Life StressNCT03139357
Behavioral Monitoring in Primary Care
An observational study of Life Stress, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Life Stress
- What is being tested?
- GAD7, SF12, medical utilization, helpfulness questionnaire
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2016to 7 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients ages 20-65 at designated UPMC primary care sites who score 5 or greater on the GAD7 (anxiety) questionnaire. This questionnaire is given as part of routine care.
Who may be able to join
- 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
Who cannot join
- under age 20 and older than 65
- GAD7 score <5
- patients with acute back pain
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Life Stress
- Being tested
- GAD7, SF12, medical utilization, helpfulness questionnaire
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAD7, SF12, medical utilization, helpfulness questionnaireOther
The questionnaires are administered to track stress level and medical utilization over a 2 year period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: GAD7, SF12, medical utilization, helpfulness questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAD7 score change over time
mesures anxiety
Measured: 2 years (6, 12, 18, 24 months)
Secondary outcomes (5)
SF-12 score change over time
measures quality of life
Measured: 2 years (6, 12, 18, 24 months)
Medical hospitalization days change over time
measures medical utilization as number of days inpatient
Measured: 2 years (6, 12, 18, 24 months)
ER visits change over time
measures medical utilization as number of visits to the emergency dept.
Measured: 2 years (6, 12, 18, 24 months)
Outpatient clinic visits change over time
measures medical utilization as number of PCP clinic visits
Measured: 2 years (6, 12, 18, 24 months)
Number of phone calls to practice change over time
Phone call from subject to PCP practice
Measured: 2 years (6, 12, 18, 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start22 Dec 2016
- Primary completion7 Mar 2017
- Study completion7 Mar 2017
Why it stopped: Tech changes made it impossible to consent patients. Not a flaw in design, practice changes caused the study end.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Life StressStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Szigethy, University of Pittsburgh
- Investigators
- Eva Szigethy, MD PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139357
- Sponsor's protocol ID
- 16090557
- Status last verified
- Dec 2018
- First submitted
- 25 Jan 2017
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Monitoring in Primary Care
- ClinicalTrials.gov ID
- NCT03139357
- Acronym / sponsor ID
- 16090557
- Conditions
- Life Stress
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Tech changes made it impossible to consent patients. Not a flaw in design, practice changes caused the study end.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 22 Dec 2016 (actual)
- Primary completion
- 7 Mar 2017 (actual)
- Study completion
- 7 Mar 2017 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary care patients | – | Other: GAD7, SF12, medical utilization, helpfulness questionnairePatients 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ages 20-65 at designated UPMC primary care sites who score 5 or greater on the GAD7 (anxiety) questionnaire. This questionnaire is given as part of routine care.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- under age 20 and older than 65
- GAD7 score <5
- patients with acute back pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GAD7, SF12, medical utilization, helpfulness questionnaireThe questionnaires are administered to track stress level and medical utilization over a 2 year period. | Other | Primary care patients |
Primary outcome
GAD7 score change over time
Time frame: 2 years (6, 12, 18, 24 months)
mesures anxiety
5 secondary outcomes
SF-12 score change over time
Time frame: 2 years (6, 12, 18, 24 months)
Medical hospitalization days change over time
Time frame: 2 years (6, 12, 18, 24 months)
ER visits change over time
Time frame: 2 years (6, 12, 18, 24 months)
Outpatient clinic visits change over time
Time frame: 2 years (6, 12, 18, 24 months)
Number of phone calls to practice change over time
Time frame: 2 years (6, 12, 18, 24 months)
Results and safety
The study was stopped early (reason given: Tech changes made it impossible to consent patients. Not a flaw in design, practice changes caused the study end.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Szigethy, MD PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Life Stress, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Tech changes made it impossible to consent patients. Not a flaw in design, practice changes caused the study end.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GAD7 score change over time (time frame: 2 years (6, 12, 18, 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2018.