Recovery and Aftercare in Post Intensive Care Therapy Patients - RAPIT Study

Study Overview
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Brief Summary
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In 2010 alone were admitted 33,361 patients for treatment in Danish intensive care units. There is evidence to former intensive care patients have a significant symptom burden that affect recovery, function and activity for up to several years after admission to the intensive care unit. For the individual patient involves the low quality of life, delayed recovery, prolonged illness and healing process, and increased mortality. It requires that health professionals should provide support so patients quicker return to their usual life. Follow-up interviews with the staff after hospitalization in ICU have been shown to support the patient and identify individual needs and symptoms that can lead to more realistic expectations and increased well-being after admission in ICU. Follow-up in Denmark is being inconsistent in both the number of hospitals that offer this service, and in the offered type of service. Follow-up interviews with and without diaries suggest to improve physical and mental well-being and health, with limited scientific evidence of the efficacy of these interventions. We will investigate the effect of a standardized follow-up program after admission to the intensive care unit, consisting of written information, patient photos taken during hospitalization and three follow-up calls compared with standard care (discharge without follow-up). During a clinical study conducted in several intensive care units in Denmark examined whether follow-up calls can improve patients' well-being and health, as well as the meaning of the follow-up program has on the patient's everyday life in the first year after hospitalization in the ICU. The investigation contribute knowledge to the international research by revealing symptom burden and efficacy of a follow-up program for up to 1 year after admission to the ICU in order to be able to target rehabilitation efforts and improved the quality of life. It will be innovative to use the results from a clinical study as a foundation for a database, and the method can serve as a precedent for evidence-based introduction of guidelines, database registration and create the groundwork for future research in intensive care. This study is expected to be profitable to society by preventing frequent readmissions, reduce medication costs and fewer referrals to specialists and have a positive effect on retention to the labor market. This will provide overall better use of society's expenses.

Official Title
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Recovery and Aftercare in Post Intensive Care Therapy Patients - The RAPIT Study. The Effectiveness and Experiences of a Follow-up Program for Danish Mechanically Ventilated ICU Patients: A Pragmatic Randomized Controlled Multicentre Trial.

Conditions
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Intensive Care (ICU) Patients

Intervention / Treatment
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* Other: Standardized Followup program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Non-invasive or invasive ventilation ≥ 48 hours (Non-invasive ventilation (NIV) from current guidelines). APACHE II score ≥ 12 ≤ 29 Unrecognized dementia diagnosis Exclusion Criteria: Delirium at randomization (Positive CAM-ICU score) Participation in scientific projects which include patient interviews Not Speak and understand Danish

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>No intervention | |
| Experimental: Standardized Followup program<br>Standardized written information, patient photos and three follow-up consultations. | Other: Standardized Followup program<br>* Standardized written information, patient photos and three followup consultations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Changes over time in patients in the intervention and control group measured with instruments used and register data, corresponding to quality of life, on the mental component of the instrument, SF-36 Intension-to-treat analysis | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Scores | Changes in score regarding symptoms scores in control and intervention groups. | 12 months | 
| Baseline data | baseline data concerning patient's demographic and clinical data | At randomization | 
| Symptom score | Changes over time in patients in the intervention and control group measured with instruments used and register data, corresponding to symptom scores. | 12 months | 
| Depression | Changes in score regarding depression in control and intervention groups | 12 months | 
| Sense of Coherence | Changes over time in patients in the intervention and control group measured with instruments used and register data, corresponding to sense of coherence | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICU, Follow-up consultations, Quality of life, Sense Of Coherence, RCT multicenter study