Background
Methods
Design
ADAPT-ITT phase | Methodology |
---|---|
1. Assessment | Conducted focus groups/needs assessment with Community Advisory Board and subcommittees |
2. Decision | Decision regarding type of intervention was pre-determined by evidence base; however, decisions regarding major adaptations to the intervention were implemented by the study team based upon Community Advisory Board recommendations (equipment and study structure) |
3. Administration | Theater testing was conducted during the Community Advisory Board patient panel focus groups with patient stakeholders iteratively (3 times across 8 months) prior to intervention implementation. |
4. Production | A draft of the tailored intervention was iteratively (3 times across 8 months) presented to the Community Advisory Board for further feedback and approval. |
5. Topical experts | The study team specifically recruited topical experts for Community Advisory Board membership; see Fig. 1. |
6. Integration | Community Advisory Board input was integrated into the final adapted version of the intervention; the telehealth software company revised the software to reflect Community Advisory Board recommendations. |
7. Training | Both clinical and recruitment specialists received training with regard to study structure and equipment use. |
8. Testing | A pilot test was conducted with 12 patients to identify “hands-on” challenges requiring adaptation; a focus group and structured interviews were subsequently held with these patients to further explore these challenges and solutions |
ADAPT-ITT phases
Phase 1 (assessment)
Methods | Process |
---|---|
Community Advisory Board Patient Advisory Committee (Spanish) Provider Advisory Committee (English) | Focus groups of Community Advisory Board Focus groups of Patient Advisory Committee Focus groups of Provider Advisory Committee January 2019 March 2019 September 2019 |
Pilot | June/July 2019 Patient focus group for completed HTM – August 2019 Patient interviews for HTM dropouts – August 2019 Patient interviews for completed COM – August 2019 Patient interviews for COM dropouts – August 2019 |
Extended Study Team | Biweekly meetings In-depth discussion of challenges and recommendations of Community Advisory Board and Pilot data |
Phase 2 (decision)
Phase 3 (adaptation)
Phase 4 (production)
Phase 5 (identification of topical experts)
Phase 6 (integration)
Month | Study component |
---|---|
January | Community Advisory Board Focus Group: Confirm Outcomes, Preliminary Intervention Adaptions & Study Design |
Patient Advisory Board Focus Group: Confirm Outcomes, Preliminary Intervention & Study Design Adaption Recommendations | |
Provider Focus Group Pre-Pilot Adaptation Recommendations | |
February | Community Advisory Board, Patient Advisory Board, Provider Focus Group Analysis |
Pre-Pilot Adaptation Approval by the Community Advisory Board | |
Pre-Pilot Adaptation Complete | |
March | Pilot |
April | |
May | |
June | |
July | Pilot Patient/Caregiver Focus Groups |
Pilot Analysis | |
August | Patient Advisory Board Focus Group: Post-Pilot Adaptions |
Provider Focus Group: Post-Pilot Adaptions | |
Community Advisory Board Finalizes Intervention Adaption |
Phase 7 (training)
Phase 8 (testing)
Participants and population
Qualitative data analysis
Description of the home telemonitoring intervention
Component 1: daily vital signs
Component 2: telemonitoring visit
Component 3: educational videos
Results
Community advisory board and stakeholder focus groups
Technology acceptance concerns
“But for people that come from a place where the technology didn’t exist, it may be shiny and sparkly, but you have to assume if this is going to be successful that you’re starting from a position where you have to train people from the most basic components of it if we’re going to be successful.”
Other themes that emerged during the community needs assessment included the importance of access to the nurse, flexibility in scheduling appointments, and using clear policies during recruitment. Furthermore, changes to the intervention tablets included requests for lighter tablets, larger font sizes, a log on or blackout screen for added security, and the need for culturally sensitive components such as language and culturally appropriate videos and food choices.“The training has to be so basic and so engaging that they don’t feel intimidated by the actual – it’s like when people have a microphone and they never talk. Hey, does this thing work? It’s the same thing.”
Tablet interface feedback
“We could have icons! We have different icons of people doing…”
Additionally, four patients noted that the information displayed was overwhelming and that too much information was being presented per screen.“Because if we do image and text, I think that would be much more beneficial.”
“I feel like it has too many options.”
“I think we need a clearer dashboard…part of the confusion is that those things, people are not understanding what they are.”
Finally, participants requested the inclusion of additional examples, particularly regarding what is considered exercise.“I think the point is that it’s very busy.”
“When you’re talking about exercise, I’m thinking about going on a treadmill or maybe I do the garden. And that is considered to be an activity as perfect as to do the treadmill.”
When reviewing the language used on the tablets, patients noted changes in terminology that should be made to make the instructions more understandable to the study population. It was suggested that language used on the tablets and videos should be at a fourth-grade comprehension level or less and assume a similar level of health literacy.“So, I just think that as long as people know that all of those things [exercise] count, that’s what’s important.”
“A lot of Spanish people they, they use “sugar” [levels] rather than “glucose.””
“So, I don’t know if ‘press’ versus ‘touch’ is the right word….or ‘verify the oxygen level’.
Clinicians also identified several instances in which information included on the screens was irrelevant to the current study, thus risking overwhelming the patients. These included requiring patients to measure their temperature daily as well as recording oxygen saturation.“I’m assuming that’s not a fourth-grade level either for sure.”
