Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134836
Status:
COMPLETED
Last Update Posted:
2008-12-16
First Post:
2005-08-23
Brief Title:
Preventive Primary Care Outreach for High Risk Older Persons
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Preventive Primary Care Outreach for High Risk Older Persons
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPCO
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
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 083 95 confidence interval CI 075 to 091 and an increased likelihood of living in the community OR 123 95 CI 106 to 143 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None