Health Registry Research Articles

Education, employment, and income among people living with cystic fibrosis across three decades – A matched cohort study using Danish health registries

BackgroundPast and ongoing advancements in cystic fibrosis (CF) care warrant long-term analysis of the societal impact of the condition. This study aims to evaluate changes in key socioeconomic factors across three decades among people living with CF (pwCF), compared with both the general population and an early-onset chronic disease population. MethodsThis nationwide, registry-based, matched cohort study included all pwCF ≥ 18 years in Denmark in the years 1990, 2000, 2010, and 2018. Each person living with CF was matched to five individuals in the general population and five individuals living with type 1 diabetes or juvenile arthritis based on age, sex, and municipality. ResultsThe Danish adult CF population increased nearly fourfold from 88 in 1990 to 331 in 2018, and mean age increased by ten years. The educational level of pwCF was similar to the two comparator cohorts, while pwCF were less often in employment and more often permanently outside the labor force. Personal and household income levels of the CF cohort were higher than those of the comparator cohorts. ConclusionsThe disadvantage in employment for pwCF remained, but, over time, the societal profiles of the one-year CF cohorts increasingly converged with those of the comparator cohorts, indicative of improved clinical management, extended life expectancy, and the supportive role of the Danish welfare system in reducing health inequalities. Further research should be done to evaluate the effects of the newly introduced modulator therapies on employment, considering the broader societal impact and impact on quality of life.

Familial adversity: association with discontinuation of adjuvant hormone therapy and breast cancer prognosis.

Many studies have examined patient-related factors affecting adjuvant hormone therapy adherence in breast cancer patients. Our study aimed to examine associations of family-related factors with adjuvant hormone therapy discontinuation and breast cancer-specific mortality. By cross-linking seven Swedish health registers, we performed a cohort study including all breast cancer patients who initiated adjuvant hormone therapy during 2006-2019 in Sweden (N = 10,701). A group-based multi-trajectory model was used to identify familial adversity groups based on three dimensions: material deprivation, negative family dynamics, and loss or threat of loss. Cox proportional hazard models were used to investigate associations of familial adversity with hormone therapy discontinuation and breast cancer-specific mortality. We identified five distinctive familial adversity groups among the cohort participants. Compared to women with low familial adversity, higher risks to discontinue adjuvant hormone therapy were observed among women with material deprivation (hazard ratio (HR), 1.31; 95% CI, 1.20-1.43), negative family dynamics (HR, 1.16; 95% CI, 1.06-1.28), loss or threat to loss (HR, 1.15; 95% CI, 1.00-1.32), or high familial adversity (HR, 1.53; 95% CI, 1.40-1.68). Furthermore, women with material deprivation (HR, 1.37; 95% CI, 1.05-1.79), negative family dynamics (HR, 1.41; 95% CI, 1.01-1.97), or high adversity (HR, 1.67; 95% CI, 1.26-2.23) were at higher risks of dying from breast cancer. Familial adversity is associated with a higher risk of adjuvant hormone therapy discontinuation and breast cancer-specific mortality. Family-related factors identified in our study may help identify high-risk patients for interventions to prevent treatment discontinuation and subsequently improve breast cancer outcomes.

Pregnancies and births in women with previous abdominal myomectomy

Background: Uterine leiomyoma may cause pelvic symptoms and may also interfere with the reproductive desires of many women. Consequently, some women may undergo myomectomy as a fertility sparring method to relieve symptoms or as a method to improve their fertility. Objective: We aimed to assess pregnancies and deliveries in women with previously myomectomy both in spontaneous pregnancies and with use of assisting reproductive techniques. Also, we aimed to asses if the reproductive prognosis differed between different surgical approaches. Study design: In this historical cohort study we collected data regarding myomectomies, pregnancies, use of assisting reproductive techniques and births from national health registries. All Danish women were followed from 1996 through 2017. Results: Of 5.281 women undergoing myomectomy, 97% had one and 3% had two or more myomectomies. Median age at first surgery was 38.5 years (interquartile range 34.1-44.6 years). Of 5.430 myomectomies conducted, 71% were done by laparotomy and 29% by laparoscopy. Of the 5.281 women treated with myomectomy, 1.586 (30%) became pregnant and 1.145 (22%) gave birth. In the entire cohort of 5.281 women, 1.056 (20%) were treated with assisting reproductive techniques. Of these 1.056 women, 659 (62%) got pregnant and 461 (44%) delivered. Median time from surgery to pregnancy was 1.2 years. Significantly more women became pregnant and gave birth when treated with laparotomy as compared to laparoscopy. However, the effect was only significant for women younger than 30 years or older than 40 years at first surgery. Conclusion: As the proportion of women attempting pregnancy was unknown, the overall figure of 30% pregnancy rate is a minimum estimate of the real chance of achieving pregnancy after myomectomy.

