Identification of Excessive Substance Use to Encourage Behaviour Change Among Young People in Primary Care: Pilot Study in Preparation for a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- The proportion of participating patients who returned a completed baseline questionnaire (=patients included in study).
研究概览
简要总结
Background: Excessive alcohol and other substance use in adolescence is prevalent and has developmental consequences that extend into adulthood. In parallel with other public health and clinical measures, early identification in primary care represents an important step to address this problem. Screening and brief intervention by primary care physicians is recommended but often fails to be implemented due to time constraints and other barriers. Working hypothesis: Recent evidence suggests that simply asking individuals about their substance use may in itself encourage behaviour change, regardless of the clinical intervention that may follow. This hypothesis has not as yet been tested in a population of young people consulting in primary care. The investigators hypothesise that inviting young people to complete a brief substance use screening questionnaire in the waiting room before their primary care consultation has the potential to lead to a decrease in substance use in the months following this consultation.
Specific aims: The aim of this pilot project is to develop and test the methods for a future randomized trial. The future trial will assess the effectiveness of pre-consultation substance use screening, compared to screening for other behaviors, on subsequent substance use in young people between the ages of 15 and 24 years consulting primary care physicians.
Expected value of the proposed project: The clinical context of primary care has the potential to trigger behavior change in young people, thus favoring improved adult outcomes in this population. If effective, pre-consultation substance use screening could contribute to a reduction in excessive substance use among young people in a simple and cost-effective way. This pilot study will provide precious feasibility data for the design of the related cluster randomised trial.
详细描述
Background:
Excessive alcohol and other substance use in adolescence has short and long term consequences on health and contributes extensively to lifelong morbidity. Since prevalence of this excessive use is high among young people consulting in primary care, primary care physicians (PCPs) are well placed to address this problem. PCPs are encouraged to screen and provide brief interventions addressing excessive substance use in young people, but a range of barriers, such as time constraints and insufficient training, limits the implementation of these recommendations in primary care practices. Several recent trials of brief primary care interventions showed substantial reductions in the proportion of participants who were excessive substance users at follow-up (20% to 30% reductions), but no statistically significant differences between the intervention and control groups. Reductions in substance use in the control group can be due to several factors: 1) Regression to the mean (repeat participant responses show a trend towards the mean values for the participating population), 2) Research participation effects (e.g. Hawthorne effect, social desirability bias), 3) Historical trends which affect the entire population, such as reductions in per capita alcohol use in relation to public health measures, 4) Assessment reactivity, when pre-intervention assessment itself encourages behavior change and thus serves as an intervention. In a randomized design these factors should apply equally to both groups, and additional effects of the tested intervention may still be visible. If reductions in substance use at follow-up are due to assessment reactivity, this suggests screening in the clinical context could act as an intervention in itself and be as effective as a brief intervention within the consultation. To date this hypothesis has not been explored in a population of young people attending primary care.
Aim of the Trial:
To assess the effectiveness of simply screening participants for excessive substance use before the consultation in the waiting room in reducing the prevalence of excessive substance use in young people attending primary care.
Objectives of the pilot study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants: Although they cannot be masked to the content of the intervention (questionnaire), they are only informed that the study is about health behaviours in general. Thus, they are masked as to whether they are in the intervention or control group.
Care provider: As they cannot have access to the participants' questionnaires, they are masked.
入排标准
- 年龄范围
- 15 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients consulting at the participating primary care practice during the recruitment period (2 months).
排除标准
- •Acute illness requiring immediate attention of the physician
- •Severe mental health conditions requiring treatment in a specialized setting
- •Inability to read the trial information in French
- •Person not consulting as a patient (e.g. parent of a child consulting a pediatrician, accompanying friend or partner).
研究组 & 干预措施
Substance use
In this screening intervention, participants complete a substance use questionnaire (=intervention).
干预措施: Substance use questionnaire (Other)
Physical activity
In this screening control condition, participants complete a physical activity questionnaire (=control).
干预措施: Physical activity (Other)
结局指标
主要结局
The proportion of participating patients who returned a completed baseline questionnaire (=patients included in study).
时间窗: 2 months
The PCPs did not check whether the questionnaires had been completed correctly (for confidentiality reasons). This proportion was thus determined by the research team. A questionnaire was considered "complete" if: 1. Consent form was signed, 2. Phone number was given, and 3. at least 50% of questions had been answered.
The proportion of patients at follow-up who consumed cannabis at least once in the last 30 days.
时间窗: 2 months
Patient self-report on follow-up telephone questionnaire. This outcome serves to ascertain that the study target group (= young people consuming alcohol or cannabis) can be reached through the study procedures.
The proportion of PCPs who recruited at least 5 patients within a 2-month period
时间窗: 2 months
The participating PCPs were asked to recruit a minimum of 5 patients, but the recruitment period was limited to 2 months (for practical and financial reasons). All participating PCPs participated in the pilot study thinking that they would be able to recruit 5 patients. This outcome thus gives us an idea about whether PCPs had a realistic idea about their ability to recruit a sufficient number of eligible patients.
The proportion of patients included in the study who answered the follow-up questionnaire at one month.
时间窗: 2 months
Patients who could be contacted by phone one month after the baseline questionnaire, and who agreed to answer the second questionnaire (over the phone, with a member of the research team).
The number of patients recruited by each PCP within a 2-month period
时间窗: 2 months
A maximum of 10 patients were to be recruited by each of the 6 participating primary care physicians (PCPs) within a 2-month period. The target number was 5 patients per PCP, but the recruitment period was not prolonged if this target was not met.
The proportion of eligible patients who agreed to participate
时间窗: 2 months
Measurement tool : A form completed by the PCPs assistants, documenting how many patients were approached, how many refused, and how many had exclusion criteria.
The proportion of PCPs who respected the pre-determined sequence of questionnaires (randomized sequence).
时间窗: 2 months
Each PCP received a unique randomized sequence of intervention and control questionnaires, in envelopes numbered from 1 to 10. At the end of the two-month recruitment period, they returned all envelopes (completed and empty questionnaires). The research team checked whether the sequence from 1 to 10 had been respected.
The proportion of patients at follow-up who consumed alcohol at least once in the last 30 days.
时间窗: 2 months
Patient self-report on follow-up telephone questionnaire. This outcome serves to ascertain that the study target group (= young people consuming alcohol or cannabis) can be reached through the study procedures.
次要结局
- The proportion of participants choosing to complete the paper questionnaire vs the online version.(2 months)
- PCPs critical comments regarding patient recruitment in their practices.(1 month)
- Proportion of patients at follow-up stating that the procedures in the PC practices respected confidentiality.(2 months)
研究者
Prof. Dagmar M. Haller
Professor
University of Geneva, Switzerland