The Effect of the Patient Activation Measure on Chronic Care

This study has been completed.
Sponsor:
Collaborator:
Visiting Nurse Service of New York
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00299468
First received: March 2, 2006
Last updated: March 12, 2008
Last verified: May 2006
  Purpose

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 Intervention Phase
Hypertension
Behavioral: Patient Activation Measure Intervention Package
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Using the Patient Activation Measure (PAM) to Improve Patient Self-Management of Hypertension

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • changes in patients' PAM scores [ Time Frame: six months ] [ Designated as safety issue: No ]
  • differences in patients' HTN knowledge [ Time Frame: six months ] [ Designated as safety issue: No ]
  • adherence to HTN medication and diet recommendations [ Time Frame: six months ] [ Designated as safety issue: No ]
  • average changes in patients' systolic and diastolic BP [ Time Frame: six months ] [ Designated as safety issue: No ]
  • percent of patients who maintain BP control, among those with controlled baseline BP [ Time Frame: six months ] [ Designated as safety issue: No ]

Enrollment: 283
Study Start Date: April 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00299468

Locations
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
Investigators
Principal Investigator: Linda M Gerber, Ph.D. Weill Medical College of Cornell University
  More Information

Additional Information:
No publications provided

Responsible Party: Linda Gerber, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00299468     History of Changes
Other Study ID Numbers: 290-00-0013
Study First Received: March 2, 2006
Last Updated: March 12, 2008
Health Authority: United States: Federal Government

Keywords provided by Weill Medical College of Cornell University:
hypertension
home care
patient activation
stages-of-change

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014