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Table 2 SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) schedule of enrollment, interventions, and assessments

From: The Substance Use Treatment and Recovery Team (START) study: protocol for a multi-site randomized controlled trial evaluating an intervention to improve initiation of medication and linkage to post-discharge care for hospitalized patients with opioid use disorder

Timepoint

Study period

Enrollment

Post-enrollment

−T1

T1

0

T2

Screening, consent

Baseline

Intervention (during hospital stay)

Intervention follow-up (post-discharge)

Follow-up interview (30–60 days post-discharge)

 Eligibility screen

X

    

 Informed consent

X

    

 Randomization

 

X

   

Interventions

 Intervention 1

X

X

X

X

X

 Control

X

X

  

X

Assessments

 ASSIST

X

    

 Demographics

X

    

 MOUD utilization

X

   

X

 Employment

 

X

  

X

 Depression (PHQ-9)

 

X

  

X

 Anxiety (GAD-7)

 

X

  

X

 Social support (MSPSS)

 

X

   

 Overdoses

 

X

  

X

 Pain intensity and frequency (PEG)

 

X

  

X

 30-day opioid (and other substance) use (adapted from NSDUH)

 

X

  

X

 SUD treatment utilization (adapted from NSDUH)

 

X

  

X

 SUD healthcare and mental health utilization (adapted from GAIN)

 

X

  

X

 Opinions about MOUD

 

X

   

 Severity of substance use (PROMIS)

 

X

  

X

 Patient experience of stigma

 

X

   

 Significant other with OUD

 

X

   

 Criminal justice involvement

 

X

   

 Patient experience of chronic illness care (PACIC)

    

X

 Therapeutic alliance (CAHPS)a

    

X

 Satisfaction with STARTa

    

X

  1. aIntervention group only