Morgan 1996.
| Study characteristics | ||
| Methods | Design: Cluster‐randomized controlled trial Setting: Primary care practices in suburban Philadelphia and eastern Pennsylvania, USA Recruitment: Conducted in practice |
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| Participants | 49 practices without a formalized smoking intervention program 1318 people who currently smoked aged 50 ‐ 74 years, presenting for a non‐emergency visit to the practice. 56% F, 20 cpd, av. age 60 |
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| Interventions | Intervention: • Practices received on‐site training to implement a modified National Cancer Institute (NCI) smoking cessation intervention based on the 4 A's. Physicians were trained to praise participants for previous quit efforts, provide personalized feedback, discuss the health benefits of quitting for older people who are smoking, and give a clear message to quit smoking • Participants received a smoking cessation guide tailored to older people who smoke and were offered help with quitting. They were also sent a follow‐up letter drafted by the Clear Horizons office from their physician within 1 week of their visit, a brief follow‐up quitline counseling call from the project staff within 2 ‐ 4 weeks of the intervention visit. They were also provided with a medical record flowchart specifically made for smoking cessation ‐ people who smoked, in the precontemplation stage, who declined help: received brief guide‐based counseling to overcome quitting barriers ‐ people who smoked, in the contemplation stage received brief guide‐based counseling to set up a quit plan and quit date and a prescription for nicotine gum (free 1‐week samples) Control (usual care): practices in this group were instructed to provide usual care to older people who smoked over the accrual and follow‐up period. No further details reported |
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| Outcomes | 7‐day PPA at 6m Validation: None Provider implementation outcomes were only measured in the intervention group |
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| Funding Source | Not reported | |
| Author's declarations of interest | Not reported | |
| Notes | Strategy: Provider training + cost‐free medications + adjunctive counseling + flowchart Level: Patient, Provider, Practice Comparison type: Multicomponent vs. standard care |
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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 | Low risk | Smoking status self‐report. At participant level, there was no variation in contact |
| Incomplete outcome data All outcomes | Unclear risk | QUOTE: "Of the 659 patients who completed the baseline questionnaire, 573 (87%) were contacted for a telephone interview at the 6‐month follow‐up". Follow‐up rates by group were not reported |
| Recruitment bias (cluster RCTs only) | Low risk | Participants were affiliated with the practice before randomization |
| Balanced baseline characteristics? (cluster RCTs only) | High risk | QUOTE: "Immediate and delayed intervention practices did not differ significantly in the mean number of patients enrolled, gender of patients enrolled, or reporting of quit attempts lasting 24 hr or more in the previous year... patients in the two conditions did differ in age, average number of cigarettes smoked daily, time elapsed until first cigarette of the morning, and contemplation status" |
| Adjustment for clustering in analysis? (cluster RCTs only) | Low risk | QUOTE: "A correlated logistic regression model that accounted for dependencies among respondents within a given practice was utilized" |