Trial Outcomes & Findings for DeADT - Living Well With Prostate Cancer (NCT NCT06199986)

NCT ID: NCT06199986

Last Updated: 2025-06-26

Results Overview

The proportion of patients receiving ADT whose prescribed ADT injections were interrupted, as shown by count of patients whose injections were interrupted.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

6 months

Results posted on

2025-06-26

Participant Flow

Participants were providers who received the study interventions and are represented by the ADT Order Check Attestation (Or) and Provider Script (Sc) arms. Patients were not participants, as they received no interventions, although their data was collected to assess the effect of the interventions on the provider participants. Patients are represented by the ADT Order Check Attestation (Or) - Patients, Provider Script (Sc) - Patients, and Control arms.

Unit of analysis: Centers

Participant milestones

Participant milestones
Measure	ADT Order Check Attestation (Or) - Providers Study staff placed a "Living Well ADT" health factor in the electronic medical record for patients already receiving ADT, and whose clinic visits the study team confirmed to be targets for ADT de-implementation. Health factors were entered as eligible clinic visits were identified. This health factor combined with a low PSA level (most recent PSA \< 2) triggered the ADT Order Check Attestation Intervention (Or) when the provider participant placed an order for ADT (e.g., Lupron, Eligard, Goserelin, and Zoladex). Provider participants could override the order check by entering text indicating the reason and continue with the ordering process. ADT Order Check Attestation (Or): Clinical reminder order check in electronic health record.	ADT Order Check Attestation (Or) - Patients Study staff placed a "Living Well ADT" health factor in the electronic medical record for patients already receiving ADT, and whose clinic visits the study team confirmed to be targets for ADT de-implementation. Health factors were entered as eligible clinic visits were identified. This health factor combined with a low PSA level (most recent PSA \< 2) triggered the ADT Order Check Attestation Intervention (Or) when the provider participant placed an order for ADT (e.g., Lupron, Eligard, Goserelin, and Zoladex). Provider participants could override the order check by entering text indicating the reason and continue with the ordering process. ADT Order Check Attestation (Or): Clinical reminder order check in electronic health record.	Provider Script (Sc) - Providers Study staff entered an electronic health record progress note approximately one business day prior to a target low-value ADT clinic visit from a patient already receiving ADT. The note included scripted talking points for the provider participant to help with discussion and recent PSA levels and could be edited, signed, or deleted by the provider, giving a quick and simple way to document the discussion. The progress note prompted provider participants to indicate whether a patient preferred to continue or discontinue ADT. The progress note included links to a patient-facing clinic handout which was posted on an external website. Provider participants could modify, ignore, or delete the progress note. Provider Script (Sc): Provider script added to progress note in electronic health record.	Provider Script (Sc) - Patients Study staff entered an electronic health record progress note approximately one business day prior to a target low-value ADT clinic visit from a patient already receiving ADT. The note included scripted talking points for the provider participant to help with discussion and recent PSA levels and could be edited, signed, or deleted by the provider, giving a quick and simple way to document the discussion. The progress note prompted provider participants to indicate whether a patient preferred to continue or discontinue ADT. The progress note included links to a patient-facing clinic handout which was posted on an external website. Provider participants could modify, ignore, or delete the progress note. Provider Script (Sc): Provider script added to progress note in electronic health record.	Control The study team matched 4 sites (i.e., medical centers) to the 4 randomized sites as contemporary controls where no interventions were deployed to compare the primary outcome of interruption of low-value ADT injections. Low-value ADT injections, eligible clinic visits, and primary outcomes for a matched 6-month period were ascertained through chart review and compared to intervention site primary outcomes.
Overall Study STARTED	36 2	105 2	14 2	99 2	282 4
Overall Study COMPLETED	36 2	105 2	14 2	99 2	282 4
Overall Study NOT COMPLETED	0 0	0 0	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age data was not collected from any provider participant, i.e., participants in the ADT Order Check Attestation (Or), Provider Script (Sc), and Control arms.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ADT Order Check Attestation (Or) - Patients n=105 Participants Study staff placed a "Living Well ADT" health factor in the electronic medical record for patients already receiving ADT, and whose clinic visits the study team confirmed to be targets for ADT de-implementation. Health factors were entered as eligible clinic visits were identified. This health factor combined with a low PSA level (most recent PSA \< 2) triggered the ADT Order Check Attestation Intervention (Or) when the provider participant placed an order for ADT (e.g., Lupron, Eligard, Goserelin, and Zoladex). Provider participants could override the order check by entering text indicating the reason and continue with the ordering process. ADT Order Check Attestation (Or): Clinical reminder order check in electronic health record.	Provider Script (Sc) - Patients n=99 Participants Study staff entered an electronic health record progress note approximately one business day prior to a target low-value ADT clinic visit from a patient already receiving ADT. The note included scripted talking points for the provider participant to help with discussion and recent PSA levels and could be edited, signed, or deleted by the provider, giving a quick and simple way to document the discussion. The progress note prompted provider participants to indicate whether a patient preferred to continue or discontinue ADT. The progress note included links to a patient-facing clinic handout which was posted on an external website. Provider participants could modify, ignore, or delete the progress note. Provider Script (Sc): Provider script added to progress note in electronic health record.	Control n=282 Participants The study team matched 4 sites (i.e., medical centers) to the 4 randomized sites as contemporary controls where no interventions were deployed to compare the primary outcome of interruption of low-value ADT injections. Low-value ADT injections, eligible clinic visits, and primary outcomes for a matched 6-month period were ascertained through chart review and compared to intervention site primary outcomes.	Total n=486 Participants Total of all reporting groups
Age, Continuous	79 years n=5 Participants • Age data was not collected from any provider participant, i.e., participants in the ADT Order Check Attestation (Or), Provider Script (Sc), and Control arms.	76 years n=7 Participants • Age data was not collected from any provider participant, i.e., participants in the ADT Order Check Attestation (Or), Provider Script (Sc), and Control arms.	76 years n=5 Participants • Age data was not collected from any provider participant, i.e., participants in the ADT Order Check Attestation (Or), Provider Script (Sc), and Control arms.	77 years n=4 Participants • Age data was not collected from any provider participant, i.e., participants in the ADT Order Check Attestation (Or), Provider Script (Sc), and Control arms.
Sex/Gender, Customized Male	105 Participants n=5 Participants	99 Participants n=7 Participants	282 Participants n=5 Participants	486 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	5 Participants n=7 Participants	26 Participants n=5 Participants	32 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	101 Participants n=5 Participants	89 Participants n=7 Participants	235 Participants n=5 Participants	425 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	5 Participants n=7 Participants	21 Participants n=5 Participants	29 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	43 Participants n=7 Participants	92 Participants n=5 Participants	142 Participants n=4 Participants
Race (NIH/OMB) White	94 Participants n=5 Participants	46 Participants n=7 Participants	156 Participants n=5 Participants	296 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	7 Participants n=7 Participants	24 Participants n=5 Participants	31 Participants n=4 Participants
Region of Enrollment United States	105 Participants n=5 Participants	99 Participants n=7 Participants	282 Participants n=5 Participants	486 Participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months

