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临床试验/NCT06869057
NCT06869057招募中不适用

Re-Engineered Discharge for Diabetes Care Transitions: Screening and Addressing Social Determinants of Health Needs at Hospital Discharge

University of Massachusetts, Worcester1 个研究点 分布在 1 个国家目标入组 412 人开始时间: 2026年6月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
412
试验地点
1
主要终点
Time to hospital service use post-discharge

研究概览

简要总结

The goal of this project is to test a novel bedside SDOH screening intervention coupled with post-discharge navigation for hospitalized patients with a diabetes diagnosis to reduce unmet social needs, compared to usual care.

详细描述

The investigators are conducting this research to test a computer-based screening tool and a care coordination protocol to help people with type 2 diabetes who report unmet social determinants of health.

Social determinants of health (SDOH) are the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks. - Office of Disease Prevention and Health Promotion Examples of SDOH include factors such as housing, transportation, education, job opportunities, income, and access to healthy food, clean air and water, and health care services. Participants who join this research will be asked to complete a screening survey about their health. Then, participants will be randomly assigned (like pulling a name out of a hat) to one of two groups:

  • Those in Group 1 will be partnered with a patient navigator whose role will be to review the results of the screening survey and help coordinate care before leaving the hospital and for 90 days after.
  • Those in Group 2 will receive treatment as usual. A list of community-based resources will be provided.

Participants in both groups will complete surveys at the beginning of the study and again at 30 and 90 days after leaving the hospital. The investigators will make reminder calls to participants in both groups about data collection and will collect information from the medical record for as long as 90 days after leaving the hospital.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None (Outcomes Assessor)

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

  • •adult aged 18 years or older
  • •diagnosed with type 2 diabetes
  • •hospitalized at Univ of Massachusetts-affiliated hospital
  • •endorsed at least 1 unmet social need via screening survey

排除标准

  • •pregnancy
  • •discharge to short or long-term nursing facility or hospital
  • •medical contraindication
  • •cognitive impairment
  • •unable to provide informed consent

研究组 & 干预措施

Intervention

Experimental

REDDCAT2 Intervention

干预措施: REDDCAT2 Post-Discharge Navigation (Behavioral)

Control

Other

Treatment as usual (TAU)

干预措施: Treatment as Usual (TAU) (Other)

结局指标

主要结局

Time to hospital service use post-discharge

时间窗: 90 days

The primary outcome is a composite measure on all types of hospital service use (emergency department, observation, or hospital readmissions), pre-specified as time-to-hospital reutilization, at 90-days post-hospital discharge. Source of the data are UMMH electronic health records and participant self-report.

次要结局

  • Changes in weight/body mass index (BMI)(Baseline, 30, and 90 days)
  • Changes in Pain Management(Baseline, 30, and 90 days)
  • Changes in Self-Management Adherence(Baseline, 30, and 90 days)
  • Changes in Illness Burden perception(Baseline, 30, and 90 days)
  • Changes in Substance Use(Baseline, 30, and 90 days)
  • Changes in Alcohol Use(Baseline, 30, and 90 days)
  • Changes in Diabetes Stigma(Baseline, 30, and 90 days)
  • Changes in Economic Quality of Life(Baseline, 30, and 90 days)
  • Changes in Depressive Symptoms(Baseline, 30, and 90 days)
  • Changes in Anxiety Symptoms(Baseline, 30, and 90 days)
  • Changes in Emotional Support(Baseline, 30, and 90 days)
  • Changes in Health Seeking Behavior(Baseline, 30, and 90 days)
  • Changes in Medication Adherence(Baseline, 30, and 90 days)
  • Changes in Perceived Competence(Baseline, 30, and 90 days)
  • Changes in Perceived diabetes self-efficacy(Baseline, 30, and 90 days)
  • Changes in Coping Skills(Baseline, 30, and 90 days)
  • Changes in Diabetes Knowledge(Baseline, 30, and 90 days)
  • Changes in Housing Insecurity(Baseline, 30, and 90 days)
  • Quantity of unmet social needs(Baseline, 30, and 90 days)
  • Changes in Glucose Control: HbA1c at point of care(Baseline and 90 days)
  • changes in Diabetes Distress(Baseline, 30, and 90 days)
  • Time to hospital service use post-discharge(30 days)
  • Changes in weight/body mass index (BMI)(Baseline, 30, and 90 days)
  • Changes in Pain Management(Baseline, 30, and 90 days)
  • Changes in Depressive Symptoms(Baseline, 30, and 90 days)
  • Changes in Self-Management Adherence(Baseline, 30, and 90 days)
  • Changes in Illness Burden perception(Baseline, 30, and 90 days)
  • Changes in Substance Use(Baseline, 30, and 90 days)
  • Changes in Alcohol Use(Baseline, 30, and 90 days)
  • Changes in Diabetes Stigma(Baseline, 30, and 90 days)
  • Changes in Economic Quality of Life(Baseline, 30, and 90 days)
  • Changes in Anxiety Symptoms(Baseline, 30, and 90 days)
  • Changes in Emotional Support(Baseline, 30, and 90 days)
  • Changes in Health Seeking Behavior(Baseline, 30, and 90 days)
  • Changes in Medication Adherence(Baseline, 30, and 90 days)
  • Changes in Perceived Competence(Baseline, 30, and 90 days)
  • Changes in Perceived diabetes self-efficacy(Baseline, 30, and 90 days)
  • Changes in Coping Skills(Baseline, 30, and 90 days)
  • Changes in Diabetes Knowledge(Baseline, 30, and 90 days)
  • Changes in Housing Insecurity(Baseline, 30, and 90 days)
  • Quantity of unmet social needs(Baseline, 30, and 90 days)
  • Changes in Glucose Control: HbA1c at point of care(Baseline and 90 days)
  • changes in Diabetes Distress(Baseline, 30, and 90 days)
  • Time to hospital service use post-discharge(30 days)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Suzanne Mitchell

Associate Professor

University of Massachusetts, Worcester

研究点 (1)

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