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Table 1 Timing of the DIGITS Trial’s assessment schedules, following SPIRIT 2013 guidelines (Standard Protocol Items: Recommendations for Interventional Trials)

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)

 

Enrollment

Allocation

Post-allocation

Close-out

TIMEPOINT

-t1

0

t1

t2

t3

t4

t5

t6

t7

t8

tx

ENROLLMENT:

           

Clinic eligibility assessment

X

          

Allocation to study arm1

 

X

         

PERIODS:

           

Active implementation

  

X

X

X

X

     

Sustainment

      

X

X

X

X

 

INTERVENTIONS:

           

reSET & reSET-O availability

  

X

X

X

X

X

X

X

X

 

Standard implementation

  

X

X

X

X

     

Practice facilitation

  

X

X

X

X

     

Health coaching

  

X

X

X

X

     

ASSESSMENTS:

           

Covariates2

X

X

X

X

X

X

X

X

X

X

 

Implementation costs

X

X

X

X

X

X

     

Reach3 & adoption

  

X

X

X

X

     

Fidelity, engagement

  

X

X

X

X

X

    

Substance use, abstinence from screening data

  

X

X

X

X

X

X

X

X

X

Substance use, abstinence from reSET & reSET-O data

  

X

X

X

X

X

    

Sustainment

      

X

X

X

X

 
  1. t1 through t8 are discrete 3-month periods. Sites with shorter active implementation and sustainment periods have shorter assessment periods. For instance, the reach & adoption assessment period will be 7 months for a site with a 7-month active implementation period.
  2. 1While sites are allocated to arms upon randomization, an open cohort design is used to identify patients for the analysis. Patients who visit a site after randomization, or in the 2 weeks before randomization, are eligible for the analysis. This 2-week period before randomization allows for the possibility that clinicians will identify patients with recent visits who could benefit from the intervention. 2Patient covariates are assessed in the year prior to a patient’s qualifying visit. 3For each patient, we will identify whether they were reached from the day of their first qualifying visit through the end of the active implementation period plus a 2 week “grace” period. The grace period allows patients who have their first qualifying visit at the end of active implementation at least 2 weeks to be reached.
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Implementation Science

ISSN: 1748-5908