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临床试验/NCT03130998
NCT03130998已完成不适用

A Cluster Randomized Trial of Tailored vs Generic Knowledge Brokering to Integrate Mood Management Into Smoking Cessation Interventions in Primary Care Settings in Ontario, Canada

Centre for Addiction and Mental Health2 个研究点 分布在 1 个国家目标入组 2,765 人开始时间: 2018年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,765
试验地点
2
主要终点
Resource accepted by patient

研究概览

简要总结

Compared to smokers who are not depressed, smokers with depression who try to quit smoking are 10% less likely to succeed when given standard treatment. A simple program with a detailed handout on relaxation exercises and a journal to record mood and urges to smoke when trying to quit has been shown to increase quit success in depressed smokers by 12 to 20%. However, it remains unclear how to best implement this knowledge into primary care settings.

Through this study, the investigators will seek to answer the following questions:

  • Does a knowledge broker communicating via generic email reminders engage clinicians to provide patients resources for mood management more or less frequently than via interactive technology (eKB)?
  • Which Knowledge Translation (KT) strategy used to change clinicians' behavior (emails vs. eKB) has the greatest effect on smoking quit rates in depressed smokers?
  • What is the incremental cost effectiveness of the two KT strategies?

详细描述

Given the cost-effectiveness of smoking cessation programs, the Centre for Addiction and Mental Health implemented the STOP program in 147 Family Health Teams (FHTs) treating 47,888 smokers with nicotine replacement therapy and counselling. Following the knowledge to action framework every FHT in STOP uses a web portal with an integrated decision aid, data collection, and feedback tool. Though STOP data finds lower quit rates among smokers with depression, it currently does not offer specialized clinical pathways for depressed smokers.

Both smoking and depression are major public health problems with high morbidity and mortality. Individuals with depression are almost twice as likely to be smokers, have lower long-term smoking abstinence (OR=0.81, 95% CI=0.67-0.97), and experience greater addiction severity and negative mood when quitting smoking. In the STOP Program, 38% of smokers have current or past depression; their 6-month quit rates are significantly lower than participants without depression (33% vs. 40%, p<0.001). This has led FHT-STOP practitioners to express the need for specialized clinical pathways for depressed smokers.

Self-help mood management (relaxation exercises and mood monitoring) integrated with smoking cessation treatment increases long-term quit rates by 12 to 20%. More research is needed to test the effectiveness of an integrated care pathway (ICP) for depression as part of cessation treatment. It is unclear which KT strategy would be more effective in engaging clinicians and driving behavior change. A randomized controlled trial in Public Health Units (PHUs) found no difference in health care provider behavior when prompted by a knowledge broker, emails or websites. However , similar to other studies, it showed the need to match organizational research culture to KT strategy; emails worked better in PHUs with a strong research culture, while KBs seemed more suitable in PHUs where research culture was low. Given that FHTs range anywhere from academic- to community-based research cultures, it is unclear which KT strategy will be most effective.

CAMH's existing Smoking Treatment for Ontario Patients (STOP) program works in partnership with 80% of eligible Family Health Teams (FHTs) in Ontario and has treated 47,888 smokers with free nicotine replacement and counselling since July 2011. Based on data already collected in the STOP Program, the STOP portal (an online data management and collection tool used by all STOP practitioners to complete participant enrollment and record smoking status at each visit), will flag smokers with current or past depressive symptoms. FHTs will be randomly allocated 1:1 to receive messages regarding depression and smoking exclusively via email (Group A) or via an eKB who will develop a one-on-one relationship with clinicians through frequent phone calls, web conferencing, and emails (Group B). The investigators will compare which method is more effective in changing clinician behavior by recording the number of times resources are provided to eligible patients. Investigators will also compare the smoking quit rates of patients from the two groups at 6-month follow-up and ask clinicians and patients what they liked and disliked about the program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • Must be Family Health Team (FHT) participating in the Smoking Treatment for Ontario Patients (STOP) program
  • FHT must use online portal to complete STOP questionnaires, in English, in real-time with patient

排除标准

  • Non-FHTs participating in STOP program
  • Clinics who conduct STOP questionnaires exclusively on paper, or in French, or not in real-time with patient

结局指标

主要结局

Resource accepted by patient

时间窗: : Approximately 2-5 minutes as part of a brief intervention between the practitioner and patient

The primary outcome will be the provision of the mood management intervention to eligible patients upon completion of the STOP smoking cessation program enrollment. This dichotomous outcome will be measured as positive by a response of "Patient accepted the resource" to the practitioner question "Did the patient accept or decline the resource?". In contrast, the outcome will be measured as negative if given a response of "Patient declined the resource" to the practitioner question "Did the patient accept or decline the resource?" or a response of "no" to the practitioner directive "Provide this patient with resources on mood management."

次要结局

  • Smoking Abstinence(Approximately 10 minutes during 1-hour appointment between practitioner and patient)
  • Cost-effectiveness(6-month follow-up)
  • Decrease in depression scores(6-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Selby

Director, Medical Education

Centre for Addiction and Mental Health

研究点 (2)

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