Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Fragility
  • Geriatric Assessment
  • Injury
  • Quality of Life
  • Recovery
  • Rehabilitation
  • Trauma
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Implementation research with control groupMasking: Single (Participant)Masking Description: Elderly trauma patientsPrimary Purpose: Supportive Care

Participation Requirements

Age
Between 65 years and 125 years
Gender
Both males and females

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 surgica...

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.' 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.

Tracking Information

NCT #
NCT04092504
Collaborators
Not Provided
Investigators
Principal Investigator: My Engström, PhD Sahlgrenska University Hospital, Department of Surgery.