- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02447445
Grip Strength Routine Implementation (GRImP)
Implementing Grip Strength Measurement Into Routine Clinical Practice; a Feasibility Study (GRImP)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This implementation research involves mixed methods combining qualitative and quantitative elements. The first preliminary part of the study will define the current baseline practice in the MOP wards in University Hospital Southampton (UHS) with regard to the identification of patients at high risk of poor healthcare outcomes, inpatients' nutritional care and management of their mobility. For this purpose, an ethnographic approach (involving interviews, focus groups, and audit of clinical records) will be followed. Understanding how the healthcare system works will enable justification and integration of GS measurement in the routine practice in an effective way. Participants and situations will be sampled on a purposive basis which means "cases/participants are sampled in a strategic way to best answer the research question". Single in-depth semi structured interviews will be conducted with different groups of healthcare staff with different levels of experiences and roles including consultants, junior doctors, ward sisters, dieticians, physiotherapists, and therapy assistants (a total of 10-15 healthcare staff members). The investigators will also conduct focus groups with nursing staff from the 5 wards, with nurses of similar seniority in each group to encourage free discussion (approximately 15-20 nurses divided into 4-5 focus groups) to gain an understanding of their shared practice.
The medical notes for the patients in the first 1-3 beds in each bay in the 5 wards will be examined (approximately 54 records). Basic information about the patient such as: age, gender, date of admission, domicile status, and reasons for admission will be first extracted. Then investigators will check the records to extract any information within the first 2-3 days of admission about risk assessment measures and what could indicate risk factors for poor healthcare outcomes. In addition, the number of and reasons for referrals weekly for the last 3 months to the dietetic team will be abstracted from the E-referral system. The number of prescribed oral nutritional supplements (ONS) will be also calculated weekly for the last 3 months from the electronic prescribing system. These figures are important for later analysis and comparison in order to assess changes in routine practice.
The second part of the research involves developing a training programme on measuring GS and creation of a care plan for older patients with low GS levels. Then, the nursing, medical and therapy staff in 5 wards in the MOP department will be trained in the measurement of grip strength and interpretation of grip strength values. There are approximately 150 nursing staff in MOP across the 5 wards, all of whom will be trained over a period of 3 months in GS measurement in groups of 5-10 each. Additional training sessions will be provided to junior doctors, consultants and therapy staff taking the opportunity to incorporate this into regular educational sessions where possible. The time and date of the training sessions will be defined and agreed liaising with the training lead in the MOP to avoid any disruption to the daily tasks of the MOP staff. The training session will last for approximately 1 hour. At the end of each session, participants will be asked to evaluate the training session using 5-points rating scale and give feedback. Nurses attending the training session will be asked as part of the training program to measure GS of a colleague according to the standard protocol as an assessment of their competency to measure GS of patients.
Implementation of GS should be start soon after completing the first training session in each ward. GS will be measured on all patients admitted to the MOP wards within 1-3 days of admission by a ward nurse. Only patients who are unable to squeeze the dynamometer handle such as patients with arthritis or who are very ill will be excluded. Grip strength will be measured by the ward nurse using a Jamar dynamometer by asking the patient to squeeze with each hand twice, starting with the right hand using the standardised protocol. A brief break of approximately 1 minute will be allowed between each squeeze. The maximum GS measurement will be recorded. A total of 5 Jamar dynamometers will be available for this study, one in each ward. The maximum GS values will be coded in two categories: score 1 representing values less than 27 kg for men and less than 16 kg for women which refers to patients at high risk of poor health outcomes, and score 2 representing values ≥27 kg for men and ≥16 kg for women representing lower risk. Patients who have low maximum GS values (men < 27 kg and women <16 kg) or those who are unable to perform the test will receive a care plan. The care plan will focus on review of dietary energy and protein intake and any need for oral nutritional supplements or dietetic review, and review of mobility with any need for physiotherapy review with regard to progressive resistance exercises to increase muscle strength.
During the implementation process, monitoring and evaluation of the outcomes of implementation which are referred to by the World Health Organisation (WHO) as "implementation outcome variables" will include assessing: acceptability of GS measurement, its adoption, coverage, fidelity, and costs.
Patients and staff acceptability will be assessed by conducting qualitative research (interviews or focus groups). A sample of 10-15 patients and 10-20 MOP staff is deemed to be enough to gain an understanding of their views and experience of GS measurement. Staff interviews will also assist understanding how GS routine implementation has been adopted and initiated in each of the five wards. Random weekly visits to MOP will be conducted to check fidelity and continuing staff competency on measuring GS as well as to audit the number of the number and proportion of patients who have their GS measured and those who have received a care plan in each ward. Coverage of GS implementation will be measured by calculating in the total number and proportion of patients who have their GS measured and those who have received a care plan in MOP within 6 months of routine implementation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Southampton, United Kingdom, SO16 6YD
- Southampton Genral Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Inclusion criteria will be older patients admitted to the MOP.
Exclusion Criteria:
Exclusion criteria will be an inability to hold the dynamometer in either hand (eg pain and/or severe arthritis), inability to understand the explanation given (eg severe dementia or delirium), and terminal phase of illness.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Older inpatient at MOP
The group includes older patients who are admitted to one of the Medicine for Older Patients (MOP) wards.
Grip strength will be part of the routine assessment of older patient when admitted to MOP.
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Grip strength will be measured by the ward nurse using a Jamar dynamometer by asking the patient to squeeze with each hand twice, starting with the right hand using the standardised protocol The maximum GS measurement will be recorded.
Patients who have low maximum GS values (men < 27 kg and women <16 kg) or those who are unable to perform the test will receive a care plan.
The care plan will focus on review of dietary energy and protein intake and any need for oral nutritional supplements or dietetic review, and review of mobility with any need for physiotherapy review with regard to progressive resistance exercises to increase muscle strength.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The feasibility and acceptability of routine implementation of grip strength assessment in older patients
Time Frame: 6-9 months
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is it feasible to implement grip strength assessment routinely in Medicine for Older People (MOP) wards ?
This will be determined by recording the proportion of older inpatients admitted to MOP wards who had their grip strength been measured and the percentage among them with low grip strength levels.
The acceptability of routine implementation of grip strength will be assessed through qualitative method (interviews and focus groups) with older inpatients, medical staff, nursing staff, therapy and dietetic teams.
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6-9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of referrals to dietetic teams and the proportion of nutritional supplements prescriptions
Time Frame: After 3 months of routine implementation of grip strength
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When routine GS measurement has been implemented and embedded in clinical practice for at least 3 months, the number (or percentage) and reasons for referrals to the dietetic weekly for the preceding 3 months will be extracted from the E-referrals and will be compared to the numbers collected at the baseline.
The number (or percentage) of ONS prescriptions will also be calculated from electronic prescribing system and compared to the baseline figures.
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After 3 months of routine implementation of grip strength
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Costs of implementing grip strength assessment routinely in MOP
Time Frame: 9-12 months
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A cost analysis will include the implementation costs and NHS resource utilisation.
The implementation costs will involve cost of equipment, recalibration, nurses training by band, and note audits.
Resource use information will be collected as part of the study and those will include: nutritional prescriptions, referral to dietician, length of stay and discharge destination.
The results will be presented as cost per patient detected and cost per unit of 120 beds.
|
9-12 months
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Helen Roberts, PhD, University General Southampton UHS
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RHM MED1250
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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