A Tool of the Future for Strengthening Compassion in a Danish Hospital Setting.

A Tool of the Future for Strengthening Compassion in a Danish Hospital Setting

This study is a multi-phase, mixed-methods clinical investigation designed to examine the feasibility, validity, and organizational applicability of a structured measurement framework for assessing compassion in a Danish hospital setting. The study is conducted at Herlev and Gentofte Hospital and involves both patients and healthcare professionals across multiple clinical departments.

The study is structured in three sequential phases, each addressing distinct methodological and implementation components.

Phase 1 (Translation and Cultural Adaptation):

The initial phase involves the linguistic translation and cultural adaptation of three versions of the Sinclair Compassion Questionnaire (SCQ) and associated healthcare professional measures. This process follows established international guidelines for cross-cultural validation, including forward translation, back-translation, expert panel review, and pilot testing. Cognitive interviewing techniques are used to evaluate comprehension, relevance, and cultural appropriateness among both patients and healthcare professionals. Particular attention is given to semantic equivalence and the contextual meaning of key constructs across languages and professional groups.

Phase 1b (Psychometric Validation):

Following adaptation, the instruments are administered to a patient sample recruited from departments of anesthesia, surgery, and intensive care. Data collected in this phase are used to assess the psychometric properties of the translated instruments, including internal consistency, construct validity, factor structure, and measurement invariance. Statistical analyses include confirmatory factor analysis and reliability testing. The aim of this phase is to ensure that the instruments demonstrate robust measurement properties within the Danish healthcare context.

Phase 2 (Observational Implementation Study):

In the second phase, the validated instruments are implemented across four hospital departments, including medical, nephrology, orthopedic surgery, and emergency care. Data are collected from both patients and healthcare professionals to allow for multi-perspective analysis. In addition to questionnaire data, contextual variables such as demographic characteristics, professional background, and organizational factors are recorded. Administrative data, including sick leave and workforce indicators, are incorporated where available.

This phase employs a cross-sectional observational design with embedded comparative analyses across departments and professional groups. Multilevel modeling approaches are used to account for clustering within departments and to explore variation at individual and organizational levels. The design enables identification of patterns and differences across settings without introducing experimental manipulation.

Phase 3 (Contextualized Implementation and Development):

The third phase involves the application of findings from earlier phases to inform targeted implementation strategies. Rather than introducing a predefined intervention, this phase adopts an adaptive approach in which context-specific initiatives are selected or developed based on identified needs. This may include integration of existing training programs, workflow adjustments, or development of new tools. The implementation process is supported by interdisciplinary collaboration, including expertise in clinical practice, education, and organizational development.

Data Collection and Management:

Data are collected using secure electronic platforms compliant with Danish data protection regulations. All participant data are handled in accordance with GDPR requirements. Identifiable data are stored separately from research data, and access is restricted to authorized personnel. Data quality assurance procedures include validation checks and standardized data entry protocols.

Participant Involvement:

Patients are recruited during their contact with hospital departments and provide self-reported data through questionnaires. Healthcare professionals participate by completing self-assessment measures. Participation is voluntary, and no experimental interventions are administered.

Statistical Considerations:

The study uses both descriptive and inferential statistical methods. Psychometric analyses are conducted in Phase 1b, while Phase 2 includes regression analyses and multilevel modeling to examine associations between variables. Missing data are handled using appropriate statistical techniques, such as multiple imputation where relevant.

Ethical Considerations:

The study adheres to ethical guidelines for clinical research involving human participants. Informed consent is obtained from all participants. Participation does not influence clinical care or employment conditions. The study design minimizes participant burden by integrating data collection into existing clinical workflows where possible.

