Interprofessional Preoperative Geriatric Assessment for Older Arthroplasty Patients With Multimorbidity (IPPGA-RCT)

Interprofessional Preoperative Geriatric Assessment for Older Arthroplasty Patients With Multimorbidity - a Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Arthrosis; Multimorbidity; Knee Arthrosis
• Intervention / Treatment: Other: Preoperative geriatric assessment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eija Lönnroos, MD, PhD; Phone Number: +358 40 3552932; Email: eija.lonnroos@uef.fi
• Study Contact Backup: Name: Kaisa Haatainen; Email: kaisa.haatainen@kuh.fi

Study Locations

• Finland
  • Kuopio, Finland, FI-70211
    • University of Eastern Finland
    • Contact: Eija Lönnroos, MD, PhD; Phone Number: +35840 3552932; Email: eija.lonnroos@uef.fi
    • Contact: Kaisa Haatainen, PhD; Phone Number: +35844 717 9322; Email: kaisa.haatainen@kuh.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care	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.
Experimental: Intervention; Preoperative assessment conducted by an interprofessional team	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life (15-D)	Change in quality of life is measured using the 15-dimensions health-related quality of life questionnaire (15-D) in three time points	Preoperative measurement at baseline, postoperative measurements 3 and 9 months after the arthroplasty.
Costs of social and health care services	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).	Changes in costs of care are evaluated for a period starting from one year before and ending two years after the baseline examinations.

Collaborators and Investigators

• Sponsor: University of Eastern Finland
• Collaborators: Kuopio University Hospital
• Investigators: Principal Investigator: Eija Lönnroos, University of Eastern Finland, Institute of Public Health and Clinical Nutrition

Study record dates

Study Major Dates

• Study Start (Anticipated): August 19, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (Actual): June 28, 2019

Study Record Updates

• Last Update Posted (Actual): June 28, 2019
• Last Update Submitted That Met QC Criteria: June 27, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: preoperative; geriatric assessment; interprofessional team
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases; Osteoarthritis, Hip
• Other Study ID Numbers: HERIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No