Trial Outcomes & Findings for De-implementation of Low Value Castration for Men With Prostate Cancer (NCT NCT03579680)

Results Overview

The percentage of pilot sites asked to participate that received MCD approval to implement the intervention (Order Check or Progress Note/Patient Handout)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Within 1 month

Results posted on

2024-09-05

Participant Flow

Providers (physicians) had the option to opt out of the study.

Unit of analysis: Centers

Participant milestones

Participant milestones
Measure	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. (In some publications, this is also referred to as Clinical Reminder Order Check (CROC).)	PROVIDER SCRIPT (SC) 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.
Overall Study STARTED	46 3	14 1
Overall Study COMPLETED	46 2	14 1
Overall Study NOT COMPLETED	0 1	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

No gender/sex data was collected on the providers/clinicians

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ADT ORDER CHECK ATTESTATION (OR) n=46 Participants 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. (In some publications, this is also referred to as Clinical Reminder Order Check (CROC).)	PROVIDER SCRIPT (SC) n=14 Participants 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.	Total n=60 Participants Total of all reporting groups
Age, Customized All clinicians were adults > age 18;	46 Participants n=46 Participants	14 Participants n=14 Participants	60 Participants n=60 Participants
Sex/Gender, Customized No gender/sex data was collected on the providers/clinicians	0 Participants No gender/sex data was collected on the providers/clinicians	0 Participants No gender/sex data was collected on the providers/clinicians	0 Participants No gender/sex data was collected on the providers/clinicians
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	46 Participants n=46 Participants	14 Participants n=14 Participants	60 Participants n=60 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	ADT ORDER CHECK ATTESTATION (OR) n=3 sites 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. (In some publications, this is also referred to as Clinical Reminder Order Check (CROC).)	PROVIDER SCRIPT (SC) n=1 sites 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.
Feasibility - Site Level: Medical Center Director (MCD) Approval	3 sites	1 sites

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ADT ORDER CHECK ATTESTATION (OR) n=3 sites 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. (In some publications, this is also referred to as Clinical Reminder Order Check (CROC).)	PROVIDER SCRIPT (SC) n=1 sites 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.
Feasibility - Site Level: Fully Operationalized Intervention	2 sites	1 sites

PRIMARY outcome

Timeframe: Within 6 months of intervention implementation

Population: While providers represented the "participants" for the purposes of participating or opting out, the relevant measure for this outcome is "sites".

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.

Outcome measures

Outcome measures
Measure	ADT ORDER CHECK ATTESTATION (OR) n=3 sites 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. (In some publications, this is also referred to as Clinical Reminder Order Check (CROC).)	PROVIDER SCRIPT (SC) n=1 sites 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.
Feasibility - Clinic Level: Clinics With Intervention Implementation	2 sites	1 sites

SECONDARY outcome

Timeframe: Within 6 months of intervention

Population: Here participants are actually providers

The percentage of providers prescribing ADT for prostate cancer sent an information sheet who did not opt out of the study.

Outcome measures

Outcome measures
Measure	ADT ORDER CHECK ATTESTATION (OR) n=46 Participants 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. (In some publications, this is also referred to as Clinical Reminder Order Check (CROC).)	PROVIDER SCRIPT (SC) n=14 Participants 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.
Reach	46 Participants	14 Participants

SECONDARY outcome

Timeframe: Within 6 months of intervention

Population: For this outcome measure, the number of providers at the site that adopted provider script is not considered. This outcome measure looks at the percentage of notes that were signed by a provider, but not the number of providers that signed notes.

Percentage of SC intervention clinic notes assigned to providers that were signed.

Outcome measures

Outcome measures
Measure	ADT ORDER CHECK ATTESTATION (OR) n=8 notes 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. (In some publications, this is also referred to as Clinical Reminder Order Check (CROC).)	PROVIDER SCRIPT (SC) 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.
Penetration - Provider Script (SC)	5 notes	—

SECONDARY outcome

Timeframe: Within 6 months of intervention

Population: For this outcome measure the number of providers at the sites that used ADT order check attestation is not considered. This outcome measure is simply looking at the percent of order checks that were justified by the provider.

Percentage of OR intervention order checks justified.

Outcome measures

Outcome measures
Measure	ADT ORDER CHECK ATTESTATION (OR) n=12 orders checked 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. (In some publications, this is also referred to as Clinical Reminder Order Check (CROC).)	PROVIDER SCRIPT (SC) 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.
Penetration - OR	8 orders checked	—

Adverse Events

ADT ORDER CHECK ATTESTATION (OR)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PROVIDER SCRIPT (SC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ted Skolarus

University of Michigan

Phone: Ph: (734) 845-3506

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place