The Effect of the Patient Activation Measure on Chronic Care

Using the Patient Activation Measure (PAM) to Improve Patient Self-Management of Hypertension

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

283

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10001
        • Visiting Nurse Service of New York Center for Home Care Policy & Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes in patients' PAM scores
Time Frame: six months
six months
differences in patients' HTN knowledge
Time Frame: six months
six months
adherence to HTN medication and diet recommendations
Time Frame: six months
six months
average changes in patients' systolic and diastolic BP
Time Frame: six months
six months
percent of patients who maintain BP control, among those with controlled baseline BP
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Linda M Gerber, Ph.D., Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

March 2, 2006

First Submitted That Met QC Criteria

March 2, 2006

First Posted (Estimate)

March 6, 2006

Study Record Updates

Last Update Posted (Estimate)

March 17, 2008

Last Update Submitted That Met QC Criteria

March 12, 2008

Last Verified

May 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 290-00-0013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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