The somatic care of patients with comorbid mental disorders: protocol of a mixed-methods study aiming to identify barriers to and enablers of utilization of somatic healthcare (SoKo).

BACKGROUND: Healthcare for people with somatic and comorbid mental diseases can pose a challenge to the healthcare system. The aim of the SoKo study (the Somatic care of patients with mental Comorbidity) is to assess the current state of care and the facilitators and barriers of somatic care of people with somatic disorders and comorbidity of a mental disorder. METHODS: The study is conducted as a mixed-methods approach and will include (a) descriptive and inferential analysis of secondary claims data of persons insured by a German statutory health insurance company in North Rhine-Westphalia (Techniker Krankenkasse, TK-NRW), (b) qualitative individual interviews and group discussions, and (c) based on (a) and (b), quantitative surveys of both patients and physicians. We intend to analyse a sample of claims data of about 2.6 million persons insured by TK-NRW (group comparisons between TK-NRW insured persons with a diagnosis of a prevalent somatic disease [ICD-10-GM E01-E07, E11, E66, I10-I15, I20-I25, I60-I64] with and without comorbidity of a mental disorder [F00-F99]), in order to assess the uptake of somatic care by people with mental and somatic comorbidity. In addition, primary data from patients with the aforementioned somatic illnesses and a mental comorbidity as well as primary data from physicians (general practitioners and medical specialists) will be collected. The focus here will be on support factors and barriers in the somatic care of people with mental comorbidity. DISCUSSION: Up to now, there have been no published results of a systematic collection of both secondary and primary data on the utilisation of different care services of somatically ill patients with mental comorbidity for Germany. The present mixed-methods study aims to address this gap. TRIAL REGISTRATION: The trial is registered with the German Clinical Trials Register DRKS: DRKS00030513. The trial was registered on 3rd February 2023.

The Role of Psychological Wellbeing in a Cross-Provider Worksite Healthcare Management Program for Employees with Musculoskeletal Disorders.

Background: Musculoskeletal and mental disorders are often comorbid, with complex correlations of pain, impairment due to pain, disability, and psychological wellbeing. This study investigates the role of psychological wellbeing in a worksite healthcare program for employees within a German randomized controlled trial. Methods: For our analyses we used data of the module for minor musculoskeletal complaints (N = 180). The intervention included a workplace-related training and case manager support. Results: Changes over time were significant in the disability score (t(179) = 9.04, p < 0.001), pain intensity (t(179) = 9.92, p < 0.001), and psychological wellbeing (t(179) = −4.65, p < 0.001). Individuals with low vs. high psychological wellbeing showed significant differences in their disability scoret0,t1 (tt0(178) = −4.230, pt0 < 0.001, tt1(178) = −2.733, pt1 < 0.001), pain intensityt0,t1 (tt0(178) = −3.127, pt0 < 0.01, tt1(178) = −3.345, pt1 < 0.01, and motivationt0 (tt0(178) = 4.223, pt0 < 0.001). The disability score∆ mediates the impact of pain intensity∆ on psychological wellbeingt1 (beta = 0.155, p < 0.05). Psychological wellbeing∆ had an impact on the disability scoret1 (beta = −0.161, p < 0.01). Conclusions: The lower the psychological wellbeing is at an intervention's beginning, the higher the potential is for its improvement, which might affect individuals' experienced impairment due to pain. In order to achieve the best outcomes, interventions should include both pain-related and psychological aspects. Future research needs to explore the causality of the found interrelationships further.

"I'll leave that to the case managers." Healthcare Service Providers' Perceptions of Organizational Readiness for Change in a Randomized Controlled Trial-A Qualitative Analysis Exploring Implementation Success.

Up to 50% of unsuccessful implementations of organizational change are due to a lack of organizational readiness for change (ORC). This qualitative study aims to investigate the experiences of occupational physicians (OPs) and staff of test and training centers (ETTCs) with team effectiveness in the context of ORC. The change setting is the implementation of a new occupational health program in a multicentric randomized controlled trial for musculoskeletal disorders (MSD) in Germany. Two rounds of expert interviews with OPs (1st round: n = 10, 2nd round: n = 13) and one round of expert interviews with ETTCs (n = 9) were conducted and analyzed with a deductive-inductive procedure. The focus of the analysis was the assessment of change commitment and change efficacy, as well as their influence on general ORC on a collective level according to Weiner's model (2009). Differential critical assessment of change by the care providers led to a missing collective change commitment and consequently to a missing organizational change commitment. Main inhibiting factors include lacking feedback about (e.g., recruitment) success, limited time resources of and narrow communication between responsible study staff, along with a low rate of utilization and limited adherence of the study population. Main facilitators include standardized procedures and documentation along with easy-access digital tools. Researchers may use the findings to improve the development of new intervention studies, especially in a randomized setting.

