Clinical trial NCT01008579: Assessing Patient Care Through Routine Use of Patient-Reported Outcomes
Official title: Routine Use of Patient Reported Outcomes Among Older Adults at High Risk of Falls: A 12-Month Cohort Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Falls
Keywords: Patient Reported Outcome Measures
falls
older adults
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2009-11-06
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Falls Prevention Clinic

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Karim Khan
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Teresa Liu-Ambrose
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Stirling Bryan
role: PRINCIPAL_INVESTIGATOR
References: