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临床试验/NCT01785485
NCT01785485Unknown不适用

IMPACT: Integrative Medicine PrimAry Care Trial: A Comparative Effectiveness Study of an Integrative Primary Care Clinic

University of Arizona1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
Total healthcare costs from the payer's perspective-total paid costs according to claims data.

研究概览

简要总结

This study is Phase II of a project by the University of Arizona Center for Integrative Medicine (AzCIM). Collaborating with AzCIM is the Health Outcomes and Pharmacoeconomics (HOPE) Center and the RAND Corporation, Inc. Phase II is a prospective evaluation of the clinical and cost effectiveness (outcomes) of an integrative medicine professional practice model for adult primary care delivery (the University of Arizona Integrative Health Center - UAIHC in Phoenix, AZ). Data will be gathered from eligible and consenting members of UAIHC. In addition, a fidelity evaluation will assess whether the practice model was implemented as planned.

The specific aims are to: 1) Recruit, consent, and enroll a sample of eligible patient and staff participants from UAIHC; 2) Conduct outcome evaluation of UAIHC care using patient data from medical records abstractions, self-report assessments, clinic administrative and service utilization/encounter data, and health insurance claims data; and, 3) Conduct fidelity evaluation of the implementation of the UAIHC model as described in its business plan using patient- and staff-reported fidelity assessments, random chart audits, and abstracted clinic administrative data.

Participants. 1) Participants from the clinic patient population for whom clinical and cost outcomes will be tracked (n=500); 2) Clinic patients from whom fidelity data will be collected (n=180); and, 3) Clinic personnel from whom fidelity data will also be collected (n=14).

Data Collection. For outcomes evaluation, data will be collected at baseline (initial clinic visit), and at 3-, 6-, and 12-month follow up periods. Sources include clinical symptoms and biomarkers from medical records abstractions; patient reported outcomes and satisfaction questionnaires; clinic service encounter logs; and, cost data from health insurance claims information and clinic financial data. For fidelity evaluation, data will be collected monthly for 6 months after study start, quarterly for the next 6 months, and semi-annually from then on. Patient data for fidelity will be gathered on a single randomized day of the week using a self-administered patient feedback questionnaire. For personnel, fidelity data will be collected at the same intervals using a self-administered provider perceptions questionnaire of inter-professional team and integrative medical care. Data from audits of randomly selected patient charts and administrative records will also be used.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Enrollment in primary care (members) at UAIHC;
  • Adults age 18 or older.

排除标准

  • Currently pregnant at time of recruitment;
  • Patients who attend the UAIHC clinic as consultation-only patients;
  • Significant cognitive impairment to the extent that the individual is unable to understand consent and respond to questionnaires.
  • Fidelity Study Sample (Patients):
  • Inclusion Criteria:
  • Enrollment in primary care (members) at UAIHC;
  • Adults age 18 or older.
  • Exclusion Criteria:
  • Significant cognitive impairment to the extent that the individual is unable to understand consent and respond to questionnaires.
  • Fidelity Study Sample (Providers):
  • Inclusion Criteria:
  • All clinical and support personnel.
  • Exclusion Criteria:

结局指标

主要结局

Total healthcare costs from the payer's perspective-total paid costs according to claims data.

时间窗: 12 months of paid costs pre and post beginning membership at UAIHC

次要结局

  • 1. Self-report instruments(Baseline, 3-, 6-, and 12-months)
  • Clinical indicators and biomarkers(3-, 6-, and 12-months)
  • Service Utilization Data and Health Insurance Claims Data(3-, 6-, and 12-months; biennially)

研究者

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

Sally Dodds

Associate Professor/Research Scholar of Medicine & Psychiatry

University of Arizona

研究点 (1)

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