Treating Pain to Reduce Disability Among Older Home Health Patients - Full Text View

Purpose

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.

Condition	Intervention
Arthritis - Post Surgical Other Activity-limiting Pain	Behavioral: Cognitive-Behavioral Pain Self-management Program

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Official Title:	Treating Pain to Reduce Disability Among Older Home Health Patients

Further study details as provided by Visiting Nurse Service of New York:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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).

Estimated Enrollment:	550
Study Start Date:	October 2012
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Usual Care Usual Physical Therapy Plan of Care	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 Plus Pain Management Program Behavioral: Cognitive-Behavioral Pain Self-management Program.	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.

Arms

Assigned Interventions

Usual Care

Usual Physical Therapy Plan of Care

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 Plus Pain Management Program

Behavioral: Cognitive-Behavioral Pain Self-management Program.

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.

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

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614340

Locations

United States, New York
Visiting Nurse Service of New York	Recruiting
New York, New York, United States, 10001
Contact: Melissa Trachtenberg, BA 212-760-3112 melissa.trachtenberg@vnsny.org
Contact: Christopher M Murtaugh, PhD 212-609-5777 christopher.murtaugh@vnsny.org
Principal Investigator: Christopher M Murtaugh, PhD

Sponsors and Collaborators

Visiting Nurse Service of New York

Agency for Healthcare Research and Quality (AHRQ)

Weill Medical College of Cornell University

Ithaca College

Cornell University

Investigators

Principal Investigator:	Christopher M Murtaugh, PhD	Visiting Nurse Service of New York
Principal Investigator:	Cary Reid, MD	Weill Medical College of Cornell University

More Information

No publications provided

Responsible Party:	Visiting Nurse Service of New York
ClinicalTrials.gov Identifier:	NCT01614340 History of Changes
Other Study ID Numbers:	1R01HS020648 - 01A1
Study First Received:	May 22, 2012
Last Updated:	November 26, 2012
Health Authority:	United States: Institutional Review Board United States: Federal Government

Keywords provided by Visiting Nurse Service of New York:

Home care
Cognitive-Behavioral techniques
Physical Therapy
Pain
Older Adults

Additional relevant MeSH terms:

Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 19, 2013