AIMS Medical Outcomes Study

Recruiting

• Conditions: PTSD; Mental Health Issue; Pain; Chronic Pain; Chronic Disease

• Registration Number: NCT04512755
• Lead Sponsor: Advanced Integrative Medical Science Institute

Brief Summary

This epidemiologic research is being conducted as an observational prospective case series outcomes study of the use of advanced integrative specialty medical care and its effect on adult and pediatric patients with chronic or serious illnesses or mental health disorders.

Detailed Description

There is growing interest in providing integrative medical care in conjunction with specialty medical care to expand the reach of integrative care to more chronically and seriously ill patient populations. At the AIMS Institute, the core specialties are naturopathy, palliative care, psychiatry, physiatry, and naturopathic oncology practiced via coordinated, team-based care by allopathic medical and psychiatric specialists, psychotherapists, specialized naturopathic physicians, advanced practice nurses, and targeted health educators, with the majority of care covered by insurance. Additionally incorporated are novel 'advanced' approaches, such as drug-assisted psychotherapy, medical cannabis education, sympathetic blocks, and some intravenous therapies.

This is an uncontrolled, prospective case series outcomes study of health-related quality of life outcomes in patients who receive care at AIMS Institute. A clinic-wide chart audit of patient characteristics and outcomes will be conducted prior to the start of enrollment.

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-14
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-02-01
• Primary Completion: 2025-07-01
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients enrolled in the study will meet the following criteria:

  1. A new patient coming in for a first office call (FOC) or first consultation via telemedicine with an AIMS physician or advanced practice provider;
  2. An established patient;
  3. If over 18 years of age are able to understand study design adequately and provide signed informed consent to enrollment;
  4. If younger than 18 years of age informed consent from a parent or guardian who is able to understand the study design adequately and provide signed informed consent for the pediatric patient.

Exclusion Criteria

• Ineligible participants:

  1. Cannot read or understand English well enough to read and sign the consent form and complete the questionnaires;
  2. Unwilling to participate in the AIMS Institute observational study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health Related Quality of Life	5 Years	Measure quality of life using GAD-7, PHQ-9, and short form questionnaire.

Secondary Outcome Measures

Name	Time	Method
Treatment	5 Years	Describe treatments prescribed and provided by AIMS Institute physicians abstracted from chart review.

Trial Locations

Locations (1)

AIMS Institute; 🇺🇸 Seattle, Washington, United States