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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02542995
Other study ID # AHRQ 1R18-HSO18160-03
Secondary ID
Status Completed
Phase N/A
First received August 27, 2015
Last updated September 3, 2015
Start date November 2009
Est. completion date January 2014

Study information

Verified date September 2015
Source Minneapolis Medical Research Foundation
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 1296
Est. completion date January 2014
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (8)

Lead Sponsor Collaborator
Minneapolis Medical Research Foundation Agency for Healthcare Research and Quality (AHRQ), Loyola University School of Medicine, Marshfield Clinic Research Foundation, New York University, University of Alabama, Tuscaloosa, University of Missouri-Columbia, University of Wisconsin, Madison

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Provider outcomes were measured approximately one year after the interventions No
Primary Patient satisfaction with care 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 No
Primary Patient quality of care Chart audits Patient quality of care was measured at baseline and approxmiaetly one yr after the interventions No
Secondary 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. Provider turnover (cost) was mesasured about one year after the interventions No
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