The objective of this randomized control trial is to investigate effects and cost effectiveness of interprofessional preoperative assessment among older knee or hip arthroplasty patients. The main hypothesis is that preoperative assessment and optimization have a positive impact on the patents' quality of life and expenditure of social and health care services.
Full Title of Study: “Interprofessional Preoperative Geriatric Assessment for Older Arthroplasty Patients With Multimorbidity – a Randomized Clinical Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Supportive Care
- Masking: None (Open Label)
- Study Primary Completion Date: December 31, 2022
Knee and hip arthrosis are common conditions among older adults. Progression of arthrosis often leads to worsening of symptoms and decreased mobility, daily functioning and quality of life. Total joint arthroplasty improves pain in end-stage arthrosis but accustomed postoperative care and rehabilitation alone may not guarantee optimal regain of functioning for frail and vulnerable older arthroplasty patients. Preoperative optimization of older patients with multimorbidity and functional limitations may improve benefits of the arthroplasty even at lower costs. Patients randomized into intervention arm of the present study receive preoperative assessment with treatment and prehabilitation plan. The focuses of the intervention are patient's chronic conditions, nutritional status, medication and physical activity. The intervention is delivered by multiprofessional team (geriatrician, registered nurse, physiotherapist and pharmacist). Older adults undergoing surgery are a rapidly growing but vulnerable patient group. Knowledge on effects of preoperative evaluation and optimization is sparse, especially on the effects of multi-domain interventions.
- Other: Preoperative geriatric assessment
- In addition to the usual care, patients randomized to the intervention group receive preoperative assessment conducted by an interprofessional team including geriatrician, registered nurse, physiotherapist and pharmacist. Based on the assessment, a preoperative optimization plan is constructed focusing on the treatment of the patient’s chronic conditions, nutritional status, medication and physical activity.
Arms, Groups and Cohorts
- Experimental: Intervention
- Preoperative assessment conducted by an interprofessional team
- Active Comparator: Usual care
- Usual care
Clinical Trial Outcome Measures
- Health-related quality of life (15-D)
- Time Frame: Preoperative measurement at baseline, postoperative measurements 3 and 9 months after the arthroplasty.
- Change in quality of life is measured using the 15-dimensions health-related quality of life questionnaire (15-D) in three time points
- Costs of social and health care services
- Time Frame: Changes in costs of care are evaluated for a period starting from one year before and ending two years after the baseline examinations.
- Data on the use and costs of social and health care services are obtained from the national and local care registers. The costs of the intervention are evaluated by measuring working time of the inter-professional team members (used per every study patient).
Participating in This Clinical Trial
- Place of residence: Kuopio or Vesanto municipality – Age ≥ 65 years – Clinical decision for knee or hip arthroplasty, elective operation with more than one month waiting time, primary arthroplasty of the index joint. – Multimorbidity: the patient has at least two chronic diseases with potential to affect functioning, diseases are defined according to the Function Comorbidity Index (FCI) Additional inclusion criteria, at least two of the following: – 5 or more medicines taken regularly (polypharmacy) – continuous walking distance less than 500 m – needs help in dressing and/or washing oneself – needs help when visiting or taking care of businesses outside home – body mass index ≤ 23 or ≥ 34 Exclusion Criteria:
- does not meet the above inclusion criteria
Gender Eligibility: All
Minimum Age: 65 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Eastern Finland
- Kuopio University Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Eija Lönnroos, professor – University of Eastern Finland
- Overall Official(s)
- Eija Lönnroos, Principal Investigator, University of Eastern Finland, Institute of Public Health and Clinical Nutrition
- Overall Contact(s)
- Eija Lönnroos, MD, PhD, +358 40 3552932, email@example.com
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