Clinical trial NCT01614340: Treating Pain to Reduce Disability Among Older Home Health Patients
Official title: Treating Pain to Reduce Disability Among Older Home Health Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis - Post Surgical
Other Activity-limiting Pain
Keywords: Home care
Cognitive-Behavioral techniques
Physical Therapy
Pain
Older Adults
Lead sponsor: Visiting Nurse Service of New York
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Weill Medical College of Cornell University
name: Ithaca College
name: Cornell University
First posted: 2012-06-07
Enrollment: 658
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall goal of this real-world comparative effectiveness research (CER) study is to reduce disability among older home health patients by treating their pain more effectively. To achieve this goal the investigators will conduct a cluster randomized controlled trial of a physical therapist (PT) delivered intervention provided to VNSNY home health care patients with activity-limiting pain. The intervention is an evidence-based non-pharmacological program to reduce pain and pain-related disability that utilizes cognitive-behavioral pain self-management (CBPSM) techniques.

Detailed description: This project will compare the effectiveness of usual care provided to older home health patients admitted with activity-limiting pain to usual care plus instruction by PTs in CBPSM techniques. The project also will examine differences in the effectiveness of the intervention among different race/ethnicity groups and individuals with different pain types, as well as the fidelity of intervention-group PTs to the CBPSM program.

The specific aims of this CER study that will include sizeable numbers of Hispanics, non-Hispanic African Americans and non-Hispanic white patients ages 55 and older are: (1) to compare the effectiveness of usual care provided to older home health patients admitted with activity-limiting pain to usual care plus instruction by PTs in CBPSM techniques; and (2) to examine the heterogeneity of CBPSM treatment effects among patients with different pain conditions and minority group status.

Eligibility criteria: Inclusion Criteria:

* VNSNY patient in the adult home healthcare program
* Services are being provided in the Bronx, Brooklyn, Manhattan, Queens, Staten Island, Nassau or Westchester
* VNSNY Plan of Care includes physical therapy
* Age 55 or older
* Speaks English
* Has a telephone
* Activity-limiting pain

Exclusion Criteria:

* Significant cognitive impairment

Primary outcomes:
measure: Improvement on Performance-Based Measures of Functioning Among Intervention Patients
timeFrame: Baseline/Intake and 60 day follow up
Secondary outcomes:
measure: Lower Rates of Service Utilization Within Intervention Group
timeFrame: 60 day follow up survey
Other outcomes:
Locations:
city: New York
country: United States
facility: Visiting Nurse Service of New York
state: New York
Study officials:
affiliation: Visiting Nurse Service of New York
name: Christopher M Murtaugh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Cary Reid, MD
role: PRINCIPAL_INVESTIGATOR
References: