Volunteer Transition Workgroup

The STARR Coalition Volunteer Transition Workgroup is tasked with finding useful ways to aid study participants in their transition from the trial back to everyday life, ensuring that they continue their recovery journey. As we start compiling post-trial activities and resources for a Best Practices or Guidelines document, determining the objectives for doing this is crucial. WHY are we doing this, aside from it being the right thing to do for our volunteers?  One of the remits of this workgroup is to make a strong argument that would support sponsors’ collaboration and funding for these activities.

Outcomes / Deliverables:

  1. Develop language and supporting arguments for why we should focus on volunteer transition (for webpage – the sponsors that we’ve spoken with about this are very interested in this topic being addressed and are on-board as far as working on ways that pharma can work with sites to ensure that the patients’ journey to wellness isn’t disrupted at the end of their participation in a clinical trial.

    This is part of what we need to be cognizant of as we develop the webpage, so the more data/facts that we have to bolster our argument for a volunteer transition program, the better.

  2. Help volunteers continue their recovery by providing resources (purely altruistic).
  3. Establish trusting relationships with volunteers (altruistic and business).
    1. patient referrals as percentage of enrolled volunteers
    2. expanding from an individual into their network via their families, support networks, peer groups, etc.
  4. Keep track of volunteers for future studies.
  5. Data on retention, recovery, etc would be helpful.
  6. Continued community engagement – part of expanding from an individual into their network via their families, support networks, peer groups, etc..
  7. Repairing / fostering the trust in mental health clinical research.
  8. For use as a recruitment tool (post-trial services as a benefit of participation in the trial).

Action Items: 

Collect data to support reasons listed above:

  1. Number of end-of-treatment / post-study visits occur in a month.
    1. Number of post-trial visits per volunteer (up to 6 visits per volunteer)?
    2. Timing of post-trial visits per volunteer (30 days post-trial evaluation)?
    3. What are the costs associated with the visits?
  2. Number of patients receiving follow-up care that enroll in another study.
  3. Number of patient referrals and/or percentage of patient referrals.

*See Feb call notes below re: data requested

 

  1. Best Practices Guidance Document: Include objective of volunteer transition activities, resource list, info on medication access, a few follow-up care visits, post-trial survey, etc.
  2. Continued access to medications if possible — if not, what is the plan?
    1. Post-Trial Access may involve open-label trial extension studies, long-term extension studies, rollover clinical studies, separate protocols, or protocol amendments.
    2. If there are no expanded access plans, extension or open-label studies available, you don’t have an alternative treatment, can another available treatment be offered??
  3. Aftercare Potential Resources:
    1. Which sites have established nonprofits  to support post-trial patient care?
      • iResearch, Neuro-Behavioral CR, Woodland, who else?
    2. A list of mental health resources and advocacy organizations in the community, including peer support groups, community centers, career support, group homes/housing, other non-profits with mental health resources, etc.
    3. Connect each site with a DBSA Peer Support Specialist 
    4. DBSA Wellness Wheel – online tool, self-guided for holistic wellness
    5. 4 or 6 month telehealth access?
    6. There are many ways to nurture and care for one’s mental health: practicing mindfulness and meditation, seeing a therapist, journaling, talking to a friend (note the importance of having a social network to keep people from isolating themselves)
    7. Access to an app to to support symptom stabilization or continued improvement: Mental health apps aren’t designed to diagnose a condition or substitute care from a mental health professional. Still, they can support your overall mental health. Apps are a convenient way to get extra support between therapy sessions or office visits, and they can offer continued support after graduating from therapy. Mental health apps may provide activities, encouragement, and other techniques to practice daily. Many types are based on research and therapy techniques to provide evidence-based interventions.

Mental health apps can give you tools, activities, and support to help you manage your stress. There are apps available to help with general mental health concerns and specific conditions.

Research from 2018 showed that mental health apps may help improve both the monitoring and management of mental health conditions.

 

Further research from 2018 also suggested apps work because they’re easy to use, increase engagement in treatment plans, and make monitoring symptoms easier. These types of apps have soared in popularity since the onset of the pandemic.

 

  1. Create a standardized Discharge Plan – check housing, finances, medical, support system, back-up contact info, etc.

 

  1. ? Create an ‘Advance Directive’ form for patients to fill out so that if they become incapacitated/psychotic, they will have already decided what is to be done with them.
  2. Post-trial survey:
    1. Do any members use post-trial surveys? If so, can we have a copy to use as a template for others?
      • Include questions on site staff, most challenging aspect of trial, favorite aspect of trial; WHAT IS THE MOST CHALLENGING ASPECT OF LEAVING A STUDY? (housing? job? lack of care?)
      • Optional: request testimonial quote on value of mental health research: how has research impacted your life?  Why does research matter to YOU?
      • Can this patient volunteer be included as a STARR Research Ambassador?
Please fill out the following to help collect data on current study volunteer information. We will use this information to help establish the need for post-trial transition activities.
Volunteer Transition WG: Volunteer Information
Feel free to provide as much or as little data as you can.
Even if you offer post-study support to your patients, how many take you up on the offer?
Or, more simply: what percentage of study participants THAT HAVE COMPLETED THE STUDY were patient referrals?