Background
Methods/design
Aim
Design
Randomisation
Eligibility criteria and recruitment
GP nurses
Patients
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Are 18 years of age or older
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Experience worry, stress or sleep problems (the latter without a medical cause such as sleep apnea as ascertained by the GP or GP nurse)
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Have access to the Internet
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Have sufficient proficiency of the Dutch language
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Have no acute or urgent comorbidity
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Provide informed consent.
Inclusion procedure
Monitoring system
Implementation strategies
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▪ Learn about the online CDMIs, the related monitoring system and guidelines for the recruitment and guidance process
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▪ Practice using the online CDMIs and its monitoring system
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▪ Discuss possible barriers and facilitators for implementation
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▪ A helpdesk service (email or telephone contact) will be provided to support GP nurses to handle technical and implementation-related issues
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▪ At least two implementation team meetings (led by the research team) will be organised in which the participating GP nurses will be able to exchange their experiences, tips, ideas and to discuss encountered implementation barriers with each other. These meetings will also provide the research team with the opportunity to provide additional information, make adjustments or reiterate important issues if necessary
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▪ Regular communication from the research team with the GP nurses through newsletters, telephone calls and emails to keep the online CDMIs on the agenda of the GP nurses, and provide ongoing information and tips
Adaptation of the online Complaint-Directed Mini-Interventions (CDMIs) to allow use by general practice (GP) nurses in a blended format | |
• Developing a monitoring system that allows GP nurses to: ◦ Invite patients to create an account ◦ Monitor use of CDMIs ◦ Track mood and complaints ◦ Provide the opportunity to message patients | |
Create awareness of CDMIs and implementation project among GPs and GP nurses | |
• Providing an information brochure for GPs to facilitate patient flow to the GP nurse and online CDMIs • Short outreach presentation during team meetings to teach/inform GP nurses about the CDMIs (including an information sheet and test-account) | |
Provide training to GP nurses in using the CDMIs and guiding patients | |
• Two visits: a training of 2 h and a follow-up meeting of 1 h (approximately 2 months after the training visit). The goals of the visits are to target: ◦ Knowledge about the CDMIs, the recruitment and guiding process, skills to use the intervention, creating self-efficacy and a positive attitude, motivation, intentions to use the CDMIs ◦ Training topics: 1. Providing information about the CDMIs, the related monitoring system and guidelines for the recruitment and guidance process 2. Practising with the use of the CDMIs and monitoring system 3. Discussing possible barriers and facilitators for implementation • With respect to guidance, flexible guidelines were given to promote maximum adaptability to local needs and procedures of GP nurses. Guidelines include:Highlighting the benefits of the CDMIs with guidance, explaining the content and goal of the intervention, discuss the desirable frequency and content of guidance sessions (suggestions for topics are given in the manual), examples of motivational interviewing techniques, monitor and discuss progress in an interim evaluation, final evaluation of the intervention (process) • The follow-up meeting is aimed at: discussing first experiences, barriers and facilitators, repeating the main elements of the way recruitment and guidance is being given. | |
Create and provide educational materials to GP nurses | |
• Developing manuals, and other supporting materials (PowerPoint presentation, flowchart) in ways that make it easier for GP nurses to learn about the CDMIs and for GP nurses to learn how to deliver the CDMIs to patients. The educational materials contain information on: The usefulness of blended e-health, the content of the CDMIs, the monitoring system, steps and guidelines to be taken in the recruitment and guidance process (including motivational interviewing techniques), the study flowchart and patient information | |
Facilitate exchange of information and experiences among GP nurses | |
• Organising at least two implementation team meetings per participating organisation during the year following the training and follow-up visits (led by the research teams). The participating GP nurses will be given time to reflect upon and share their experiences, share lessons learned and support each other’s learning. Moreover, the research team can provide additional information, support or solve problems as needed. The aim is to contribute to increasing motivation, self-efficacy, and intentions to use the CDMIs and to remove potential barriers for implementation | |
Facilitate a process of interactive problem solving and support for GP nurses | |
• Providing a helpdesk (by telephone or email) for the GP nurses for either technical questions or questions about the implementation process, and actively providing information and tips to GP nurses through newsletters, telephone calls and emails. The aim is to contribute to increasing motivation, self-efficacy and intentions to use the CDMIs and to remove potential barriers for implementation | |
Create awareness among patients about the CDMIs and the implementation project | |
• Providing an information brochure and letter for patients to inform them about the online CDMIs and the research study | |
Facilitate and encourage the use of the CDMIs among patients | |
• Making adjustments to CDMIs to make them user friendly (e.g. providing reminders for use, simplifying some of the navigation and texts) • Providing additional information about the CDMIs and offering the opportunity to ask questions during the GP nurse consultation • The GP nurse can also show a demo video in which the content and goal of the online CDMIs are explained. | |
Motivate and provide support to patients when using the online CDMIs | |
• Providing guidance at each step during the intervention, if necessary. The aim is to teach the necessary skills to use the intervention, and create a positive attitude and motivate patients to use the CDMIs. • Guidance is provided according to the regular implementation strategy guidelines described above |
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▪ Extra guidance from the GP nurse, when needed, during the registration process (creating an account, username/password, intake questionnaire, etc.)
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▪ Extra guidance from the GP nurse, if necessary, with the exercises (e.g. the GP nurse and the patient practice the exercise together during a consultation)
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▪ A more proactive approach of delivering support by the GP nurse (e.g. extra reminders, extra contact moments by email or phone)
Outcome measures
Primary outcome
Secondary outcomes
Psychological complaints
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▪ Depressive complaints will be measured using the 8-item Patient Health Questionnaire (PHQ-8) [40]. Items can be scored from 0 (not at all bothered) to 3 (bothered nearly every day) which results in a total score ranging from 0 to 24. Higher scores correspond to higher levels of depressive complaints. Sum scores of 5, 10, 15 and 20 represent cut-off points for mild, moderate, moderately severe and severe depression, respectively
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▪ Sleep problems will be measured with the Jenkins Sleep Evaluation Questionnaire (JSEQ) [41]. It consists of four items that are scored on a 6-point scale (0 = not at all, 5 = 22–31 days) and can be added to obtain a total score ranging from 0 to 20. Higher scores indicate more sleep problems
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▪ Stress will be measured with the 10-item Perceived Stress Scale (PSS-10) [42]. Items are scored on a 4-point scale (0 = never, 4 = very often), resulting in a total score ranging from 0 to 40. Higher score indicate higher levels of stress
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▪ Worry will be assessed using the 11-item Penn State Worry Questionnaire (PSWQ) [43]. Items can be scored from 0 (not at all typical of me) to 5 (very typical of me) which results in a total score ranging from 11 to 55. Higher scores correspond to higher levels of worry
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▪ Anxiety will be measured with the Generalised Anxiety Disorder Scale (GAD-7) [44]. The seven items are rated on a 4-point scale (0 = not at all sure, 4 = nearly every day). Items are summed which results in a total score (range 0–28), with higher scores defining a higher level of anxiety severity
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▪ Well-being will assessed with the 5-item World Health Organisation Well-Being Index (WHO-5) [45]. The items can be scored from 0 (at no time) to 5 (all of the time) which results in a total score ranging from 0 to 25. Higher scores correspond to higher levels of well-being