Implementation of personalized self-management support using the self-management screening questionnaire SeMaS; a study protocol for a cluster randomized trial

Abstract

BackgroundThe number of patients with one or more chronic diseases is rising. In several standards of care there is a focus on enhancing self-management. We applied the concept of personalization on self-management support and developed a self-management screening questionnaire (SeMaS). The main research objective is to assess the effectiveness of the SeMaS questionnaire and subsequent personalized self-management on patients’ self-management behaviors.Methods/DesignA cluster randomized controlled trial will be set up in 15 general practices in the Netherlands. The practices are all group practices, and member of one care group. The practices will be assigned to the control or intervention arms by stratified randomization. The strata are determined by the participation of the practice nurses in a course for behavioral change, and the nurse’s workload. Patients can be included if they are over 18 years of age, have at least one chronic condition and have a checkup appointment with the practice nurse in the inclusion period. The intervention consists of screening patients with the SeMaS questionnaire, producing a graphic profile with the abilities or barriers for self-management. Patients will receive tailored feedback. Practice nurses are trained in using the profile to enhance self-management of the patient and provide personalized self-management support. The use of individual care plans and self-management interventions is stimulated. In the control arm patients will receive care as usual. Patients of both trial arms will be asked to fill in the SeMaS questionnaire and additional questionnaires at inclusion and after 6 months. The primary outcome is the difference in the level of patient activation (PAM-13) between baseline and 6 months. Secondary outcomes include patient measures for lifestyle factors (exercise, diet, smoking), and process measures from medical record data analysis.DiscussionThis manuscript presents the protocol for a cluster randomized clinical trial of personalized self-management support using the SeMaS questionnaire in chronically ill patients in primary care. By carrying out this study, scientific evidence is built for the effectiveness of personalized self-management support.Trial registrationThe Netherlands National Trial Register: NTR3960.

Effectiveness of personalised support for self-management in primary care: a cluster randomised controlled trial

“…15 A multivariate, multilevel linear regression model was used to assess the difference in PAM-13 scores, exercise, nutrition, and the number of consultations and referrals between the intervention and control arms at 6 months, when controlled for baseline scores. The covariates were controlled for:…”

“…15 More details on the method are available from the authors. Parallel to the RCT a process evaluation was performed including interviews with practices nurses, which are reported on separately.…”

“…The intervention was hypothesised to affect patient activation and health-related behaviour, as shown in the logic model (available from the authors on request) and the study protocol. 15 Two authors together provided one 2-hour group training session to the practice nurses and GPs on:…”

“…9,15 Of the two authors who conducted the training, one is a researcher with expertise on SeMaS and the other trainer is a psychologist with expertise on training in behavioural change methods. 16 To provide additional support, the author with expertise in SeMaS visited intervention practices shortly after starting the study to ensure that practice nurses understood the information and were able to work with SeMaS in their consultations.…”

“…15 Anticipating a 30% response rate and a 33% attrition rate, 150 patients per practice were invited to participate. Based on the number of included patients after 3 months, 100 additional patients were invited from one control (n = 50) and one intervention practice (n = 50).…”