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Implementation Trial of Evidence Based Practices for Mood Disorders

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ClinicalTrials.gov Identifier: NCT02150577
Recruitment Status : Completed
First Posted : May 30, 2014
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Tracking Information
First Submitted Date  ICMJE May 27, 2014
First Posted Date  ICMJE May 30, 2014
Last Update Posted Date December 8, 2017
Actual Study Start Date  ICMJE May 1, 2014
Actual Primary Completion Date November 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2014)
Patient Reach [ Time Frame: 3 months ]
For patients in the Bipolar Depression Sample and Treatment Resistant Depression Sample, we will measure psychotherapy reach defined as the percentage of patients who report using the on-line cognitive behavioral therapy computer program. We will measure peer support reach defined as the percentage of patients who report using the Depression and Bipolar Support Alliance website chat room. We will measure tele-psychiatry reach as the percentage of patients who report seeing a tele-psychiatrist. For the Bipolar Depression Sample, we will measure diagnostic reach defined as the percentage of patients who are assigned a Bipolar Disorder diagnosis and mood stabilizer reach as the percentage of patients who are prescribed a mood stabilizer. For the Treatment Resistant Depression Sample, we will measure antidepressant prescription change reach as the percentage of patients who are prescribed a different antidepressant than the one prescribed when they screened positive for depression.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02150577 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2014)
Depression Symptoms [ Time Frame: 3 months ]
Depression severity at baseline and follow-up will be measured using the 9-item PHQ9.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: May 27, 2014)
  • Provider Adoption [ Time Frame: 3 months ]
    Psychotherapy adoption will be measured as the percentage of a provider's patients who report use the Beating the Blues on-line cognitive behavioral therapy computer program. Peer support adoption, will be measured as the percentage of a provider's patients who report using the Depression and Bipolar Support Alliance website chat rooms. Tele-psychiatry adoption will be measured as the percentage of a provider's patients who report seeing a tele-psychiatrist. For the Bipolar Depression Sample, diagnostic adoption defined as the percentage of a provider's patients who are assigned a Bipolar Disorder diagnosis and mood stabilizer adoption defined as the percentage of a provider's patients who are prescribed a mood stabilizer. For the Treatment Resistant Depression Sample, we will measure antidepressant prescription change adoption as the percentage of a provider's patients who prescribed a different antidepressant than the one prescribed when they screened positive for depression.
  • Screening Reach and Adoption [ Time Frame: 12 months ]
    For patients who have a current positive PHQ9 depression screen (Full Sample), screening reach will be measured as the percentage of patients who are screened for Bipolar Disorder using the 12-item CIDI bipolar screen. Screening adoption will be measured as the percentage of a provider's patients with a current positive PHQ9 depression screen (Full Sample), who are screened for Bipolar Disorder using the CIDI bipolar screen.
 
Descriptive Information
Brief Title  ICMJE Implementation Trial of Evidence Based Practices for Mood Disorders
Official Title  ICMJE Partnership for Implementation of Evidence-Based Practices in Rural Primary Care
Brief Summary The objective of this Implementation Trial is to evaluate the implementation of evidence based practices for Bipolar Disorder and Treatment Resistant Depression in small rural Federally Qualified Health Centers. The evidence based practices chosen and adapted by Health Center providers and patients in consultation with clinical experts include: screening for and diagnosing Bipolar Disorder, prescribing mood stabilizers, on-line cognitive behavioral therapy, on-line peer support, collaborative care management and tele-psychiatry consultation. A quasi-experimental study design will be used, with each of the six participating Federally Qualified Health Centers choosing one implementation clinic and one control clinic. Implementation outcomes include: reach, adoption, implementation-fidelity and effectiveness. Providers and patients may choose to use all, any or none of the evidence based practices based on their needs and preferences. Data will be collected from chart review and patient surveys will be administered by an Interactive Voice Response telephone system.
Detailed Description

The objective of this Implementation Trial is to evaluate the implementation of evidence based practices for Bipolar Disorder and Treatment Resistant Depression in small rural Federally Qualified Health Centers. The evidence based practices were chosen and adapted by Health Center providers and patients in consultation with clinical experts. The evidence based practices include: screening for and diagnosing Bipolar Disorder, prescribing one of five mood stabilizers, on-line cognitive behavioral therapy (Beating the Blues), on-line peer support (Depression and Bipolar Support Alliance), collaborative care management and tele-psychiatry consultation. These evidence based practices were chosen based on the strength of the research evidence and the feasibility of implementation in small primary clinics serving a low income rural patient population. Providers may choose to use all, any or none of the evidence based practices with their patients. Patients may choose to adhere to all, any, or none of the treatment recommendations prescribed by their provider.

A quasi-experimental study design will be used. There are Federally Qualified Health Centers participating in the Implementation Trial. Each Federally Qualified Health Center chose one implementation clinic and one control clinic. Patients will be enrolled from both implementation and control clinics and outcomes will be compared for the three month period following enrollment. Implementation outcomes are based on the "RE-AIM" framework and include: reach, adoption, implementation-fidelity and effectiveness. Reach represents the proportion of patients who receive evidence based practices. Reach will be compiled at the patient level. Adoption represents the proportion of providers delivering evidence based practices. Provider adoption will be compiled at the primary care provider level. Implementation-Fidelity represents whether the evidence based practices are being delivered as intended. Implementation will be compiled at the patient level. Effectiveness represents the clinical improvement experienced by patients. Effectiveness will be compiled at the patient level. Data will be collected from chart review and patient surveys will be administered by an Interactive Voice Response telephone system.

