For agencies

Pilot design

What a first phase has to look like if it is going to produce an answer rather than a testimonial.

The failure mode to avoid

The standard pilot in this field enrolls a small, cooperative, easily reached group, runs for a few months, reports process measures, and produces a favorable narrative that nobody can act on. It is not dishonest; it is just uninformative, and it is uninformative in a predictable way.

What makes a pilot informative

  1. A population defined by a rule, not by convenience. Everyone in a defined geography meeting defined criteria, including the people who are hard to reach — because they are the population the program claims to help and the one it is most likely to fail.
  2. A comparison of some kind. A matched population, a stepped-wedge rollout across sites, or at minimum a well-characterized pre-period. Without one, every finding is confounded with time, and time is doing a great deal in this field right now: opioid-involved deaths nationally fell from 82,851 in 2022 to 55,007 in 2024 with no help from anybody’s pilot.
  3. Long enough to see the outcome you care about. Overdose is a low-frequency event. A three-month pilot in a small population cannot detect a change in it, and reporting one would be noise.
  4. Pre-registered measures, including the negative ones from measurement and evaluation.
  5. A stopping rule. Agreed in advance: what result would cause this to be halted early. A program with no stopping rule cannot fail, which means it cannot succeed either.
  6. An independent evaluator with access to the data.

A worked outline

ElementA defensible choice
PopulationAll patients in a defined county on long-term opioid therapy for chronic non-cancer pain, identified by a stated rule
ComparisonStepped-wedge across sites, or a matched county
DurationAt minimum 12 months of follow-up after enrollment closes
Primary outcomesFatal and non-fatal overdose; mental health crisis events; loss of prescribing clinician
Secondary outcomesTherapy gaps; emergency department presentations; screening completion and response time
Safety outcomesPatients leaving care; differential outcomes by race, insurance and geography
Stopping rulePre-agreed thresholds on the safety outcomes
AnalysisAgency epidemiology or independent evaluator, plan agreed before data exists
PublicationResults published whatever they show
An indicative pilot outline. The actual design is agreed in phase two of engagement.

On publication

We think pilot results should be published regardless of what they show, and we will agree to that in writing. The literature in this field is distorted by the pilots that were never written up, and a foundation running a program of this kind has no good reason to add to that.

Sources

Every figure on this page is traceable to the source listed here.

  • National Center for Health Statistics. VSRR Provisional Drug Overdose Death Counts (dataset xkb8-kh2a), 12-month-ending counts for the United States. Data accessed 20 August 2026. View source.