Welcome to our Wellness study entitled:
“Evaluation of Institutional Job Demands-Resources and a Novel Mindfulness Tool on Burnout Intensity in a Cross-sectional Cohort of Colorado Health Care Practitioners”
Study Sponsors: Parkview Medical Center Graduate Medical Education Internal Medicine Residency Program and Sangre de Cristo Internal Medicine (SDCIM) the study’s independent data aggregator; Doug Duffee MD, Mdiv, FACP principle investigator.
The purpose of this study is to:
1) identify unique institutional job demands-resources whose presence-absence contribute to Health Care Provider burnout and 2) assess the ability of a novel mindfulness tool intervention as a personal job resource to positively affect Health Care Provider well-being. This will be accomplished by using the “Health Care Provider Wellness Assessment” survey (HCPWA) and the “Insights and Exercises in Personal Forgiveness” tool (IEPF).
Internal screening reviews have suggested that Health Care Provider stress level is elevated. This is YOUR CHANCE to provide input into improving the support systems of workplace culture!
The HCPWA: is a 71 question anonymous SURVEY on workplace demands, resources and personal burnout assessment that takes an estimated 10 minutes to complete.
The IEPF: is a 5 minute daily meditation TOOL with 28 daily exercises for introspection based on an ancient Semitic poem called Psalm 19.
What to do? In a completely anonymous fashion, please complete the IEPF over 4 weeks and then complete the HCPWA
OR…
go straight to the HCPWA and take the survey now.
As study participation with the wellness tool, the survey or both is completely voluntary and anonymous, we are hoping to recruit 300 MA’s, PA’s, NP’s, RN’s, DO’s, MD’s and PharmD’s to complete the survey to give us insight into current Health Care Provider work environments. We hope to improve future workplace wellness systems based on your input. Additionally we hope enough of you will do the wellness tool (IEPF) before taking the survey (HCPWA) so we can also assess if this specific resource model can be used as part of future wellness supports.
__________________________________________________
Informed Consent to Participate in a Research Study
Title of the Project: Evaluation of Institutional Job Demands-Resources and a Novel Mindfulness Tool on Burnout Intensity in a Cross-Sectional Cohort of Colorado Health Care Practitioners
Protocol Number: PIRB67
Sponsor: Name: SDCIM and Parkview Internal Medicine Residency Program
Principal Investigator: Name: Doug Duffee MD, Mdiv, FACP. https://www.sdcim.com or
Address: 400 W. 16th St
City, State, Zip Code: Pueblo, CO 81003
Principal Investigator: Credentials: Owner/Consultant Sangre de Cristo Internal Medicine and Faculty Attending Physician, Parkview IM Residency Program
Institution Affiliation: SDCIM as the independent data aggregating sponsor with Parkview Medical Center
Study Related Phone Number(s) Name: Doug Duffee
Phone Number: 719-595-7968
Co-investigator: Jessica Sels DO, Parkview Internal Medicine Resident
Faculty Advisor: Teresa Braden, Program Director Parkview IM Residency program
Invitation to Participate in a Research Study
A person who takes part in a research study is called a research or study subject. In this consent form “you” always refers to the research subject. If you are a legally authorized representative, please remember that “you” means research (study) subject.
Summary
This study involves a review of healthcare provider attitudes toward their workplace. It involves voluntary and anonymous completion of a wellness meditation tool followed by a survey OR the survey by itself (your choice). The individual survey responses will not be linked to personal identifiers in any way.
You are being asked to be in a research study. The purpose of this consent form is to help you decide if you want to be in the research study.
Things to know before deciding to take part in a research study: The main goal of a research study is to learn things to help health care providers in the future.
Purpose of the Study
§ Internal departmental assessments have noted that health care provider stress is elevated. This study seeks to clarify and quantify that stress in order to identify areas of further evaluation for support structure implementation, including a novel interventional meditational tool.
§ Particular components of this study include a survey to measure individual health care provider burnout. In order to assess the effectiveness of a medical wellness meditation tool, the survey can be completed after completing the wellness tool which will then be compared to the survey results of those who did not elect to complete the wellness tool.
How long will the research last?
We expect that you will be in this research study for 6 months.
How many people will be studied?
We expect about 300 people will be in this research study.
