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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03139357
Other study ID # 16090557
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date December 22, 2016
Est. completion date March 7, 2017

Study information

Verified date December 2018
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 11
Est. completion date March 7, 2017
Est. primary completion date March 7, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
GAD7, SF12, medical utilization, helpfulness questionnaire
The questionnaires are administered to track stress level and medical utilization over a 2 year period.

Locations

Country Name City State
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary GAD7 score change over time mesures anxiety 2 years (6, 12, 18, 24 months)
Secondary SF-12 score change over time measures quality of life 2 years (6, 12, 18, 24 months)
Secondary Medical hospitalization days change over time measures medical utilization as number of days inpatient 2 years (6, 12, 18, 24 months)
Secondary ER visits change over time measures medical utilization as number of visits to the emergency dept. 2 years (6, 12, 18, 24 months)
Secondary Outpatient clinic visits change over time measures medical utilization as number of PCP clinic visits 2 years (6, 12, 18, 24 months)
Secondary Number of phone calls to practice change over time Phone call from subject to PCP practice 2 years (6, 12, 18, 24 months)
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