Preventive Primary Care Outreach for High Risk Older Persons (PPCO)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 23, 2005 | ||||
| Last Updated Date | December 11, 2008 | ||||
| Start Date ICMJE | April 2004 | ||||
| Primary Completion Date | June 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Health related quality of life (quality adjusted life years [QALYs]) [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Health related quality of life (quality adjusted life years QALYs) | ||||
| Change History | Complete list of historical versions of study NCT00134836 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
|
||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Preventive Primary Care Outreach for High Risk Older Persons | ||||
| Official Title ICMJE | Preventive Primary Care Outreach for High Risk Older Persons | ||||
| 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:
|
||||
| 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 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 Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Prevention |
||||
| Condition ICMJE | Frailty | ||||
| Intervention ICMJE | Behavioral: Preventive Primary Care Outreach
Nurse home visit at baseline, 6 months, 12 months, including comprehensive assessment using MDS HC, care planning, referral to appropriate services
Other Name: nurse home visit |
||||
| Study Arm (s) | Not Provided | ||||
| Publications * | 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. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 719 | ||||
| Completion Date | June 2006 | ||||
| Primary Completion Date | June 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 75 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00134836 | ||||
| Other Study ID Numbers ICMJE | PHCTF G03-02795 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jenny Ploeg, McMaster University | ||||
| Study Sponsor ICMJE | McMaster University | ||||
| Collaborators ICMJE | Ontario Ministry of Health and Long Term Care | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | McMaster University | ||||
| Verification Date | December 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||