Implementation of a Structured Post-pulmonary Embolism Follow-up Model

Implementation of a Structured Post-pulmonary Embolism Follow-up Model in a Danish Hospital Setting

Venous thromboembolism (VTE), clinically presenting as deep vein thrombosis or pulmonary embolism (PE) is the third most frequent cardiovascular disease and is associated with substantial short- and long-term morbidity and mortality and high costs of care. In addition negative physical and mental complications following VTE are common. However in terms of PE, there are no structured follow-up programs in Denmark and there is considerable variation in practice patterns of post-PE management both within and between countries.

This project aims to develop, test and implement a structured follow-up care model for patients with PE (The Attend-PE model). This project is a pre-post intervention study and will estimate the effectiveness of implementing the structured follow-up care model on a national level.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Other: Attend-PE model

Detailed Description

The pre-post intervention study aims to measure differences in self-reported and clinical outcomes in patients with PE before and after the developed Attend-PE model has been implemented.

For the pre-intervention period, patient-reported questionnaires and registry data will be collected on all persons having received a CT-verified diagnosis of PE in the period March 2022 - May 2023. At 6 and 12 months following the PE event, the patients will receive an online letter with an invitation to complete an online questionnaire. The questionnaire includes validated patient-reported outcome measures and questions about sociodemographic factors. Furthermore, for all patients who have been invited to participate, register data will be retrieved on use of health care services, sick leave, prescription medication, as well as information on hospital of admission. Thus, the last PROM and register data for the 12-month follow-up will be retrieved in May 2024.

From October 2023 - Juni 2024 implementation of the Attend-PE model takes place on a national level, with a project team managing training of personnel and supporting the reorganization of care at the participating hospitals. 16 Danish hospitals have agreed to participate.

Following the implementation of the Attend-PE model, the post-intervention period is initiated. From October 2023 - Juni 2025 a data collection period similar to the pre-intervention period will take place, with patient-reported questionnaires forwarded to patients following a diagnosis of PE at 6 and 12 months, and data from registries being collected in the same time period. Thus, the last 12-month follow-up is expected to be completed in Juni 2026.

Detailed description of Attend-PE model:

• During hospitalization patients are given standardized patient information. This includes a written leaflet, oral information and links for online information (e.g., videos). An assessment of need for cancer screening is made, and in case of symptomatic DVT compressions stockings are provided. Before discharge patients are referred to a VTE clinic.
• Following discharge, patients and their relatives are invited to participate in a 2-hour group-based patient education session, ideally taking place within the first 2 weeks after discharge. This is managed by a nurse, physician and/or allied health professional and includes education about the condition, treatment, symptom management, physical and mental health, importance of physical activity and social support, and an overview of the care pathway. Time is given for questions and discussion with peers.
• Following the patient education, an individual follow-up consultation is offered, depending on an assessment of the individual patients needs. This allows for a recapitulation of the previous information given, and specific questions or worries related to the individual patients situation.
• At three months post-discharge, patients are invited for a consultation with a physician at the VTE clinic. Prior to the consultation, the patient completes an online questionnaire in the waiting room, including validated questionnaires about treatment satisfaction (Anti-Clot Treatment Scale) and physical and mental wellbeing (Pulmonary Embolism Quality of Life with cascading questions about dyspnea (MRC), anxiety (GAD-7) and depression (PHQ-9). The physician uses the patients responses actively during the consultation for discussion of continued treatment and assessment of whether further referral is required, i.e. to physiotherapist for assessment of physical function and rehabilitation needs, or to the GP for assessment of anxiety or depression and potential treatment hereof. If CTEPH is suspected, referral for VQ scan and/or echochardiography is made. Finally, referral for genetic testing may be considered if thrombophilia is suspected. For patients with provoked PE where medical treatment is completed at 3 months, and where none of the above referrals are required, patients are referred to their GP with standardized a discharge summary for the GP, and information material for the patient.
• For patients continuing medical treatment, a new consultation with a nurse is planned at 6 months, depending on the patients needs. Core elements are adjustment of medication and assessment of physical and psychosocial well-being.
• For patients with individual needs due to complex health conditions, frailty, few psychosocial resources or similar, extra consultations may be provided during follow-up.

