Clinical trial NCT00299468: The Effect of the Patient Activation Measure on Chronic Care
Official title: Using the Patient Activation Measure (PAM) to Improve Patient Self-Management of Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Keywords: hypertension
home care
patient activation
stages-of-change
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Visiting Nurse Service of New York
First posted: 2006-03-06
Enrollment: 283
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: changes in patients' PAM scores
timeFrame: six months
measure: differences in patients' HTN knowledge
timeFrame: six months
measure: adherence to HTN medication and diet recommendations
timeFrame: six months
measure: average changes in patients' systolic and diastolic BP
timeFrame: six months
measure: percent of patients who maintain BP control, among those with controlled baseline BP
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Visiting Nurse Service of New York Center for Home Care Policy & Research
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Linda M Gerber, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: