Geriatric AssessmentNCT04092504
Optimized Recovery After Trauma in Geriatric Patient
A study testing gero-erat in people with Geriatric Assessment and Quality of Life, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
Currently, there is evidence that structured care within the healthcare system increases the conditions for good care and better recovery. We want to investigate whether a new care concept (gero-ERAT) that combines two variants of structured care can improve the recovery of elderly patients affected by a physical… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Assessment, Quality of Life, Trauma
- What is being tested?
- gero-erat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteSweden
- Study dates
- 9 May 2019to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥ 65 years old
- In hospital due to physical trauma
- Able to speak and understand Swedish
Who cannot join
- Documented palliative care
- Cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska university hospital
Gothenburg, 41345
My Engstrom, + 46 (31) 3428404, my.engstrom@vgregion.se
Hanna Jarbrink, + 46 (31) 3428404, hanna.jarbrink@vgregion.se
About this study
Official title: Optimized Recovery After Trauma in Geriatric Patient (Gero - ERAT)
Currently, there is evidence that structured care within the healthcare system increases the conditions for good care and better recovery. We want to investigate whether a new care concept (gero-ERAT) that combines two variants of structured care can improve the recovery of elderly patients affected by a physical trauma.
Our hope is that the project will reduce the complications, short care times, fewer re-admissions and that more patients can return to regular living, which reduces the suffering for the patient and his relatives. In addition to patient benefit, a successful outcome will also result in reduced costs for healthcare and society as a whole. The concept of care is based on an increased patient participation, which is in line with the values of the Västra Götaland region and the Sahlgrenska university hospital
Read more
Through the PhD project, four studies will be published. A qualitative interview study to investigate patients' experiences of care and recovery after trauma.
After that, a prospective cohort survey of two groups is carried out; conventional care and gero-ERAT. Data will begin to be collected in the control group and when the control group is full geroRATAT will be implemented in the care department and we then collect data in the intervention group.
Based on collected data, we will publish two additional studies one with a focus on health economics as well as one focusing on care time and recovery based on age and harvest estimation.
Read the detailed description
At present, there is evidence that structured care within healthcare (CGA and ERAS) increases the conditions for good care and better recoveries after acute conditions, planned and unplanned surgery. However, there are gaps in knowledge regarding elderly patients who are cared for within the surgical context. In this project we want to investigate whether a new care concept that combines CGA and ERAS can improve care and recovery for elderly patients who have suffered a physical trauma. We call care concepts for Geriatric Enhanced Recovery After Trauma (gero-ERAT). The project will be implemented as a PhD project for a maximum of 8 years. In the doctoral project, a qualitative interview study is planned during the spring and autumn of 2019. The purpose is to investigate experiences of care and recovery in elderly patients who have been cared for physical trauma. The findings from that study can contribute with new knowledge to the gero-ERAT concept.
The overall purpose of the project is to develop, implement and evaluate a structured care with the aim of improving care and recovery in elderly patients affected by physical trauma.
Specific purposes
- Investigate patients experience of the recovery process after trauma
- Establish, implement and evaluate the gero-ERAT concept (ie the effect of the intervention during the care period) at the trauma care unit at the university hospital.
- Examine health economics when introducing and using gero-ERAT in the continuum care at the university hospital
- Investigate in hospital time and recovery based on age and harvest estimation when using gero-ERAT
The first study will be a qualitative interview study, 20-25 (depending on when saturation of data occurs) patients will be deeply interviewed at approximately one hour.
The interviews will be semi-structured, and the questions are designed so that patients are given the opportunity to tell about their own perception and experience of care and recovery in connection with trauma. Transcribed coded data will be analyzed with the Constructive Grounded Theory methodology of Charmaz.
Potential participants will be asked by researchers who are involved in the project upon discharge from the hospital, patients receive both oral and written information. The patients will be interviewed approximately six weeks after discharge from the hospital and the interview session is expected to take between 1-3 hours.
The second study which is a Prospective cohort of two groups; conventional care and gero-ERAT will generate three studies.
Data will be collected from the patients journal and by surveys that the patient replies to The measurement variables will be collected in connection with the care period when the patient is included in the study (baseline value), as well as at six and 12 months after the patients have been written out from the hospital. The items 1-5 below will be collected via the patients' records and items 6-11 will be filled in by the patients.
