Burnout, ProfessionalHWPNCT02542995
Creating Healthy Work Places (HWP) Study
A study testing QI interventions in people with Burnout, Professional, run by Hennepin Healthcare Research Institute.
Trial summary
The health of the public depends upon smoothly functioning physician offices that promote the health of both workers and their patients. This study targets ambulatory health care offices with rapid paced, chaotic environments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burnout, Professional
- What is being tested?
- QI interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,296 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Jan 2014
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+,
- have a primary care provider at one of enrolling institutions,
- have a primary care visit within year of enrollment
Who cannot join
- Deceased,
- inability to communicate (hard of hearing), etc.
About this study
Official title: Creating Healthy Workplaces: Improving Outcomes for Providers and Patients
The health of the public depends upon smoothly functioning physician offices that promote the health of both workers and their patients. This study targets ambulatory health care offices with rapid paced, chaotic environments. Investigators will measure adverse outcomes for providers and staff (e.g., stress and burnout), the impact these have on quality of care for hypertensive, diabetic and depressed patients, and identify areas where practice redesign to create "healthy workplaces" improves these outcomes.
Read the detailed description
The context in which primary care is delivered is rarely evaluated as part of quality improvement initiatives or research projects. Data from the MEMO Study (Minimizing Error, Maximizing Outcome) confirm a relationship between the work environment, provider reactions, and patient care. Time pressure is associated with physician satisfaction, stress, burnout, and intent to leave as well as lower quality care for hypertensive patients. Lack of values alignment between physicians and leaders is associated with physician satisfaction, stress, burnout, and intent to leave as well as poorer diabetes care and fewer prevention activities. Thus, providers are not the only ones at risk in adverse work conditions. An important coexisting factor is the impending primary care physician shortage. Less than optimal work conditions are associated with physician intent to leave and with reduced medical student interest in primary care. This randomized study assessed the impact of applying a novel quality improvement strategy designed to create "healthy workplaces".
The investigators hypothesized that addressing adverse primary care work conditions (workflow, work control, organizational culture) would lead to greater clinician participation in programs to improve health care delivery. As part of MEMO, the investigators developed the Office and Work Life (OWL) measurement tool. The OWL assesses the primary care workplace and identifies specific working conditions that impact provider outcomes and quality of care. The current proposal assessed the ability of the OWL and a focused QI process to facilitate changes in the work environment and improve outcomes for providers and patients.
Thirty-four primary care clinics were recruited in New York City and the upper Midwest. Physicians, physician assistants, and nurse practitioners (n=165) were surveyed to collect OWL data on provider outcomes, and organizational structure and culture. Managers were asked to provide information on clinic structure, policies and procedures. Eight patients per provider (n=1131) with hypertension and /or diabetes will be surveyed on health literacy, quality of life, medication compliance, satisfaction, and trust. Patient charts were audited to assess hypertension and diabetes management. The data was then compiled into an OWL measure for each clinic.
34 clinics were randomized. Local leaders, providers, and staff in 17 intervention clinics received their OWL measure and discussed the successes and challenges to care illustrated by the data. Assisted by the study team, they developed QI plans focusing on workplace variables that investigators found contributed to care quality: time pressure, work control, work pace (chaos), and organizational culture. Twelve months later (Aug. 2012 - Jan. 2013), OWL data was recollected in all 34 clinics and compared.
New OWL data was fed back to personnel in the 17 intervention clinics to formalize its role in continuous QI processes. Control clinics received their OWL data at study end. Subsets of data were analyzed to determine the best ways to modify the work environment to improve outcomes for underrepresented groups (women and minority providers and minority patients).
- Conditions
- Burnout, Professional
- Being tested
- QI interventions
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QI interventionsOther
Intervention categories: communication improvement, chronic disease QI projects (for patients), workflow redesign
| Study group | Role | What they receive |
|---|---|---|
| Non-intervention | No intervention | Usual clinical conditions |
| Intevention | Other | QI interventions and got to see their own survey data - examples include:
Workflow redesign:
Medical Assistant (MA) data entry Improved clinic efficiency projects Assessed workflow with staff Provided time for MAs and RNs to perform tasks Paired MAs and providers Non-physician staff assist with forms
Communication improvement:
Improved teamwork Improved communication between provider groups Routine clinician meetings discussing meaningful topics Survey of providers for "wish list" of issues Routine emails from leaders Clinicians meeting with leaders
Chronic disease QI projects:
Establishing quality metrics with clinician input Automated Rx refill line Med reconciliation project Screening project for diabetics Screening for depression Improved patient portals Receives: Other: QI interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical provider stress and burnout
Survey tools: to measure provider stress and burnout developed (for providers), the survey tools were used in the MEMO study and have 1-5 scales.