The proportion of patients receiving ADT whose prescribed ADT injections were interrupted, as shown by count of patients whose injections were interrupted.

Outcome measures

Outcome measures
Measure	ADT Order Check Attestation (Or) - Patients n=105 Participants Study staff placed a "Living Well ADT" health factor in the electronic medical record for patients already receiving ADT, and whose clinic visits the study team confirmed to be targets for ADT de-implementation. Health factors were entered as eligible clinic visits were identified. This health factor combined with a low PSA level (most recent PSA \< 2) triggered the ADT Order Check Attestation Intervention (Or) when the provider participant placed an order for ADT (e.g., Lupron, Eligard, Goserelin, and Zoladex). Provider participants could override the order check by entering text indicating the reason and continue with the ordering process. ADT Order Check Attestation (Or): Clinical reminder order check in electronic health record.	Provider Script (Sc) - Patients n=99 Participants Study staff entered an electronic health record progress note approximately one business day prior to a target low-value ADT clinic visit from a patient already receiving ADT. The note included scripted talking points for the provider participant to help with discussion and recent PSA levels and could be edited, signed, or deleted by the provider, giving a quick and simple way to document the discussion. The progress note prompted provider participants to indicate whether a patient preferred to continue or discontinue ADT. The progress note included links to a patient-facing clinic handout which was posted on an external website. Provider participants could modify, ignore, or delete the progress note. Provider Script (Sc): Provider script added to progress note in electronic health record.	Control n=282 Participants The study team matched 4 sites (i.e., medical centers) to the 4 randomized sites as contemporary controls where no interventions were deployed to compare the primary outcome of interruption of low-value ADT injections. Low-value ADT injections, eligible clinic visits, and primary outcomes for a matched 6-month period were ascertained through chart review and compared to intervention site primary outcomes.
Effectiveness - Interruption in Low Value ADT Injection (i.e., Take a Break From ADT)	12 Participants	28 Participants	24 Participants

SECONDARY outcome

Timeframe: 6 months

The percentage of provider participants who have prescribed ADT before, were asked to participate in the study, and did not opt out of the study.