Distinguishing Primary Prevention From Secondary Prevention Implantable Cardioverter Defibrillators Using Administrative Health and Cardiac Device Registry Data

BackgroundAdministrative health data and cardiac device registries can be used to empirically evaluate outcomes and costs after implantable cardioverter defibrillator (ICD) implantation. These datasets often have incomplete information on the indication for implantation (primary vs secondary prevention of sudden cardiac death). MethodsWe used 16 years of population-based cardiac device registry and administrative health data from British Columbia, Canada, to derive and internally validate statistical models that predict the likely indication for ICD implantation. We used chart review data as the reference standard for ICD indication in the Cardiac Device Registry database (CDR; 2004-2012 [Cardiac Services BC]) and nonmissing indication as the reference standard in the Heart Information System registry database (HEARTis; 2013-2019 [Cardiac Services BC]). We created 3 logistic regression prediction models in each database: one using only registry data, one using only administrative data, and one using both registry and administrative data. We assessed the predictive performance of each model using standard metrics after optimism correction with 200 bootstrap resamples. ResultsModels that used registry data alone demonstrated excellent predictive performance (sensitivity ≥ 89%; specificity ≥ 87%). Models that used only administrative data performed well (sensitivity ≥ 84%; specificity ≥ 70%). Models that used both registry and administrative data showed modest gains over those that used registry data alone (sensitivity ≥ 90%; specificity ≥ 89%). ConclusionsAdministrative health data and cardiac device registry data can distinguish secondary prevention ICDs from primary prevention ICDs with acceptable sensitivity and specificity. Imputation of missing ICD indication might make these data resources more useful for research and health system monitoring.

Genome-Wide Polygenic Score for Muscle Strength Predicts Risk for Common Diseases and Lifespan: A Prospective Cohort Study.

We used a polygenic score for hand grip strength (PGS HGS) to investigate whether genetic predisposition for higher muscle strength predicts age-related noncommunicable diseases, survival from acute adverse health events, and mortality. This study consisted of 342443 Finnish biobank participants from FinnGen Data Freeze 10 (53% women) aged 40-108 with combined genotype and health registry data. Associations between PGS HGS and a total of 27 clinical endpoints were explored with linear or Cox regression models. A higher PGS HGS was associated with a reduced risk of selected common noncommunicable diseases and mortality by 2%-10%. The risk for these medical conditions decreased by 5%-23% for participants in the highest PGS HGS quintile compared to those in the lowest PGS HGS quintile. A 1 standard deviation (SD) increase in the PGS HGS predicted a lower body mass index (β = -0.112kg/m2, standard error [SE] = 0.017, p = 1.69E-11) in women but not in men (β = 0.004kg/m2, p = .768). PGS HGS was not associated with better survival after acute adverse health events compared to the nondiseased period. The genotype that supports higher muscle strength appears to protect against future health adversities, albeit with modest effect sizes. Further research is needed to investigate whether or how a favorable lifestyle modifies this intrinsic capacity to resist diseases, and if the impacts of lifestyle behavior on health differs due to genetic predisposition for muscle strength.

The Danish Aging and Cognition (DanACo) cohort

BackgroundWith aging populations worldwide, identification of predictors of age-related cognitive decline is becoming increasingly important. The Danish Aging and Cognition Cohort (DanACo) including more than 5000 Danish men was established to investigate predictors of age-related cognitive decline from young adulthood to late mid-life.Construction and contentThe DanACo cohort was established through two separate data collections with identical designs involving a follow-up examination in late mid-life of men for whom intelligence test scores were available from their mandatory conscription board examination. The cohort consists of 5,183 men born from 1949 through 1961, with a mean age of 20.4 years at baseline and a mean age of 64.4 years at follow-up. The baseline measures consisted of height, weight, intelligence test score and educational level collected at the conscription board examination. The follow-up assessment consisted of a re-administration of the same intelligence test and a comprehensive questionnaire covering socio-demographic factors, lifestyle, and health-related factors. The data were collected in test sessions with up to 24 participants per session. Using the unique personal identification number assigned to all Danes, the cohort has been linked to data from national administrative and health registers for prospectively collected data on socioeconomic and health-related factors.Utility and discussionThe DanACo cohort has some major strengths compared to existing cognitive aging cohorts such as a large sample size (n = 5,183 men), a validated global measure of cognitive ability, a long retest interval (mean 44.0 years) and the availability of prospectively collected data from registries as well as comprehensive questionnaire data. The main weakness is the low participation rate (14.3%) and that the cohort consists of men only.ConclusionCognitive decline is a result of a summary of factors across the life-course. The DanACo cohort is characterized by a long retest interval and contains data on a wealth of factors across adult life which is essential to establish evidence on predictors of cognitive decline. Moreover, the size of the cohort ensures sufficient statistical power to identify even relatively weak predictors of cognitive decline.