A Cross-Provider Healthcare Management Program for Musculoskeletal Disorders: Results of a Randomized Controlled Trial in 22 German Companies.

Musculoskeletal disorders (MSDs) are among the most common cause for reduced work capacity and sick leave. Workplace health promotion programs are often neither tailored to the workplace nor the individual needs of the employees. To counteract lacking intersectional care, this four-year randomized controlled trial (RCT) aimed to investigate the effects of modular coordinating case management (treatment group) compared to supported self-management (control group) on MSD specific sick leave days (routine data), workability (WAI), self-efficacy (self-efficacy scale), and pain (German pain questionnaire, GPQ). The study network comprised 22 companies, 15 company health insurance funds, and 12 pension funds in Germany. Overall, 852 participants (Module A/early intervention: n = 651, Module B/rehabilitation: n = 190, Module C/reintegration: n = 10) participated. Both groups achieved fewer sick leave days, higher workability, and less pain (p < 0.0001) at follow-up compared to baseline. At follow-up, the coordinating case management group showed fewer disability days (GPQ), lower disability scores (GPQ), and lower pain intensities (GPQ) than the supported self-management group (p < 0.05), but no superiority regarding MSD specific sick leave days, workability, nor self-efficacy. Module A showed more comprehensive differences. The accompanying process evaluation shows barriers and facilitators for the implementation of the program, especially in a RCT setting.

Occupational Physicians' Perspectives on Determinants of Employee Participation in a Randomized Controlled Musculoskeletal Health Promotion Measure: A Qualitative Study.

Occupational physicians (OPs) are key figures for advising employees and employers about prevention and health at the workplace. However, knowledge of their views on participation in health promotion measures is sparse. This qualitative study aims to explore occupational physicians' experiences with employee participation in a randomized controlled workplace measure for musculoskeletal disorders (MSDs) in Germany. We conducted eight semi-structured telephone interviews with occupational physicians. Interviews were transcribed verbatim and analyzed using a combination of conventional and directed content analysis. Findings were mapped based on Andersen's behavioral model of health services use, resulting in four categories and 10 subcategories. (a) Contextual factors of the measure comprised impacts of the healthcare system and company environment, (b) individual factors of measure participation comprised demographic, social, belief, and MSD need characteristics, (c) health behavior during the measure included OPs' communication, employees' personal practices and measure participation, and (d) outcomes of participation included health status, satisfaction, and dissatisfaction with the measure. Findings imply occupational physicians' and employees' views should be investigated on a broader scale. Researchers should use present statements for the development of intervention studies, while political and managerial authorities can improve organizational conditions of prevention based on these findings.

"And Then He Got into the Wrong Group": A Qualitative Study Exploring the Effects of Randomization in Recruitment to a Randomized Controlled Trial.

BACKGROUND: Randomized controlled trials (RCTs) are regarded as the most internally valid means of estimating the effectiveness of complex public health interventions, but the recruitment of participants can be difficult. The aim of this study was to explore factors that may have affected the recruitment of employees with musculoskeletal disorders (MSDs) to a multicenter worksite health promotion program from the perspective of recruiting case managers. METHODS: Factors in recruitment to the RCT were explored using three focus group discussions with case managers. Data were processed using MAXQDA and analyzed with a combination of content and sequence analysis. RESULTS: Findings showed that randomization is a major challenge for recruitment. Case managers adapted their communication with, and approaches to possible participants because of the randomization design and employed coping strategies to compensate for allocation into the control arm of the study. Perceptions of the superiority of the intervention group over the control group, perceptions of the (mis)match of participants to one of the groups, as well as the understanding of the necessity of randomization for effectiveness evaluations, further affected recruitment. Perceived expectations of possible participants and their (emotional) reactions to the randomization allocation also complicated recruitment. CONCLUSION: We were able to gain insight into the challenges of randomization for the recruitment of participants to a multicenter RCT. This study assisted the development of strategies to overcome barriers in the ongoing implementation process of the trial (i.e., the adaption of best practice information sheets and newsletters). There remains a need to develop effective interventions to help those recruiting to trials.