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

Not Applicable

Completed

• Conditions: Intensive Care (ICU) Patients
• Interventions: Other: Standardized Followup program

• Registration Number: NCT01721239
• Lead Sponsor: Hillerod Hospital, Denmark

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-31
• Study First Submitted QC: 2012-11-01
• Study First Posted: 2012-11-04
• Study Start: 2012-12-01
• Primary Completion: 2016-02
• Study Completion: 2016-10
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standardized Followup program	Standardized Followup program	Standardized written information, patient photos and three follow-up consultations.

Primary Outcome Measures

Name	Time	Method
Quality of Life	12 months	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anaestesiology; 🇩🇰 Hillerod, Denmark