Creating Healthy Work Places (HWP) Study (HWP)

September 3, 2015 updated by: Mark Linzer, Hennepin Healthcare Research Institute

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1296

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18+,
  • have a primary care provider at one of enrolling institutions,
  • have a primary care visit within year of enrollment

Exclusion Criteria:

  • Deceased,
  • inability to communicate (hard of hearing), etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Non-intervention
Usual clinical conditions
Other: Intevention

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
Other: QI interventions
Intervention categories: communication improvement, chronic disease QI projects (for patients), workflow redesign

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Provider outcomes were measured approximately one year after the interventions
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 satisfaction was measured at baseline and approxmiaetly one year after the interventions
Patient quality of care
Time Frame: Patient quality of care was measured at baseline and approxmiaetly one yr after the interventions
Chart audits
Patient quality of care was measured at baseline and approxmiaetly one yr after the interventions

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Provider turnover (cost)
Time Frame: Provider turnover (cost) was mesasured about one year after the interventions
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.
Provider turnover (cost) was mesasured about one year after the interventions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hennepin Healthcare Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Missouri-Columbia
New York University
University of Wisconsin, Madison
University of Alabama, Tuscaloosa
Marshfield Clinic Research Foundation
Agency for Healthcare Research and Quality (AHRQ)
Loyola University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark Linzer, MD, MMRF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AHRQ 1R18-HSO18160-03

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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