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Preventive Primary Care Outreach for High Risk Older Persons (PPCO)

Primary Purpose

Frailty

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Preventive Primary Care Outreach
Sponsored by
McMaster University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frailty

Eligibility Criteria

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

Inclusion Criteria: Patient is 75 years of age and older Patient is listed on the roster of a participating family physician practice Patient resides in the Hamilton, Ontario, Canada area Patient or proxy able to answer questions in English Exclusion Criteria: Principal residence is nursing home or long term care facility Patient is identified by family physician as palliative Patient currently receives home care services through the Community Care Access Centre Patient is a 'snowbird' and out of town for more than four weeks in any year Patient is scheduled for major elective surgery in the next year

Sites / Locations

  • McMaster University

Outcomes

Primary Outcome Measures

Health related quality of life (quality adjusted life years [QALYs])

Secondary Outcome Measures

Health and social service utilization and costs
mortality
institutionalization
functional status
perceived health status

Full Information

First Posted
August 23, 2005
Last Updated
December 11, 2008
Sponsor
McMaster University
Collaborators
Ontario Ministry of Health and Long Term Care
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1. Study Identification

Unique Protocol Identification Number
NCT00134836
Brief Title
Preventive Primary Care Outreach for High Risk Older Persons
Acronym
PPCO
Official Title
Preventive Primary Care Outreach for High Risk Older Persons
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
McMaster University
Collaborators
Ontario Ministry of Health and Long Term Care

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
It is recognized that a significant proportion of seniors over 75 years of age are at risk of functional decline, and thus of institutionalization and death. The investigators at McMaster University Medical Centre, are conducting is a randomized controlled trial of a preventive primary care outreach (PPCO) service provided to high risk seniors living in the community. The goal of this service is to identify unrecognized problems and individuals at increased risk and to link individuals to care. This preventive primary care service is provided by nurse case managers. The investigators have recruited patients through their family physicians who work in primary care networks. The investigators are screening all seniors aged 75 and over within these practices. The sample includes seniors aged 75 and over who are identified to be at risk according to the Sherbrooke Postal Questionnaire. Patients are randomly allocated to intervention and control groups. A research assistant, who is blind to group allocation, will collect data from seniors at baseline, six months, and at the end of one year. Outcome measures include health-related quality of life (quality adjusted life years [QALYs]), health and social service utilization and costs, mortality, institutionalization, functional status, and perceived health status. Primary Hypothesis: The intervention compared to usual care will result in higher health-related quality of life. Secondary Hypotheses: Compared to usual care, the PPCO intervention will result in: the same or lower costs associated with service utilization; less functional decline; reduced mortality; lower rates of institutionalization; and better self-rated health.
Detailed Description
Seniors consume a large proportion of health care resources in Canada. It is recognized that a significant proportion of seniors over 75 years of age are at risk of functional decline, and thus of institutionalization and death. A recent meta-analysis of nineteen studies of preventive primary care outreach interventions with older persons found that such interventions were associated with a significant reduction of mortality (Summary Odds Ratio [OR] 0.83, 95% confidence interval [CI] 0.75 to 0.91) and an increased likelihood of living in the community (OR 1.23, 95% CI 1.06 to 1.43). While four of the nineteen studies were conducted in Canada, none of these examined health-related quality of life or the cost effectiveness of the intervention. The study we are conducting is a randomized controlled trial of a preventive primary care outreach service provided to high risk seniors living in the community. The goal of this service is to identify unrecognized problems and individuals at increased risk and to link individuals to care. This preventive primary care service is provided by nurse case managers. At an initial home visit, the nurse will conduct a comprehensive, multidimensional assessment, identify problems and develop a plan of care, using the Minimum Data Set for Home Care and Client Assessment Protocols. The nurse will work with the senior and the family physician to plan and implement care. While frequency of home and phone visits will depend on the needs of seniors, it is expected that, on average, seniors in the intervention group will receive 10 hours of nursing contact during the one year of intervention. We have recruited primary care networks and family physician practices within these networks. Within these practices, we are screening all seniors aged 75 and over. The sample includes seniors aged 75 and over who are identified to be at risk according to the Sherbrooke Postal Questionnaire. We will recruit 640 patients for the study and randomly allocate them to intervention and control groups. A research assistant, who is blind to group allocation, will collect data from seniors at baseline, six months, and at the end of one year. Outcome measures include health-related quality of life (quality adjusted life years [QALYs]), health and social service utilization and costs, mortality, institutionalization, functional status, and perceived health status. Primary Hypothesis: The intervention compared to usual care will result in higher health-related quality of life. Secondary Hypotheses: Compared to usual care, the PPCO intervention will result in: the same or lower costs associated with service utilization; less functional decline; reduced mortality; lower rates of institutionalization; and better self-rated health. The available evidence regarding the effectiveness and economic impact of primary care interventions with seniors is inadequate for the development of health care policy in Ontario and Canada. The present proposal employs a research design that addresses the limitations of research conducted to date. The results of this study will guide policy makers in addressing problems in primary care for seniors and assist in decision making related to services for high risk seniors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
719 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Preventive Primary Care Outreach
Other Intervention Name(s)
nurse home visit
Intervention Description
Nurse home visit at baseline, 6 months, 12 months, including comprehensive assessment using MDS HC, care planning, referral to appropriate services
Primary Outcome Measure Information:
Title
Health related quality of life (quality adjusted life years [QALYs])
Time Frame
baseline, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Health and social service utilization and costs
Time Frame
baseline, 6 months, 12 months
Title
mortality
Time Frame
12 months
Title
institutionalization
Time Frame
12 months
Title
functional status
Time Frame
baseline, 6 months, 12 months
Title
perceived health status
Time Frame
baseline, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is 75 years of age and older Patient is listed on the roster of a participating family physician practice Patient resides in the Hamilton, Ontario, Canada area Patient or proxy able to answer questions in English Exclusion Criteria: Principal residence is nursing home or long term care facility Patient is identified by family physician as palliative Patient currently receives home care services through the Community Care Access Centre Patient is a 'snowbird' and out of town for more than four weeks in any year Patient is scheduled for major elective surgery in the next year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenny Ploeg, RN, PhD
Organizational Affiliation
School of Nursing, Faculty of Health Sciences, McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20400483
Citation
Ploeg J, Brazil K, Hutchison B, Kaczorowski J, Dalby DM, Goldsmith CH, Furlong W. Effect of preventive primary care outreach on health related quality of life among older adults at risk of functional decline: randomised controlled trial. BMJ. 2010 Apr 16;340:c1480. doi: 10.1136/bmj.c1480.
Results Reference
derived

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