Risk and adverse clinical outcomes of thrombocytopenia among patients with solid tumors—a Danish population-based cohort study

BackgroundKnowledge about thrombocytopenia among patients with solid tumors is scarce. We examined the risk of thrombocytopenia among patients with solid tumors and its association with adverse outcomes.MethodsUsing Danish health registries, we identified all patients with incident solid tumors from 2015-2018 (n = 52,380) and a platelet count measurement within 2 weeks prior to or on their cancer diagnosis date. The risk of thrombocytopenia was categorized as grades 0 (any platelet count × 109/L): <150; 1: <100; 2: <75; 3: <50; 4: <25, and 5: <10. To study the outcomes, each patient with thrombocytopenia was matched with up to five cancer patients without thrombocytopenia by age, sex, cancer type, and stage. Cox regression was used to compute hazard ratios (HRs) of bleeding, transfusion, or death, adjusting for confounding factors.ResultsThe 1-year risk of thrombocytopenia was 23%, increasing to 30% at 4 years. This risk was higher in patients receiving chemotherapy (43% at 1 year and 49% at 4 years). Overall, patients with thrombocytopenia had higher 30-days rates of bleeding (HR = 1.72 [95% confidence interval, CI: 1.41–2.11]). Thrombocytopenia was also associated with an increased rate of transfusion, and death, but some of the risk estimates were imprecise.ConclusionsThe risk of thrombocytopenia was substantial among patients with solid tumors and associated with adverse outcomes.

Burden of Disease of Duchenne Muscular Dystrophy in Denmark - A National Register-Based Study of Individuals with Duchenne Muscular Dystrophy and their Closest Relatives.

Duchenne Muscular Dystrophy (DMD) is a progressive genetic disease with a prevalence of 1 per 3,600-6,000 male births. Individuals with DMD are typically diagnosed at age 4-7 years; median survival is 30 years. They require multidisciplinary care, personal assistance, and often special education. The aim was to assess the burden of disease in DMD in Denmark. This includes incidence, prevalence, use of healthcare services, labour market participation, educational outcomes, and overall attributable costs due to DMD. Impact on the closest relatives (siblings and parents) was also investigated. The comprehensive Danish national health and administrative registers were used to assess the burden of disease following individuals with DMD and closest relatives from five years before, and up to 20 years after DMD diagnosis. Individuals with DMD (and relatives) from 1994-2021 were included. All outcomes were compared to matched control groups without the disease drawn from the Danish population. 213 unique individuals with DMD were identified. They had lower grades in school, required more special education and more healthcare and home care compared to their control group. The extra costs of special education summed to EUR 180,900 over the course of 11 years elementary school. They had an annual average productivity loss of EUR 20,200 between the age of 18 to 30. The extra healthcare costs of DMD in the 20 years after diagnosis were estimated to EUR 1,524,000. If an individual with DMD lives to be 30, total extra costs sum to EUR 2,365,800. Using national register data this study presented detailed results on the burden of disease of DMD, including impact on closest relatives. With 60 additional hospital admissions and 200 extra outpatient contacts in 20 years healthcare costs, but also costs of home care and special education, increases as disease progresses.