Participants also expressed a desire for more training and/or explanation on tablet use. As previously discussed, the study population required substantial assistance from a caregiver to effectively use the technology, thus more information on using the device was requested.“I understand it but I couldn’t tell you what these translations are.”
New videos developed by KPMG were presented to the Spanish-speaking patient groups, which were considered more acceptable and culturally congruent, both in terms of homophily (the actors “look like me”) and the foods/cultural practices presented. Participants greatly preferred these new videos, while noting additional aspects of the video(s) that were not culturally appropriate or hard to understand for the given population. Participants liked the simplicity of the videos.“In other words, or for example, you know, uh, you’re going to hear a sound. I don’t know exactly how it works. But, you know, or you’re going to feel it pressuring, whatever it is that they’re going to be feeling so that they are part of the process.”
“But I think that’s the only thing is culturally going back to is very often, people measure by spoon. They don’t necessarily use measuring cups, which we will try to teach them, but most people don’t. Most people do it by their spoon.”
Video review
“I thought it was really important that on two different occasions they talked about exercise and physical activity.”
Both groups noted that certain aspects of the educational videos made it difficult to understand the messaging. These challenges included the narrator speaking too fast and the framing of the information being presented. Specifically, while it is important to communicate the dangers associated with uncontrolled diabetes, it is just as important to outline the steps one should take to avoid the danger and foster better health.“I thought the recap at the end really summed it up nicely.”
“It’s kind of a downer. Like I get it. I like how they were honest about their feelings. But not until the last sentence of so what do you do about it. They could have spent more time with that.”
Both groups also expressed concerns regarding the complicated verbiage used throughout the videos. These concerns included suggestions for changing more complex verbiage to simpler words that would be easily understood, including definitions for words, and being provided additional educational information.“No, it scared me at the very beginning. I mean, imagine we’re already scared when we hear about the diagnosis of diabetes and now you’re telling me all these frickin’ complications at the very beginning. It’s like just shut off light.”
“Ophthalmologist and podiatrist, that’s a little bit complex. They should have said eye doctor or foot doctor just to simplify.”
“I had to look up what urinating meant. I didn't know what urinating meant.”
Spanish-speaking participants emphasized the need for the videos to be tailored to be more culturally appropriate. Participants highlighted issues with the translation in the videos being inaccurate as well as the food being presented being representative of a traditional American, rather than a Hispanic, diet.“…the word statistic is probably not even a very familiar word for a lot of people.”
“It needs to be culturally appropriate for Spanish folks. So, there was nothing about this that made me feel as a Spanish speaker, I should be watching this video versus any other – it seems like it was an English translation into Spanish as opposed to a transcultural…”
Spanish-speaking participants also noted a need for a personal connection with the video actors for the information to be most effective. Most common among these concerns was an inability to relate to the actors (e.g., “someone like me” i.e., homophily), who were American actors with dubbed over Spanish voice.“You also – it says Latino population. It didn’t seem to be food from the Caribbean or South America. It looked like an American diet.”
“There was no connection and that’s a big problem with my mother…”
The committees requested that the study team identify alternate, culturally congruent videos that more aligned with the cultural experiences and needs of the target population. The study team searched for educational videos that met the requirements of the committees. New videos that were developed by KPMG were presented at the third Community Advisory Board meeting and found to be acceptable by the committees. Thus, these videos were incorporated into the final intervention (without KPMG’s logo).“It didn’t have any cultural connection, like for my mom…”
Consent process concerns
“At that point, they have already seen the doctor, they’ve asked their questions and they’re checking out. They’re, they’re -- want to do is make their next appointment that they might not be as interested in hearing from [recruiter].”
Feedback from pilot study participants
“Everything was very easy. [The recruiter] explained everything and that made the process even easier.”
Participants expressed a desire to enter the program because it targeted Latino/Hispanic people specifically. Participants also yearned to learn more about diabetes and how to manage the disease, in general.“I wanted to hear a verbal explanation of what I was going to do and how it was going to help me. And that is why it took longer.”
Participants involved their immediate family as caregivers throughout the study.“Honestly, sometimes as a Hispanic you tend to doubt this type of help…[the recruiter] explained the program to me and I am very interested because I have seen the consequences of diabetes.”
“I think that the right person, in my opinion, is a relative.”
Participants considered the Spanish speaking nurse to be integral to the study, and that the trust developed between patient and nurse was crucial. Additionally, the scheduling flexibility afforded to participants for virtual visits was important.“My family also got very involved and they were looking out for my weight and the food I ate. All of that is very important.”
“Yes, the most important thing for me was the language because my doctor speaks English and I was more comfortable speaking to [the nurse] than with my doctor.”
Finally, participants were skeptical of the tablet and felt their privacy may be compromised with the device in their home.“I got home late and she called me and called me and when I got home, I called her and told her, we should do this tomorrow because it’s too late. And she said, [name], it’s fine. And I was sorry because I explained to her that just like him, I come home from work very late. But she – she worked around my schedule.”
“He felt suspicious because the tablet was there all the time and he felt like he was being watched.”
“It would be good if the personnel could tell us this before they hand us the tablet. Tell us that will not be a problem.”
“They thought they could spy us through the camera.”