AMOS: AIMS Medical Outcomes Study

Sponsor

Advanced Integrative Medical Science Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04512755

Collaborator

(none)

500

Enrollment

Location

126

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mental Health Issue PTSD Pain Chronic Pain Chronic Disease

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 Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

AIMS Medical Outcomes Study

Actual Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Dec 31, 2030

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Treatment [5 Years]
Describe treatments prescribed and provided by AIMS Institute physicians abstracted from chart review.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Patients enrolled in the study will meet the following criteria:

A new patient coming in for a first office call (FOC) or first consultation via telemedicine with an AIMS physician or advanced practice provider;
An established patient;
If over 18 years of age are able to understand study design adequately and provide signed informed consent to enrollment;
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:

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