Study Overview

• Status: Recruiting
• Conditions: Burnout; Compassion Ability; Compassion Competence; Compassionate Care; Investigate Compassionate Care and Burnout in Healthcare
• Intervention / Treatment: Other: Sinclair Compassion Scale

Detailed Description

Compassion in healthcare is increasingly recognized as a multidimensional construct that influences patient experiences, clinical effectiveness, and workforce sustainability. However, the integration of compassion into routine clinical assessment remains limited due to a lack of standardized, context-sensitive measurement approaches. This study is designed to operationalize compassion within a hospital setting by systematically introducing and evaluating structured measurement instruments in real-world clinical practice.

The study is conducted at Herlev and Gentofte Hospital and follows a prospective, mixed-methods design with both cross-sectional and longitudinal components. It includes multiple clinical departments to ensure representation across different specialties, care intensities, and patient pathways. This diversity enables the assessment of compassion across heterogeneous contexts, including acute care, outpatient services, and longer-term treatment trajectories.

Participants include adult patients receiving care within participating departments and healthcare professionals employed in those units. Recruitment will occur consecutively to minimize selection bias and to reflect routine clinical populations. Healthcare professionals from various disciplines-including nursing staff, physicians, and allied health professionals-will be included to capture interdisciplinary perspectives on compassionate care delivery.

The study consists of several phases. The initial phase focuses on cultural and linguistic adaptation of the included measurement tools to ensure relevance and comprehensibility within a Danish healthcare context. This process includes translation, back-translation, and pilot testing with representative users. Feedback from this phase will inform minor adjustments to optimize clarity and usability.

The main data collection phase involves systematic administration of validated questionnaires to both patients and healthcare professionals. Patients will be invited to complete assessments in close temporal proximity to their care experience to reduce recall bias. Healthcare professionals will complete self-assessments at predefined intervals. Data collection will be facilitated through secure electronic platforms, with options for paper-based completion if needed to ensure inclusivity.

A longitudinal component is incorporated through repeated measurements over time. This allows for evaluation of temporal stability, responsiveness to organizational changes, and potential trends within and across departments. It also enables examination of how compassion-related measures evolve in relation to workplace conditions and clinical environments.

In parallel, a qualitative sub-study will be conducted to enrich interpretation of quantitative findings. Semi-structured interviews and focus groups with a purposive sample of patients and healthcare professionals will explore lived experiences, perceptions of compassionate care, and contextual factors influencing these experiences. This component will provide insight into mechanisms, barriers, and facilitators that are not captured through quantitative instruments alone.

Implementation processes will be systematically evaluated using principles from implementation science. Key domains include feasibility, acceptability, appropriateness, and integration into existing workflows. The study will examine how the introduction of compassion measurement tools interacts with organizational structures, leadership support, and daily clinical practice. Attention will also be given to potential unintended consequences, such as increased administrative burden or response fatigue.

Data analysis will include psychometric evaluation of measurement tools (e.g., internal consistency, construct validity, factor structure) and statistical modeling to explore patterns and associations within the data. Multilevel analytical approaches will be used to account for clustering at departmental levels. Longitudinal analyses will assess changes over time and potential predictors of variation in measured outcomes.

All data will be handled in compliance with applicable data protection regulations, including the General Data Protection Regulation (GDPR). Participation is voluntary, and informed consent will be obtained from all participants. Data will be anonymized prior to analysis, and results will be reported at an aggregated level to ensure confidentiality.

By embedding structured assessment of compassion into routine clinical settings, this study aims to generate actionable knowledge on how compassion can be systematically understood, monitored, and supported in healthcare organizations. The findings are expected to contribute to the development of scalable approaches for integrating relational aspects of care into quality improvement frameworks, thereby supporting both patient-centered care and sustainable working conditions for healthcare professionals.

