Trial Outcomes & Findings for The Effect of Informative Letters on the Prescription and Receipt of Schedule II Controlled Substances (NCT NCT02345434)

Results Overview

The prescribing of schedule II controlled substances over the 3 months following the initial sending of the letters. Prescribing is defined as the total "days supply" of schedule II controlled substances attributed to the prescriber, expressed in "30-day equivalents" i.e. divided by 30.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1525 participants

Primary outcome timeframe

3 months

Results posted on

2021-11-08

Participant Flow

There was no recruitment in the traditional sense. High prescribers of Schedule II controlled substances were identified in Medicare administrative data using a Tukey outlier method.

Seven of the identified outliers had died by the time of the study and were excluded from the intervention and later analysis.

Participant milestones

Participant milestones
Measure	No Informative Letter This is the control arm and it involves no contact with the prescriber	Informative Letter This is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report) Informative letter: The intervention is a letter that describes the Schedule II prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers.
Overall Study STARTED	763	762
Overall Study COMPLETED	758	760
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	No Informative Letter This is the control arm and it involves no contact with the prescriber	Informative Letter This is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report) Informative letter: The intervention is a letter that describes the Schedule II prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers.
Overall Study Deceased (excluded from intervention and analysis)	5	2

Baseline Characteristics

The Effect of Informative Letters on the Prescription and Receipt of Schedule II Controlled Substances

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 3 months

The prescribing of schedule II controlled substances over the 3 months following the initial sending of the letters. Prescribing is defined as the total "days supply" of schedule II controlled substances attributed to the prescriber, expressed in "30-day equivalents" i.e. divided by 30.

Outcome measures

Outcome measures
Measure	No Informative Letter n=758 Participants This is the control arm and it involves no contact with the prescriber	Informative Letter n=760 Participants This is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report) Informative letter: The intervention is a letter that describes the Schedule II prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers.
30-day Equivalent Prescribing of Schedule II Controlled Substances	461.1 30-day equivalent prescription fills Standard Deviation 443.9	450.0 30-day equivalent prescription fills Standard Deviation 450.9

SECONDARY outcome

Timeframe: 1 month

Outcome measures

Outcome measures
Measure	No Informative Letter n=758 Participants This is the control arm and it involves no contact with the prescriber	Informative Letter n=760 Participants This is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report) Informative letter: The intervention is a letter that describes the Schedule II prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers.
30-day Equivalent Prescribing of Schedule II Controlled Substances	155.5 30-day equivalent prescription fills Standard Deviation 148.8	151.1 30-day equivalent prescription fills Standard Deviation 150.4

SECONDARY outcome

Timeframe: 6 months

Population: Outcome measure not collected for study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 months

Population: Outcome measure not collected for study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Outcome measure not collected for study

Outcome measures

Outcome data not reported

Adverse Events

No Informative Letter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Informative Letter

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

Adam Sacarny

Columbia University

Phone: 212 305 7084

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place