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临床试验/NCT05180721
NCT05180721已完成不适用

A Multi-level Intervention to Increase Access and Use of the Patient Portal

Yale University4 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年10月3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
26
试验地点
4
主要终点
Usage of Portal

研究概览

简要总结

The purpose of the study is to develop and evaluate a multi-level intervention aimed at increasing access and use of patient portals for diabetes management (MAP) in community health centers (CHCs).

详细描述

Prior to the clinical trial, qualitative methods were used to inform the intervention protocol. For the clinical trial, a pilot study will be conducted to evaluate the effect of the intervention on patient portal use, patient engagement with care, and clinical outcomes in adults with type 2 diabetes. The focus of this registration is the clinical trial.

Using a within subjects, pre-post design the investigator will pilot MAP in an anticipated 30 adults with T2D who are not using the portal. Data will be collected at baseline, 3, and 6 months. The investigators will evaluate the feasibility of MAP using an established framework (acceptability, demand, implementation, adaptation, and integration.

The intervention will consist of the following:

  1. provide free access to tablets and internet (material circumstances);
  2. technology training and ongoing support (psychosocial factors);
  3. assess social determinants of health and refer to community resources (material circumstances);
  4. support diabetes self-management behaviors and refer to clinic services (behavioral and biological factors).

MAP will be delivered by community health workers (CHW) and nurses already embedded in CHCs (healthcare system). The 3-month intervention is thoughtfully sequenced to first have CHWs address patient portal access (tablet, home internet), and then move on to patient mastery of the tablet and portal functionality. Next, CHWs will assess social determinants of health using an established measure and connect the participant to relevant community resources (e.g., SNAP benefits). It is anticipated that participants will have 4-6 individual sessions with the CHW, approximately 30 minutes each, followed by ongoing technology support as needed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • Established patient of one of the partner CHCs
  • Age > 18 years
  • Diagnosed with T2D >6 months
  • Able to read in English or Spanish
  • Not using the patient portal
  • A1c >7.5%

排除标准

  • Cognitive impairment (≥3 errors on the Six Item Screener for cognitive impairment in clinical research [SIS]) (Callahan et al. 2002) as they will have difficulty in completing the study requirements
  • Gestational diabetes

结局指标

主要结局

Usage of Portal

时间窗: Monthly for 6 months

Frequency. Mean portal login days/per month will be calculated using the EMR system

Change in A1C Value

时间窗: Baseline, 3 months and 6 months

The A1C value will be assessed via fingerprick point of care A1c kits.

Usage of Portal

时间窗: Monthly for 6 months

Frequency. Mean portal login days/per month will be calculated using the EMR system

次要结局

  • Problem Areas in Diabetes (PAID)(Baseline, 3 and 6 months)
  • Summary of Self-Care in Diabetes Survey- Diet(Baseline, 3 months, and 6 months)
  • Diabetes Self-Efficacy(Baseline, 3 months, 6 months)
  • Health Care Climate Questionnaire(Baseline, 3 months, 6 months)
  • Diabetes Self-Efficacy(Baseline, 3 months, 6 months)
  • Health Care Climate Questionnaire(Baseline, 3 months, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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