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Table 4 Interview guide patient recruitment—translated from Danish to English

From: Challenges in reaching patients with severe mental illness for trials in general practice—a convergent mixed methods study based on the SOFIA pilot trial

Theme

Content

Information and questions

Briefing

Introduction of interviewer and study purpose

A brief introduction to the interviewer (KT) and what the study seeks to investigate.

Data processing

Information for the participant on how we store data safely in the project, who has access to the interview, and how we anonymise names and personal information when sharing in presentations and publications.

Payment

Their time was honored with a fee for every 10 min in the interview.

Informed consent

Interlocuters were informed about the written consent, the meaning of the consent, that they were always able to withdraw their consent, whom to contact if they wanted to withdraw consent, and finally signed the consent form.

Introduction of the interlocuter

Work tasks, experience

I would like you to present yourself briefly:

Will you tell me a bit about yourself, and your experience in general practice?

Previous experience with patients with SMI

The SOFIA study is focused on patients with severe mental illnesses in general practice:

Why did you/your practice choose to be a part of this study?

Is the study of particular relevance to you?

Research question

How was the patient recruitment performed in the SOFIA pilot trial and why?

Introduction to the recruitment process and distribution of work tasks

The next questions I have will be closely related to your recruitment of patients for the pilot study and will be aligned with the recruitment process elements that you performed in practice

For starters, I would like to ask you how you divided the different work tasks during the recruitment?

• How did you choose to divide the different tasks?

• Who did what?

• Did this division work well for you?

• Did you change anything during the process—what and why?

• How many from your practice participate in the study?

• Which effect does this have?

Extracting data from the GP record system

To identify patients with SMI in your system, the SOFIA project office has asked you to extract data from your record system on patients, their diseases, and previous contact to practice

How did this process work for you?

• How did you perform the data extraction?

• Have you experienced any challenges in this regard?

• Were you provided with the help you needed to perform this task?

• In your experience—does the data you extracted match your expectations?

• Why/why not?

• In your opinion—do you consider this an appropriate method for identifying patients to the study?

Patient exclusion process (only to GPs)

After you extracted patient data from your record systems, you were provided with a list of patients that potentially fulfilled the eligibility criteria from the SOFIA project office. Afterwards, you had to verify their diagnosis.

Will you tell me how you approached that process?

• Can you tell me how you reviewed the patients and why?

• How much time did you spend on this part of the recruitment?

• If you did not manage to review all patients on the list—why was that?

• How did you choose to verify the patient’s diagnosis with SMI?

• How did you experience this process? Was it easy or hard—can you give an example?

• Did you find any diagnosis harder to verify than others?

• How did you review the exclusion criteria?

• Did you do this in a specific way—can you give an example?

• Did you experience times, when you were in doubt and what did you do?

• Would you say that there is anything that characterizes the patients that you included in the study/or excluded in the study?

• How would you describe the patients you included in the study?

• How would you describe the patients you excluded from the study?

• Did you know all the patients on the list from before?

• Did that affect how you included them?

We know from research on the area, that many patients with SMI have co-occurring substance use. Is this something you experience when you review the patients and does this impact these patients’ ability to be included in the study?

Contacting the patients

When you finished reviewing the patients, you were instructed to contact the patients you included in the study.

Will you tell me how you performed this process and contacted the patients?

• Who was primarily in charge of contacting the patients?

• How did you contact them?

• Was it possible to reach the patients?

• Did you change the way you contacted the patients and why?

I would like you to tell me about the conversations you had with the patients during the recruitment process—how did you experience this?

• What did you tell them?

• How did they react to your call?

• What was it like for you?

• Were there any challenges?

• Did the patients ask any questions—and what did they ask you?

• What worked particularly well during the conversations?

Physical meeting in practice (collecting the informed consent)

How did you experience the information meeting with the patient in practice?

• Where and how did you meet up?

• What went well?

• What was challenging?

• Did the patient show?

• Did they have any questions?

• Did you feel well prepared for the conversations?

Non-participants

I would like to ask you about the patients that declined to participate in the study. You have talked with them on the phone and/or if they attended the information meeting physically.

Will you tell me about the patients that declined?

• If you were to give your point of view—what characterizes the patients saying no?

• Which reasons do the patients give for wanting to participate or not participate?

• What do you think influences if the patient wants to participate?

• What do you think impacts the project’s ability to recruit patients to the study—and why?

Post-recruitment

Did the patients contact you after they agreed to participate—besides their regular contact and treatment?

Why did they contact you and which questions did they have?

Filling out the questionnaires

In the practice recruitment phase, some GPs and staff was concerned about the patients’ ability to fill out the questionnaires on quality of life in the study. Due to this, I would like to ask you if you have helped any of the patients fulfil the questionnaires—and how?

spørgeskemaerne vedrørende livskvalitet enten i elektronisk—eller papirform.

• How did you help them?

• What did you help them with?

• Which questions did they have?

• Did they themselves have any concerns about filling out the questionnaires?

• Did you experience any challenges in this regard?

Registering process data on patient recruitment in REDCap

Connected to the recruitment, you were instructed to document the recruitment process in REDCap. I would like to hear your experiences and thoughts on using this system—will you tell me about that?

• Did you use REDCap yourself?

• If no—why was that?

• Did you fill in all the information asked for?

• What would make it easier for you to use the program?

Info meetings during practice recruitment

Before you started recruiting patients, you had two meetings with the SOFIA project office—one concerning general information on participation and an additional meeting on the use of REDCap

I would like to ask you what you gained from these meetings and whether there is anything you could have wanted to be different—in retrospect.

• Did you feel ready for the task?

• What do you think about having a GP inform you on the meetings instead of a project manager?

• Did you contact the project office during the recruitment process for help?

• Was the help you needed provided?

• Moving forward—what could be improved?

End

I am about to have runned thorugh all of the questions I had for you today regarding recruiting patients for the pilot study. Is there anything you would like to add, that we did not touch opon?

Something you find relevant regarding the recruitment process or would have liked to be different?

Moving forward in the study

Comments regarding the project

Lastly, I want to ask you if you fell there is anything about the intervention/study that you feel is currently unclear?

• Is there something that is not clear to you?

• Something that will be of importance for you in the following process?

Debriefing

Final ending

Turn of recorder “Off the record”

Thank you very much for taking the time for answering my questions.

Now i have turned of the recorder—is there anything you would like to ask me off the record?

Thank you again