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Trial record 1 of 1 for:    NCT02868983
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Integrating Behavioral Health and Primary Care for Comorbid Behavioral and Medical Problems (IBHPC)

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02868983
First Posted: August 16, 2016
Last Update Posted: August 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Arizona State University
State University of New York at Buffalo
Case Western Reserve University
DARTNet
National Committee for Quality Assurance
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Benjamin Littenberg, University of Vermont
  Purpose

Behavioral problems are part of many of the chronic diseases that cause the majority of illness, disability and death. Tobacco, diet, physical inactivity, alcohol, drug abuse, failure to take treatment, sleep problems, anxiety, depression, and stress are major issues, especially when chronic medical problems such as heart disease, lung disease, diabetes, or kidney disease are also present. These behavioral problems can often be helped, but the current health care system doesn't do a good job of getting the right care to these patients.

Behavioral health includes mental health care, substance abuse care, health behavior change, and attention to family and other psychological and social factors. Many people with behavioral health needs present to primary care and may be referred to mental health or substance abuse specialists, but this method is often unacceptable to patients. Two newer ways have been proposed for helping these patients. In co-location, a behavioral health clinician (such as a Psychologist or Social Worker) is located in or near the primary practice to increase the chance that the patient will make it to treatment. In Integrated Behavioral Health (IBH), a Behavioral Health Clinician is specially trained to work closely with the medical provider as a full member of the primary treatment team.

The research question is: Does increased integration of evidence-supported behavioral health and primary care services, compared to simple co-location of providers, improve outcomes? The key decisions affected by the research are those made at the practice level: whether and how best to use behavioral health services. For patients, whether to seek out or accept offered behavioral health services will be influenced by the manner they are made available.

The investigators plan to do a study of 40 practices which will each start off using co-location. Over time, each one will convert to IBH using a practice improvement method that has helped in other settings. The investigators will measure the health status of patients in each practice before and after they start using IBH. The investigators will compare the change in those outcomes to health status changes of patients in practices who have not yet started using IBH.

The investigators plan to study adults who each have both medical and behavioral problems, and get their care in Family Medicine clinics, General Internal Medicine practices, and Community Health Centers.


Condition Intervention
Arthritis Asthma Chronic Obstructive Lung Disease Diabetes Heart Failure Hypertension Anxiety Chronic Pain Depression Fibromyalgia Insomnia Irritable Bowel Syndrome Problem Drinking Substance Use Disorder Other: Integration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Integrating Behavioral Health and Primary Care for Comorbid Behavioral and Medical Problems

Further study details as provided by Benjamin Littenberg, University of Vermont:

Primary Outcome Measures:
  • PROMIS-29 v2 [ Time Frame: 24 months ]
    Change in general health


Secondary Outcome Measures:
  • CAHPS 12-Month PCMH Adult Questionnaire 2.0 [ Time Frame: 24 months ]
    Quality of provider communication

  • Consultation and Relational Empathy measure [ Time Frame: 24 months ]
    Quality of provider empathy

  • Patient Activation Measure-13 [ Time Frame: 24 months ]
    Self-management

  • Modified Self-reported Medication-taking Scale [ Time Frame: 24 months ]
    Medication adherence

  • Patient Report of Utilization [ Time Frame: 24 months ]
    Health care utilization

  • Restricted Activity Days [ Time Frame: 24 months ]
    Time lost due to disability

  • Duke Activity Status Index [ Time Frame: 24 months ]
    Physical Function

  • Hgb A1C [ Time Frame: 24 months ]
    Glycemic control

  • 30-day use [ Time Frame: 24 months ]
    Substance Use disorder & Problem Drinking

  • Global Appraisal of Individual Needs - Short Screener [ Time Frame: 24 months ]
    Substance Use disorder & Problem Drinking

  • Systolic blood pressure [ Time Frame: 24 months ]
    Hypertension

  • Asthma Symptom Utility Index [ Time Frame: 24 months ]
    Asthma symptoms


Estimated Enrollment: 3000
Study Start Date: April 2016
Estimated Study Completion Date: April 2021
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Integration

The intervention consists of training for practice leaders, BHCs, PCPs, and office staff, a Protocolized Redesign Process support for practice redesign, and a toolkit of suggested tactics for implementing Tasks A through D:

A. Identification B. Assessment C. Treatment D. Surveillance

Other: Integration

The intervention consists of training for practice leaders, BHCs, PCPs, and office staff, a Protocolized Redesign Process support for practice redesign, and a toolkit of suggested tactics for implementing Tasks A through D:

A. Identification B. Assessment C. Treatment D. Surveillance

No Intervention: Co-Location
A Behavioral Health Clinician (BHC) such as a psychologist or counselor is housed in or near the primary care practice.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over 18 years of age
  • At least one target chronic medical condition:
  • arthritis
  • asthma
  • chronic obstructive lung disease
  • diabetes
  • heart failure
  • or hypertension.
  • Evidence of a behavioral problem or need:
  • Diagnosis of:
  • anxiety
  • chronic pain including headache
  • depression
  • fibromyalgia
  • insomnia
  • irritable bowel syndrome
  • problem drinking
  • substance use disorder
  • OR persistent use of certain medications used for behavioral concerns:
  • antidepressants
  • anxiolytics
  • opioids
  • antineuropathy agents
  • OR persistent failure to attain physiologic control of a medical problem:
  • blood pressure>165 while on 3 or more medications
  • A1C > 9% for 6 months)
  • OR the presence of three or more of the target chronic medical conditions.

Exclusion Criteria:

No exclusions apply.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868983


Locations
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
Arizona State University
State University of New York at Buffalo
Case Western Reserve University
DARTNet
National Committee for Quality Assurance
University of Massachusetts, Worcester
Investigators
Principal Investigator: Benjamin Littenberg, MD University of Vermont
  More Information

Responsible Party: Benjamin Littenberg, Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT02868983     History of Changes
Other Study ID Numbers: WLPS-1409-24372
First Submitted: August 9, 2016
First Posted: August 16, 2016
Last Update Posted: August 17, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A complete, cleaned, de-identified copy of the final dataset used in conducting the final analyses will be made available within one year after the completion of the study. It will include a data dictionary with response and missing values defined as well as a complete set of survey instruments (excluding copyright protected material not licensed for transfer). The data will be available as an encrypted Stata data set or comma-separated file. The investigators will not make data from qualitative results available because of the potential for identifying individuals.

Additional relevant MeSH terms:
Heart Failure
Chronic Pain
Lung Diseases
Fibromyalgia
Irritable Bowel Syndrome
Substance-Related Disorders
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Heart Diseases
Cardiovascular Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Respiratory Tract Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Chemically-Induced Disorders
Mental Disorders


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