Registry for Integrative Medicine Interventions Effectiveness

NCT01754038 | Completed

• 1 other identifier: Pro00040886
• Study Type: observational
• Target: 5,069
• Locations: 1 country
• Sites: 14

Brief Summary

This registry will perform prospective surveillance of participants attending collaborating Integrative Medicine clinic sites for clinical services. All decisions about medication use, treatments, visit frequency, assessment of tolerance, and other aspects of patient management will be left to the clinical providers' discretion. We will attempt to follow the participants in the PRIMIER Registry for up to 2 years. Essential data elements that capture patient-reported outcomes and measures of clinical activity will be obtained at approximately 2-month intervals for the first 6 months, then every 6 months through the end of year 2.

Conditions

All Conditions of Integrative Medicine Clinic Patients

Keywords

Patient Reported Outcomes; PRO; Registry

Outcome Measures

Primary Outcomes (1)

• PROMIS® CAT

  PROMIS® can integrate Item Response Theory (IRT) with computers to administer a PRO instrument. IRT selects questions on the basis of a patient's response to previously administered questions, measurement is "adapted" to individual, skips uninformative items to minimize response burden and allows determination of person's standing on a domain without a loss in measurement precision. The PROMIS® CAT for PRIMIER will be designed to assess anxiety, depression, sleep disturbance, fatigue, pain interference, physical function, and satisfaction with participation in social roles. Questions will be answered electronically using a standard 1-5 Likert scale. Participants will answer between 4 and 12 questions per domain, for a total of 29 to 85 questions.

  Baseline, 2, 4, 6 months, then every 6 months through year 2,.

Secondary Outcomes (3)

• Perceived Stress Scale - 4

  Baseline, 2, 4, 6 months, then every 6 months through year 2.

• Patient Activation Measure (PAM)

  Baseline, 2, 4, 6 months, then every 6 months through year 2.

• Cost Indicators

  Every 6 months

Study Arms (1)

Integrative Medicine Clinic Attendees

All patients attending a participating Integrative Medicine clinic for clinical services will be invited to participate in the PRIMIER Registry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients attending a participating Integrative Medicine Clinic

You may qualify if:

• Be seen as a clinical patient in one of the participating Integrative Medicine (IM) clinics and willing to participate in the Registry
• Be 18 years of age or older
• Have access to a computer with internet connection and a valid email address
• Be willing to be contacted in the future by study investigators

You may not qualify if:

• Not being seen by a provider for clinical purposes, but only involved in an education program or one-time activity

Sponsors & Collaborators

• BraveNet: lead
• The Bravewell Collaborative: collaborator

Study Sites (14)

Scripps Center for Integrative Medicine

La Jolla, California, 92037, United States

Location

UCSF Osher Center for Integrative Medicine

San Francisco, California, 94143, United States

Location

Venice Family Clinic at Simms/Mann Health and Wellness Center

Santa Monica, California, 90405, United States

Location

University of Colorado School of Medicine, Center for Integrative Medicine

Aurora, Colorado, 80045, United States

Location

Northwestern Integrative Medicine - Northwestern Memorial Physicians Group

Chicago, Illinois, 60611, United States

Location

University of Maryland Center for Integrative Medicine

Baltimore, Maryland, 21201, United States

Location

Program for Integrative Medicine and Health Care Disparities

Boston, Massachusetts, 02118, United States

Location

Penny George Institute for Health and Healing

Minneapolis, Minnesota, 55407, United States

Location

Beth Israel Integrative Medicine Continuum Center for Health and Healing

New York, New York, 10016, United States

Location

Duke Integrative Medicine Clinic

Durham, North Carolina, 27705, United States

Location

Alliance Institute for Health and Healing

Cincinnati, Ohio, 45236, United States

Location

Jefferson-Myrna Brind Center of Integrative Medicine

Philadelphia, Pennsylvania, 19107, United States

Location

UPMC Shadyside Center for Integrative Medicine

Pittsburgh, Pennsylvania, 15232, United States

Location

Vanderbilt Center for Integrative Health

Nashville, Tennessee, 37203, United States

Location

Related Publications (2)

• Dusek JA, Gao Q, Kim RS, Abrams DI, Kligler B, Dyer NL, Hansen K, Roseen EJ, McKee MD; PRIMIER Writing Group*. Patients Receiving Integrative Medicine Effectiveness Registry (PRIMIER) of the BraveNet practice-based research network: Results of the chronic pain cohort. Integr Med Res. 2025 Jun;14(2):101141. doi: 10.1016/j.imr.2025.101141. Epub 2025 Mar 25.

  PMID: 40297756 DERIVED

• 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.

  PMID: 26846166 DERIVED

Study Officials

• Donald I Abrams, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Jeffrey A Dusek, PhD

  Penny George Institute for Health and Healing, Abbott Northwestern Hospital

  PRINCIPAL INVESTIGATOR

• Diane McKee, MD MS

  Albert Einstein College of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: December 21, 2012
• Study Start: August 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: July 10, 2019

Record last verified: 2019-07

Locations

US (14)