Hospital-Induced Immobility

Geriatric Clinical Trial

Official title:

Hospital-Induced Immobility - A Backstage Story of Lack of Chairs, Time, and Assistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05926908
• Other study ID #: P-2020-1173
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Inactivity and bedrest during hospitalisation have numerous negative consequences, and it is especially important that older patients are mobile during hospitalisation. In this study the investigators aimed to identify whether the introduction of formal education of clinical staff and a Mobilisation Initiative could increase mobilisation of patients in a geriatric and a medical ward. Furthermore, the investigators wanted to explore patients' and health care staffs' view on facilitators and barriers for mobilisation during hospitalisation

Description:

Staying in bed and being inactive during hospitalisation can lead to a range of adverse consequences especially among older adults. The consequences include loss of muscle mass and strength leading to problems with loss of functional independence, risk of re-hospitalisation, and death. Moreover, older adults do not recover as well as younger adults with poor long-term recovery. The lack of in-hospital mobilisation is due to several factors including the hospital culture and organisational factors. Therefore, it is necessary to bring attention to this problem among the hospital staff. The aim of this study is to identify whether the introduction of formal education of clinical staff and a Mobilisation Initiative can increase the number of patients mobilised for breakfast and lunch among patients admitted to geriatric and medical wards. The activities planned in this study is self-reported level of mealtime mobilisation and observations of the patients, focus group interviews and survey on mobilisation awareness among the clinical staff, introduction of formal education and a Mobilisation Initiative. As hypothesized, this will result in an increased awareness of in-hospital mobilisation leading to an increase in the number of patients mobilised at mealtimes. Accordingly, expectations are that this will affect the activity level of the hospitalised patients and reduce adverse consequences leading to an increase in functional independence and reduce the number of readmissions resulting in a socioeconomic benefit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 596
• Est. completion date: December 31, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• In-hospital patients in the geriatric and medical ward at Copenhagen University Hospital, Rigshospitalet

Exclusion Criteria:

• Patients declared moribund or delirious in the electronical medical journal

• Patients isolated in the hospital room

• Patients requiring interpreter for communication

Related Conditions & MeSH terms

• Geriatric
• Immobilization

Intervention

Behavioral:
• A Mobilisation Initiative
The Mobilisation Initiative consists of physiotherapists assisting nursing staff in mobilising patients to sit in a chair for breakfast and lunch. This intervention follows the interventions of focus group interviews, formal education, observations of patients and the environment, and awareness of mobilisation survey
• Focus Group Interviews
Focus group interviews using a semi-structured interview guide are conducted with health care professionals at the wards to explore the acceptability and demand for the contents of the Mobilisation Initiative, including the identification of facilitators and barriers to mobilisation
• Formal Education
Formal education for all nursing staff employed at the two wards includes information on the consequences of immobilisation, with the purpose of enhancing confidence, competencies, and awareness of mobilisation
• Self-reported Level of Mobilisation
Patient's self-reported mealtime mobilisation level reported through interview-based surveys, including structured follow-up questions
• Observations of Patients and the Environment
During breakfast and lunch, the mobilisation status of all patients in the wards is observed using an observation checklist
• Awareness of Mobilisation Survey
To assess the nursing staff's awareness of and confidence in the mobilisation of the patients, a short survey on mobilisation awareness is distributed to the nursing staff at both wards

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patients mobilised at lunch	Change in percentage of patients mobilised at lunch t0-t1 Change in percentage of patients mobilised at lunch t1-t2 Change in percentage of patients mobilised at lunch t2-t3 Change in percentage of patients mobilised at lunch t3-t4 Change in percentage of patients mobilised at lunch t4-t5 Change in percentage of patients mobilised at lunch t5-t6	One, two, three, four, five, and six months
Primary	Change in patients mobilised at breakfast	Change in percentage of patients mobilised at breakfast t0-t1 Change in percentage of patients mobilised at breakfast t1-t2 Change in percentage of patients mobilised at breakfast t2-t3 Change in percentage of patients mobilised at breakfast t3-t4 Change in percentage of patients mobilised at breakfast t4-t5 Change in percentage of patients mobilised at breakfast t5-t6	One, two, three, four, five, and six months
Secondary	Change in chairs present bedside at breakfast	Change in percentage of chairs observed placed bedside at breakfast for each patient t1-t2 Change in percentage of chairs observed placed bedside at breakfast for each patient t2-t3 Change in percentage of chairs observed placed bedside at breakfast for each patient t3-t4 Change in percentage of chairs observed placed bedside at breakfast for each patient t4-t5 Change in percentage of chairs observed placed bedside at breakfast for each patient t5-t6	Two, three, four, five, and six months
Secondary	Change in chairs present bedside at lunch	Change in percentage of chairs observed placed bedside at lunch for each patient t1-t2 Change in percentage of chairs observed placed bedside at lunch for each patient t2-t3 Change in percentage of chairs observed placed bedside at lunch for each patient t3-t4 Change in percentage of chairs observed placed bedside at lunch for each patient t4-t5 Change in percentage of chairs observed placed bedside at lunch for each patient t5-t6	Two, three, four, five, and six months
Secondary	Self-reported level of mobilisation	Level of patient's mealtime mobilisation level reported through interview-based surveys on a 5-item ordinal scale: independently, with supervision, with the physical help of one person, with the physical help of two persons, or never sit in a chair.	One and six months
Secondary	The Mobilisation Initiative	The utilisation of the Mobilisation Initiative recorded as the daily number of patients referred to and mobilised in the Mobilisation Initiative at each ward	One and six months
Secondary	Formal Education	The number of nursing staff attending formal education	Four and five months
Secondary	Focus Group Interviews	Description of facilitators and barriers for mobilising the patients at each ward	Two months
Secondary	Awareness of mobilisation among the nursing staff	Levels of awareness on mobilisation among the nursing staff at each ward reported through questionnaires including the questions: "Do you feel confident mobilising your patients to sit in a chair at mealtimes?," "To what degree do you feel prepared to do a safe transfer from the bed to a chair with a patient you do not know?," and "How often do you talk to your colleagues about mobilisation?". Questions are answered on 5-item Likert scales: never, less than half of the time, half of the time, more than half of the time, and every time; and to a very low degree, to a low degree, neither/nor, to a high degree, and to a very high degree	Two months and follow up at eight months