Clinical trial NCT04512755: AIMS Medical Outcomes Study
Official title: AIMS Medical Outcomes Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mental Health Issue
PTSD
Pain
Chronic Pain
Chronic Disease
Keywords: Naturopathic Oncology
Integrative Medicine
Integrative Psychiatry
Integrative Physical Medicine and Rehabilitation
Integrative Palliative Care Medicine
Serious Illness
Life Threatening Illness
Lead sponsor: Advanced Integrative Medical Science Institute
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who seek care at AIMS Institute and meet inclusion/exclusion criteria are eligible to participate in this study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Health Related Quality of Life
timeFrame: 5 Years
Secondary outcomes:
measure: Treatment
timeFrame: 5 Years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: AIMS Institute
state: Washington
Study officials:
affiliation: AIMS Institute
name: Therry Eparwa, DNP, FNP-BC
role: PRINCIPAL_INVESTIGATOR
affiliation: AIMS Institute
name: Sunil K Aggarwal, MD, PhD
role: STUDY_DIRECTOR
affiliation: AIMS Institute
name: Leanna J Standish, ND, PhD, LAc
role: STUDY_DIRECTOR
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