• Study Type: Observational
• Enrollment (Estimated): 2200

Contacts and Locations

• Study Contact: Name: Camilla B. Sørensen, MD; Phone Number: +45 21 35 77 43; Email: camilla.birgitte.sorensen@regionh.dk
• Study Contact Backup: Name: Nanja H. Hansen, Psychologist; Phone Number: +45 21 35 77 43; Email: nanja.holland.hansen@regionh.dk

Study Locations

• Denmark
  • Herlev, Denmark, 2630
    • Recruiting
    • Herlev Gentofte Hospital
    • Contact: Camilla Birgitte Soerensen, MD; Phone Number: 004525671293; Email: Camilla.Birgitte.Soerensen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients and healthcare professionals in 5 different departments at Herlev Gentofte Hospital

Description

Patients:

Inclusion Criteria:

1. A patient at either the a. Department of Nephrology, b. Department of Internal Medicine, c. Emergency Department (ED) d. Department of Orthopedic Surgery.Rheumatology and Orthopedics or e. Perioperative and Intensive Care Department
2. Age 18-100+
3. All genders
4. Danish speaking
5. Must have had contact with at least one healthcare professional before completing the questionnaire.

Exclusion Criteria:

1. Patient exclusion criteria:
2. Age 0-17
3. Non-Danish speaking
4. Not a patient at the a. Department of Nephrology, b. Department of Internal Medicine, c. Emergency Department (ED) d. Department of Orthopedic Surgery or e. Department of Anesthesia, Operation and Intensive Care)
5. No contact with a healthcare professional
6. Has answered the questionnaire before

Healthcare professionals:

HCP inclusion criteria

1. Employed in one of the five departments included (phase 1b and 2): a. Department of Nephrology, b. Department of Internal Medicine c. Emergency Department, d. Department of Orthopedic Surgery or e. Department of Anesthesia, Operation and Intensive Care.
2. All genders
3. Danish speaking
4. Must have engaged with a patient

HCP exclusion criteria

1. Not employed in one of the five departments included (a. Department of Nephrology, b. Department of Internal Medicine, c. Emergency Department, d. Department of Orthopedic Surgery or e. Department of Anesthesia, Operation and Intensive Care)
2. Not Danish speaking

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Department cohorts; Cohort 1 with 5 subgroups; Department of Anaesthesia, operation and intensive care; Department of Nephrology; Department of Internal Medicine; Emergency Department; Department of Orthopedic Surgery	Other: Sinclair Compassion Scale; Patients are given the SCQ, healthcare providers are given the SCQ-ability and the SCQ-competence and the CBI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sinclair Compassion Scale (SCQ)	An overall score is obtained by summing all individual items and calculating a single mean score, in which a higher final score is indicative of a greater experience of compassion.	September 1st 2025 - July 31st 2027
Sinclair Compassion Questionnaire -Health Care Professional Ability Self Assessment (SCQ-HCPASA)	The Sinclair Compassion Questionnaire -Health Care Professional Ability Self Assessment (SCQ-HCPASA) is a self-report questionnaire which measures health care professionals ability to provide compassionate care to their patients.	February 16th 2026 - July 31st 2027
Sinclair Compassion Questionnaire Health Care Professional Competence Self Assessment (SCQ-HCPCSA)	The Sinclair Compassion Questionnaire Health Care Professional Competence Self Assessment (SCQ-HCPCSA) is a self-report questionnaire that measures healthcare providers own competence in providing compassionate care	February 16th 2026 - July 31st 2027
Copenhagen Burnout Inventory (CBI)	The Copenhagen Burnout Inventory (CBI) is a self report questionnaire that measures healthcare professionels own experience of personal and work-related burnout.	February 16th 2026 - July 31st 2027

Collaborators and Investigators

• Sponsor: Herlev and Gentofte Hospital
• Collaborators: University of Copenhagen; University of Calgary
• Investigators: Principal Investigator: Camilla B Sorensen, MD, Herlev Gentofte Hospital; Principal Investigator: Nanja H Hansen, Psychologist, Herlev Gentofte Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: May 1, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Validation; Sinclair Compassion Questionnaire (SCQ); Compassion ability for healthcare providers; Compassion competence for healthcare providers; Compassionate care for patients; burnout in healthcare providers
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Behavior; Burnout, Psychological
• Other Study ID Numbers: CompassionHGH-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No