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Table 4 Primary, secondary, and other outcomes in the DIGITS Trial1

From: Study protocol for a factorial-randomized controlled trial evaluating the implementation, costs, effectiveness, and sustainment of digital therapeutics for substance use disorder in primary care (DIGITS Trial)

Primary Outcome Measures

Reach. Reach of the digital therapeutic to patients in the primary care clinic, measured as the proportion of patients who initiate the digital therapeutic, defined by instances in which patients open the app, enter the prescription code, and use a treatment module

Fidelity. Fidelity of patients' use of the digital therapeutic to clinical recommendations, measured as the mean number of weeks during patients’ 12-week prescription in which patients use 4 app modules/week and have visited a clinician in the past 30 days2,3

Secondary Outcome Measures

Engagement (patient engagement in substance use care). Mean number of months in which patients make ≥1 visit for substance use disorder2,3

Economic costs. Costs from the perspective of a health system and payer including implementation, direct intervention, operating, and other indirect healthcare costs. This measure will be used to calculate the population-level cost effectiveness of increasing reach, fidelity, and engagement.

Other Pre-Specified Outcome Measures

Reach-2. The proportion of patients prescribed the digital therapeutic

Fidelity-2. Mean number of weeks in which patients use at least 1 module/week3

Substance use. The proportion of patients who are reached and reduce their substance use4

Abstinence. The proportion of patients who are reached and are abstinent from substances4

Sustainment. The proportion of patients who are reached during the sustainment period.

Other Explanatory and Sensitivity Analysis Measures

Adoption. The proportion of healthcare provider prescribing the digital therapeutic, overall and by provider type

Adoption-2. The mean number of months in which providers access clinician dashboards

Reach-3. Proportion of patients who download and unlock the digital therapeutic

Fidelity-3: Mean number of weeks in which the patients use at least 1 module/week3

Fidelity-4: Mean number of weeks in which the patients use 4 modules per week but without the requirement that they visit a clinician3

Fidelity-5: Mean number of modules completed over the 12-week prescription3

Substance use-2. The proportion of patients who are reached and reduce their substance use, as measured by self-report data collected by the digital therapeutic

Abstinence-2. The proportion of patients who are reached and are abstinent from substances, as measured by self-report data collected by the digital therapeutic

Abstinence-3. Abstinence verified by urine drug screens among patients prescribed the digital therapeutic for opioid use disorder, based on EHR data

  1. EHR=electronic health record
  2. 1Primary, secondary, and other pre-specified outcome measures are described as registered on ClinicalTrials.Gov. The other explanatory and sensitivity analysis measures were not registered.
  3. 2Visits must indicate that the clinician coded an International Classification of Disease (ICD-10) substance use disorder diagnosis.
  4. 3Fidelity and engagement are measured while a prescription is active, even if the prescription starts before but ends after their clinic’s active implementation period is complete.
  5. 4Pre-specified substance use and abstinence are collected via self-report as part of routine annual screening for cannabis, alcohol, and other drug use [22]. The assessment period includes up to 18 months after each patient’s qualifying visit to help ensure a follow-up measure is collected. These will be analyzed among patients who become eligible before the last 3 months of active implementation (to help ensure the patients could complete the 12-week prescription before the outcomes were measured). Substance use will also be assessed separately by each type (i.e., drug-specific reductions in the frequency of cannabis use, illicit drug and prescription medications use, and alcohol use separately).
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Implementation Science

ISSN: 1748-5908