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临床试验/NCT05461066
NCT05461066已完成不适用

Tobacco Cessation Care Service in the Community Pharmacy: Cost-effectiveness of a Non-randomized Cluster-controlled Trial at 12-months' Follow-up

Sociedad Espanola de Farmacia Clinica, Familiar y Comunitaria0 个研究点目标入组 800 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
800
主要终点
Cost-effectiveness

研究概览

简要总结

The study was a non-randomized controlled trial of 12-months' follow-up with 182 Spanish community pharmacists. Intervention community pharmacists received the CESAR training to improve their smoking cessation services, consisting of an initial interview and follow-up visits to identify obstacles and reinforce behaviours. The control group received the usual care. Data were self-reported and collected in a computerized health registration system. Outcomes were smoking cessation and quality of life (EuroQOL-5D) collected at baseline, 6 months', and 12 months' follow-up. Cost data were collected for the study period and included direct health costs, sick leave, and intervention costs. Smoking cessation was analysed through logistic regression models. Generalized linear models were carried out for quality-adjusted life year costs. Incremental cost-effectiveness ratios (ICERs) and cost-utility ratios (RCUI) were calculated. Sensitivity analyses were performed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •smoker over 18 years old
  • •consent to participate
  • •presence at the community pharmacy for one of three reasons (a) a medical prescription for a treatment to stop smoking, (b) a consultation about how to stop smoking, (c) asking if he/she smokes when he/she consults for associated symptoms or harm.

排除标准

  • •cognitive impairment
  • •drug uses
  • •pregnancy or lactation.

研究组 & 干预措施

Intervention

Experimental

Smoking cessation intervention in community pharmacies

干预措施: CESAR training (Behavioral)

Control

Active Comparator

Usual care of smoking cessation in community pharmacies

干预措施: CESAR training (Behavioral)

结局指标

主要结局

Cost-effectiveness

时间窗: 1 year

In cost-effectiveness, the deterministic Incremental Cost Effectiveness Ratio (ICER) is the coefficient resulting from dividing the difference between groups in costs by the difference in probability between groups that an additional patient will cease their smoking history.

Smoking cessation

时间窗: Before/after the intervention (1 year)

Dichotomicus variable (yes/no)

Quality of Life (EuroQOL-5D)

时间窗: 1 year

Measured with EuroQOL-5D

Cost-utility

时间窗: 1 year

For the cost-utility, the Deterministic Incremental Cost-Utility Ratio (ICUR) is the coefficient resulting from dividing the difference between groups in costs by the difference between groups in quality-adjusted life years.

次要结局

未报告次要终点

研究者

发起方
Sociedad Espanola de Farmacia Clinica, Familiar y Comunitaria
申办方类型
Other
责任方
Sponsor

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