AIMS Medical Outcomes Study

NCT ID: NCT04512755

Last Updated: 2023-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2030-12-31

Brief Summary

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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

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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.

Conditions

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Mental Health Issue PTSD Pain Chronic Pain Chronic Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advanced Integrative Medical Science Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Therry Eparwa, DNP, FNP-BC

Role: PRINCIPAL_INVESTIGATOR

AIMS Institute

Sunil K Aggarwal, MD, PhD

Role: STUDY_DIRECTOR

AIMS Institute

Leanna J Standish, ND, PhD, LAc

Role: STUDY_DIRECTOR

AIMS Institute

Locations

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AIMS Institute

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michelle Speaks, MBA

Role: CONTACT

2064201321

Sunil K Aggarwal, MD, PhD

Role: CONTACT

2064201321

Facility Contacts

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Michelle Speaks, MBA

Role: primary

206-420-1321

Sunil K Aggarwal, MD, PhD

Role: backup

2064201321

References

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De Lima L, Bennett MI, Murray SA, Hudson P, Doyle D, Bruera E, Granda-Cameron C, Strasser F, Downing J, Wenk R. International Association for Hospice and Palliative Care (IAHPC) List of Essential Practices in Palliative Care. J Pain Palliat Care Pharmacother. 2012 Jun;26(2):118-22. doi: 10.3109/15360288.2012.680010.

Reference Type BACKGROUND
PMID: 22764847 (View on PubMed)

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.

Reference Type BACKGROUND

Bercovitz A, Sengupta M, Jones A, Harris-Kojetin LD. Complementary and alternative therapies in hospice: The national home and hospice care survey: United States, 2007. Natl Health Stat Report. 2011 Jan 19;(33):1-20.

Reference Type BACKGROUND
PMID: 25585442 (View on PubMed)

Leskowitz E. (2002) Complementary and alternative medicine in rehabilitation. Churchill Livingstone.

Reference Type BACKGROUND

Monti, D.A. & Newberg, A.B. (2018). Integrative psychiatry and brain health (2nd ed.) Weil Integrative Medicine Library, Oxford University Press.

Reference Type BACKGROUND

Scotton, B.W., Chinen, A.B., &Battista, J.R. (Eds.). (1996). Textbook of transpersonal psychiatry and psychology. Basic Books.

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Wolfson, P. & Hartelius, G. (Eds). (2016). The ketamine papers: Science, therapy, and transformation. Multidisciplinary Association for Psychedelic Studies.

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Cyr C, Arboleda MF, Aggarwal SK, Balneaves LG, Daeninck P, Neron A, Prosk E, Vigano A. Cannabis in palliative care: current challenges and practical recommendations. Ann Palliat Med. 2018 Oct;7(4):463-477. doi: 10.21037/apm.2018.06.04. Epub 2018 Jun 28.

Reference Type BACKGROUND
PMID: 30180728 (View on PubMed)

Wolever RQ, Abrams DI, Kligler B, Dusek JA, Roberts R, Frye J, Edman JS, Amoils S, Pradhan E, Spar M, Gaudet T, Guarneri E, Homel P, Amoils S, Lee RA, Berman B, Monti DA, Dolor R. Patients seek integrative medicine for preventive approach to optimize health. Explore (NY). 2012 Nov-Dec;8(6):348-52. doi: 10.1016/j.explore.2012.08.005.

Reference Type BACKGROUND
PMID: 23141791 (View on PubMed)

Abrams DI, Dolor R, Roberts R, Pechura C, Dusek J, Amoils S, Amoils S, Barrows K, Edman JS, Frye J, Guarneri E, Kligler B, Monti D, Spar M, Wolever RQ. The BraveNet prospective observational study on integrative medicine treatment approaches for pain. BMC Complement Altern Med. 2013 Jun 24;13:146. doi: 10.1186/1472-6882-13-146.

Reference Type BACKGROUND
PMID: 23800144 (View on PubMed)

Edman JS, Roberts RS, Dusek JA, Dolor R, Wolever RQ, Abrams DI. Characteristics of cancer patients presenting to an integrative medicine practice-based research network. Integr Cancer Ther. 2014 Sep;13(5):405-10. doi: 10.1177/1534735414537876. Epub 2014 Jun 9.

Reference Type BACKGROUND
PMID: 24913179 (View on PubMed)

Dusek JA, Abrams DI, Roberts R, Griffin KH, Trebesch D, Dolor RJ, Wolever RQ, McKee MD, Kligler B. Patients Receiving Integrative Medicine Effectiveness Registry (PRIMIER) of the BraveNet practice-based research network: study protocol. BMC Complement Altern Med. 2016 Feb 4;16:53. doi: 10.1186/s12906-016-1025-0.

Reference Type BACKGROUND
PMID: 26846166 (View on PubMed)

Ameli R, Sinaii N, Luna MJ, Cheringal J, Gril B, Berger A. The National Institutes of Health measure of Healing Experience of All Life Stressors (NIH-HEALS): Factor analysis and validation. PLoS One. 2018 Dec 12;13(12):e0207820. doi: 10.1371/journal.pone.0207820. eCollection 2018.

Reference Type BACKGROUND
PMID: 30540764 (View on PubMed)

Other Identifiers

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AMOS

Identifier Type: -

Identifier Source: org_study_id

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