- Demographic data (age, gender, type of trauma, other morbidity, social status, housing type)
- Length of stay
- Complications
- Re-admissions
- Mortality
- RAND-SF36 (Short Form Health Survey); is a validated generic questionnaire on health-related quality of life and consists of 36 questions that can be divided into two domains; physical and mental health.
- EQ-5D-5L (EuroQol); is a validated generic questionnaire consisting of five questions (health domains) and a VAS scale. In addition to health outcomes, data can be used as a basis for health economic calculations
- ADL (Activities in daily life) The staircase describes the degree of dependence / independence with three scale steps for five basic physical activities and a function (food intake, continence, movement, toilet visits, dressing and undressing and bathing).
- ESAS (Edmonton Symptom Assessment Scale); are validated symptom estimation scales consisting of ten symptoms (eg, pain, indigestion, nausea).
- PREM (Patient Reported Experienced Measures) is a measure for measuring the patient's experience and satisfaction of care.
- The PRP Questionnaire (Post Operational Recovery Profile) is a validated form consisting of 19 questions regarding symptoms such as appetite, insomnia and concentration ability that can be answered with four options.
Descriptive data will be used to describe the groups. The differences between the groups will be calculated with Fisher's exact test for nominal data, Chi two test (X2) test for ordinal distribution, and normal distributed continuous variables will be calculated with Student t test or if continuous data is not normally distributed with Mann-Whitney U- Test.'
- The third study will be a health-economic analysis that is based on data from the EQ-5D, which can be used to obtain quality-of-life weights to calculate quality-adjusted life years (QALY). Length of hospital stay, complications and re-admissions will also be collected and reported systematically. While working on this sub study, in addition to statistics, a person within the clinic with expertise in health-economic calculations will also be involved.
- The fourth study will be Examining length of hospital stay and recovery based on age and frailty estimation when using gero-ERAT. These sub-group analyzes will take place on all collected data described in sub-study II. Before the statistical analyzes begin, consultation with statisticians will take into account the problem of the mass significance's ability to adjust for this.
- Conditions
- Geriatric Assessment, Quality of Life, Trauma, Fragility, Injury, Rehabilitation
- Being tested
- gero-erat
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gero-eratOther
The intervention is a standardize Care Plan which will be developed based on the evidence of caring for elderly patients in a trauma setting. The Care Plan will have its base in, the concept of ERAS and CGA. Also, patient experience will be taken in consideration and complement the care pathway.
Patients admitted to the trauma unit will be given the care and asked to be a part of the study witch include to fill out surveys at baseline, six months and 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Standard care at the unit |
| Gero-Erat | Experimental | New care pathway that is built on the concept of ERAS and CGA Receives: Other: gero-erat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay (LOS)
Length of hospital stay (LOS) in days
Measured: One year
Secondary outcomes (9)
SF-36
The Short Form (36) Health Survey is a 36-item generic HRQoL questionnaire assessing eight domains: Physical function, Role-physical, Bodily pain, General health, Vitality, Social function, Role-emotional and Mental health. The first four domains reflect physical health and the last four mental health. A score is calculated for each domain on a scale from 0 (worst possible health state) to 100 (best possible health state)
Measured: One year
Euro Quality of life - 5D
This is a standardized instrument for measure health outcome, it consists of a descriptive system and a VAS (Visual Analogue Scale). The descriptive system comprises five dimensions: Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety/Depression. Each dimension has 5 levels: No problems, Slight problems, Moderate problems, Severe problems and Extreme problems. Each domains can be calculated to a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale between 0-100 (100 = best imaginable health; 0 = worst imaginable health)
Measured: One year
The Katz ADL (Activities of Daily Living Index)
Measures the individuals physical function, based on six activities: Feeding, Bathing, Dressing, Toileting, Continence and Transferring. Scoring: Each function can be answered with a yes/no for independence. The answers are then summarized and the result is compared with a list of seven steps between A to G, which indicates the alternative that best meets the assessed person's need for help.
A = Independent of assistance in all six activities B = Dependent on assistance with one of the activities C = Dependent on bathing / showering assistance and one more activity D = Depending on assistance with bathing, dressing and undressing, toilet visits and additional activities E = Depending on assistance with bathing, dressing and undressing, toilet visits and another activity F = Depending on assistance with bathing, dressing and undressing, toilet visits, transfer and another activity G = Dependent on assistance with all activities.
