Clinical trial NCT04092504: Optimized Recovery After Trauma in Geriatric Patient
Official title: Optimized Recovery After Trauma in Geriatric Patient (Gero - ERAT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Geriatric Assessment
Quality of Life
Trauma
Fragility
Injury
Rehabilitation
Recovery
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2019-09-17
Enrollment: 540
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Implementation research with control group
Primary purpose: SUPPORTIVE_CARE

Brief 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 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

1. Investigate patients experience of the recovery process after trauma
2. 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.
3. Examine health economics when introducing and using gero-ERAT in the continuum care at the university hospital
4. 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.'

3. 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.

4. 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.

Eligibility criteria: Inclusion Criteria:

* ≥ 65 years old
* In hospital due to physical trauma
* Able to speak and understand Swedish

Exclusion Criteria:

* Documented palliative care
* Cognitive impairment

Primary outcomes:
measure: Length of hospital stay (LOS)
timeFrame: One year
Secondary outcomes:
measure: SF-36
timeFrame: One year
measure: Euro Quality of life - 5D
timeFrame: One year
measure: The Katz ADL (Activities of Daily Living Index)
timeFrame: One year
measure: ESAS (Edmonton Symptom Assessment Scale)
timeFrame: One year
measure: PREM (Patient Reported Experienced Measures)
timeFrame: One year
measure: Postoperative Recovery Profile (PRP)
timeFrame: One year
measure: Complications
timeFrame: One year
measure: Mortality
timeFrame: One year
measure: Readmissions
timeFrame: One year
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska university hospital
Study officials:
affiliation: Sahlgrenska University Hospital, Department of Surgery.
name: My Engström, PhD
role: PRINCIPAL_INVESTIGATOR
References: