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临床试验/NCT05864612
NCT05864612已完成不适用

Developing Interoperable Tools for Anxiety and Depression Screening in Epilepsy

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 880 人开始时间: 2023年9月20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
入组人数
880
试验地点
1
主要终点
Percentage of Subjects Completing Screening Instruments

研究概览

简要总结

A randomized trial to compare patient-completion success of REDCap and Electronic Health Record (EHR)-based anxiety & depression instrument delivery methods. Study hypothesis is that the screening completion proportion will vary across the 4 modalities tested.

详细描述

In this randomized study of four modalities, we will compare Twilio text message delivery via REDCap versus (vs.) REDCap email survey links vs. EHR portal questionnaires with reminder message vs. current standard delivery EHR portal questionnaires without reminder. Screening instruments will be delivered by randomized method 7 days prior to scheduled clinic visit and outcomes occur by the time of the scheduled clinic visit. The study setting is the Wake Forest Comprehensive Epilepsy Center, with 2 clinic sites where adult patients are served (Atrium Health Wake Forest Baptist main campus, Atrium Health High Point Medical Center). EHR portal questionnaires without reminder is the current standard care screener delivery method. An exploratory supplement randomizing individuals to text message versus email survey link was later added.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • •Visit scheduled 7 days in advance at an adult-focused epilepsy clinic at the study site

排除标准

  • •No exclusions

研究组 & 干预措施

Text Message

Active Comparator

Subjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by Twilio text message.

干预措施: Screening Questionnaires (Behavioral)

Customized Email Prompt

Active Comparator

Subjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by an email with a REDCap email survey link.

干预措施: Screening Questionnaires (Behavioral)

Generic Electronic Health Record (EHR) portal email

Active Comparator

Subjects in this arm will be prompted with customized EHR portal message after login to EHR portal.

干预措施: Screening Questionnaires (Behavioral)

EHR Portal with No Message

Active Comparator

Subjects in this arm will not receive a reminder, but previsit questionnaires associated with a visit will be in their EHR portal.

干预措施: Screening Questionnaires (Behavioral)

结局指标

主要结局

Percentage of Subjects Completing Screening Instruments

时间窗: Week 1

Percentage of subjects completing screening instruments by each of the 4 methods prior to clinic visit will be used to compare the effect of the different methods on patient self-completion, and to estimate completion rates by different methods for use in future screening implementation trials.

次要结局

  • Research Team Time-sending Instruments(Baseline Day 0)
  • Research Team Time-instrument Data Entry(Week 1)
  • Participant Time From Instrument Delivery to Completion(Week 1)
  • Percent Accuracy of Kit Application Programming Interface (API)(Week 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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