跳至主要内容
临床试验/NCT01781013
NCT01781013已完成不适用

Care Management Technology to Facilitate Depression Care in Safety Net Diabetes Clinics

University of Southern California16 个研究点 分布在 1 个国家目标入组 1,485 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,485
试验地点
16
主要终点
Change from baseline in depression outcome at 6-months

研究概览

简要总结

The specific aims of the proposed study are to:

  1. Develop the innovative depression care management technology, including the speech recognition technology for automated monitoring and patient prompts over time, automatic integration of the responses into the patient registry, and evidence-based decision-support algorithms for care actions;
  2. Conduct the quasi-experiment in eight Los Angeles County Department of Health Services (LAC-DHS) clinics to test the interventions;
  3. Use mixed-method evaluation to assess the extent of the implementation of the interventions, the acceptance to the providers and to the patients, and the impact on adoption of depression screening and treatment management over time, utilization, and cost of healthcare services, and patient health outcomes; and
  4. Conduct a cost-effectiveness analysis of the three study arms. Successful completion of the study will demonstrate which Comparative Effectiveness Research (CER) adoption strategies are successful and why, their comparative cost-effectiveness, as well as which strategies are successful under which circumstances to inform system-wide implementation of same.

Hypotheses of the Proposed Study

The following are the main hypotheses of the study:

  1. There will be statistically significant difference in the adoption of depression care screening and management over time among the three study groups.

1.1. The adoption rate will be Technology-supported care (TC) > Supported Care (SC) > Usual Care (UC). 2. There will be statistically significant difference in the depression symptom reduction, and better functional status, and quality of life among the three study groups.

2.1. The difference between the TC and the SC will not be statistically significant, but both will be greater than the UC group. 3. There will be statistically significant difference in the diabetes care process and outcomes among the three study groups.

3.1. The difference between the TC and the SC will not be statistically significant, but both will be greater than the UC group. 4. There will also be statistically significant differences in healthcare utilization among the three study groups, with least utilization in the TC group where the greatest level of technology is applied. 5. Of the three groups compared, the TC group will be the most cost-effective approach for accelerating adoption of the CER depression care results.

详细描述

In addition, the study will aim to answer the secondary research questions listed below:

  1. What is medical provider satisfaction with the technology used in the TC (Technology Care) group?
  2. What is patient acceptance with the technology used in the TC group?
  3. What factors are identified by medical providers and clinic administrators as related to satisfaction, barriers, and sustaining the intervention post-trial?
  4. What are patients' reported satisfaction and facilitating factors and barriers to receipt and acceptance of depression care?

研究设计

研究类型
Interventional
分配方式
Non 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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age equal to or greater than 18 years
  • receiving primary care at DHS safety net clinics
  • having a current diagnosis of type 2 diabetes mellitus (non-gestational).
  • have a working telephone or cellular phone.

排除标准

  • current suicidal ideation;
  • inability to speak either English or Spanish;
  • a score of 2 or greater on the CAGE (4M) alcohol assessment;
  • having schizophrenia, schizoaffective disorder, manic-depressive, or needing lithium;
  • and cognitive impairment precluding ability to give informed consent or participating in the intervention, i.e., Short Portable Mental Status Questionnaire(SPMSQ) score of 6 or more errors.
  • Provider and administrator inclusion criteria are: practicing or managing at one of the eight study sites; involved with diabetes or depression care
  • No specific exclusion criteria will be applied to providers and administrators.

结局指标

主要结局

Change from baseline in depression outcome at 6-months

时间窗: 6-months from enrollment

Depression is measured using depression scales Patient Health Questionnaire (PHQ)-9. Major depression is classified as PHQ-9\>=10.

次要结局

  • Change from baseline in diabetes self-care score in 6 months(6 months from enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shinyi Wu

Associate Professor

University of Southern California

研究点 (16)

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