Intensive Care (ICU) Patients Clinical Trial
— RAPITOfficial 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.
| Verified date | April 2018 |
| Source | Hillerod Hospital, Denmark |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 340 |
| Est. completion date | October 2016 |
| Est. primary completion date | February 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Department of Anaestesiology | Hillerod |
| Lead Sponsor | Collaborator |
|---|---|
| Hillerod Hospital, Denmark | Herlev Hospital, Naestved Hospital, Nykøbing Falster County Hospital, Odense University Hospital, Region of Southern Denmark, Regionshospitalet Horsens, Rigshospitalet, Denmark, Sonderborg Hospital |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Post traumatic stress | Changes in score regarding post traumatic stress in control and intervention groups. | 12 months | |
| Other | Anxiety | Changes in score regarding anxiety in control and intervention groups. | 12months | |
| Other | Register data | Changes in score regarding register data concerning: Mortality The number of readmissions Outpatient visits Referrals to specialists, physical and occupational therapy, including in control and intervention groups |
12 months | |
| Other | Non-respondent | A non-respondent analysis. The number of participants who dropout of the study will be separated, analyzed in control and intervention groups regarding demographic and clinical data collected during ICU stay. Investigate if there is difference in dropout in the interventiongroup versus the controlgruop. Intension-to-treat analysis of participants recieving the first consultation. |
12 months | |
| Primary | 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 | Symptom Scores | Changes in score regarding symptoms scores in control and intervention groups. | 12 months | |
| Secondary | Baseline data | baseline data concerning patient's demographic and clinical data | At randomization | |
| Secondary | 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 | |
| Secondary | Depression | Changes in score regarding depression in control and intervention groups | 12 months | |
| Secondary | 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 |