The Effect of the Patient Activation Measure on Chronic Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00299468
Recruitment Status : Completed
First Posted : March 6, 2006
Last Update Posted : March 17, 2008
Visiting Nurse Service of New York
Information provided by:
Weill Medical College of Cornell University

Brief Summary:
We will test - in a chronically ill managed long term care population - the effectiveness of an intervention that provides nurse Care Managers with an inventory of evidence-based practices tailored to patients with different levels of knowledge, skills and confidence to engage in self-care management. Specifically, we will develop a "change package" of evidence-based hypertension (HTN) management strategies geared to patients scoring at the four different stages of activation on the Patient Activation Measure (PAM). We will randomly assign a group of interdisciplinary teams in the managed long-term care plan to intervention or control status and will train the Care Managers on the Intervention teams to use the change package in conjunction with a patient's PAM score to design - with the involvement of the patient - an individualized HTN management plan. We then will assess the impact of the intervention on patient activation and outcomes.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Patient Activation Measure Intervention Package Phase 1

Detailed Description:

The three main aims of the project are to:

  1. Determine whether the PAM-driven intervention increases patients' knowledge and self-management skills, measured by both generic PAM scores and HTN-specific measures developed by the research team.
  2. Determine whether the PAM-driven intervention improves HTN patients' systolic and diastolic blood pressure (BP), measured in three ways:

    • Average percent reduction in systolic and diastolic BP.
    • Percent of patients who achieve BP control (defined as <140 systolic and <90 diastolic BP or <130 systolic and <80 diastolic for patients with diabetes or renal disease).
    • Percent of patients with controlled HTN who maintain control.
  3. Conduct an analysis to examine implementation of the intervention by trainers and Care Managers in the Intervention group and to understand the barriers and facilitators affecting the implementation process.

    In addition, we will conduct a feasibility study with a subset of Care Managers to determine how the Visual Scan Assessment of Patient Activation might be incorporated into routine assessment and care planning procedures. Therefore, the fourth aim of the project is to:

  4. Assess the feasibility and perceived usefulness of the Visual Scan Assessment as a tool to increase feedback to Care Managers on how well they are supporting patient self-care management.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 283 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Using the Patient Activation Measure (PAM) to Improve Patient Self-Management of Hypertension
Study Start Date : April 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Primary Outcome Measures :
  1. changes in patients' PAM scores [ Time Frame: six months ]
  2. differences in patients' HTN knowledge [ Time Frame: six months ]
  3. adherence to HTN medication and diet recommendations [ Time Frame: six months ]
  4. average changes in patients' systolic and diastolic BP [ Time Frame: six months ]
  5. percent of patients who maintain BP control, among those with controlled baseline BP [ Time Frame: six months ]

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • active VNS CHOICE patient on one of the 22 Intervention or Control teams at the start of the intervention period,
  • in care for less than or equal to 730 days,
  • a formal diagnosis of HTN (using appropriate ICD codes recorded in the patient record), and
  • English speaking.

Exclusion Criteria:

  • moderate or severe cognitive impairment as measured by a six-item short portable mental status assessment
  • organic brain disease dx in as one of the top 5 dx as measured by information in OASIS, the uniform home care assessment instrument mandated by the Centers for Medicare and Medicaid Services
  • End Stage Renal disease dx as one of the top 5 dx as measured by information in OASIS

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00299468

United States, New York
Visiting Nurse Service of New York Center for Home Care Policy & Research
New York, New York, United States, 10001
Sponsors and Collaborators
Weill Medical College of Cornell University
Visiting Nurse Service of New York
Principal Investigator: Linda M Gerber, Ph.D. Weill Medical College of Cornell University

Additional Information:
Responsible Party: Linda Gerber, Weill Medical College of Cornell University Identifier: NCT00299468     History of Changes
Other Study ID Numbers: 290-00-0013
First Posted: March 6, 2006    Key Record Dates
Last Update Posted: March 17, 2008
Last Verified: May 2006

Keywords provided by Weill Medical College of Cornell University:
home care
patient activation

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases