Frail Elderly, InpatientsNCT02447445
Grip Strength Routine Implementation (GRImP)
An observational study of Frail Elderly, Inpatients, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Hand grip strength (GS) is a non-invasive marker of whole body skeletal muscle strength and function used in research and recommended as a simple inexpensive measure suitable for clinical use. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Frail Elderly, Inpatients
- What is being tested?
- Grip strength assessment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Grip strength of older patients admitted to the MOP will be measured by a ward nurse.
Who may be able to join
- Inclusion criteria will be older patients admitted to the MOP.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing Grip Strength Measurement Into Routine Clinical Practice; a Feasibility Study (GRImP)
Hand grip strength (GS) is a non-invasive marker of whole body skeletal muscle strength and function used in research and recommended as a simple inexpensive measure suitable for clinical use. Research has shown that low GS in hospital inpatients is associated with poor healthcare outcomes including increased postoperative complications, longer length of stay, increased functional limitations and disability. Measuring GS on admission to hospital has the potential to identify people at risk of poor healthcare outcomes allowing early intervention including focus on nutrition and mobility. Yet, GS measurement is not routinely used in clinical practice. The aim of this study is to evaluate the implementation of GS measurement into routine clinical practice in Medicine for Older People wards at UHS.
Read the 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.
- Conditions
- Frail Elderly, Inpatients
- Being tested
- Grip strength assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grip strength assessmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Grip strength assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility and acceptability of routine implementation of grip strength assessment in older patients
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.
Measured: 6-9 months
Secondary outcomes (2)
The proportion of referrals to dietetic teams and the proportion of nutritional supplements prescriptions
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.
Measured: After 3 months of routine implementation of grip strength
Costs of implementing grip strength assessment routinely in MOP
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.
Measured: 9-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly, InpatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Helen Roberts, PhD, Study chair, University General Southampton UHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447445
- Sponsor's protocol ID
- RHM MED1250
- Status last verified
- Apr 2018
- First submitted
- 14 May 2015
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Ibrahim K, May CR, Patel HP, Baxter M, Sayer AA, Roberts HC. Implementation of grip strength measurement in medicine for older people wards as part of routine admission assessment: identifying facilitators and barriers using a theory-led intervention. BMC Geriatr. 2018 Mar 22;18(1):79. doi: 10.1186/s12877-018-0768-5.
PubMed 29566673
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Grip Strength Measurement Into Routine Clinical Practice; a Feasibility Study (GRImP)
- ClinicalTrials.gov ID
- NCT02447445
- Acronym / sponsor ID
- RHM MED1250
- Conditions
- Frail Elderly, Inpatients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 18 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hand grip strength (GS) is a non-invasive marker of whole body skeletal muscle strength and function used in research and recommended as a simple inexpensive measure suitable for clinical use. Research has shown that low GS in hospital inpatients is associated with poor healthcare outcomes including increased postoperative complications, longer length of stay, increased functional limitations and disability. Measuring GS on admission to hospital has the potential to identify people at risk of poor healthcare outcomes allowing early intervention including focus on nutrition and mobility. Yet, GS measurement is not routinely used in clinical practice. The aim of this study is to evaluate the implementation of GS measurement into routine clinical practice in Medicine for Older People wards at UHS.
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 design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older inpatient at MOP | – | Procedure: Grip strength assessmentThe 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. |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Grip strength of older patients admitted to the MOP will be measured by a ward nurse.
Key inclusion criteria (1 listed)
- Inclusion criteria will be older patients admitted to the MOP.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grip strength assessmentGrip 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. | Procedure or surgery | Older inpatient at MOP |
Primary outcome
The feasibility and acceptability of routine implementation of grip strength assessment in older patients
Time frame: 6-9 months
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.
2 secondary outcomes
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
Costs of implementing grip strength assessment routinely in MOP
Time frame: 9-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Derived from this study: PubMed 29566673Ibrahim K, May CR, Patel HP, Baxter M, Sayer AA, Roberts HC. Implementation of grip strength measurement in medicine for older people wards as part of routine admission assessment: identifying facilitators and barriers using a theory-led intervention. BMC Geriatr. 2018 Mar 22;18(1):79. doi: 10.1186/s12877-018-0768-5.
- study protocolLink provided by the sponsor.
- the study main findingsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Roberts, PhD study chair
University General Southampton UHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frail Elderly, Inpatients, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility and acceptability of routine implementation of grip strength assessment in older patients (time frame: 6-9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02447445, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.