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The Whole Health Study: Collaborative Care for OUD and Mental Health Conditions

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04245423
Recruitment Status : Not yet recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
David Mandell, University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE January 25, 2020
First Posted Date  ICMJE January 28, 2020
Last Update Posted Date January 28, 2020
Estimated Study Start Date  ICMJE September 2020
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2020)
  • Opioid use - Self-reported [ Time Frame: up to 12 months ]
    Timeline Followback
  • Opioid use - Toxicology [ Time Frame: up to 12 months ]
    Urine Drug Screens
  • Psychiatric Symptoms - Depression [ Time Frame: up to 12 months ]
    Patient Health Questionnaire (PHQ-9)
  • Psychiatric Symptoms - Anxiety [ Time Frame: up to 12 months ]
    Generalized Anxiety Disorder Screener (GAD-7)
  • Psychiatric Symptoms - Posttraumatic Stress Disorder [ Time Frame: up to 12 months ]
    Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Whole Health Study: Collaborative Care for OUD and Mental Health Conditions
Official Title  ICMJE The Whole Health Study: Collaborative Care for OUD and Mental Health Conditions
Brief Summary Collaborative care for mental health is increasingly common, but most primary care practices have not embraced similar models for opioid use disorder (OUD). The investigators will rapidly prototype and test elements of collaborative care models to optimize it for implementation with individuals with co-occurring mental health needs and OUD. The investigators will also conduct a randomized study comparing different intensities of collaborative care models to determine which is most effective in improving outcomes and examine the cost effectiveness of these different care models.
Detailed Description This research aims to refine and rigorously test a collaborative care model for patients with opioid use disorder (OUD) and major depression, post-traumatic stress disorder, or an anxiety disorder in primary care. The investigators will also examine clinician and practice characteristics associated with successful implementation and the cost effectiveness of different care models. The primary aims of this proposal are: (1) Rapidly prototype and test each element of collaborative care models to optimize it for implementation; (2) Conduct a randomized study of three collaborative care conditions with 39 practices to determine which is most effective in improving outcomes for people with OUD and mental health conditions: (a) Augmented Usual Care:Primary Care Physician (PCP) waivered to prescribe buprenorphine and mental health care manager, (b) Collaborative Care: Waivered PCP; mental health care manager receives OUD training; practice receives telephonic psychiatric consultation, or (c) Collaborative Care + Social Worker to address social determinants of health; (3) Measure clinician and organizational-level factors associated with implementation of each component, with the goal of developing strategies to increase successful implementation; and (4) Conduct a cost evaluation of each collaborative care model. Successful completion of the proposed study will provide definitive evidence regarding the most parsimonious set of elements of integrated collaborative care required to maximize outcomes for individuals with OUD and psychiatric disorders. Because of the study design, the investigators' examination of implementation factors, and community partnerships, the results also will have high probability of adoption and implementation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Opioid-use Disorder
  • Mental Health Issue
Intervention  ICMJE
  • Behavioral: Collaborative Care for Opioid Use Disorders and Mental Health Conditions
    CC is delivered using the investigators' Foundations for Integrated Care model. The first line pharmacotherapy is buprenorphine-naloxone. The second line pharmacotherapy included is extended-release injectable naltrexone. Pharmacotherapy is accompanied by brief problem-solving therapy, cognitive-behavioral therapy, and/or motivational interviewing. The primary care physician, in consultation with the addictions psychiatrist and care manager, also will provide psychotropic medications for psychiatric disorders. In-person and telephone visits consist of the care manager carrying out intervention activities over 12 months. Visits are at baseline (90-minute intake appointment), home or office induction when in moderate opiate withdrawal if buprenorphine is prescribed, twice a week for two weeks with telephone calls in between visits, then weekly, and when stable once a month. There will be a final visit at 12 months. The intervention includes routine collection of urine drug screens.
  • Behavioral: Augmented Usual Care
    If not already waivered, PCPs will be trained and waivered to treat OUD with medications. All practices will have mental health clinicians to treat mild psychiatric disorders. Other than that, the research team will provide no support to the PCP or practice staff. However, an addiction psychiatrist is available for consultation for OUD.
  • Behavioral: Collaborative Care for Opioid Use Disorders and Mental Health Conditions Plus Social Workers
    This intervention includes the Collaborative Care Intervention plus social workers to address social determinants of health.
Study Arms  ICMJE
  • Active Comparator: Augmented Usual Care (AUC)
    If not already waivered, PCPs will be trained and waivered to treat OUD with medications. Almost all practices have hired mental health clinicians, equivalent to the care managers in the investigators' collaborative care model, to treat mild and moderate depression and anxiety. These clinicians typically are licensed clinical social workers; a few are nurses or psychologists. No care managers have received systematic training in treating patients with OUD. The clinicians will retain their role and continue to treat and monitor patients with mental health conditions in these practices. Other than that, the research team will provide no support to the PCP or practice staff. However, an addiction psychiatrist is available for consultation for OUD. Patients are informed that the primary care practice provides both OUD and mental health treatment and are referred back to their provider for referral or to schedule care. A list of available community resources are available to the patient.
    Intervention: Behavioral: Augmented Usual Care
  • Experimental: Collaborative Care (CC)

