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

This study has been completed.
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00134836
First received: August 23, 2005
Last updated: December 11, 2008
Last verified: December 2008
  Purpose

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.

Condition Intervention Phase
Frailty
Behavioral: Preventive Primary Care Outreach
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventive Primary Care Outreach for High Risk Older Persons

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Health related quality of life (quality adjusted life years [QALYs]) [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health and social service utilization and costs [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
  • mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • institutionalization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • functional status [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
  • perceived health status [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]

Enrollment: 719
Study Start Date: April 2004
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134836

Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
McMaster University
Ontario Ministry of Health and Long Term Care
Investigators
Principal Investigator: Jenny Ploeg, RN, PhD School of Nursing, Faculty of Health Sciences, McMaster University
  More Information

No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jenny Ploeg, McMaster University
ClinicalTrials.gov Identifier: NCT00134836     History of Changes
Other Study ID Numbers: PHCTF G03-02795
Study First Received: August 23, 2005
Last Updated: December 11, 2008
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on July 29, 2014