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临床试验/NCT02924207
NCT02924207已完成不适用

Electronic Decision Support for Intervention in Poorly Controlled Type 2 Diabetes

St Elizabeth Healthcare1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2016年9月1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
77
试验地点
1
主要终点
change in hemoglobin A1c from baseline

研究概览

简要总结

To determine the impact of an electronic decision support tool on physician decision making and patient outcomes for the treatment of poorly controlled diabetes mellitus. Primary endpoint will measure change in hemoglobin A1c. Secondary endpoints will examine cost of therapy and patient satisfaction with therapy. Study hypothesis is that use of the PATH decision tool will produce greater reduction overall in measurements of hemoglobin A1c in patients who participate and follow the PATH decision tool than patients who elect not to follow the PATH decision tool. PATH decision tool will provide more cost effective solutions for management of diabetic medication than current methods.

详细描述

  1. Patients of selected St. Elizabeth Physicians Primary Care Physicians without a new intervention related to the management of the patient's diabetes in the last 3 months may be contacted via telephone by research staff.
  2. During the telephone call, patients will be offered the opportunity to manage their diabetic medication by following the PATH decision tool, explaining that PATH is a computer program which finds a balance between low cost and high effectiveness. If participation is elected, informed consent will be mailed with a follow up phone call from staff, or an informed consent will be signed at their upcoming primary care office visit. Some patients may be approached during their office visit, without a prior phone call. Patients who do not have an eligible hemoglobin A1c on file, but are expecting to have an eligible hemoglobin A1c value on an upcoming blood test may consent prior to the blood test. If the hemoglobin A1c comes back >=7.0, the patient will continue following protocol. If the hemoglobin A1c comes back <7.0, the patient will be categorized as a screen failure, but will remain eligible for later enrollment. If the patient becomes eligible and is later enrolled, the patient will be assigned a new study ID number.

i) If a patient elects not to participate, the reason for not participating may be recorded in the screening log. As part of the standard of care, patients not selecting the study will be offered an appointment outside the study to address their poorly controlled diabetes.

ii) If a patient elects to participate and a hemoglobin A1c has not been drawn in the last 3 months, one will be ordered through their insurance as part of the standard of care, to be used as the baseline hemoglobin A1c for Path calculations.

  1. Patients who agree to participate maybe contacted by telephone by a licensed provider (MD or ARNP) who will enter non identifiable data from the patient's chart into the PATH decision support software. Information will be gathered from the Epic EHR and the questionnaire found on Article #2. This questionnaire may be completed by the patient, or by staff during patient interview. Some patients may complete this process during their scheduled office visit.

i) Study specific items will be recorded as illustrated in Article #4 ii) Time spent populating the data will be recorded, as part of the secondary analysis.

研究设计

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

入选标准

  • •Patient under the care of a primary care physician within St. Elizabeth Physicians
  • •>=18 years of age
  • •Diagnosis of Type 2 Diabetes for at least 6 months
  • •Hemoglobin A1c values of >= 7.0 (drawn within the last year).

排除标准

  • •Type 1 Diabetes, Secondary Diabetes, Gestational Diabetes or LADA (presence of anti-GAD, IA-2, C-Peptide <0.5)
  • •Participant is currently or intended to start hemodialysis or peritoneal dialysis during the course of the study.
  • •Chronic or planned systemic glucocorticoid use
  • •Scheduled prandial insulin therapy (premix and basal okay)
  • •Other health threatening disease state at investigator's discretion
  • •Potential participant is unable to fully comprehend the risks of study participation or comply with study procedures.
  • •New diabetes intervention in the last 3 months (change in diabetes medication or dosage)

研究组 & 干预措施

Intervention

Experimental

Path Electronic decision support arm

干预措施: PATH electronic decision support tool (Other)

结局指标

主要结局

change in hemoglobin A1c from baseline

时间窗: 1 year

change in hemoglobin A1c from baseline

次要结局

  • change in patient's perception of cost of diabetes medicine and side effects(1 year)
  • actual cost and change in frequency of drug side effects(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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