Measured: One year
ESAS (Edmonton Symptom Assessment Scale)
Measuring symptoms and illness. ESAS is a tool that estimate nine common symptoms for patients within palliative care: Pain, Tiredness, Drowsiness, Nausea, Appetite, Depression, Anxiety, Shortness of breath and Well-being. Each symptom are reported on a 10-grade scale ranges from no problem to worst possible problems.
Measured: One year
PREM (Patient Reported Experienced Measures)
Patients satisfaction with provided care
Measured: One year
Postoperative Recovery Profile (PRP)
This questionnaire is intended for self-assessment of general recovery after surgery. The questionnaire contains 19 items common after surgery, each item is estimated with a 4-degree verbal category scale from hard to none. The answers is coded and transformed in to a number and calculated on a scale from 0-19 on how well the person has recovered after surgery where <7 is not recovered at all and 19 is fully recovered.
Measured: One year
Complications
Measuring rate of complications six months and one year after trauma
Measured: One year
Mortality
Mortality measured six months and one year after trauma
Measured: One year
Readmissions
Readmissions do to the trauma during one year after trauma
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start9 May 2019
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric AssessmentStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Implementation research with control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- My Engström, PhD, Principal investigator, Sahlgrenska University Hospital, Department of Surgery.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092504
- Sponsor's protocol ID
- 766-18
- Status last verified
- Nov 2024
- First submitted
- 29 May 2019
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Recovery After Trauma in Geriatric Patient (Gero - ERAT)
- ClinicalTrials.gov ID
- NCT04092504
- Acronym / sponsor ID
- 766-18
- Conditions
- Geriatric Assessment, Quality of Life, Trauma, Fragility, Injury, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 9 May 2019 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 17 Sep 2019 (actual)
- 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.
Currently, there is evidence that structured care within the healthcare system increases the conditions for good care and better recovery. We want to investigate whether a new care concept (gero-ERAT) that combines two variants of structured care can improve the recovery of elderly patients affected by a physical trauma.
Our hope is that the project will reduce the complications, short care times, fewer re-admissions and that more patients can return to regular living, which reduces the suffering for the patient and his relatives. In addition to patient benefit, a successful outcome will also result in reduced costs for healthcare and society as a whole. The concept of care is based on an increased patient participation, which is in line with the values of the Västra Götaland region and the Sahlgrenska university hospital
Through the PhD project, four studies will be published. A qualitative interview study to investigate patients' experiences of care and recovery after trauma.
After that, a prospective cohort survey of two groups is carried out; conventional care and gero-ERAT. Data will begin to be collected in the control group and when the control group is full geroRATAT will be implemented in the care department and we then collect data in the intervention group.
Based on collected data, we will publish two additional studies one with a focus on health economics as well as one focusing on care time and recovery based on age and harvest estimation.
Detailed description
At present, there is evidence that structured care within healthcare (CGA and ERAS) increases the conditions for good care and better recoveries after acute conditions, planned and unplanned surgery. However, there are gaps in knowledge regarding elderly patients who are cared for within the surgical context. In this project we want to investigate whether a new care concept that combines CGA and ERAS can improve care and recovery for elderly patients who have suffered a physical trauma. We call care concepts for Geriatric Enhanced Recovery After Trauma (gero-ERAT). The project will be implemented as a PhD project for a maximum of 8 years. In the doctoral project, a qualitative interview study is planned during the spring and autumn of 2019. The purpose is to investigate experiences of care and recovery in elderly patients who have been cared for physical trauma. The findings from that study can contribute with new knowledge to the gero-ERAT concept.
The overall purpose of the project is to develop, implement and evaluate a structured care with the aim of improving care and recovery in elderly patients affected by physical trauma.
Specific purposes
- Investigate patients experience of the recovery process after trauma
- Establish, implement and evaluate the gero-ERAT concept (ie the effect of the intervention during the care period) at the trauma care unit at the university hospital.
- Examine health economics when introducing and using gero-ERAT in the continuum care at the university hospital
- Investigate in hospital time and recovery based on age and harvest estimation when using gero-ERAT
The first study will be a qualitative interview study, 20-25 (depending on when saturation of data occurs) patients will be deeply interviewed at approximately one hour.
The interviews will be semi-structured, and the questions are designed so that patients are given the opportunity to tell about their own perception and experience of care and recovery in connection with trauma. Transcribed coded data will be analyzed with the Constructive Grounded Theory methodology of Charmaz.