Outcome measures

Outcome measures
Measure	ADT Order Check Attestation (Or) - Patients n=36 Participants Study staff placed a "Living Well ADT" health factor in the electronic medical record for patients already receiving ADT, and whose clinic visits the study team confirmed to be targets for ADT de-implementation. Health factors were entered as eligible clinic visits were identified. This health factor combined with a low PSA level (most recent PSA \< 2) triggered the ADT Order Check Attestation Intervention (Or) when the provider participant placed an order for ADT (e.g., Lupron, Eligard, Goserelin, and Zoladex). Provider participants could override the order check by entering text indicating the reason and continue with the ordering process. ADT Order Check Attestation (Or): Clinical reminder order check in electronic health record.	Provider Script (Sc) - Patients n=14 Participants Study staff entered an electronic health record progress note approximately one business day prior to a target low-value ADT clinic visit from a patient already receiving ADT. The note included scripted talking points for the provider participant to help with discussion and recent PSA levels and could be edited, signed, or deleted by the provider, giving a quick and simple way to document the discussion. The progress note prompted provider participants to indicate whether a patient preferred to continue or discontinue ADT. The progress note included links to a patient-facing clinic handout which was posted on an external website. Provider participants could modify, ignore, or delete the progress note. Provider Script (Sc): Provider script added to progress note in electronic health record.	Control The study team matched 4 sites (i.e., medical centers) to the 4 randomized sites as contemporary controls where no interventions were deployed to compare the primary outcome of interruption of low-value ADT injections. Low-value ADT injections, eligible clinic visits, and primary outcomes for a matched 6-month period were ascertained through chart review and compared to intervention site primary outcomes.
Reach	100 percentage of provider participants	100 percentage of provider participants	—

SECONDARY outcome

Timeframe: 6 months

Proportion of OR interventions where the provider participant did not override the order check and prescribe ADT. These providers received the education session about the order checks in the study. However, because of technological problems, the order check did not activate within the 6-month study period.

Outcome measures

Outcome measures
Measure	ADT Order Check Attestation (Or) - Patients n=105 Order checks Study staff placed a "Living Well ADT" health factor in the electronic medical record for patients already receiving ADT, and whose clinic visits the study team confirmed to be targets for ADT de-implementation. Health factors were entered as eligible clinic visits were identified. This health factor combined with a low PSA level (most recent PSA \< 2) triggered the ADT Order Check Attestation Intervention (Or) when the provider participant placed an order for ADT (e.g., Lupron, Eligard, Goserelin, and Zoladex). Provider participants could override the order check by entering text indicating the reason and continue with the ordering process. ADT Order Check Attestation (Or): Clinical reminder order check in electronic health record.	Provider Script (Sc) - Patients Study staff entered an electronic health record progress note approximately one business day prior to a target low-value ADT clinic visit from a patient already receiving ADT. The note included scripted talking points for the provider participant to help with discussion and recent PSA levels and could be edited, signed, or deleted by the provider, giving a quick and simple way to document the discussion. The progress note prompted provider participants to indicate whether a patient preferred to continue or discontinue ADT. The progress note included links to a patient-facing clinic handout which was posted on an external website. Provider participants could modify, ignore, or delete the progress note. Provider Script (Sc): Provider script added to progress note in electronic health record.	Control The study team matched 4 sites (i.e., medical centers) to the 4 randomized sites as contemporary controls where no interventions were deployed to compare the primary outcome of interruption of low-value ADT injections. Low-value ADT injections, eligible clinic visits, and primary outcomes for a matched 6-month period were ascertained through chart review and compared to intervention site primary outcomes.
Penetration - ADT Order Check Attestation (OR) Intervention	0 proportion of OR interventions	—	—

SECONDARY outcome

Timeframe: 6 months

Population: Of 99 eligible cases, 81 were actually assigned the script progress note because of unavailability of provider visit, missed appointment, or study team not available for note placement.

The total number of SC intervention notes assigned to participant providers by the study team that were actually signed by the providers.

Outcome measures

Outcome measures
Measure	ADT Order Check Attestation (Or) - Patients n=81 notes Study staff placed a "Living Well ADT" health factor in the electronic medical record for patients already receiving ADT, and whose clinic visits the study team confirmed to be targets for ADT de-implementation. Health factors were entered as eligible clinic visits were identified. This health factor combined with a low PSA level (most recent PSA \< 2) triggered the ADT Order Check Attestation Intervention (Or) when the provider participant placed an order for ADT (e.g., Lupron, Eligard, Goserelin, and Zoladex). Provider participants could override the order check by entering text indicating the reason and continue with the ordering process. ADT Order Check Attestation (Or): Clinical reminder order check in electronic health record.	Provider Script (Sc) - Patients Study staff entered an electronic health record progress note approximately one business day prior to a target low-value ADT clinic visit from a patient already receiving ADT. The note included scripted talking points for the provider participant to help with discussion and recent PSA levels and could be edited, signed, or deleted by the provider, giving a quick and simple way to document the discussion. The progress note prompted provider participants to indicate whether a patient preferred to continue or discontinue ADT. The progress note included links to a patient-facing clinic handout which was posted on an external website. Provider participants could modify, ignore, or delete the progress note. Provider Script (Sc): Provider script added to progress note in electronic health record.	Control The study team matched 4 sites (i.e., medical centers) to the 4 randomized sites as contemporary controls where no interventions were deployed to compare the primary outcome of interruption of low-value ADT injections. Low-value ADT injections, eligible clinic visits, and primary outcomes for a matched 6-month period were ascertained through chart review and compared to intervention site primary outcomes.
Penetration - Provider Script (SC) Intervention	64 notes	—	—

