The self-regulation skills instrument in transplantation (SSIt): Development and measurement properties of a self-report self-management instrument.

OBJECTIVE: To develop a self-management instrument for organ transplant recipients that incorporates self-regulations skills and to determine its measurement properties. METHODS: The instrument includes concepts from social cognitive models: problem awareness, attitude, self-efficacy, motivation, social support, goal setting, goal pursuit, skills and goal affect. The measurement properties were evaluated based on the COSMIN guidelines. Face and content validity were determined through patient assessment, Three-Step Test-Interview and expert assessment using the Content Validity Index. Structural validity and reliability were tested using exploratory factor analysis and Cronbach's alpha. Construct validity was tested by comparing subscales with the Health Education Impact Questionnaire (heiQ). RESULTS: After face and content validity assessment 47 items were entered into the exploratory factor analysis. The analysis showed two meaningful factors, with internal consistency of 0.90 and 0.89. Spearman correlations between the subscales and heiQ were moderate (0.55; 0.46). The final version consists of 21 items, divided into two scales: 'Setbacks' and 'Successes'. CONCLUSIONS: The Self-regulation skills instrument in transplantation (SSIt) is a valid and reliable instrument to asses necessary skills for self-management after transplantation and may be useful for other patients as well. PRACTICE IMPLICATIONS: Insight into self-regulation competencies can help healthcare professionals to tailor self-management support.

Nurse-led self-management support after organ transplantation-protocol of a multicentre, stepped-wedge randomized controlled trial.

BACKGROUND: Recipients of an organ transplantation face a number of challenges and often need to change their health behaviour. Good self-management skills are essential for optimal clinical outcomes. However, few interventions are available to support post-transplant self-management. To fill this gap, we developed a self-management support intervention offered by nurse practitioners. The primary aim of the study is to implement and test the effectiveness of the ZENN intervention in promoting self-management skills among heart, kidney liver and lung transplant recipients in comparison to standard care. The secondary aim is to assess the self-management support skills of nurse practitioners who will deliver the intervention. METHODS: This multi-centre stepped-wedge randomized controlled trial will take place from September 2020 until May 2023. All departments will commence with inclusion of patients in the control period. Each department will be randomly assigned to a start date (step in the wedge) to commence the experimental period. Patients in the control period will receive standard care and will be asked to complete questionnaires at baseline (T0), 6 months (T1) and 12 months (T2), to assess self-management, self-regulation, quality of life and adherence. During the experimental period, patients will receive standard care plus the ZENN intervention and receive the same set of questionnaires as participants in the control period. Nurse practitioners will complete a baseline and follow-up questionnaire to assess differences in self-management support skills. Video recordings of outpatient clinic consultations during the control and experimental periods will determine the differences in nurses' needs-thwarting and needs-supporting skills between the control and experimental period. DISCUSSION: The ZENN intervention could be a useful approach to support patients' self-management skills after organ transplantation and thus promote clinical outcomes as well as avoid adverse events. TRIAL REGISTRATION: Dutch Trial Register NL8469 . Registered on March 19, 2020.

Is simplification of immunosuppressive medication a way to promote medication adherence of kidney transplant recipients? Findings from a randomized controlled trial.

After kidney transplantation, a strict immunosuppressive medication regimen is necessary for graft survival. However, nonadherence to medication has been shown to occur early after transplantation and to increase over time. Weaning the recipient off dual therapy onto monotherapy in order to reduce immunosuppressive burden may also be a way to promote adherence, although little is known about the impact of such a regimen on fear of rejection. We performed a cohort study on medication adherence and fear of rejection in a randomized, investigator-driven, open-label, single-centre pilot study. Recipients were randomized at 6-months post-transplant to either continue Tacrolimus and Mycophenolate mofetil (TAC/MMF) or to taper MMF at 6 months and discontinue MMF at 9 months (TAC monotherapy). Recipients completed questionnaires about medication adherence and fear of rejection at 6 and 12-months post-transplantation. Medication adherence was significantly higher in the TAC monotherapy group compared to dual TAC/MMF therapy group (χ2 (1) = 4.582; P = 0.032). We found no difference in fear of rejection between the two groups of recipients (P = 0.887). Simplification of the medication regimen is a potential tool for increasing adherence in clinical practice (Netherlands Trial Register - NL4672).

Self-Determination Theory to observe healthcare professionals' counselling in chronic care encounters: Development of the COUNSEL-CCE tool.

OBJECTIVE: To develop and psychometrically evaluate an observation tool to rate healthcare professionals' engagement in need-supportive and need-thwarting counselling in chronic care encounters. METHODS: The observation tool was developed through three stages (January 2018 - June 2019). First, a set of items was developed according to essential components of need-supportive and need-thwarting counselling as identified in Self-Determination Theory. Second, content validation by five experts. Third, ecological validation using video-recorded real-life consultations. For the psychometric evaluation (June - October 2019), the tool was used by three observers to code 55 units of real-life encounters. RESULTS: The Coding and Observing Need-Supportive Counselling in Chronic Care Encounters (COUNSEL-CCE) consists of 44 items clustered into nine theoretically underpinned behavioural approaches. Psychometric testing indicated acceptable to good consistency in scoring between observers and strong consistency within observers. CONCLUSION: The COUNSEL-CCE captures person-oriented alongside process-oriented aspects during chronic care encounters. A person-oriented approach expresses counselling that is responsive to individual preferences and needs, whereas a process-oriented approach indicates the necessity to support competency building within patients, and is more instrumental of nature. PRACTICE IMPLICATIONS: COUNSEL-CCE is a valuable observation tool to assess (graduate) healthcare professionals' counselling style and address if, and how, counselling evolves as a result of professional training.