## Protocol Section
### Identification Module
**NCT ID:** NCT01008579

**Brief Title:** 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

#### Organization Study ID Info
**ID:** H09-01655
#### Organization
**Class:** OTHER
**Full Name:** University of British Columbia
### Status Module
#### Completion Date
**Date:** 2011-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-11-06

**Type:** ACTUAL

**Last Update Submit Date:** 2017-11-02

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2011-04

**Type:** ACTUAL

#### Start Date
**Date:** 2009-12

**Status Verified Date:** 2017-11

#### Study First Post Date
**Date:** 2009-11-06
**Type:** ESTIMATED
**Study First Submit Date:** 2009-11-04
**Study First Submit QC Date:** 2009-11-05
**Why Stopped:** Redundant with another study
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of British Columbia

#### Responsible Party

**Investigator Affiliation:** University of British Columbia

**Investigator Full Name:** Teresa Liu-Ambrose

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Falls

**Keywords:**

- Patient Reported Outcome Measures

- falls

- older adults

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Eligibility Module

**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.

**Minimum Age:** 60 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Falls Prevention Clinic

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Vancouver

**Country:** Canada

**Facility:** Vancouver General Hospital

**State:** British Columbia

#### Overall Officials

**Official 1:**

**Affiliation:** University of British Columbia

**Name:** Karim Khan

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** University of British Columbia

**Name:** Teresa Liu-Ambrose

**Role:** STUDY_DIRECTOR

**Official 3:**

**Affiliation:** University of British Columbia

**Name:** Stirling Bryan

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