    CC condition includes the following elements:

    1. Routine, universal screening for all indicated conditions;
    2. Personnel trained to assist with scheduling, reminders and referrals;
    3. PCP trained and waivered to provide evidence-based pharmacotherapy for OUD;
    4. Addictions psychiatrist with collaborative care expertise to provide treatment consultation and supervision in both OUD and psychiatric disorders;
    5. A care manager trained in evidence-based interventions for individuals with OUD and psychiatric disorders, who provides care in the primary care practice as part of the collaborative care team;
    6. Measurement-guided care and treat-to-target practices, using validated measures;
    7. Electronic and in-person systematic communication regarding patient care among team members, facilitated by the electronic health record; and
    8. Shared patient-provider decision making.
    Intervention: Behavioral: Collaborative Care for Opioid Use Disorders and Mental Health Conditions
  • Experimental: Collaborative Care + Social Worker (CC+)
    In addition to the collaborative care model described above, patients in the CC+ condition will have access to a separate social worker to assist in addressing the social determinants of health. In-person visits will consist of the care manager carrying out intervention activities followed by the social worker addressing social determinants of health (e.g. financial difficulties, housing needs, food scarcity, or unsafe neighborhoods). The goal will be to identify priorities that are likely to influence retention, engagement and adherence to treatment. For example, if the patient prioritizes housing, then the social worker will determine, with the patient, the need for referral to further services. The investigators seek to improve linkages among medical, social and community services including links to advocacy organizations, affordable housing, legal services, employment services, and financial counseling.
    Intervention: Behavioral: Collaborative Care for Opioid Use Disorders and Mental Health Conditions Plus Social Workers
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 27, 2020)
587
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2024
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 18 years and older;
  2. opioid use disorder and not currently receiving medication-assisted treatment
  3. major depression, post-traumatic stress disorder, or an anxiety disorder (panic disorder, agoraphobia, social anxiety disorder, obsessive compulsive disorder, or generalized anxiety disorder);
  4. able to communicate in English or Spanish; and
  5. willing to give informed consent.

Exclusion Criteria:

  1. meet diagnostic criteria for mania or hypomania;
  2. meet diagnostic criteria for psychotic syndrome;
  3. acutely suicidal or psychotic (patients will not be randomized and PI or study physician covering for PI will be paged immediately);
  4. significant cognitive impairment at baseline, as assessed by a total score on the Mini-Mental State Examination (MMSE < 18);
  5. active participation in formal addiction program outside the primary care office; and
  6. lack of a phone.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Donna M Coviello, PhD 215-746-6713 coviello@upenn.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04245423
Other Study ID Numbers  ICMJE UF1MH121944( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Mandell, University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Weill Medical College of Cornell University
Investigators  ICMJE
Principal Investigator: David Mandell, ScD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP