018
- Last updated
- 5 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Members of the scientific community who would like a copy of the de-identified final data sets (i.e., data sets underlying any publication) from this study can request a copy by e-mailing Jennifer Burns at jennifer.burns@va.gov. They should state their reason for requesting the data and their plans for analyzing the data. Final data sets will be copied onto an encrypted CD. The CD will be sent to the requestor via FedEx.
Publications
Skolarus TA, Hawley ST, Forman J, Sales AE, Sparks JB, Metreger T, Burns J, Caram MV, Radhakrishnan A, Dossett LA, Makarov DV, Leppert JT, Shelton JB, Stensland KD, Dunsmore J, Maclennan S, Saini S, Hollenbeck BK, Shahinian V, Wittmann DA, Deolankar V, Sriram S. Unpacking overuse of androgen deprivation therapy for prostate cancer to inform de-implementation strategies. Implement Sci Commun. 2024 Apr 9;5(1):37. doi: 10.1186/s43058-024-00576-x.
PubMed 38594740Skolarus TA, Forman J, Sparks JB, Metreger T, Hawley ST, Caram MV, Dossett L, Paniagua-Cruz A, Makarov DV, Leppert JT, Shelton JB, Stensland KD, Hollenbeck BK, Shahinian V, Sales AE, Wittmann DA. Learning from the "tail end" of de-implementation: the case of chemical castration for localized prostate cancer. Implement Sci Commun. 2021 Oct 28;2(1):124. doi: 10.1186/s43058-021-00224-8.
PubMed 34711274Skolarus 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.
PubMed 30486836
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-implementation of Low Value Castration for Men With Prostate Cancer
- ClinicalTrials.gov ID
- NCT03579680
- Acronym / sponsor ID
- DeADT / HUM00133932-1
- Conditions
- Cancer of Prostate
- Keywords
- Prostatic Neoplasms, De-implementation, androgen deprivation therapy, Provider Preferences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Posted 5 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADT ORDER CHECK ATTESTATION (OR) | Experimental | Behavioral: ADT ORDER CHECK ATTESTATION (OR)Experimental: ADT ORDER CHECK ATTESTATION (OR) Order restrictions (Or) operate as an organizational constraint, widely perceived as a forcing function giving providers little leeway to exercise judgment but have a strong evidence-base for changing provider behavior. Study staff will place a "health factor" structured data element in the EMR of patients whose clinic visits study staff have confirmed to be targets for ADT de-implementation. This health factor combined with a low PSA level will trigger the ADT Order Check Attestation Intervention (Or) when the provider places an order for ADT. |
| PROVIDER SCRIPT (SC) | Experimental | Behavioral: PROVIDER SCRIPT (SC)Experimental: PROVIDER SCRIPT (SC) The provider script (Sc) is a communication aid to be used and documented as an accountable justification in the electronic medical record. This strategy also has a strong evidence-base for changing provider behavior. Study staff will enter a pre-populated CPRS EMR progress note 1 business day prior to a target clinic visit. The note includes talking points for the provider to help with a discussion. It can be edited and cosigned by the provider, giving a quick and simple way to document the discussion. The progress note template asks providers to indicate whether patient prefers to continue or discontinue low-value ADT. Appropriate documentation of the decision will be tracked for fidelity. We will also have a patient handout entitled: "Living well with prostate cancer: Is hormone therapy still right for you?" as a patient engagement and information resource. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any provider at participating sites who prescribes ADT for prostate cancer patients
Key exclusion criteria (1 listed)
- Providers opting out of study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADT ORDER CHECK ATTESTATION (OR)Order restrictions (Or) operate as an organizational constraint, widely perceived as a forcing function giving providers little leeway to exercise judgment but have a strong evidence-base for changing provider behavior. | Behavioural | ADT ORDER CHECK ATTESTATION (OR) |
| PROVIDER SCRIPT (SC)The provider script (Sc) is a communication aid to be used and documented as an accountable justification in the electronic medical record. This strategy also has a strong evidence-base for changing provider behavior. | Behavioural | PROVIDER SCRIPT (SC) |
Primary outcome
Feasibility - Site Level: Medical Center Director (MCD) Approval
Time frame: Within 1 month
The percentage of pilot sites asked to participate that received MCD approval to implement the intervention (Order Check or Progress Note/Patient Handout)
Feasibility - Site Level: Fully Operationalized Intervention
Time frame: Within 6 months of approval
The percentage of approved pilot sites with fully operationalized intervention, i.e. intervention successfully programmed into site Electronic Health Records and ready to be implemented. Depending on randomization arm, this includes either health factor placement or script assignment prior to at least one patient visit.
Feasibility - Clinic Level: Clinics With Intervention Implementation
Time frame: Within 6 months of intervention implementation
The percentage of clinics at approved pilot sites with at least 1 intervention implemented, i.e. at least 1 health factor assigned and/or at least 1 progress note assigned to a provider. Clinics may include Urology, Medical Oncology, and Radiation Oncology.
3 secondary outcomes
Reach
Time frame: Within 6 months of intervention
Penetration - Provider Script (SC)
Time frame: Within 6 months of intervention
Penetration - OR
Time frame: Within 6 months of intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38594740Skolarus TA, Hawley ST, Forman J, Sales AE, Sparks JB, Metreger T, Burns J, Caram MV, Radhakrishnan A, Dossett LA, Makarov DV, Leppert JT, Shelton JB, Stensland KD, Dunsmore J, Maclennan S, Saini S, Hollenbeck BK, Shahinian V, Wittmann DA, Deolankar V, Sriram S. Unpacking overuse of androgen deprivation therapy for prostate cancer to inform de-implementation strategies. Implement Sci Commun. 2024 Apr 9;5(1):37. doi: 10.1186/s43058-024-00576-x.
- Derived from this study: PubMed 34711274Skolarus TA, Forman J, Sparks JB, Metreger T, Hawley ST, Caram MV, Dossett L, Paniagua-Cruz A, Makarov DV, Leppert JT, Shelton JB, Stensland KD, Hollenbeck BK, Shahinian V, Sales AE, Wittmann DA. Learning from the "tail end" of de-implementation: the case of chemical castration for localized prostate cancer. Implement Sci Commun. 2021 Oct 28;2(1):124. doi: 10.1186/s43058-021-00224-8.
- Derived from this study: PubMed 30486836Skolarus 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.
- Individual participant dataSharing planned: Yes. Members of the scientific community who would like a copy of the de-identified final data sets (i.e., data sets underlying any publication) from this study can request a copy by e-mailing Jennifer Burns at jennifer.burns@va.gov. They should state their reason for requesting the data and their plans for analyzing the data. Final data sets will be copied onto an encrypted CD. The CD will be sent to the requestor via FedEx.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ted Skolarus, MD principal investigator
University of Michigan/Department of Veterans Affairs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADT ORDER CHECK ATTESTATION (OR) and PROVIDER SCRIPT (SC) in people with Cancer of Prostate, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Site Level: Medical Center Director (MCD) Approval (time frame: Within 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03579680, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.