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

Primary Purpose

Multimorbidity, Knee Arthrosis, Hip Arthrosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Preoperative geriatric assessment
Sponsored by
University of Eastern Finland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multimorbidity focused on measuring preoperative, geriatric assessment, interprofessional team

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Eastern Finland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Usual care

Arm Description

Preoperative assessment conducted by an interprofessional team

Usual care

Outcomes

Primary Outcome Measures

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
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).

Secondary Outcome Measures

Full Information

First Posted
June 25, 2019
Last Updated
June 27, 2019
Sponsor
University of Eastern Finland
Collaborators
Kuopio University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04001699
Brief Title
Interprofessional Preoperative Geriatric Assessment for Older Arthroplasty Patients With Multimorbidity
Acronym
IPPGA-RCT
Official Title
Interprofessional Preoperative Geriatric Assessment for Older Arthroplasty Patients With Multimorbidity - a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 19, 2019 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Eastern Finland
Collaborators
Kuopio University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multimorbidity, Knee Arthrosis, Hip Arthrosis
Keywords
preoperative, geriatric assessment, interprofessional team

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Preoperative assessment conducted by an interprofessional team
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Preoperative geriatric assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health-related quality of life (15-D)
Description
Change in quality of life is measured using the 15-dimensions health-related quality of life questionnaire (15-D) in three time points
Time Frame
Preoperative measurement at baseline, postoperative measurements 3 and 9 months after the arthroplasty.
Title
Costs of social and health care services
Description
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).
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eija Lönnroos, MD, PhD
Phone
+358 40 3552932
Email
eija.lonnroos@uef.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Kaisa Haatainen
Email
kaisa.haatainen@kuh.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eija Lönnroos
Organizational Affiliation
University of Eastern Finland, Institute of Public Health and Clinical Nutrition
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Eastern Finland
City
Kuopio
ZIP/Postal Code
FI-70211
Country
Finland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eija Lönnroos, MD, PhD
Phone
+35840 3552932
Email
eija.lonnroos@uef.fi
First Name & Middle Initial & Last Name & Degree
Kaisa Haatainen, PhD
Phone
+35844 717 9322
Email
kaisa.haatainen@kuh.fi

12. IPD Sharing Statement

Plan to Share IPD
No

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Interprofessional Preoperative Geriatric Assessment for Older Arthroplasty Patients With Multimorbidity

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