Measured: Provider outcomes were measured approximately one year after the interventions
Patient satisfaction with care
Survey tool (patients self reported), the survey tools were used in the MEMO study and have 1-5 scales.
Measured: Patient satisfaction was measured at baseline and approxmiaetly one year after the interventions
Patient quality of care
Chart audits
Measured: Patient quality of care was measured at baseline and approxmiaetly one yr after the interventions
Secondary outcomes (1)
Provider turnover (cost)
Clinic managers were given a survey (similar to the ones used by provider and patients) and asked to document the clinic staff make up, how often positions were posted and the length of time of the posting to help assess cost of provider turnover.
Measured: Provider turnover (cost) was mesasured about one year after the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startNov 2009
- Primary completionMar 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), University of Wisconsin, Madison, Marshfield Clinic Research Foundation, New York University, Loyola University School of Medicine, University of Alabama, Tuscaloosa, University of Missouri-Columbia
- Responsible party
- Principal investigator, Mark Linzer, Hennepin Healthcare Research Institute
- Investigators
- Mark Linzer, MD, Principal investigator, MMRF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542995
- Sponsor's protocol ID
- AHRQ 1R18-HSO18160-03
- Acronym
- HWP
- Status last verified
- Sep 2015
- First submitted
- 27 Aug 2015
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Khullar D, Prasad K, Neprash H, Poplau S, Brown RL, Williams ES, Audi C, Linzer M. Factors associated with patient trust in their clinicians: Results from the Healthy Work Place Study. Health Care Manage Rev. 2022 Oct-Dec 01;47(4):289-296. doi: 10.1097/HMR.0000000000000336. Epub 2022 Feb 17.
PubMed 35170482Linzer M, Poplau S, Brown R, Grossman E, Varkey A, Yale S, Williams ES, Hicks L, Wallock J, Kohnhorst D, Barbouche M. Do Work Condition Interventions Affect Quality and Errors in Primary Care? Results from the Healthy Work Place Study. J Gen Intern Med. 2017 Jan;32(1):56-61. doi: 10.1007/s11606-016-3856-2. Epub 2016 Sep 9.
PubMed 27612486
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating Healthy Workplaces: Improving Outcomes for Providers and Patients
- ClinicalTrials.gov ID
- NCT02542995
- Acronym / sponsor ID
- HWP / AHRQ 1R18-HSO18160-03
- Conditions
- Burnout, Professional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,296 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), University of Wisconsin, Madison, Marshfield Clinic Research Foundation, New York University, Loyola University School of Medicine, University of Alabama, Tuscaloosa, University of Missouri-Columbia
- Study start
- Nov 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 7 Sep 2015 (estimated)
- 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.
The health of the public depends upon smoothly functioning physician offices that promote the health of both workers and their patients. This study targets ambulatory health care offices with rapid paced, chaotic environments. Investigators will measure adverse outcomes for providers and staff (e.g., stress and burnout), the impact these have on quality of care for hypertensive, diabetic and depressed patients, and identify areas where practice redesign to create "healthy workplaces" improves these outcomes.
Detailed description
The context in which primary care is delivered is rarely evaluated as part of quality improvement initiatives or research projects. Data from the MEMO Study (Minimizing Error, Maximizing Outcome) confirm a relationship between the work environment, provider reactions, and patient care. Time pressure is associated with physician satisfaction, stress, burnout, and intent to leave as well as lower quality care for hypertensive patients. Lack of values alignment between physicians and leaders is associated with physician satisfaction, stress, burnout, and intent to leave as well as poorer diabetes care and fewer prevention activities. Thus, providers are not the only ones at risk in adverse work conditions. An important coexisting factor is the impending primary care physician shortage. Less than optimal work conditions are associated with physician intent to leave and with reduced medical student interest in primary care. This randomized study assessed the impact of applying a novel quality improvement strategy designed to create "healthy workplaces".
The investigators hypothesized that addressing adverse primary care work conditions (workflow, work control, organizational culture) would lead to greater clinician participation in programs to improve health care delivery. As part of MEMO, the investigators developed the Office and Work Life (OWL) measurement tool. The OWL assesses the primary care workplace and identifies specific working conditions that impact provider outcomes and quality of care. The current proposal assessed the ability of the OWL and a focused QI process to facilitate changes in the work environment and improve outcomes for providers and patients.
