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

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06037096
• Other study ID #: Attend-PE
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: October 2025

Study information

• Verified date: September 2023
• Source: Aalborg University Hospital
• Contact: Anette A. Højen
• Phone: +4529299114
• Email: a.wind[@]rn.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Venous thromboembolism (VTE), clinically presenting as deep vein thrombosis or pulmonary embolism (PE) is the third most common 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.

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

Description:

The pre-post intervention study aims to measure potential change in self-reported and clinical outcomes before and after the developed Attend-PE follow-up 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 - March 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 March 2024.

From April 2023 - September 2023 implementation of the Attend-PE model takes place on a national level, with a project team managing training of personnel and supporting the re-organization of care at the participating hospitals. 18 Danish hospitals have agreed to participate.

Following the implementation of the Attend-PE model, the post-intervention period is initiated. From September 2023 - September 2024 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 September 2025.

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 patient's 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 patient's 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• CT-verified diagnosis of PE

• Expected survival at least 12 months at the time of PE

Exclusion Criteria:

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Other:
• Attend-PE model
A pulmonary embolism follow-up care model consisting of structured elements for follow-up after discharge from hospital.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University Hospital	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 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.	Change from baseline to 6 month follow-up
Secondary	Change in 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).	Change from baseline to 6 month follow-up
Secondary	Change in 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.	Change from baseline to 6 month follow-up
Secondary	Change in 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.	Change from baseline to 6 month follow-up
Secondary	Change in 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.	Change from baseline to 6 month follow-up
Secondary	Change in 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.	Change from baseline to 6 month follow-up
Secondary	Change in 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.	Change from baseline to 6 month follow-up
Secondary	Change in 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.	Change from baseline to 6 month follow-up