Potential participants will be asked by researchers who are involved in the project upon discharge from the hospital, patients receive both oral and written information. The patients will be interviewed approximately six weeks after discharge from the hospital and the interview session is expected to take between 1-3 hours.
The second study which is a Prospective cohort of two groups; conventional care and gero-ERAT will generate three studies.
Data will be collected from the patients journal and by surveys that the patient replies to The measurement variables will be collected in connection with the care period when the patient is included in the study (baseline value), as well as at six and 12 months after the patients have been written out from the hospital. The items 1-5 below will be collected via the patients' records and items 6-11 will be filled in by the patients.
- Demographic data (age, gender, type of trauma, other morbidity, social status, housing type)
- Length of stay
- Complications
- Re-admissions
- Mortality
- RAND-SF36 (Short Form Health Survey); is a validated generic questionnaire on health-related quality of life and consists of 36 questions that can be divided into two domains; physical and mental health.
- EQ-5D-5L (EuroQol); is a validated generic questionnaire consisting of five questions (health domains) and a VAS scale. In addition to health outcomes, data can be used as a basis for health economic calculations
- ADL (Activities in daily life) The staircase describes the degree of dependence / independence with three scale steps for five basic physical activities and a function (food intake, continence, movement, toilet visits, dressing and undressing and bathing).
- ESAS (Edmonton Symptom Assessment Scale); are validated symptom estimation scales consisting of ten symptoms (eg, pain, indigestion, nausea).
- PREM (Patient Reported Experienced Measures) is a measure for measuring the patient's experience and satisfaction of care.
- The PRP Questionnaire (Post Operational Recovery Profile) is a validated form consisting of 19 questions regarding symptoms such as appetite, insomnia and concentration ability that can be answered with four options.
Descriptive data will be used to describe the groups. The differences between the groups will be calculated with Fisher's exact test for nominal data, Chi two test (X2) test for ordinal distribution, and normal distributed continuous variables will be calculated with Student t test or if continuous data is not normally distributed with Mann-Whitney U- Test.'
- The third study will be a health-economic analysis that is based on data from the EQ-5D, which can be used to obtain quality-of-life weights to calculate quality-adjusted life years (QALY). Length of hospital stay, complications and re-admissions will also be collected and reported systematically. While working on this sub study, in addition to statistics, a person within the clinic with expertise in health-economic calculations will also be involved.
- The fourth study will be Examining length of hospital stay and recovery based on age and frailty estimation when using gero-ERAT. These sub-group analyzes will take place on all collected data described in sub-study II. Before the statistical analyzes begin, consultation with statisticians will take into account the problem of the mass significance's ability to adjust for this.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Implementation research with control group
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Standard care at the unit |
| Gero-Erat | Experimental | Other: gero-eratNew care pathway that is built on the concept of ERAS and CGA |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- ≥ 65 years old
- In hospital due to physical trauma
- Able to speak and understand Swedish
Key exclusion criteria (2 listed)
- Documented palliative care
- Cognitive impairment
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 |
|---|---|---|
| gero-eratThe intervention is a standardize Care Plan which will be developed based on the evidence of caring for elderly patients in a trauma setting. The Care Plan will have its base in, the concept of ERAS and CGA. Also, patient experience will be taken in consideration and complement the care pathway. Patients admitted to the trauma unit will be given the care and asked to be a part of the study witch include to fill out surveys at baseline, six months and 1 year. | Other | Gero-Erat |
Primary outcome
Length of hospital stay (LOS)
Time frame: One year
Length of hospital stay (LOS) in days
9 secondary outcomes
SF-36
Time frame: One year
Euro Quality of life - 5D
Time frame: One year
The Katz ADL (Activities of Daily Living Index)
Time frame: One year
ESAS (Edmonton Symptom Assessment Scale)
Time frame: One year
PREM (Patient Reported Experienced Measures)
Time frame: One year
Postoperative Recovery Profile (PRP)
Time frame: One year
Complications
Time frame: One year
Mortality
Time frame: One year
Readmissions
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: No
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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.
My Engström, PhD principal investigator
Sahlgrenska University Hospital, Department of Surgery.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gero-erat in people with Geriatric Assessment and Quality of Life, run by Vastra Gotaland Region at 1 site in Sweden.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 25 Nov 2024. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact My Engstrom, PhD (+ 46 (31) 3428404, my.engstrom@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (LOS) (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2024.