Sherman 2008.
| Study characteristics | ||
| Methods | Design: Cluster‐randomized controlled trial Setting: 18 Veterans Health Administration (VA) sites in California, USA Recruitment: Proactive calls to patients |
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| Participants | 2965 patients referred for smoking cessation telephone counseling. av.age 57, 93% M, av. cpd not reported | |
| Interventions | Intervention: • Practices received telephone care coordination program which allowed providers to be able to make a simple 2‐click referral. Practices were also provided with proactive care coordination • Participants, once connected to the quitline, were scheduled to receive a single 30 ‐ 45‐minute counseling sessions within 7 days. A Veterans Health Administration care coordinator monitored medications (nicotine patches or bupropion) prescribed by a designated smoking cessation clinician. The care coordinators also offered follow‐up counseling telephone calls at 2, 4, 6 and 8 weeks after the quit date and at 6 months. Control: usual care comprising direct treatment by a primary care provider, referral to a Veterans Health Administration smoking clinic, or informal referral to an outside resource such as a quitline |
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| Outcomes | 30‐day PPA at 6m Valdiation: None Providers were asked to approximate the following provider implementation outcomes:Assist, Arrange; |
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| Funding Source | Grant SUDCC 3.10 from the Veterans Affairs Substance Use Disorders Quality Enhancement Research Initiative and by grant HFP 94‐028 from the Veterans Affairs Health Services Research and Development Center of Excellence for the Study of Healthcare Provider Behavior | |
| Author's declarations of interest | QUOTE: "the authors (SES, NT, PK, EG, JWF, JC, JFK, GJJ, WK) report no relationship or financial interest with any entry that would pose a conflict of interest with the subject matter of this article" | |
| Notes | Strategy: Adjunctive counseling + EMR prompts Level: Patient, practice Comparison type: Multicomponent vs. standard care Abstinence is only reported for the intervention arm and not the standard‐care arm. Attempts to contact the authors were unsuccessful. Data are therefore not analyzed for any of the outcomes |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Sequence Generation | Unclear risk | No details reported |
| Allocation concealment | Unclear risk | No details reported |
| Blinding of outcome assessors All outcomes | High risk | Smoking status self‐report. Person‐to‐person contact was different between groups |
| Incomplete outcome data All outcomes | Unclear risk | No details on loss to follow‐up at participant level were reported |
| Recruitment bias (cluster RCTs only) | Low risk | Participants were affiliated with the sites before randomization |
| Balanced baseline characteristics? (cluster RCTs only) | Unclear risk | No details reported |
| Adjustment for clustering in analysis? (cluster RCTs only) | Unclear risk | No details reported |