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临床试验/NCT02560090
NCT02560090已完成不适用

Transforming Patient-Centered Medical Homes Into Medical Communities for Underserved Rural Patients

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2015年6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
58
试验地点
2
主要终点
Change of Number of Hospital Re-admissions from 2 Years Prior to Study Enrollment to 1 Year After Study Completion

研究概览

简要总结

Bamberg County residents who has been diagnosed with or is at high risk for diabetes, may be eligible for a clinical research study to improve diabetes self-management and decrease hospital re-admissions.

The purpose of this study is to compare the effectiveness of three hospital discharge follow-up methods:

  1. standard of care,
  2. a nurse telephone intervention (care coordination and education), and
  3. an in-home community health worker intervention (care coordination and education).

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Bamberg County resident
  • between 18 and 75 years of age
  • a patient discharged from the Regional Medical Center emergency department or Regional Medical Center hospital within 72 hours prior to consent
  • diagnosed with diabetes or at high risk for diabetes
  • will be a Regional Medical Center patient for follow-up care
  • speaks English
  • has access to a phone
  • Stage 2 Recruitment:
  • If recruitment at 3 weeks after the first patient is enrolled is < 15 or the recruitment at 12 weeks is < 45, additional inclusion criteria will include the following: Regional Medical Center outpatient or unassigned community member with uncontrolled diabetes (defined as A1C >8 or blood pressure >140/90) is uninsured or who self-reports problems with obtaining medications.

排除标准

  • end-stage renal disease
  • terminal illness (e.g., advanced cancer, end-stage chronic obstructive pulmonary disease, advanced dementia)
  • incarceration
  • resident in a skilled nursing home.

研究组 & 干预措施

Control Group

Placebo Comparator

Survey assessments as well as collection of medical records and billing information.

干预措施: Surveys (Behavioral)

Telephonic Nurse Intervention

Active Comparator

Survey assessments as well as collection of medical records and billing information. A nurse will communicate with participants via telephone to support diabetes self-management practices.

干预措施: Surveys (Behavioral)

Telephonic Nurse Intervention

Active Comparator

Survey assessments as well as collection of medical records and billing information. A nurse will communicate with participants via telephone to support diabetes self-management practices.

干预措施: Telephonic Nurse Intervention (Behavioral)

In-person Community Health Worker Intervention

Active Comparator

Survey assessments as well as collection of medical records and billing information. A community health worker will work with participants in person to support diabetes self-management practices.

干预措施: Surveys (Behavioral)

In-person Community Health Worker Intervention

Active Comparator

Survey assessments as well as collection of medical records and billing information. A community health worker will work with participants in person to support diabetes self-management practices.

干预措施: In-person Community Health Worker (Behavioral)

结局指标

主要结局

Change of Number of Hospital Re-admissions from 2 Years Prior to Study Enrollment to 1 Year After Study Completion

时间窗: Retrospective billing collection 2 years prior to study enrollment and 1 year after study completion

Hospital data will be obtained from Revenue and Financial Affairs South Carolina Data Oversight Council. These data come from the health organization where patients receive care and include components such as age, health care facility type, dates of admission/ discharge, length of stay, charges, payment source, primary and secondary procedure codes.

Change of Self-management Success Measured by Diabetes Self-Management Assessment Survey Tool from Baseline to Study Completion

时间窗: Baseline, 1 month post-enrollment, 2 months post-enrollment, 3 months post-enrollment (study completion)

Diabetes self-management assessment tool administered to participant over the phone or in-person

次要结局

  • Change of Diet Measured By a 24-item Introduction to the Lifestyle Survey from Baseline to Study Completion(Baseline, 1 month post-enrollment, 2 months post-enrollment, 3 months post-enrollment (study completion))
  • Change of Health Goal Progress Captured by Field Notes to Track Intervention Activities from Baseline to Study Completion(Baseline, 1 month post-enrollment, 2 months post-enrollment, 3 months post-enrollment (study completion))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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