– Information Sheet –

Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention (RAMP)

You are being asked to participate in a research study conducted by Dr. Diana Burgess at the Minneapolis Veterans Affairs (VA) Healthcare System, Dr. Roni Evans at the University of Minnesota, and Dr. Katherine Hadlandsmyth at the University of Iowa.  This is a study to see if an online mind-body program can help rural Veterans better manage and cope with their pain and improve their overall quality of life.  In this program, you will learn “mind-body strategies” – techniques that use the connection between our mind and body to reduce stress and manage pain.  These techniques have been shown to improve people’s chronic pain and overall quality of life.  You are being asked to participate because your name was selected from a list of patients in the VA Healthcare System with a chronic pain diagnosis, who live in a rural area.  Your participation in this research study is voluntary.  You may choose not to participate at all, and you can leave the study at any time without penalty or loss of benefits to which you are otherwise entitled.     

Why is this study being done?

Rural Veterans are highly impacted by pain and have less access to mind-body approaches to pain management.  The RAMP team has worked with Veterans to create a new, online mind-body program for pain.  Our goals are: 

  1. to give rural Veterans additional tools and support to better manage and cope with their pain and improve their overall quality of life and 

  2. to see if the new program works compared to usual care and find out what Veterans think of it.

What will happen if I participate in this study?

If you agree to participate:

  • First, you will answer a short survey (5-10 minutes) to see if you meet the study requirements.  Then, if you meet the requirements, you will fill out a survey to assess your health and pain.  This survey will take about 40 minutes, and you will receive $40 for completing it.  
    • The RAMP staff will also review your medical record to see if you qualify to be in the study.
  • If you are eligible, you will be placed, randomly (like a flip of a coin), into 1 of 2 groups:
    • Usual Care Group: 6 months of doing what you usually do for your pain.  You can continue with any treatment you are currently receiving.  After the study, you will be given access to the study website to do the program on your own if you choose. 
    • RAMP Mind-Body Group: consists of 9 weekly online group sessions (each 1 ½ hour long) with pre-recorded videos by experts, who will provide education on specific mind-body skills, and then practice those skills with you.  During the sessions there will also be discussions with other Veterans, led by a facilitator.  You will be encouraged to practice what you learned between sessions.  It's important to be able to participate from a quiet, private space where you can give your full attention during sessions so you can fully benefit from the program.  A requirement is to have your video on for the whole session.  This helps us make sure that everyone stays safe; it also helps the group work effectively together.  While you are in the RAMP Mind-Body Group you can continue doing what you usually do for your pain, including continuing with any treatment you are currently receiving.
  • All participants will receive two follow-up surveys at 3 and 6 months after the study starts.
    • These surveys will ask you questions about your health and pain and what you thought about the group you were in.  
    • The surveys can be completed online, on paper via mail, or over the phone.  They will take about 40 minutes to complete, and you may skip any question(s) you feel uncomfortable answering or discontinue at any time. 
    • You will receive $40 each for completing them. 
    • If you respond “yes” to a question on the last survey about whether you are OK being contacted again, we may reach out additional time(s) for further information and/or help with our research.  You can always say no if you don’t want to participate.

 

Number of participants

Our goal is to fully enroll 500 VA patients to be in this study. 

Duration of research

This overall research study is expected to take approximately 3 years.  Your individual participation in the project will take 40 minutes for each of the 3 surveys.  Your overall total participation will last about 7 months.

  • If you are in the Usual Care group, you will not be asked to do anything in addition to what you usually do for your pain.  
  • If you are in the RAMP Mind-Body Group, you will be participating in 9, 1 ½ hour-long weekly group sessions, as well as practice between sessions.  All group sessions are held online. 

Sponsor

This project is funded by the National Institutes of Health National Institute of Nursing Research (NIH NINR).  This project is part of the HEAL (Helping End Addiction Long-term) Initiative (Award # 4UH3NR020929-02).

Right of investigator to terminate

We may have to end your participation in this study for the following reasons:

  1. You display abusive behavior toward other participants and/or the RAMP staff.
  2. The RAMP staff believe it is not in your best interest to stay in the study.  
  3. You become ineligible to participate.
  4. You do not follow instructions from the researchers.
  5. The study is suspended or canceled. 
  6. You choose to withdraw consent. 

