NCT02913833

Brief Summary

The financing of the Belgian hospitals is based on a system taking into account the length of hospitalization of a given patient according to his/her pathology, his/her age and his/her geriatric characteristics. This system encourages all hospital to lower the hospitalization duration to the national average for these criteria. This results in better efficiency in the management of hospitalizations but also means a swifter transfer to structures exempted from this system such as revalidation units, nursing homes and psychiatric units. An assessment of the differences in the medical practice, in terms of quality and outcomes of care, is essential for any reform willing to reduce medical costs. Pain management is part of the quality indicators within hospitals. Pain is defined by the International Association for the Study of Pain as "an unpleasant sensory and emotional experience, associated to present or potential tissue damage, or described in terms of such a damage". Several studies have showed that pain affects the quality of life and impacts the daily activities. Acute or chronic pain can cause adverse symptoms such as sleep disturbance, appetite loss, decreased concentration, mood changes and the disruption of familial, work and social activities. Pain might also slow down revalidation processes. A study performed by Aprile et al showed that pain negatively influenced the rehabilitation program of a quarter of the patients having had a stroke. The functional recovery was slower and the costs were higher. The aim of this study is to determine if the systematic evaluation of the pain of a patient hospitalized in a revalidation unit has an impact on his/her length of stay.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2017

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

1.8 years

First QC Date

September 15, 2016

Last Update Submit

January 18, 2018

Conditions

Keywords

PainHospital length of stayRevalidation unit

Outcome Measures

Primary Outcomes (7)

  • Pain score (EVA)

    Pain assessment on the Visual Analogic Scale (EVA)

    5 minutes, 4 times per day

  • Hospitalization duration

    Hospitalization length (average of 48 days)

  • HADS score

    Hospital Anxiety Depression Scale (questionnaire)

    Baseline (first day of hospitalisation)

  • HADS score

    Hospital Anxiety Depression Scale (questionnaire)

    Day 30 of hospitalisation

  • Barthel Index

    Daily life activities assessment

    Baseline (first day of hospitalisation)

  • Barthel Index

    Daily life activities assessment

    Day 30 of hospitalisation

  • CACS score

    Composite score of analgesics consumption

    Hospitalization length (average of 48 days)

Study Arms (2)

Daily pain evaluation

EXPERIMENTAL

Patients recruited in a sequential order within the chronic revalidation unit of the CHU Brugmann hospital, Queen Astrid site.

Other: Pain evaluation

Control

NO INTERVENTION

Patients recruited in a sequential order within the chronic revalidation unit of the CHU Brugmann hospital, Queen Astrid site.

Interventions

Pain will be assessed four times per day on a visual analogic scale.

Daily pain evaluation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Pathological cognitive state (MMS\<23/30)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (3)

  • Aprile I, Briani C, Pazzaglia C, Cecchi F, Negrini S, Padua L; Don Carlo Gnocchi Pain-Rehab Group. Pain in stroke patients: characteristics and impact on the rehabilitation treatment. A multicenter cross-sectional study. Eur J Phys Rehabil Med. 2015 Dec;51(6):725-36. Epub 2015 Feb 26.

    PMID: 25739508BACKGROUND
  • Kreling MC, da Cruz DA, Pimenta CA. [Prevalence of chronic pain in adult workers]. Rev Bras Enferm. 2006 Jul-Aug;59(4):509-13. doi: 10.1590/s0034-71672006000400007. Portuguese.

    PMID: 17340726BACKGROUND
  • Schoenthaler M, Miernik A, Offner K, Karcz WK, Hauschke D, Sevcenco S, Kuehhas FE, Bach C, Buchholz N, Wilhelm K. The cumulative analgesic consumption score (CACS): evaluation of a new score to describe postsurgical analgesic consumption as a surrogate parameter for postoperative pain and invasiveness of surgical procedures. Int Braz J Urol. 2014 May-Jun;40(3):330-6. doi: 10.1590/S1677-5538.IBJU.2014.03.06.

    PMID: 25010299BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinic

Study Record Dates

First Submitted

September 15, 2016

First Posted

September 26, 2016

Study Start

March 9, 2016

Primary Completion

December 12, 2017

Study Completion

December 12, 2017

Last Updated

January 23, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations