Clinical trial NCT01721239: Recovery and Aftercare in Post Intensive Care Therapy Patients - RAPIT Study
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care (ICU) Patients
Keywords: ICU
Follow-up consultations
Quality of life
Sense Of Coherence
RCT multicenter study
Lead sponsor: Hillerod Hospital, Denmark
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
name: Rigshospitalet, Denmark
name: Nykøbing Falster County Hospital
name: Odense University Hospital
name: Sonderborg Hospital
name: Region of Southern Denmark
name: Regionshospitalet Horsens
name: Naestved Hospital
First posted: 2012-11-04
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life
timeFrame: 12 months
Secondary outcomes:
measure: Symptom Scores
timeFrame: 12 months
measure: Baseline data
timeFrame: At randomization
measure: Symptom score
timeFrame: 12 months
measure: Depression
timeFrame: 12 months
measure: Sense of Coherence
timeFrame: 12 months
Other outcomes:
measure: Post traumatic stress
timeFrame: 12 months
measure: Anxiety
timeFrame: 12months
measure: Register data
timeFrame: 12 months
measure: Non-respondent
timeFrame: 12 months
Locations:
city: Hillerod
country: Denmark
facility: Department of Anaestesiology
Study officials:
affiliation: Hillerod Hospital, department of Anaesthesiology
name: Janet F Jensen, PhD-student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jensen JF, Egerod I, Bestle MH, Christensen DF, Elklit A, Hansen RL, Knudsen H, Grode LB, Overgaard D. A recovery program to improve quality of life, sense of coherence and psychological health in ICU survivors: a multicenter randomized controlled trial, the RAPIT study. Intensive Care Med. 2016 Nov;42(11):1733-1743. doi: 10.1007/s00134-016-4522-1. Epub 2016 Sep 30.