Examining Demographic Factors, Psychosocial Wellbeing and Cardiovascular Health in Subjective Cognitive Decline in the Brain Health Registry Cohort

BackgroundSubjective cognitive decline (SCD) is defined as an individual’s perception of sustained cognitive decline compared to their normal state while still performing within boundaries for normal functioning. Demographic, psychosocial and medical factors have been linked to age-related cognitive decline, and Alzheimer’s dementia (AD). However, their relation to risk for SCD remains unclear. This study aims to identify demographic factors, psychosocial and cardiovascular health associated with SCD within the Brain Health Registry (BHR) online cohort.MethodsParticipants aged 55+ (N=27,596) in the BHR self-reported SCD measured using the Everyday Cognition Scale (ECog) and medical conditions, depressive symptoms, body mass index, quality of sleep, health, family history of AD, years of education, race, ethnicity and gender. Multivariable linear regression was used to examine whether SCD was associated with demographic, psychosocial, and medical conditions.ResultsWe found that advanced age, depressive symptoms, poorer sleep quality and poorer quality of health were positively associated with more self-reported SCD in all models. No race or ethnicity differences were found in association with SCD. Males who reported alcohol and tobacco use or underweight BMI had higher ECog scores compared with females.ConclusionIn addition to well-established risk factors for cognitive decline, such as age, our study consistently and robustly identified a strong association between psychosocial factors and self-reported cognitive decline in an online cohort. These findings provide further evidence that psychosocial health plays a pivotal role in comprehending the risk of SCD and early-stage cognitive ageing. Our findings emphasise the significance of psychosocial factors within the broader context of cardiovascular and demographic risk factors.

The role of registries in improving health and bridging healthcare, research, education, innovation and development: a research department perspective.

Health registries are organized systems that collect data on individuals with a particular disease, condition or exposure. The aim of this narrative review was to provide an integrated perspective from the Research Department at the Hospital Italiano de Buenos Aires, Argentina, on how health registries can be used as a bridge between healthcare, research, education, innovation and development while addressing ethical challenges. The review includes a description of the experience of a registry implemented at our institution, which has provided healthcare for 170 years, and is committed to support, education and research. We focus on the potential of health registries to provide better value healthcare by reducing healthcare costs and improving health outcomes and quality of care, and to improve medical knowledge. However, we also acknowledge and discuss the challenges that accompany these achievements, such as that of ethical issues. Through effective collaboration and integration with other healthcare stakeholders, health registries can be a powerful tool to promote better health.

Cohort profile: The Health, Food, Purchases and Lifestyle (SMIL) cohort – a Danish open cohort

PurposeThe Health, Food, Purchases and Lifestyle (SMIL) cohort is a prospective open Danish cohort that collects electronic consumer purchase data, which can be linked to Danish nationwide administrative health and...

Frailty risk and treatment strategy in elderly-onset inflammatory bowel disease. A Norwegian nationwide population-based registry study

Background/AimsTo determine real-world medical and surgical treatment patterns in elderly-onset inflammatory bowel disease in a nationwide cohort, and to investigate associations between frailty and treatment choices. MethodsNorwegian health registries were used to identify adult-onset (born 1950–1989) and elderly-onset (born 1910–1949) patients with Crohn's disease (CD) and ulcerative colitis (UC) diagnosed 2010–2017 (n = 13,006). Patients were classified as no, low and intermediate/high frailty risk after the Hospital Frailty Risk Score. Outcomes included use of medical and surgical treatment. ResultsWithin five years, elderly-onset patients received less biologics (13% [CD], 7% [UC]) and immunomodulators (24% [CD], 11% [UC]), and major surgery was more frequent (22% [CD], 9% [UC]) than in adult-onset. Respective log rank tests were significant (p < 0.01). Compared to no frailty risk groups, elderly-onset UC with intermediate/high frailty risk had lower probability of starting biologics (4% versus 9%), immunomodulators (7% versus 13%) and 5-aminosalisylic acids (66% versus 84%), and elderly-onset CD with intermediate/high frailty risk had higher probability of starting prednisolone (67% versus 49%). Respective log rank tests were significant (p < 0.05). ConclusionsElderly-onset patients received less biologics and immunomodulators and a larger proportion underwent major surgery. Frailty risk in elderly-onset patients was associated with increased use of prednisolone, and less use of 5-aminosalisylic acids, immunomodulators and biologics.

Relationship Between Hepatitis C Infection and Treatment Status and Coronavirus Disease 2019-Related Hospitalizations in Georgia.

