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Recruiting NCT04512755

AIMS Medical Outcomes Study

Observational Mental Health Issue PTSD Pain Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Mental Health Issue, PTSD, Pain, Chronic Pain. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Health Related Quality of Life [Time frame: 5 Years]
Secondary outcome measures (1)
  • Treatment [Time frame: 5 Years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • AIMS Institute — Seattle

Publications

  • 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. PMID 22764847
  • 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.
  • 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. PMID 25585442
  • 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.

Identifiers

NCT: NCT04512755 · AMOS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