 

Are there any risks or discomforts?

There is the possibility that you may be uncomfortable answering some of the questions. 

You may withdraw from the study at any time by calling the Project Director at 877-467-5079.

As with any study, there is a risk of loss of privacy.  We will make every effort to protect your privacy, and we will not contact your providers at your facility regarding your participation.  We will only break confidentiality if you express an intent to harm yourself or others, at which point we would disclose only the information necessary to protect you or others.  We will communicate with you directly whenever possible.  If we are concerned for your immediate safety, we may try calling and/or emailing you, contacting your emergency contact person, and escalate further (for example, asking the Veteran Crisis Line staff to contact you, asking the Suicide Prevention team at your VA site to contact you, or asking your local police to do a wellness check) as it seems necessary to protect you or others.

Risks associated with this type of mind-body program are considered minimal and rare.  

  • Some people may experience minor discomfort while performing mindfulness and other mind-body practices in certain positions (e.g., sitting, walking, gentle movements).  
  • Some people experience difficult feelings (e.g., sadness, anxiousness) or other mental symptoms while engaging in a mind-body, mindfulness or meditation practice or when participating in group activities.

 

Medical treatment and compensation for injury

Every reasonable safety measure will be used to protect your wellbeing.  If you are injured as a result of taking part in this study, the VA will provide necessary medical treatment at no cost to you unless the injury was due to you not following the study procedures.  

You do not give up any of your legal rights and you do not release the VA from any liability by agreeing to participate in this study.   

Are there any benefits?

There are many benefits of mind-body practices.  Mind-body practices (such as mindfulness meditation, guided imagery, breathing and mini practices that can be done anytime, anywhere) have been shown to improve chronic pain and conditions that often co-occur with pain, like depression and insomnia.  Mind-body practices have also been shown to reduce stress and improve people’s general health.  Your participation may also benefit others in the future by guiding the development of strategies to improve healthcare within the VA, particularly for Veterans with chronic pain.

Who will see my information?

We are committed to respecting your privacy and to keeping your personal information confidential.  When choosing to take part in this study, you are giving us permission to use your information, including health information in your medical records that can identify you.  If all identifiers are removed from your private information that are collected during this research, that information could be used for future research studies or distributed to another investigator for future research studies without your additional agreement.

The information collected for this study will be kept confidential.  There are times when we might have to show your records to other people.  For example, someone from the Office of Human Research Protections, the Government Accountability Office, the Office of the Inspector General, the VA Office of Research Oversight, the Minneapolis VA IRB, our local Research and Development Committee, and other study monitors may look at or copy portions of records that identify you.  The National Institutes of Health (NIH) may access your records as part of its human subjects protection oversight activities.

If we discover that you are experiencing significantly worsening depression or suicidal thoughts, we will share this with your VA primary physician and, if you have one, with your mental health provider immediately.  If you express an imminent intent to harm yourself or others, we will break confidentiality, disclosing only the information necessary to protect you or others.

Information collected for this study may be used for other research studies or shared with other researchers who are conducting their own research studies.  This may include sharing with researchers outside of the VA and sharing with private companies.  It may also include making the information available in public and private databases of research data so that other researchers can use the information to answer research questions.  As required by our study sponsor, the National Institutes of Health (NIH), we will save participant data for an external repository (i.e., a secure location where the data will be stored).  By participating in this research and signing the separate HIPAA Authorization Form, you agree to allow your study data to be shared with the repository managed by our external collaborator.  When sharing your information in any of these ways, we will remove as much identifiable information as possible. 

Will I receive any payment if I participate in this study? 

As a thank you for your time, you will receive $40 for each of the surveys you complete for a total of $120. 

Who can I talk to about the study?

In the event of a research-related injury, please immediately contact Dr. Diana Burgess at 612-467-1591.  If you have any questions, comments or concerns about the research, please contact the RAMP staff at 877-467-5079 or [email protected].

If you have questions about your rights as a study participant, or you want to make sure this is a valid VA study, you may contact the Minneapolis VAHCS IRB.  This is the Board that is responsible for overseeing the safety of human participants in this study.  You may call 612-629-7387, if you have questions, complaints or concerns about the study or if you would like to obtain information or offer input.