- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03139357
Behavioral Monitoring in Primary Care
Stress and anxiety can worsen quality of life in patients seen in primary care practices. Patients at predetermined practices age 20-65 receive psychosocial screening instruments for anxiety and quality of life (GAD7 and SF-12) at six month intervals for twenty-four months as part of routine care. Assessing anxiety and quality of life every six months will provide data to analyze whether anxiety and quality of life changes over time.
Patients who consent will also be asked at 6, 12, 18, and 24 months about medical utilization of behavioral care or any medical care outside of University of Pittsburgh Medical Center in order to be part of their research record for good clinical care. If patients received any behavioral treatment, the patient will also be asked questions regarding the helpfulness of this treatment.
This is an observational characterization study to understand the psychiatric and behavioral needs of primary care patients. The follow-up questionnaires and medical record information will look at the rates and predictors of hospitalizations and/ or behavioral health treatment as a longitudinal way to track these symptoms over time. These resources are critical to determine the need for embedded behavioral care in primary care settings.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients who are receiving or seeking medical care at University of Pittsburgh Medical Center CMI practices are given the GAD7(anxiety) and SF-12(quality of life) as a part of routine medical care. Patient scores become part of the EMR (Epic). A best practice alert will be generated for patients in the age range of 20-65 (inclusive) and in the targeted GAD7 score range (GAD7 ≥5) to prompt the provider to obtain consent. Within 2-4 weeks after consent, a UPMC research team member will administer via phone a brief, approximately 10 minute questionnaire for patients who score ≥10 on the GAD7 questionnaire and have signed consent. This DSM5 cross-cutting measure level 1 is a validated screening tool capturing primary psychiatric symptoms present across a range of disorders. A secure database will be maintained within the UPMC firewall where all patient information will be de-identified. Routine care safety protocols are in place if a patient's anxiety/stress worsens. At 6,12,18, and 24 months post-consent, the research team will contact the patient by phone to complete routine questionnaires (GAD7 and SF-12) if questionnaires have not been completed in clinic at an appointment or via the patient portal, MyUPMC. As part of the study, the patient will complete the Medical Utilization/Follow up questionnaire by phone with the research team at the 6, 12, 18, and 24 month time points. If the patient had any behavioral health treatment the research team will also ask the Helpfulness Questionnaire at the six month time point. In addition to these questionnaires, the research team will access Epic records to understand medical utilization.
CARe will provide the information from the medical record.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- receiving or seeking medical care at UPMC CMI
- ages 20-65
- GAD7 (anxiety questionnaire) score ≥ 5
- Speaks English speaking
- Capable of understanding and providing consent or assent
Exclusion Criteria:
- under age 20 and older than 65
- GAD7 score <5
- patients with acute back pain
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Primary care patients
Patients ages 20-65 who score 5 or greater on the GAD-7 will be given the SF12, GAD7, medial utilization, and helpfulness questionnaires at 6 month intervals for a 2 year period.
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The questionnaires are administered to track stress level and medical utilization over a 2 year period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GAD7 score change over time
Time Frame: 2 years (6, 12, 18, 24 months)
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mesures anxiety
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2 years (6, 12, 18, 24 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SF-12 score change over time
Time Frame: 2 years (6, 12, 18, 24 months)
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measures quality of life
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2 years (6, 12, 18, 24 months)
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Medical hospitalization days change over time
Time Frame: 2 years (6, 12, 18, 24 months)
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measures medical utilization as number of days inpatient
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2 years (6, 12, 18, 24 months)
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ER visits change over time
Time Frame: 2 years (6, 12, 18, 24 months)
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measures medical utilization as number of visits to the emergency dept.
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2 years (6, 12, 18, 24 months)
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Outpatient clinic visits change over time
Time Frame: 2 years (6, 12, 18, 24 months)
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measures medical utilization as number of PCP clinic visits
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2 years (6, 12, 18, 24 months)
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Number of phone calls to practice change over time
Time Frame: 2 years (6, 12, 18, 24 months)
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Phone call from subject to PCP practice
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2 years (6, 12, 18, 24 months)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eva Szigethy, MD PhD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16090557
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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