Increasing Digital Equity and Access Among Rural Patients (IDEA) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Trial engagement
研究概览
简要总结
The purpose of this research is to learn more about how access to digital resources impacts healthcare and smoking cessation in rural areas of Minnesota, Iowa, and Wisconsin.
Aim 1: Conduct a pragmatic randomized clinical trial and use mixed methods to assess the impact of providing access to technology and/or coaching support on participation in and response to a digital, evidence-based behavioral health program for smoking cessation.
Aim 2: Assess the feasibility and patient experience of providing electronic remuneration and a loaner device with data plan coverage to access the Internet for remote clinical trials participation.
详细描述
Rural Community Advisory Committee (CAC) The investigators partnered with the Mayo Clinic Community Engagement Program and Center for Health Equity and Community Engaged Research (CHCR) to form a study-specific Community Advisory Committee (CAC) consisting of 13 members. The CAC is comprised of rural patient advocates, community members and other stakeholders (e.g., MCHS clinicians, Minnesota Rural Broadband Coalition representative). The charge of the CAC is to provide advice and co-design all study materials, digital health access interventions, recruitment messaging, and study dissemination materials and strategies. The CAC met three times with the study team virtually by zoom in September, October, and November of 2021, with each meeting about 90 minutes duration. Members provided feedback on the study protocol including the recruitment messaging and materials, as well as the electronic remuneration process, smoking cessation program, and digital access interventions. The protocol and study materials that are included incorporated this feedback. The CAC will meet four times in 2022. Members will receive a $150 honorarium for each meeting attended.
Study Design
This pragmatic trial is a three-arm, randomized, parallel group design with 90 participants. All participants will receive a 12-week, digital, evidence-based behavioral health program for smoking cessation delivered through the patient portal. All participants will also receive a written guide on existing digital access resources and any other necessary materials. Participants will be stratified based on geographic location (MN, IA, WI) and randomized with 1:1:1 allocation to one of three digital health access intervention groups:
- Control Condition- no additional study intervention (n=30),
- Loaner Digital Device - participants will be loaned a Bluetooth enabled iPad with data plan coverage for the study duration (n=30),
- Loaner Digital Device + Coaching Support - participants will receive the same loaner device described for Group 2 plus up to six coaching calls, 15-20 minutes each in duration. The research coach will use motivational interviewing and goal setting to enhance the participant's technology access and use and digital literacy (n=30).
All participants will complete study assessments at baseline, and at 4 and 12-weeks post-randomization. Outcomes will be assessed using mixed methods. The primary outcome is a composite measure of trial engagement derived from measures of online smoking cessation program engagement (e.g., opening portal messages) and study assessment completion. Secondary outcomes are smoking-related treatment response (self-reported smoking abstinence and use of evidence-based cessation treatment). We will also assess patient experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Mayo Clinic Midwest patient (Rochester or Mayo Clinic Health System [MCHS]) (has a Mayo Clinic number)
- •Can read and speak in the English language. Based on 2019 data, 97% of our Rochester and MCHS patients speak English. The study will provide all participants with a smoking cessation program delivered through the Mayo Clinic patient portal. Currently, Mayo Clinic's portal services are not offered in languages other than English.
- •Has a Minnesota, Iowa, or Wisconsin address currently or at date of most recent visit.
- •Rural resident based on RUCA codes derived from ZIP code of current or last known address.
- •Has access to a phone (of any type). Access to a phone is needed to complete the coaching support intervention and to follow-up with participants if there are issues with accessing the patient portal for the smoking cessation intervention.
- •Current smoker defined as one or more cigarettes, cigarillos or cigars (even a puff) smoked in the past 30 days. This definition allows for enrollment of non-daily and/or "light smokers" enhancing the generalizability. To enhance the generalizability of our findings, we will enroll participants using other tobacco/nicotine products if cigarette, cigarillo, or cigar smoking is the primary product used.
- •For past 3 months not enrolled in a program or use of cessation pharmacotherapy other than ad hoc use, for example used nicotine gum or lozenge once or twice.
- •Willing to make a quit smoking attempt.
- •Has digital access barriers defined by one or more of the following:
- •based on participant ZIP code from current or last known address geocoded census block group indicates area of poor BB internet coverage; no existing Mayo Clinic patient portal account; or has a Mayo Clinic patient portal account but has not used it in the past 5 years; self-reports having no access to broadband (high speed) internet connection for personal use; and/or self-reports low digital literacy defined with the screening question "How comfortable are you using technology to manage your health care remotely? For example, using patient online services (i.e., patient portal) to schedule appointments, check for test results, or send a message to your provider?" (included: not at all or a little comfortable).
排除标准
- •Anyone not meeting all inclusion criteria will be excluded.
- •Has participated in a behavioral smoking cessation program in the past 3 months
结局指标
主要结局
Trial engagement
时间窗: 12 weeks
Composite measure of assessment completion and use of online cessation program
次要结局
- Smoking abstinence(4 and 12 weeks)
- Use of evidence-based smoking cessation treatment(4 and 12 weeks)
- Patient experience(12 weeks)
研究者
Christi Patten
Principal Investigator
Mayo Clinic