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Table 1 Major study design differences between Helping HAND 1 and Helping HAND 2

From: Comparative effectiveness of post-discharge strategies for hospitalized smokers: study protocol for the Helping HAND 2 randomized controlled trial

Characteristics

Helping HAND 1

Helping HAND 2

Goal of the Change

Enrollment

   

Study sites

MGH

MGH, NSMC, UPMC

Increase generalizability

Enrollment criteria

Exclude active alcoholics

Include active alcoholics

Increase generalizability

Exclude past year substance users (except marijuana)

Substance use allowed unless current admission was for IV drug overdose

No suicidal attempt in past year

No suicidal attempt in past 3 months

Patients with HIV infection

Not prioritized

Prioritized

Increase enrollment of vulnerable population with high prevalence of smoking

Intervention

   

Counseling after hospital discharge

Hospital tobacco counselor by telephone

Quit Coach by telephone

Streamline access to live counselor by linking IVR call directly to counseling resource using ‘real world’ counseling resource

Nicotine Replacement Therapy after discharge

Refilled and shipped by hospital study staff

NRT refilled through Quit Coach and shipped from Alere warehouse

Streamline medication refill process using ‘real-world’ design

Follow-up

   

Follow-up calls

1, 3, and 6 months

1, 3 and 6 months (all) 12 months if continuously abstinent at 6-month follow-up

Determine stability of cessation

  1. MGH = Massachusetts General Hospital.
  2. NSMC = North Shore Medical Center.
  3. UPMC = University of Pittsburgh Medical Center.