Baker 2018.
Methods | 2‐group randomised clinical trial. 2012 to 2016 Country: USA Setting: A perinatal support programme (First breath (FB)). Private and community health clinics providing perinatal healthcare services across Wisconsin as part of the FB programme |
|
Participants | 1014 pregnant women, aged 18+, smoking daily (at least 1 CPD each day for at least 1 week) at some time within the last 6 months, enrolled in Wisconsin Medicaid (BadgerCare Plus or Medicaid SSI). Intervention n = 505, control n = 509. Mean age 26, ethnicity: % white CG: 47.2% IG: 45.4%, black or African American CG: 36.9% IG: 39.8%, Asian CG: 0.8% IG: 0.2%, American Indian/Alaska Native CG: 2.0% IG: 1.0%, 'Other' CG: 2.8% IG: 1.0%, Refused/do not know/missing CG: 7.5% IG: 8.5%, Hispanic CG: 5.3% IG: 4.8%, Non‐Hispanic CG: 81.7% IG: 81.8%, Refused to answer/missing CG: 13.0% IG: 13.5% Education % Less than high school CG: 3.7% IG: 4.2%, Some high school CG: 20.6% IG: 20.6%, High school or GED CG: 34.2% IG: 34.3%, Some college or 2‐year degree CG: 25.55 IG: 22.0%, College degree CG: 3.0% IG: 5.4%, Refused to answer/missing CG: 13.0% IG: 13.7%. CPD: 1 to 10 CG: 39.3% IG: 38.4%; 11 to 20 CG: 39.1% IG: IG: 39.4%; 20+ CG: 17.5% IG: 19.4%; Refused to answer/missing CG: 4.1% IG: 2.8% |
|
Interventions |
Control Group: The study compensated all participants USD 40 for study registration/enrolment and USD 40/visit for attendance at post‐birth Visit 1 (1 to 3 weeks post‐birth) and post‐birth Visit 4 (at month 6). Participants attending visits 1 and 4 completed CO testing to biochemically verify self‐reports of abstinence from smoking; participants with CO test values of 7 ppm were considered to be abstinent. Thus, control condition participants could receive up to USD 120 Experimental Group(s): Incentive condition participants received a further USD 25/visit for any of the 6 pre‐birth visits they completed, USD 25/visit for attendance at post‐birth visits 2 and 3, USD 20/call for completion of 5 post‐birth calls, and USD 40/visit for biochemically‐confirmed abstinence at post‐birth visits 1 and 4. Thus, incentive condition participants could receive up to USD 500 for meeting all payment criteria Theoretical basis for intervention: not reported Duration of intervention: 6 months post‐birth Length of follow‐up: 6 months post‐birth |
|
Outcomes | PPA at 6 months with cut‐off CO < 7 ppm. Number of post‐birth home visits and phone calls taken; biochemically‐confirmed abstinence at the post‐birth week 1 visit; and self‐reported smoking status at the 2‐ and 4‐month visits Engagement in treatment and cost effectiveness also cited on NCT record but not reported |
|
Notes | New for 2019 update’ Previously listed as ongoing Funding: not reported Decarations of interest: not reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | FB staff used randomisation tables prepared by the UW‐CTRI to randomise women upon consent. Separate computer determined randomisation tables were created based on race (white/non‐white) and county with proportional randomisation (1:1) into the incentive and control conditions |
Allocation concealment (selection bias) | Unclear risk | Allocation not reported |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Results were CO‐verified |
Incomplete outcome data (attrition bias) All outcomes | Low risk | For the primary outcome, 316 of 509 (37.9%) control condition participants had missing data; 145 of 505 (28.7%) incentive condition participants had missing data. Participants with missing data for the primary outcome were counted as smoking (ITT) |
Other bias | Unclear risk | 6‐month follow‐up stated for primary outcome, but Table 2 results reports "4‐6 months" follow‐up |