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stine F. Lindegaard; Phone Number: +4525545415; Email: s.lindegaard@rn.dk
• Study Contact Backup: Name: Anette A. Højen; Phone Number: +45 29299114; Email: a.wind@rn.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Aalborg University Hospital
    • Contact: Anette A. Højen; Phone Number: +4529299114; Email: a.wind@rn.dk
    • Contact: Stine F. Lindegaard; Phone Number: +4525545415; Email: s.lindegaard@rn.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• adult patients (≥18 years)
• CT-verified diagnosis of PE

Exclusion Criteria:

• patients who are not living in Denmark on the extraction date
• patients with a active cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Attend-PE	Other: Attend-PE model; A pulmonary embolism follow-up care model consisting of structured elements for follow-up after discharge from hospital.; Other Names: A structured post-pulmonary embolism follow-up model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire	42 item covering health-related quality of life after pulmonary embolism. Transformed scale show score from 0-100, where 0 is the worst outcome and 100 is the best outcome.	6 and 12 month follow-up
Adherence to the anticoagulant treatment	Patients having redeemed ≥80% of the prescribed anticoagulant medication. Using The Danish National Prescription Registry.	within the first 6 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EuroQol 5 Dimensions (EQ-5D)	Covering general Health in five dimension. The scores fall on a scale of -0.757 (worst health state) to 1.0 (best health state).	6 and 12 month follow-up
Post-VTE Functional Status Scale (PFVS)	Covering functional status in 5 categories of functional limitations. In total 5 grades of functional limitations, where 1 is the worst grade and 5 is the best grade.	6 and 12 month follow-up
Anti-Clot Treatment Scale (ACTS)	Covering satisfaction with anticoagulant treatment (12-item ACTS Burdens scale and 3-item ACTS Benefits scale). 5-point to 7-point scales, where higher scores indicate higher satisfaction with treatment.	6 and 12 month follow-up
General Anxiety Disorder-7 (GAD7)	Covering anxiety. Score from 0-3 and total score range from 0 to 21, where 21 is the worst outcome and 0 is the best outcome.	6 and 12 month follow-up
Patient Health Questionnaire (PHQ-9)	Covering depression. Score from 0-3 and total score range from 0 to 27, where 27 is the worst outcome and 0 is the best outcome.	6 and 12 month follow-up
Patient Activation Measure (PAM)	Covering individual's knowledge, skills and confidence integral to managing one's own health and healthcare on a 4-point likert scale. Transformed scale show score from 0-100, where 0 is the worst outcome and 100 is the best outcome.	6 and 12 month follow-up
Work Productivity and Activity Impairment questionnaire (WPAI:GH, v2.0.)	Covering work productivity and activity impairment (6 questions). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.	6 and 12 month follow-up
Recurrent VTE	New hospital admission with a diagnosis of deep vein thrombosis or pulmonary embolism. Using the Danish National Patient registry (DNPR).	within the first 6 and 12 months
Major and clinically relevant nonmajor bleeding	According to The International Society for Thrombosis and Haemostasis (ISTH) definitions. Using the Danish National Patient registry (DNPR).	within the first 6 and 12 months
VTE-related death	Death of VTE. Using the Danish Death Register and CPR Registry.	within the first 6 and 12 months

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Collaborators: Aarhus University Hospital
• Investigators: Principal Investigator: Anette A. Højen, Aalborg University Hospital; Principal Investigator: Nanna Rolving, Aarhus University Hospital; Principal Investigator: Søren P. Johnsen, Aalborg University

Publications and helpful links

General Publications

• Lindegaard SF, Hojen AA, Rolving N. Electronic adaptation and danish cross-cultural translation of PEmb-QoL and VEINES-QoL/Sym for patients with venous thromboembolism. J Patient Rep Outcomes. 2024 Feb 26;8(1):21. doi: 10.1186/s41687-024-00698-9.
• Rolving N, Lindegaard SF, Johnsen SP, Grove EL, Kumler T, Valentin JB, Risor BW, Klok FA, Konstantinides S, Hojen AA. Effectiveness and cost-effectiveness of a structured integrated post-pulmonary embolism follow-up care model (Attend-PE): a rationale and protocol for a multicentre clinical pre-post study. BMJ Open. 2024 Dec 11;14(12):e088533. doi: 10.1136/bmjopen-2024-088533.
• Hojen AA, Lindegaard SF, Grove EL, Hansen AL, Larsen TB, Kumler T, Johnsen SP, Rolving N. Development of A structured integrated post-Pulmonary Embolism care model: The Attend-PE model. J Thromb Haemost. 2024 Nov;22(11):3137-3147. doi: 10.1016/j.jtha.2024.06.027. Epub 2024 Aug 8.
• Hansen AL, Hojen AA, Lindegaard SF, Grove EL, Jakobsen C, Rolving N. The Attend-PE model: A feasibility study of a structured follow-up care model for patients with pulmonary embolism. Thromb Res. 2024 Oct;242:109133. doi: 10.1016/j.thromres.2024.109133. Epub 2024 Aug 24.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Implementation; Intervention; Pulmonary embolism; Health related quality of life; Health care model
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Pulmonary Embolism; Embolism
• Other Study ID Numbers: Attend-PE

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
• product manufactured in and exported from the U.S.: No