Background: Neck and shoulder complaints are common in primary care physiotherapy. These patients experience pain and disability, resulting in high societal costs due to, for example, healthcare use and work absence. Content and intensity of physiotherapy care can be matched to a patient’s risk of persistent disabling pain. Mode of care delivery can be matched to the patient’s suitability for blended care (integrating eHealth with physiotherapy sessions). It is hypothesized that combining these two approaches to stratified care (referred to from this point as Stratified Blended Approach) will improve the effectiveness and cost-effectiveness of physiotherapy for patients with neck and/or shoulder complaints compared to usual physiotherapy. Methods: This paper presents the protocol of a multicenter, pragmatic, two-arm, parallel-group, cluster randomized controlled trial. A total of 92 physiotherapists will be recruited from Dutch primary care physiotherapy practices. Physiotherapy practices will be randomized to the Stratified Blended Approach arm or usual physiotherapy arm by a computer-generated random sequence table using SPSS (1:1 allocation). Number of physiotherapists (1 or > 1) will be used as a stratification variable. A total of 238 adults consulting with neck and/or shoulder complaints will be recruited to the trial by the physiotherapy practices. In the Stratified Blended Approach arm, physiotherapists will match I) the content and intensity of physiotherapy care to the patient’s risk of persistent disabling pain, categorized as low, medium or high (using the Keele STarT MSK Tool) and II) the mode of care delivery to the patient’s suitability and willingness to receive blended care. The control arm will receive physiotherapy as usual. Neither physiotherapists nor patients in the control arm will be informed about the Stratified Blended Approach arm. The primary outcome is region-specific pain and disability (combined score of Shoulder Pain and Disability Index & Neck Pain and Disability Scale) over 9 months. Effectiveness will be compared using linear mixed models. An economic evaluation will be performed from the societal and healthcare perspective. Discussion: The trial will be the first to provide evidence on the effectiveness and cost-effectiveness of the Stratified Blended Approach compared with usual physiotherapy in patients with neck and/or shoulder complaints.
Introduction: Over the past decade, frequent use of large quantities of nitrous oxide (N2O) has become more common in the Netherlands. Although N2O poses several negative health consequences for a subgroup of problematic N2O users, there is a lack of knowledge on what characterizes these intensive users. This study therefore aims to provide the demographic and substance use characteristics and experiences during treatment of treatment seeking problematic N2O users and to compare this with a matched group of treatment-seeking problematic cocaine users. Methods: A retrospective chart review was performed of patients who were referred for treatment of problematic N2O use at a large Dutch addiction care facility from January 2020 to September 2022, extracting demographics, pattern of use and follow-up data. Additionally, a subgroup of N2O users was propensity-score matched (1:1) with a subgroup of treatment seeking problematic cocaine users, both groups excluding users with substance use disorders or frequent use of substances other than N2O and cocaine, respectively. Results: 128 patients with a N2O use disorder were included in the total sample and a subgroup of 77 N2O-only users was propensity-score matched on age and sex to 77 cocaine-only users. N2O users were typically young (mean age 26.2 years), male (66.4%), unmarried (82.9%), with a low education level (59.0%) and born in the Netherlands (88.2%), with parents born in Morocco (45.3%). N2O was used intermittently (median 10 days/month, IQR 4.0–17.5 days) and often in very large quantities (median 5 kg [ca. 750 balloons] per average using day, IQR 2–10 kg). Compared to the patients with a cocaine use disorder, matched N2O users were lower educated, more often from Moroccan descent, and less likely to be alcohol or polysubstance users. Despite receiving similar treatments, N2O users were twice as likely to discontinue treatment before completion compared to cocaine users (63 vs. 35%, p = 0.004). Conclusion: Treatment-seeking problematic N2O users are demographically different from treatment-seeking problematic cocaine users and are much more likely to dropout from psychological treatment. Further research is needed into the needs and other factors of problematic N2O users that relate to poor treatment adherence in problematic N2O users.
Background:Postoperative complications and readmissions to hospital are factors known to negatively influence the short- and long-term quality of life of patients with gastrointestinal cancer. Active family involvement in activities, such as fundamental care activities, has the potential to improve the quality of health care. However, there is a lack of evidence regarding the relationship between active family involvement and outcomes in patients with gastrointestinal cancer after surgery.Objective:This protocol aims to evaluate the effect of a family involvement program (FIP) on unplanned readmissions of adult patients undergoing surgery for malignant gastrointestinal tumors. Furthermore, the study aims to evaluate the effect of the FIP on family caregiver (FC) burden and their well-being and the fidelity of the FIP.Methods:This cohort study will be conducted in 2 academic hospitals in the Netherlands. The FIP will be offered to adult patients and their FCs. Patients are scheduled for oncological gastrointestinal surgery and have an expected hospital stay of at least 5 days after surgery. FCs must be willing to participate in fundamental care activities during hospitalization and after discharge. Consenting patients and their families will choose to either participate in the FIP or be included in the usual care group. According to the power calculation, we will recruit 150 patients and families in the FIP group and 150 in the usual care group. The intervention group will receive the FIP that consists of information, shared goal setting, task-oriented training, participation in fundamental care, presence of FCs during ward rounds, and rooming-in for at least 8 hours a day. Patients in the comparison group will receive usual postoperative care. The primary outcome measure is the number of unplanned readmissions up to 30 days after surgery. Several secondary outcomes will be collected, that is, total number of complications (sensitive to fundamental care activities) at 30 and 90 days after surgery, emergency department visits, intensive care unit admissions up to 30 and 90 days after surgery, hospital length of stay, patients’ quality of life, and the amount of home care needed after discharge. FC outcomes are caregiver burden and well-being up to 90 days after participating in the FIP. To evaluate fidelity, we will check whether the FIP is executed as intended. Univariable regression and multivariable regression analyses will be conducted.Results:The first participant was enrolled in April 2019. The follow-up period of the last participant ended in May 2022. The study was funded by an unrestricted grant of the University hospital in 2018. We aim to publish the results in 2023.Conclusions:This study will provide evidence on outcomes from a FIP and will provide health care professionals practical tools for family involvement in the oncological surgical care setting.
