BraveNet Integrative Medicine Descriptive Study (BraveNet)

BraveNet Multi-Center Integrative Medicine Survey

The Bravewell Integrative Medicine Research Network (BraveNet) is a newly formed practice-based research network of nine leading integrative medicine centers around the U.S. collaborating in clinical outcomes research to increase the knowledge and evidence-base of integrative medicine.

Study Overview

• Status: Completed
• Conditions: Healthy

Detailed Description

Specific Aims of BraveNet:

1. Demonstrate feasibility for the nine sites of BraveNet to coordinate in specifying data elements, developing and implementing smooth data collection procedures, analyzing the data, publishing and disseminating the results through scientific conferences and journals.

2. Describe the patients seeking care at Integrative Medicine centers, in terms of:

   1. demographics, presenting symptoms, health conditions, type of care sought, and expectations for treatment;
   2. quality of life, mood, stress; and
   3. lifestyle factors.
3. Explore potential patterns within the sample [e.g., do the survey scores vary by demographics, by condition, by type patient (new vs return), by type of help sought, etc.].
4. Utilize above data as pilot data for future studies and funding opportunities.

Up to five hundred eligible patients seen at each of the nine participating Centers will be approached (by mail, phone, at the time of their visit, etc.) and invited to consent to the paper and pencil study. The patient survey will clearly state that participation is voluntary with a written consent to participate on the front. Individual practices will report the response rate in order to monitor the potential effect of volunteer bias. Participant completion of questionnaires should take 15 to 30 minutes, and should be completed within 2 weeks of the patient visit., The corresponding provider form will be completed by the provider/research staff within 5 days of the visit.

Measures:

1. Baseline Questionnaires - Demographics and reason for visit
2. Quality of Life. The SF-12 (Short Form 12)
3. Mood (Depression). The Center for Epidemiologic Studies Depression Scale (CES-D)
4. Stress. The Perceived Stress Scale (PSS)
5. Visual Analog Scales (VAS). Four self-report VASs will be used to measure aspects of pain, fatigue and restfulness of sleep.
6. Provider Form. Providers/ Research Staff will complete this form to indicate the type of provider seen, the CPT codes used to describe/bill for the service, the services provided, and the provider's assessment of current medical conditions/co-morbidities.

• Study Type: Observational
• Enrollment (Actual): 4340

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Center for Integrative Medicine
    • San Francisco, California, United States, 94143
      • Osher Center for Integrative Medicine
    • Santa Monica, California, United States, 90405
      • Venice Family Clinic
  • Maryland
    • Baltimore, Maryland, United States, 21207
      • University of Maryland Center for Integrative Medicine
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Penny George Institute for Health and Healing
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Integrative Medicine
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Alliance Center for Integrative Medicine
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson-Myrna Brind Center of Integrative Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

500 patients from each of the nine participating Integrative Medicine Centers who are seeing any type of clinicial on the day of their visit.

Description

Inclusion Criteria:

• Subjects will be eligible for inclusion in this study only if all of the following criteria apply:

  1. Age: At least 18 years of age.
  2. Patient Status: Participants are eligible if seen individually by any type of clinician on the day of the visit.
  3. English or Spanish Literacy: Ability to read and write English or Spanish as confirmed by the site personnel and ability to provide informed consent.

Exclusion Criteria:

• Subjects will be excluded from this study if any of the following criteria apply:

  1. Cognitive Impairment: A subject will not be eligible if he/she has a history of psychiatric disease, dementia, Alzheimer's disease, or other conditions which will limit the validity of providing informed consent to participate in the study.
  2. Inability to read and write in English or Spanish.
  3. Participating only in educational Center activities, not as a clinical patient.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; Up to five hundred eligible patients seen at each of the nine participating Integrative Medicine Centers will be approached (by mail, phone, at the time of their visit, etc.) and invited to consent to the paper and pencil study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Describe the patients seeking care at Integrative Medicine centers, in terms of:a.demographics, presenting symptoms, health conditions, type of care sought, and expectations for treatment; b.quality of life, mood, stress; and c.lifestyle factors.	Once per patient

Secondary Outcome Measures

Outcome Measure	Time Frame
Explore potential patterns within the sample [e.g., do the survey scores vary by demographics, by condition, by type patient (new vs return), by type of help sought, etc.]and utilize data as pilot data for future studies and funding opportunities.	Once all surveys have been entered into the EDC system

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: University of Maryland; University of California, San Francisco; Thomas Jefferson University; Allina Health System; The Bravewell Collaborative; Alliance Institute for Integrative Medicine; Scripps Center for Integrative Medicine; The Continuum Center for Health and Healing; Venice Family Clinic
• Investigators: Principal Investigator: Rowena Dolor, MD, Duke Clinical Research Institute; Principal Investigator: Ruth Wolever, PhD, Duke Integrative Medicine Center

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: March 9, 2008
• First Submitted That Met QC Criteria: March 9, 2008
• First Posted (Estimate): March 14, 2008

Study Record Updates

• Last Update Posted (Estimate): June 14, 2011
• Last Update Submitted That Met QC Criteria: June 12, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: Pro00006850

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No