Registry for Integrative Medicine Interventions Effectiveness (PRIMIER)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Duke University
Sponsor:
Collaborator:
The Bravewell Collaborative
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01754038
First received: December 17, 2012
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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.


Condition
All Conditions of Integrative Medicine Clinic Patients

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Patients Receiving Integrative Medicine Interventions Effectiveness Registry

Further study details as provided by Duke University:

Primary Outcome Measures:
  • PROMIS® CAT [ Time Frame: Baseline, 2, 4, 6 months, then every 6 months through year 2, and then yearly through year 5 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Perceived Stress Scale - 4 [ Time Frame: Baseline, 2, 4, 6 months, then every 6 months through year 2, and then yearly through year 5 ] [ Designated as safety issue: No ]
    The PSS-4 is brief, validated and widely used psychological instrument for assessing a participant's perception of stress change. The PSS-4 consists of 4 questions to measure the degree to which situations in the participant's life are perceived as stressful including questions related to perceived unpredictability and lack of control. Participants choose responses ranging from never (0) to very often (4) with a total score ranging from 0 to 16.

  • Patient Activation Measure (PAM) [ Time Frame: Baseline, 2, 4, 6 months, then every 6 months through year 2, and then yearly through year 5 ] [ Designated as safety issue: No ]
    The PAM is a brief, validated instrument for gauging the knowledge, skills and confidence essential to managing one's own health and healthcare. The 13-item PAM assessment segments consumers into one of four progressively higher activation levels. Each level addresses a broad array of self-care behaviors and offers deep insight into the characteristics that drive health activation.

  • Cost Indicators [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
    From the subjects' medical and financial records we will capture ICD codes, CPT codes, and payments made by subjects and their insurance companies.


Estimated Enrollment: 10000
Study Start Date: August 2013
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Integrative Medicine Clinic Attendees
All patients attending a participating Integrative Medicine clinic for clinical services will be invited to participate in the PRIMIER Registry

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All patients attending a participating Integrative Medicine Clinic

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Not being seen by a provider for clinical purposes, but only involved in an education program or one-time activity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754038

Contacts
Contact: Ronald Roddy 919-668-8974 ron.roddy@duke.edu
Contact: Rowena Dolor, MD 919-668-8596 rowena.dolor@duke.edu

Locations
United States, California
Scripps Center for Integrative Medicine Recruiting
La Jolla, California, United States, 92037
Contact: Eva Stuart    858-544-3340    stuart.eva@scrippshealth.org   
Contact: Christopher Suhar, MD       suhar.christopher@scrippshealth.org   
Principal Investigator: Christopher Suhar, MD         
UCSF Osher Center for Integrative Medicine Recruiting
San Francisco, California, United States, 94143
Contact: Vierka Goldman    415-353-7561    GoldmanV@ocim.ucsf.edu   
Contact: Kevin Barrows, MD       barrowsk@ocim.ucsf.edu   
Principal Investigator: Kevin Barrows, MD         
Venice Family Clinic at Simms/Mann Health and Wellness Center Recruiting
Santa Monica, California, United States, 90405
Contact: Nancy Rodriguez    310-664-7831    nyrodriguez@mednet.ucla.edu   
Contact: Myles Spar, MD    310-664-7674    MSpar@mednet.ucla.edu   
Principal Investigator: Myles Spar, MD         
United States, Colorado
University of Colorado School of Medicine, Center for Integrative Medicine Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Lisa Corbin, MD    720-848-1090    lisa.corbin@ucdenver.edu   
Contact: Jacinda Nicklas, MD    303-724-9028    jacinda.nicklas@ucdenver.edu   
Principal Investigator: Lisa Corbin, MD         
United States, Illinois
Northwestern Integrative Medicine - Northwestern Memorial Physicians Group Recruiting
Chicago, Illinois, United States, 60611
Contact: Natalie M Pace    312-503-2519    npace@nmh.org   
Contact: Melinda Ring, MD       mring@nmh.org   
Sub-Investigator: David Victorson, PhD         
Principal Investigator: Melinda Ring, MD         
United States, Maryland
University of Maryland Center for Integrative Medicine Recruiting
Baltimore, Maryland, United States, 21201
Contact: Meizi Zheng    410-448-6462    mzheng@som.umaryland.edu   
Contact: Mary Bahr-Robertson       mbahr@compmed.umm.edu   
Principal Investigator: Christopher D'Adamo, PhD         
United States, Massachusetts
Program for Integrative Medicine and Health Care Disparities Not yet recruiting
Boston, Massachusetts, United States, 02118
Contact: Daniel Do    617-414-4464    Daniel.Do@bmc.org   
Contact: Robert Saper, MD       Robert.Saper@bmc.org   
Principal Investigator: Robert Saper, MD         
United States, Minnesota
Penny George Institute for Health and Healing Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Desiree Trebesch    612-863-9767    Desiree.Trebesch@allina.com   
Contact: Jeffrey A Dusek, PhD    612-863-9769    Jeffery.Dusek@allina.com   
Principal Investigator: Jeffrey A. Dusek, PhD         
United States, New York
Beth Israel Integrative Medicine Continuum Center for Health and Healing Recruiting
New York, New York, United States, 10016
Contact: Jenna Cantor       jcantor@chpnet.org   
Contact: Benjamin Kligler, MD    646-935-2257    bkligler@chpnet.org   
Principal Investigator: Benjamin Kligler, MD         
United States, North Carolina
Duke Integrative Medicine Clinic Recruiting
Durham, North Carolina, United States, 27705
Contact: Teresa Keever    919-660-6681    teresa.l.keever@duke.edu   
Contact: Ruth Q Wolever, PhD       ruth.wolerver@duke.edu   
Principal Investigator: Ruth Q Wolever, PhD         
Sub-Investigator: Adam Pearlman, MD         
United States, Ohio
Alliance Institute for Health and Healing Recruiting
Cincinnati, Ohio, United States, 45236
Contact: Nancy Merrell    513-791-5521    nancy.merrell@myhealingpartner.com   
Contact: Steve Amoils, MD       Steve.Amoils@myhealingpartner.com   
Principal Investigator: Steve Amoils, MD         
United States, Pennsylvania
Jefferson-Myrna Brind Center of Integrative Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Nancy Wintering    215-503-3423    nancy.wintering@jefferson.edu   
Contact: Andrew Newberg, MD    (215) 503-3422    Andrew.Newberg@jefferson.edu   
Principal Investigator: Andrew Newberg, MD         
UPMC Shadyside Center for Integrative Medicine Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Christine McFarland    412-623-6872    mcfarlandce@upmc.edu   
Contact: Carol Greco       grecocm@upmc.edu   
Principal Investigator: Carol Greco, Ph.D.         
United States, Tennessee
Vanderbilt Center for Integrative Health Not yet recruiting
Nashville, Tennessee, United States, 37203
Contact: Oluwaseyi Balasire    615-936-8489    PRIMIER@vanderbilt.edu   
Contact: Gurjeet Birdee, MD       gurjeet.birdee@Vanderbilt.Edu   
Principal Investigator: Gurjeet Birdee, MD         
Sponsors and Collaborators
Duke University
The Bravewell Collaborative
Investigators
Principal Investigator: 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
Study Director: Rowena Dolor, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01754038     History of Changes
Other Study ID Numbers: Pro00040886
Study First Received: December 17, 2012
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Patient Reported Outcomes
PRO
Registry

ClinicalTrials.gov processed this record on August 26, 2014