The aim of this study was to evaluate the impact of hepatitis C virus (HCV) infection and treatment status on coronavirus disease 2019 (COVID-19)-related hospitalizations in Georgia. We analyzed 2020-2021 Georgian health registry data for COVID-19-positive individuals and categorized the data by HCV infection and treatment status. Logistic regression was used to assess the strengths of the associations. Treated individuals with HCV had lower odds of COVID-19-related hospitalization compared to anti-HCV-negative individuals, while untreated HCV-viremic and anti-HCV-positive nonviremic individuals had higher odds. HCV treatment prior to COVID-19 infection was associated with lower odds of COVID-19-related hospitalization, highlighting the benefits of HCV management in the context of the pandemic.

Efficacy of migraine prophylaxis treatments for treatment-naïve patients and those with prior treatment failure: a protocol for systematic review and network meta-analysis of randomised controlled trials

IntroductionMigraine headache is a significant health problem affecting patients’ psychological well-being and quality of life. Several network meta-analyses (NMAs) have compared the efficacy of migraine prophylaxis medications. However, some have...

Loneliness and the risk of type 2 diabetes

IntroductionThe incidence of type 2 diabetes is increasing globally. Recent research suggests that loneliness could be a potential risk factor for the development of type 2 diabetes. We aimed to...

Major bleeding in patients with atrial fibrillation treated with apixaban versus warfarin in combination with amiodarone: nationwide cohort study

BackgroundAmiodarone is an established treatment for atrial fibrillation (AF) but might interfere with the metabolism of apixaban or warfarin. Therefore, the aim was to investigate the occurrence of major bleeding...

The Danish Nationwide Electrocardiogram (ECG) Cohort

The electrocardiogram (ECG) is a non-invasive diagnostic tool holding significant clinical importance in the diagnosis and risk stratification of cardiac disease. However, access to large-scale, population-based digital ECG data for research purposes remains limited and challenging. Consequently, we established the Danish Nationwide ECG Cohort to provide data from standard 12-lead digital ECGs in both pre- and in-hospital settings, which can be linked to comprehensive Danish nationwide administrative registers on health and social data with long-term follow-up. The Danish Nationwide ECG Cohort is an open real-world cohort including all patients with at least one digital pre- or in-hospital ECG in Denmark from January 01, 2000, to December 31, 2021. The cohort includes data on standardized and uniform ECG diagnostic statements and ECG measurements including global parameters as well as lead-specific measures of waveform amplitudes, durations, and intervals. Currently, the cohort comprises 2,485,987 unique patients with a median age at the first ECG of 57 years (25th–75th percentiles, 40–71 years; males, 48%), resulting in a total of 11,952,430 ECGs. In conclusion, the Danish Nationwide ECG Cohort represents a novel and extensive population-based digital ECG dataset for cardiovascular research, encompassing both pre- and in-hospital settings. The cohort contains ECG diagnostic statements and ECG measurements that can be linked to various nationwide health and social registers without loss to follow-up.

Sex Differences in Psychopathology Following Potentially Traumatic Experiences

Various psychopathology may follow trauma; however, sex differences in these ranging manifestations of posttraumatic psychopathology remain understudied. To investigate sex-specific incidence of posttraumatic psychopathology. This population-based cohort study of Danish national health registries included a cohort of individuals who experienced a potentially traumatic event (PTE) from 1994 to 2016. Individuals were further categorized by presence of any pretrauma psychopathology. A comparison group of individuals who experienced a nontraumatic stressor (nonsuicide death of a first-degree relative) was examined as a reference cohort. At least 1 of 8 PTEs (eg, physical assault, transportation accident) derived through health registry International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) codes, with additional qualifiers to improve classification accuracy. Incidence of 9 categories of ICD-10 psychiatric disorders recorded in registries within 5 years of PTEs. The standardized morbidity ratios (SMRs) for psychopathology outcomes were also calculated to compare individuals experiencing PTEs with those experiencing a nontraumatic stressor. This study included 1 398 026 individuals who had been exposed to trauma (475 280 males [34.0%]; 922 750 females [66.0%]). The group of males who had been exposed to trauma were evenly distributed across age, while most females in the trauma-exposed group were aged 16 to 39 years (592 385 [64.2%]). Males and females were equally distributed across income quartiles and predominantly single. Following PTEs, the most common diagnosis was substance use disorders for males (35 160 [7.4%]) and depressive disorders for females (29 255 [3.2%]); incidence proportions for these and other disorders were higher among males and females with any pretrauma psychopathology. Certain PTEs had elevated onset of various psychiatric disorders and some sex differences emerged. Following physical assault, associations were found with schizophrenia or psychotic disorders for males (SMR, 17.5; 95% CI, 15.9-19.3) and adult personality disorders for females (SMR, 16.3; 95% CI, 14.6-18.3). For noninterpersonal PTEs, males had larger SMRs for substance use, schizophrenia or psychotic disorders, and adult personality disorders (SMR, 43.4; 95% CI, 41.9-45.0), and females had larger SMRs for depressive disorders (SMR, 19.0; 95% CI, 18.6-19.4). Sex differences were also observed, particularly when considering pretrauma psychopathology. For example, among interpersonal PTEs, males were most likely to develop substance use disorders after physical assault, whereas females were more likely to develop various disorders, with stronger associations seen for females without pretrauma psychiatric diagnoses. Among noninterpersonal PTEs, exposure to toxic substance showed robust associations with psychopathology, particularly in those without pretrauma psychopathology, with sex-specific differences across psychiatric categories. Mental disorders after trauma were wide-ranging for males and females, and sex differences in patterns of posttraumatic psychopathology were more pronounced when accounting for pretrauma psychopathology. Findings provide new insights for sex-relevant PTEs and their mental health consequences. It also outlines future directions for advancing understanding of a constellation of posttraumatic psychopathology in males and females.