SECONDARY outcome

Timeframe: Within 1 month of request to participate being sent

The percentage of sites (i.e., medical centers) asked to participate that received MCD approval to implement the intervention (Order Check or Progress Note/Patient Handout). Each site has only one MCD.

Outcome measures

Outcome measures
Measure	ADT Order Check Attestation (Or) - Patients n=2 sites Study staff placed a "Living Well ADT" health factor in the electronic medical record for patients already receiving ADT, and whose clinic visits the study team confirmed to be targets for ADT de-implementation. Health factors were entered as eligible clinic visits were identified. This health factor combined with a low PSA level (most recent PSA \< 2) triggered the ADT Order Check Attestation Intervention (Or) when the provider participant placed an order for ADT (e.g., Lupron, Eligard, Goserelin, and Zoladex). Provider participants could override the order check by entering text indicating the reason and continue with the ordering process. ADT Order Check Attestation (Or): Clinical reminder order check in electronic health record.	Provider Script (Sc) - Patients n=2 sites Study staff entered an electronic health record progress note approximately one business day prior to a target low-value ADT clinic visit from a patient already receiving ADT. The note included scripted talking points for the provider participant to help with discussion and recent PSA levels and could be edited, signed, or deleted by the provider, giving a quick and simple way to document the discussion. The progress note prompted provider participants to indicate whether a patient preferred to continue or discontinue ADT. The progress note included links to a patient-facing clinic handout which was posted on an external website. Provider participants could modify, ignore, or delete the progress note. Provider Script (Sc): Provider script added to progress note in electronic health record.	Control The study team matched 4 sites (i.e., medical centers) to the 4 randomized sites as contemporary controls where no interventions were deployed to compare the primary outcome of interruption of low-value ADT injections. Low-value ADT injections, eligible clinic visits, and primary outcomes for a matched 6-month period were ascertained through chart review and compared to intervention site primary outcomes.
Feasibility - Site Level: Medical Center Director (MCD) Approval	2 sites	2 sites	—

SECONDARY outcome

Timeframe: 6 months

The percentage of approved sites with fully operationalized intervention, i.e. intervention programmed into site EHR and ready to be implemented. Depending on randomization arm, this included either health factor placement or script assignment prior to at least one patient visit.

Outcome measures

Outcome measures
Measure	ADT Order Check Attestation (Or) - Patients n=2 sites Study staff placed a "Living Well ADT" health factor in the electronic medical record for patients already receiving ADT, and whose clinic visits the study team confirmed to be targets for ADT de-implementation. Health factors were entered as eligible clinic visits were identified. This health factor combined with a low PSA level (most recent PSA \< 2) triggered the ADT Order Check Attestation Intervention (Or) when the provider participant placed an order for ADT (e.g., Lupron, Eligard, Goserelin, and Zoladex). Provider participants could override the order check by entering text indicating the reason and continue with the ordering process. ADT Order Check Attestation (Or): Clinical reminder order check in electronic health record.	Provider Script (Sc) - Patients n=2 sites Study staff entered an electronic health record progress note approximately one business day prior to a target low-value ADT clinic visit from a patient already receiving ADT. The note included scripted talking points for the provider participant to help with discussion and recent PSA levels and could be edited, signed, or deleted by the provider, giving a quick and simple way to document the discussion. The progress note prompted provider participants to indicate whether a patient preferred to continue or discontinue ADT. The progress note included links to a patient-facing clinic handout which was posted on an external website. Provider participants could modify, ignore, or delete the progress note. Provider Script (Sc): Provider script added to progress note in electronic health record.	Control The study team matched 4 sites (i.e., medical centers) to the 4 randomized sites as contemporary controls where no interventions were deployed to compare the primary outcome of interruption of low-value ADT injections. Low-value ADT injections, eligible clinic visits, and primary outcomes for a matched 6-month period were ascertained through chart review and compared to intervention site primary outcomes.
Feasibility - Site Level: Fully Operationalized Intervention	2 sites	2 sites	—

SECONDARY outcome

Timeframe: Within 6 months

The percentage of approved 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 participant.