Thirty-four primary care clinics were recruited in New York City and the upper Midwest. Physicians, physician assistants, and nurse practitioners (n=165) were surveyed to collect OWL data on provider outcomes, and organizational structure and culture. Managers were asked to provide information on clinic structure, policies and procedures. Eight patients per provider (n=1131) with hypertension and /or diabetes will be surveyed on health literacy, quality of life, medication compliance, satisfaction, and trust. Patient charts were audited to assess hypertension and diabetes management. The data was then compiled into an OWL measure for each clinic.
34 clinics were randomized. Local leaders, providers, and staff in 17 intervention clinics received their OWL measure and discussed the successes and challenges to care illustrated by the data. Assisted by the study team, they developed QI plans focusing on workplace variables that investigators found contributed to care quality: time pressure, work control, work pace (chaos), and organizational culture. Twelve months later (Aug. 2012 - Jan. 2013), OWL data was recollected in all 34 clinics and compared.
New OWL data was fed back to personnel in the 17 intervention clinics to formalize its role in continuous QI processes. Control clinics received their OWL data at study end. Subsets of data were analyzed to determine the best ways to modify the work environment to improve outcomes for underrepresented groups (women and minority providers and minority patients).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-intervention | No intervention | –Usual clinical conditions |
| Intevention | Other | Other: QI interventionsQI interventions and got to see their own survey data - examples include: Workflow redesign: Medical Assistant (MA) data entry Improved clinic efficiency projects Assessed workflow with staff Provided time for MAs and RNs to perform tasks Paired MAs and providers Non-physician staff assist with forms Communication improvement: Improved teamwork Improved communication between provider groups Routine clinician meetings discussing meaningful topics Survey of providers for "wish list" of issues Routine emails from leaders Clinicians meeting with leaders Chronic disease QI projects: Establishing quality metrics with clinician input Automated Rx refill line Med reconciliation project Screening project for diabetics Screening for depression Improved patient portals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18+,
- have a primary care provider at one of enrolling institutions,
- have a primary care visit within year of enrollment
Key exclusion criteria (2 listed)
- Deceased,
- inability to communicate (hard of hearing), etc.
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 |
|---|---|---|
| QI interventionsIntervention categories: communication improvement, chronic disease QI projects (for patients), workflow redesign | Other | Intevention |
Primary outcome
Medical provider stress and burnout
Time frame: Provider outcomes were measured approximately one year after the interventions
Survey tools: to measure provider stress and burnout developed (for providers), the survey tools were used in the MEMO study and have 1-5 scales.
Patient satisfaction with care
Time frame: Patient satisfaction was measured at baseline and approxmiaetly one year after the interventions
Survey tool (patients self reported), the survey tools were used in the MEMO study and have 1-5 scales.
Patient quality of care
Time frame: Patient quality of care was measured at baseline and approxmiaetly one yr after the interventions
Chart audits
1 secondary outcome
Provider turnover (cost)
Time frame: Provider turnover (cost) was mesasured about one year after the interventions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
- Derived from this study: PubMed 35170482Khullar D, Prasad K, Neprash H, Poplau S, Brown RL, Williams ES, Audi C, Linzer M. Factors associated with patient trust in their clinicians: Results from the Healthy Work Place Study. Health Care Manage Rev. 2022 Oct-Dec 01;47(4):289-296. doi: 10.1097/HMR.0000000000000336. Epub 2022 Feb 17.
- Derived from this study: PubMed 27612486Linzer M, Poplau S, Brown R, Grossman E, Varkey A, Yale S, Williams ES, Hicks L, Wallock J, Kohnhorst D, Barbouche M. Do Work Condition Interventions Affect Quality and Errors in Primary Care? Results from the Healthy Work Place Study. J Gen Intern Med. 2017 Jan;32(1):56-61. doi: 10.1007/s11606-016-3856-2. Epub 2016 Sep 9.
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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.
Mark Linzer, MD principal investigator
MMRF
Questions about this trial
What is this clinical trial studying?
A study testing QI interventions in people with Burnout, Professional, run by Hennepin Healthcare Research Institute.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Medical provider stress and burnout (time frame: Provider outcomes were measured approximately one year after the interventions). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02542995, which also lists 2 linked publications.
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 Sep 2015.