Developing the Minimum Data Set for a Disaster Mental Health Registry System

Introduction: There is a close relationship between mental health and psychosocial problems in disaster settings, as well as overlap in the support provided for these problems. Therefore, public health officials need to understand the burden of behavioral health conditions among survivors and the needs of the affected community. This study aimed to develop a mental health minimum data set for an electronic disaster registry system to provide timely, essential, and accurate information to personnel on the ground and policymakers to design a disaster response and develop an action plan rapidly.Material and Methods: The present study is a mixed‑method (sequential exploratory) study. In the qualitative phase, a literature review and semi‑structured interviews with experts were conducted to generate an item pool for the mental health response in disasters. In the quantitative phase the quantitative content validity, content validity ratio and content validity index were used.Results: proposed data elements, 85 data elements were confirmed according to the opinion of experts and categorized into two main parts, pre-disaster part with three sections; including region profile, mental health local background, regional mental health committee affairs, and post-disaster parts with five sections including disaster information, information of mental health teams, mental health status, mental health interventions, and mental health need assessment.Conclusion: Collecting this minimum data set is critical for helping policymakers and healthcare providers prevent, control, and manage the mental health impacts of disasters during the response phase. Besides facilitating and promoting disaster prevention and response programs and measures.

Implementation of advance care planning in the routine care for acutely admitted patients in geriatric units: protocol for a cluster randomized controlled trial

BackgroundAcutely ill and frail older adults and their next of kin are often poorly involved in treatment and care decisions. This may lead to either over- or undertreatment and unnecessary burdens. The aim of this project is to improve user involvement and health services for frail older adults living at home, and their relatives, by implementing advance care planning (ACP) in selected hospital wards, and to evaluate the clinical and the implementation interventions.MethodsThis is a cluster randomized trial with 12 hospital units. The intervention arm receives implementation support for 18 months; control units receive the same support afterwards. The ACP intervention consists of 1. Clinical intervention: ACP; 2. Implementation interventions: Implementation team, ACP coordinator, network meetings, training and supervision for health care personnel, documentation tools and other resources, and fidelity measurements with tailored feedback; 3. Implementation strategies: leadership commitment, whole ward approach and responsive evaluation. Fidelity will be measured three times in the intervention arm and twice in the control arm. Here, the primary outcome is the difference in fidelity changes between the arms. We will also include 420 geriatric patients with one close relative and an attending clinician in a triadic sub-study. Here, the primary outcomes are quality of communication and decision-making when approaching the end of life as perceived by patients and next of kin, and congruence between the patient’s preferences for information and involvement and the clinician’s perceptions of the same. For patients we will also collect clinical data and health register data. Additionally, all clinical staff in both arms will be invited to answer a questionnaire before and during the implementation period. To explore barriers and facilitators and further explore the significance of ACP, qualitative interviews will be performed in the intervention units with patients, next of kin, health care personnel and implementation teams, and with other stakeholders up to national level. Lastly, we will evaluate resource utilization, costs and health outcomes in a cost-effectiveness analysis.DiscussionThe project may contribute to improved implementation of ACP as well as valuable knowledge and methodological developments in the scientific fields of ACP, health service research and implementation science.Trial registrationClinicalTrials.gov Identifier NCT05681585. Registered 03.01.23.