Preventive Primary Care Outreach for High Risk Older Persons
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 719
- 试验地点
- 2
- 主要终点
- Health related quality of life (quality adjusted life years [QALYs])
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Health related quality of life (quality adjusted life years [QALYs])
时间窗: baseline, 6 months, 12 months
次要结局
- Health and social service utilization and costs(baseline, 6 months, 12 months)
- mortality(12 months)
- institutionalization(12 months)
- functional status(baseline, 6 months, 12 months)
- perceived health status(baseline, 6 months, 12 months)