Assessing Patient Care Through Routine Use of Patient-Reported Outcomes

Routine Use of Patient Reported Outcomes Among Older Adults at High Risk of Falls: A 12-Month Cohort Study

Patient reported outcome measures (PROMs) are assessments of health status or health-related quality of life. The EuroQol-5D (EQ5D) is an example of a generic instrument to assess health-related quality of life. The investigators will use the EQ5D in the Falls Prevention Clinic as part of routine clinical assessment at baseline, 6 months and 12 months to track patient care in a cohort of 300 older adults who are at high-risk of falls.

Study Overview

• Status: Withdrawn
• Conditions: Falls

Detailed Description

1. Purpose: We will use the EQ5D in the Falls Prevention Clinic as part of routine clinical assessment at baseline, 6-months and 12-months to track patient care in a cohort of 300 older adults who are at high-risk of falls.
2. Objectives:

O1: Our primary objective is to use a routinely administered patient reported outcomes measure, the EuroQol-5D (EQ-5D), in older adults at high risk of falls to determine patients self-reported health status over a 12-month followup period.

O2: Our secondary objective is to develop an explanatory model and a predictive model of covariates that explain significant gains or losses in health related quality of life.

• Study Type: Observational

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Vancouver General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Falls Prevention Clinic

Description

Inclusion Criteria:

1. Referred to falls clinic for assessment by general practitioner or emergency department physician.
2. Index fall presentation not due to overwhelming force resulting in presentation to Emergency Department or general practitioner (including syncopal presentation, see below).
3. At least 70 years of age.
4. No progressive neurological disorder (e.g. Dementia, Parkinson's, Alzheimer's).
5. Community dwelling (within Vancouver and Burnaby only).
6. Mini Mental State Examination Score of at least 24.
7. Walk at least 3 meters.

8. Has at least one of the following 'high-risk' criteria:

   • At least one other non-syncopal fall in the past 12 months
   • PPA of at least 1.0 (using dominant score for strength test)
   • TUG of at least 15 seconds
9. Life expectancy of greater than 12 months as determined by the geriatrician.

Exclusion Criteria:

1. Any patients who do not meet the inclusion criteria specified above will be excluded from assessment at the Falls Prevention Clinic.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Study Director: Karim Khan, University of British Columbia; Study Director: Teresa Liu-Ambrose, University of British Columbia; Principal Investigator: Stirling Bryan, University of British Columbia

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: November 4, 2009
• First Submitted That Met QC Criteria: November 5, 2009
• First Posted (Estimate): November 6, 2009

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: older adults; falls; Patient Reported Outcome Measures
• Other Study ID Numbers: H09-01655

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No