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AIMS Medical Outcomes Study (AMOS)

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ClinicalTrials.gov Identifier: NCT04512755
Recruitment Status : Recruiting
First Posted : August 14, 2020
Last Update Posted : August 14, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: AIMS Medical Outcomes Study
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 1, 2025
Estimated Study Completion Date : December 31, 2030



Primary Outcome Measures :
  1. Health Related Quality of Life [ Time Frame: 5 Years ]
    Measure quality of life using GAD-7, PHQ-9, and short form questionnaire.


Secondary Outcome Measures :
  1. Treatment [ Time Frame: 5 Years ]
    Describe treatments prescribed and provided by AIMS Institute physicians abstracted from chart review.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04512755


Contacts
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Contact: Michelle Speaks, MBA 2064201321 mspeaks@aimsinstitute.net
Contact: Sunil K Aggarwal, MD, PhD 2064201321 saggarwal@aimsinstitute.net

Locations
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United States, Washington
AIMS Institute Recruiting
Seattle, Washington, United States, 98102
Contact: Michelle Speaks, MBA    206-420-1321    mspeaks@aimsinstitute.net   
Contact: Sunil K Aggarwal, MD, PhD    2064201321    saggarwal@aimsinstitute.net   
Principal Investigator: Therry Eparwa, DNP         
Sub-Investigator: Leanna J Standish, ND, PhD         
Sub-Investigator: Sunil K Aggarwal, MD, PhD         
Sponsors and Collaborators
Advanced Integrative Medical Science Institute
Investigators
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Principal Investigator: Therry Eparwa, DNP, FNP-BC AIMS Institute
Study Director: Sunil K Aggarwal, MD, PhD AIMS Institute
Study Director: Leanna J Standish, ND, PhD, LAc AIMS Institute
Publications:
Stjernsward, J. & Clark, D. (2005). Palliative medicine: a global perspective. In Doyle, D., Hanks, G., Cherny, N., & Calman, K. (Eds.). Oxford textbook of palliative medicine (3rd ed., pp. 1197-224). Oxford University Press.
Leskowitz E. (2002) Complementary and alternative medicine in rehabilitation. Churchill Livingstone.
Monti, D.A. & Newberg, A.B. (2018). Integrative psychiatry and brain health (2nd ed.) Weil Integrative Medicine Library, Oxford University Press.
Scotton, B.W., Chinen, A.B., &Battista, J.R. (Eds.). (1996). Textbook of transpersonal psychiatry and psychology. Basic Books.
Association of Accredited Naturopathic Medical Colleges. (2019). Naturopathic medicine: Become the doctor you want to have. [Whitepaper]. Association of Accredited Naturopathic Medical Colleges. Retrieved May 13, 2020 from: https://aanmc.org/wp-content/uploads/2019/02/Naturopathic-Medicine-White-Paper.pdf
Standish, L.J. & Aggarwal, S.K. (2019). Advanced integrative oncology treatment for adult and pediatric patients with cancer: A prospective outcomes study. AIMS Institute Clinical Study Protocol.
Wolfson, P. & Hartelius, G. (Eds). (2016). The ketamine papers: Science, therapy, and transformation. Multidisciplinary Association for Psychedelic Studies.
Ghebreyesus, Tedros Adhanom. (2019, January 24). Tedros Adhanom Ghebreyesus to António Guterres. World Health Organization. Retrieved from https://www.who.int/medicines/access/controlled-substances/UNSG_letter_ECDD41_recommendations_cannabis_24Jan19.pdf

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Responsible Party: Advanced Integrative Medical Science Institute
ClinicalTrials.gov Identifier: NCT04512755    
Other Study ID Numbers: AMOS
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Advanced Integrative Medical Science Institute:
Naturopathic Oncology
Integrative Medicine
Integrative Psychiatry
Integrative Physical Medicine and Rehabilitation
Integrative Palliative Care Medicine
Serious Illness
Life Threatening Illness
Additional relevant MeSH terms:
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Chronic Pain
Chronic Disease
Pain
Neurologic Manifestations
Disease Attributes
Pathologic Processes