There will be three samples. The Full Sample will be all patients screening positive for depression on the Patient Health Questionnaire (PHQ9) screening tool during the 9 month enrollment period. The PHQ9 is used to routinely screen patients for depression at participating clinics. The Full Sample is expected to include approximately 2,400 patients. The Bipolar Depression Sample will be patients screening positive for depression, screening positive for Bipolar Disorder (on the CIDI), and providing informed consent to collect primary data. The Treatment Resistant Depression Sample will be patients screening positive for depression, screening negative for Bipolar Disorder, currently prescribed an antidepressant, and providing informed consent to collect primary data. The purpose of the "currently prescribed an antidepressant" inclusion criterion is to identify patients who do not respond to treatment. This inclusion criterion will be determined from chart review. We expect approximately 40 patients from each of six Federally Qualified Health Centers (two clinics per system) to be eligible for the Bipolar Depression and Treatment Resistant Depression samples and to provide informed consent. Thus, the combined size of the Bipolar Depression and Treatment Resistant Depression samples is expected to be 240.

Health Center evaluation staff will test differences in patient outcomes at implementation and control sites using ordinary least squares and logistic regression analyses that will control for demographic characteristics. Compared to patients at control sites, we hypothesize that patients with a positive depression screen at implementation sites will be more likely to be screened for Bipolar Disorder than patients at control sites. With automated chart review data for 2,400 patients, we will have 84% power to detect a 5% (e.g., 25% versus 20%) difference in Bipolar Disorder screening rates. Compared to patients at control sites, we hypothesize that patients in the Bipolar Disorder Sample at implementation sites will be more likely to see receive a Bipolar diagnosis, be prescribed a mood stabilizer, engage in on-line cognitive behavioral therapy, engage in on-line peer support, receive collaborative care management, have a tele-psychiatry consultation, experience depression symptom improvement and report greater satisfaction. For the Bipolar Disorder Sample, we plan to enroll approximately 20 patients from each of six Federally Qualified Health Centers (two clinics per system) and expect at least a 75% follow-up rate (n=90), which will give us 79% power to detect a 25% (e.g., 15% versus 40%) difference in Bipolar Disorder specific outcomes (e.g., diagnosed with Bipolar Disorder). Compared to patients at control sites, we hypothesize that patients in the Treatment Resistant Depression Sample at implementation sites will be more likely to have their antidepressant prescription changed, engage in on-line cognitive behavioral therapy, engage in on-line peer support, receive collaborative care management, have a tele-psychiatry consultation, experience depression symptom improvement and report greater satisfaction. For the Treatment Resistant Depression Sample, we plan to enroll approximately 20 patients from each of six Federally Qualified Health Centers (two clinics per system) and expect at least a 75% follow-up rate (n=90), which will give us 79% power to detect a 25% (e.g., 15% versus 40%) difference in Treatment Resistant Depression specific outcomes (e.g., antidepressant prescription changed). For the combined Bipolar Disorder Sample and Treatment Resistant Depression Sample, we plan to enroll approximately 40 patients from each of six Federally Qualified Health Centers (two clinics per system) and expect at least a 75% follow-up rate (n=180), which will give us 87% power to detect a 15% (e.g., 25% versus 40%) difference in trans-diagnostic outcomes (e.g., satisfaction).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • Treatment Resistant Depression
Intervention  ICMJE Behavioral: Evidence Based Quality Improvement
Facilitation of the identification, adoption, adaption and implementation of evidence based practices.
Study Arms  ICMJE
  • Experimental: Implementation
    Evidence Based Quality Improvement
    Intervention: Behavioral: Evidence Based Quality Improvement
  • No Intervention: Control
    Usual Quality Improvement
Publications * Hunt JB, Curran G, Kramer T, Mouden S, Ward-Jones S, Owen R, Fortney J. Partnership for implementation of evidence-based mental health practices in rural federally qualified health centers: theory and methods. Prog Community Health Partnersh. 2012 Fall;6(3):389-98. doi: 10.1353/cpr.2012.0039.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2017)
291
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2014)
240
Actual Study Completion Date  ICMJE November 1, 2017
Actual Primary Completion Date November 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Full sample - screening positive for depression Bipolar Disorder sample - screening positive for depression, screening positive for bipolar disorder, not currently in a manic state Treatment Resistant Depression - screening positive for depression, screening negative for bipolar disorder, currently prescribed an antidepressant by primary care provider

Exclusion Criteria:

Full sample - none Bipolar Disorder sample - currently in a manic state Treatment Resistant Depression - none

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02150577
Other Study ID Numbers  ICMJE MH085104
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Arkansas
Study Sponsor  ICMJE University of Arkansas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Geoffrey Curran, PhD University of Arkansas
PRS Account University of Arkansas
Verification Date December 2017

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