Treating Pain to Reduce Disability Among Older Home Health Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Visiting Nurse Service of New York
Sponsor:
Collaborators:
Weill Medical College of Cornell University
Ithaca College
Cornell University
Information provided by (Responsible Party):
Visiting Nurse Service of New York
ClinicalTrials.gov Identifier:
NCT01614340
First received: May 22, 2012
Last updated: January 13, 2014
Last verified: January 2014

May 22, 2012
January 13, 2014
October 2012
April 2014   (final data collection date for primary outcome measure)
Improvement on Performance-Based Measures of Functioning Among Intervention Patients [ Time Frame: Baseline/Intake and 60 day follow up ] [ Designated as safety issue: No ]
Patients receiving usual care plus the intervention when compared with participants receiving usual care only will demonstrate (1) Significantly better results as measured by the Timed Up and Go test; Timed Chair Stands, and Timed Foot Taps test;(2) Significantly better ADL functioning;(3) Significantly reduced levels of pain-related disability as measured by the Roland Morris Disability Questionnaire; and (4) Significantly reduced levels of pain intensity and increased levels of pain relief as measured by the Brief Pain Inventory.
Same as current
Complete list of historical versions of study NCT01614340 on ClinicalTrials.gov Archive Site
Lower Rates of Service Utilization Within Intervention Group [ Time Frame: 60 day follow up survey ] [ Designated as safety issue: No ]
Patients receiving the intervention plus usual care when compared to patients receiving usual care only will demonstrate significantly lower emergency department and hospital use during the follow-up period (as reported by the patient).
Same as current
Not Provided
Not Provided
 
Treating Pain to Reduce Disability Among Older Home Health Patients
Treating Pain to Reduce Disability Among Older Home Health Patients

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Arthritis - Post Surgical
  • Other Activity-limiting Pain
Behavioral: Cognitive-Behavioral Pain Self-management Program
The main study intervention is training of the PTs on teams randomized into the intervention group in the evidence-based CBPSM program which has been translated for use in home health care with patients who have activity-limiting pain. The program is designed to be implemented in a manner that allows for maximal integration into routine PT care of home health patients. This will be possible because the CBPSM techniques, together with exercise and other PT techniques that constitute customary PT care, are reciprocally reinforcing. Both treatments (CBPSM and PT) encourage the use of similar behavioral and pain self-management coping skills to enhance behavioral activation, perceptions of self-efficacy, self-control, and personal mastery with regard to the management of pain.
  • Usual Care
    Usual Physical Therapy Plan of Care
    Intervention: Behavioral: Cognitive-Behavioral Pain Self-management Program
  • Usual Care Plus Pain Management Program
    Behavioral: Cognitive-Behavioral Pain Self-management Program.
    Intervention: Behavioral: Cognitive-Behavioral Pain Self-management Program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
550
June 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
55 Years and older
No
United States
 
NCT01614340
1R01HS020648 - 01A1
Yes
Visiting Nurse Service of New York
Visiting Nurse Service of New York
  • Agency for Healthcare Research and Quality (AHRQ)
  • Weill Medical College of Cornell University
  • Ithaca College
  • Cornell University
Principal Investigator: Christopher M Murtaugh, PhD Visiting Nurse Service of New York
Principal Investigator: Cary Reid, MD Weill Medical College of Cornell University
Visiting Nurse Service of New York
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP