NCT04092504

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
540

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
May 2019Jan 2028

Study Start

First participant enrolled

May 9, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

7.7 years

First QC Date

May 29, 2019

Last Update Submit

November 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay (LOS)

    Length of hospital stay (LOS) in days

    One year

Secondary Outcomes (9)

  • SF-36

    One year

  • Euro Quality of life - 5D

    One year

  • The Katz ADL (Activities of Daily Living Index)

    One year

  • ESAS (Edmonton Symptom Assessment Scale)

    One year

  • PREM (Patient Reported Experienced Measures)

    One year

  • +4 more secondary outcomes

Study Arms (2)

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

Other: gero-erat

Interventions

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.

Gero-Erat

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Documented palliative care
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska university hospital

Gothenburg, 41345, Sweden

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • My Engström, PhD

    Sahlgrenska University Hospital, Department of Surgery.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Elderly trauma patients
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Implementation research with control group
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2019

First Posted

September 17, 2019

Study Start

May 9, 2019

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

November 25, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations