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Table 6 Themes regarding considerations for conducting mental health related research in the orthopedic care setting

From: Multi-stakeholder perspectives regarding preferred modalities for mental health intervention delivered in the orthopedic clinic: a qualitative analysis

Theme

Representative quotes

Feasibility

Clinical team interest and facilitators for recruitment success: Most orthopedic clinicians would be interested in contributing to a mental health related trial if participation is convenient such that: (1) the eligibility criteria are well-defined, (2) a dedicated research member is present real-time to complete the vast majority of the recruitment and enrollment activities, (3) frequent reminders are sent to clinicians as needed, (4) the study does not interfere with other ongoing studies, and (5) enrollment does not slow down clinic flow (e.g., due to space limitations). Study advertisements in the patient rooms would help patients initiate the conversation and would remind clinicians to discuss it, as well.

“The less work that we have to do in clinic to enroll somebody and the less it slows us down, the more likely I’m going to be to enroll patients. Then also make it very clear and easy to identify inclusion and exclusion criteria, because that’s always a difficult thing to remember in a busy clinic.” (Physician)

“I think there has to be somebody to do it, whoever that is. There has to be a person for whom it’s on their radar. I feel like most of the time, my brain is full or empty or whatever. It usually can’t handle much more, you know?” (Physician)

“If my team knows, I can ask them ahead of time to identify the patients. They can put a note in the appointment comment, or they can remind me as I’m running down the hallway to my next room. And then have something in the rooms, like a little a flyer in a brochure holder. Because then I have a visual reminder in the room when I’m engaging with the patient.” (Nurse practitioner)

“I think it’s important to know that a lot of patients at [this institution] are enrolled in a lot of different studies. There’s a lot of concern when you introduce a new study that it’s going to impact the results of another study, which may be industry funded.” (Physician)

Patient interest and facilitators for enrollment success: Orthopedic patients report that motivators to participate in a mental health related randomized controlled trial in an orthopedic care setting include: (1) a desire to improve their pain and function, and (2) a desire to help people. Many orthopedic clinicians believe patients would be more likely to participate in the research study if: (1) the clinician voices support for the study and recommends it, (2) the topic is introduced in an approachable and compelling manner, and (3) the added burden is minimal.

“For me, the interesting part of this is I feel like I’m suffering from mental issues, and at the same time, have the pain. So if there is really a relationship between these two and if there is a solution, I really would like to know. That’s the reason to participate for me.” (Patient, 30-year-old Black woman)

“I think it’s important for somebody on the [clinical] team to mention the study to the patient. ‘Hey, we’re doing this study. We think it can be potentially really helpful. Would you mind talking to the research coordinator?’” (Physician)

“I think just the presentation – having them feel accepted and that this is really looking at an overall perspective for health and wellness…that we’re on their side and they’re not feeling, I guess, judged or bad. Taking a more positive approach to it. I think that delivery would be helpful for them to accept it.” (Nurse practitioner)

“If it were a lot of time or a lot of effort for anyone, they would not be okay with it.” (Physician)

Patient barriers to participation: Patients reported the following anticipated barriers to participation: (1) worsening of mental health such that the patient loses motivation and energy to participate in typical daily activities, or (2) excessive burden from the study.

“One, if I can afford it, and two, if I can get there. And three, if my mental capacity is willing to take this on that day. But yeah, I definitely would [participate].” (Patient, 35-year-old Black woman)

“If you catch me while I’m down and not feeling great about things, it would be harder to find the motivation to try something new, even if it would be helpful.” (Patient, 44-year-old White man)

Acceptability

Acceptability of randomization: Generally, orthopedic clinicians believe patients would be willing to participate and be randomized to one of a variety of mental health interventions. While most patients expressed willingness to be randomized, many also expressed a preference for one intervention over the other (e.g., digital or printed). Offering all interventions by the end of the study period increased the appeal to many patients.

“I think patients are less likely to participate and be randomized into interventions where they have a vested interest and a clear prejudice for a certain outcome…Trying to get somebody to commit to a randomization for surgery is very difficult because they may have strong feelings, but for this, I don’t think that they’re going to feel strongly about it.” (Physician)

“To me, either one would be okay.” (Patient, 71-year-old Black woman)