Procedures to Follow
A description of this clinical trial will be available on http://www.ClinicalTrials.gov as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
Procedures
§ The study involves completion of a personal burnout assessment survey or completion of a personal wellness meditation tool followed by completion of a personal burnout assessment survey.
Description of Your Involvement
If you agree to be part of the research study, we will ask you to complete a 71 question survey which takes about 10 minutes to complete. Also if you choose, you can do a 28 day, daily 5 minute intervention tool prior to taking the survey.
Reasonably Foreseeable Risks or Discomforts to the Subjects
There are no foreseeable risks of harm in this study.
Significant New Findings
The knowledge gained through participant responses may help to guide supportive changes to healthcare provider workplace environment.
Costs
There is no cost to you for this study. The wellness tool can be downloaded for free from the study website link at the bottom of this page or reviewed for free directly online inside the study website link below at the bottom of this page. If you would like a bound book copy of the wellness tool, it is available on Amazon for a small charge to cover production costs.
Compensation for Participation
There is no compensation for participation in this study.
Authorization to Use and Disclose Information for Research Purposes
§ No personal identifying information will be obtained.
The anonymous responses you provide through your participation in this study may be given to:
§ The U.S. Food and Drug Administration (FDA),
§ Department of Health and Human Services (DHHS) agencies,
§ Sponsor of this research,
§ Parkview Institutional Review Board,
§ Western Institutional Review Board,
§ Governmental agencies in other countries
If the results of this study are made public, information that identifies you will not be used.
If you decide not to give permission for your anonymous information to be used and shared, then you will not be able to participate in this research study.
You may review or copy your information only after the research is over.
Confidentiality
Although the results of this study may be published, no information will identify you. Your privacy will be protected and your research records will be confidential. No participant responses will be linked to any personal identifiers other than professional certification (MA, RN, NP, PA, DO, MD, PharmD). The overall data will be stored in the Graduate Medical Education Surveymonkey online account.
It is possible that other people may need to see the information you give us as part of the study, such as organizations responsible for making sure the research is done safely and properly, like the Parkview Medical Center Institutional Review Board, government offices or the study sponsor.
Storage and Future Use of Data
We will store your data for use in future research studies. Your name will never be publicly linked to your data. The principle investigator and co-investigator will be the only people with data access to the survey monkey platform.
Voluntary Participation and Withdrawal
Participating in this study is completely voluntary. You may decide not to participate or you may leave the study at any time. Your decision will not result in any penalty.
Compensation for Injury
There are no foreseeable risks or harm in this study.
Questions
Whom do I call if I have questions or problems?
For questions about the study, contact Dr. Duffee at 719-595-7968 or d.duffee@outlook.com. For questions about your rights as a participant in this research study, contact the Parkview IRB at 719-584-4855 or greg_harder@parkviewmc.com.
If you have questions about your rights as a research participant, or wish to obtain information, ask questions or discuss any concerns about this study with someone other than the researcher(s), please contact:
Parkview Medical Center Institutional Review Board
400 West 16th Street
Pueblo, Colorado 81003
Telephone: (719) 584-4855
Email: greg_harder@parkviewmc.com
Parkview IRB is a group of people who independently review research.
Do not proceed with the survey unless you have had a chance to ask any questions and have gotten satisfactory answers.
Consent
Before making the decision regarding enrollment in this research, you should:
· Review the information in this form, and
· Have the opportunity to ask any questions you may have.
By proceeding with the survey, you acknowledge that you have received and reviewed this information, have asked questions you currently have about the research and those questions have been answered (if any).
Participant: By proceeding with the survey, you indicate that you are voluntarily choosing to take part in this research in accordance with the consent disclaimers
The survey while anonymous, contains some questions which prompt emotional introspection and in theory could trigger internal stress. The intervention tool, while applied philosophically and not liturgically, is based on insights from ancient religious Semitic literature but is culturally neutral. None of the survey or intervention tool content would be deemed vulgar or offensive. If you should experience any discord as part of this process, you can stop participation at any time and/or contact your Human Resources Behavioral Health Hotline. Any opinions or ideas presented belong solely to the Principle Investigator and do not necessarily reflect or represent viewpoints of Parkview Medical Center.
Please complete the survey one time only.