IMPACT: Integrative Medicine PrimAry Care Trial: A Comparative Effectiveness Study of an Integrative Primary Care Clinic
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
- 是
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
Sally Dodds
Associate Professor/Research Scholar of Medicine & Psychiatry
University of Arizona
