Treating Pain to Reduce Disability Among Older Home Health Patients
Primary Purpose
Arthritis - Post Surgical, Other Activity-limiting Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Pain Self-management Program
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis - Post Surgical focused on measuring Home care, Cognitive-Behavioral techniques, Physical Therapy, Pain, Older Adults
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
Sites / Locations
- Visiting Nurse Service of New York
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Usual Care
Usual Care Plus Pain Management Program
Arm Description
Usual Physical Therapy Plan of Care
Behavioral: Cognitive-Behavioral Pain Self-management Program.
Outcomes
Primary Outcome Measures
Improvement on Performance-Based Measures of Functioning Among Intervention Patients
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
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).
Full Information
NCT ID
NCT01614340
First Posted
May 22, 2012
Last Updated
August 15, 2018
Sponsor
Visiting Nurse Service of New York
Collaborators
Agency for Healthcare Research and Quality (AHRQ), Weill Medical College of Cornell University, Ithaca College, Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT01614340
Brief Title
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
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Visiting Nurse Service of New York
Collaborators
Agency for Healthcare Research and Quality (AHRQ), Weill Medical College of Cornell University, Ithaca College, Cornell University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis - Post Surgical, Other Activity-limiting Pain
Keywords
Home care, Cognitive-Behavioral techniques, Physical Therapy, Pain, Older Adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
658 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
Other
Arm Description
Usual Physical Therapy Plan of Care
Arm Title
Usual Care Plus Pain Management Program
Arm Type
Other
Arm Description
Behavioral: Cognitive-Behavioral Pain Self-management Program.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Pain Self-management Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement on Performance-Based Measures of Functioning Among Intervention Patients
Description
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.
Time Frame
Baseline/Intake and 60 day follow up
Secondary Outcome Measure Information:
Title
Lower Rates of Service Utilization Within Intervention Group
Description
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).
Time Frame
60 day follow up survey
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher M Murtaugh, PhD
Organizational Affiliation
Visiting Nurse Service of New York
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cary Reid, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Visiting Nurse Service of New York
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5555786
Description
Related Info
Learn more about this trial
Treating Pain to Reduce Disability Among Older Home Health Patients
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