The Perioperative Pain Self-Management Program Trial (PePS)
Primary Purpose
Postoperative Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Perioperative Pain Self-management (PePS)
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain focused on measuring postoperative pain, opioid
Eligibility Criteria
Inclusion Criteria:
- scheduled for total hip, knee, or shoulder joint arthroplasty through the Iowa City, IA, Des Moines, IA, Minneapolis, IA, or Milwaukee WI, VA medical centers
Exclusion Criteria:
- inability to complete study forms/procedures because of a language/literacy barrier
- active bipolar or psychotic disorder
- history of brain injury
- dementia
- CBT therapy within the past year
- lack of access to a telephone for PePS sessions
Sites / Locations
- Iowa City VA Health Care System, Iowa City, IARecruiting
- Minneapolis VA Health Care System, Minneapolis, MNRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PePS
Standard Care
Arm Description
4 sessions of telephone CBT-based pain self-management in addition to standard perioperative care.
Standard perioperative care.
Outcomes
Primary Outcome Measures
Numeric Pain Rating Scale
Surgical Site Pain
The Numeric Rating Scale (NRS) is a 0-10 measure where 0 = no pain.
Secondary Outcome Measures
opioid use
Time to opioid cessation following surgery: daily opioid use will be collected via weekly phone calls for the first 6 weeks post-surgery.
Full Information
NCT ID
NCT04979429
First Posted
July 15, 2021
Last Updated
August 1, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04979429
Brief Title
The Perioperative Pain Self-Management Program Trial
Acronym
PePS
Official Title
Preventing Chronic Post-Surgical Pain and Prolonged Opioid Use: The Perioperative Pain Self-Management Program
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2021 (Actual)
Primary Completion Date
July 30, 2025 (Anticipated)
Study Completion Date
July 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will trial the impact of teaching surgical patients a pain self-management approach to compliment medical post-surgical pain management.
Detailed Description
Surgery can precipitate the development of both chronic pain and long-term opioid use. There is a need for strategies to augment perioperative pharmacotherapeutic management of pain with non-pharmacologic strategies to prevent long-term sequelae. Psychological interventions such as cognitive behavioral therapy (CBT) can effectively reduce distress and improve functioning among patients with chronic pain. While CBT has been used extensively in patients with established chronic pain, it has not been used as a preventive intervention targeting the transition from acute to chronic postsurgical pain. The Perioperative Pain Self-management (PePS) program has the potential to reduce the incidence of chronic post-surgical pain and long-term opioid use among Veterans. This study will: Examine the efficacy of PePS compared to standard care on 6-month pain (primary outcome), mood and functioning outcomes as well as time to post-surgical opioid and other analgesic use cessation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
postoperative pain, opioid
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to either receive the pain self-management sessions (PePS) or standard care (SC).
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will be blinded to randomization status.
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PePS
Arm Type
Experimental
Arm Description
4 sessions of telephone CBT-based pain self-management in addition to standard perioperative care.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Standard perioperative care.
Intervention Type
Behavioral
Intervention Name(s)
Perioperative Pain Self-management (PePS)
Other Intervention Name(s)
PePS
Intervention Description
4 sessions of telephone CBT-based pain self-management.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
Surgical Site Pain
The Numeric Rating Scale (NRS) is a 0-10 measure where 0 = no pain.
Time Frame
6-months post-surgery
Secondary Outcome Measure Information:
Title
opioid use
Description
Time to opioid cessation following surgery: daily opioid use will be collected via weekly phone calls for the first 6 weeks post-surgery.
Time Frame
time to cessation post surgery (weekly phone calls for the first 6 weeks)
Other Pre-specified Outcome Measures:
Title
Patient Health Questionnaire 8-item version (PHQ-8)
Description
A measure of depressive symptoms. Scores range from 0-24 with higher scores indicating more depressive symptoms.
Time Frame
Change between pre-surgery and 6-months post-surgery
Title
General Anxiety Disorder Scale: 7-item (GAD-7)
Description
A measure of anxious symptoms. Scores range from 0-21 with higher scores indicating more anxious symptoms.
Time Frame
Change between pre-surgery and 6-months post-surgery
Title
Pain Disability Index (PDI)
Description
A measure of pain-related functioning. Scores range from 0-70 with higher scores indicating greater pain-related disability.
Time Frame
Change between pre-surgery and 6-months post-surgery
Title
Brief pain inventory
Description
Generalized body pain intensity and pain interference. Scores range from 0-10 with higher scores indicating more pain severity and interference.
Time Frame
6 months post-surgery
Title
Other analgesic use
Description
Time to cessation of other analgesics following surgery: daily analgesic use will be collected via weekly phone calls for the first 6 weeks post-surgery.
Time Frame
time to cessation post-surgery (weekly phone calls for the first 6 weeks post-surgery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
scheduled for total hip, knee, or shoulder joint arthroplasty through the Iowa City, IA, Des Moines, IA, Minneapolis, IA, or Milwaukee WI, VA medical centers
Exclusion Criteria:
inability to complete study forms/procedures because of a language/literacy barrier
active bipolar or psychotic disorder
history of brain injury
dementia
CBT therapy within the past year
lack of access to a telephone for PePS sessions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine E Hadlandsmyth, PhD MA MS
Phone
(319) 594-1885
Email
Katherine.Hadlandsmyth@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Hilary J Mosher, MD MFA BA
Phone
(319) 338-0581
Ext
6100
Email
Hilary.mosher@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine E Hadlandsmyth, PhD MA MS
Organizational Affiliation
Iowa City VA Health Care System, Iowa City, IA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hilary J Mosher, MD MFA BA
Organizational Affiliation
Iowa City VA Health Care System, Iowa City, IA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iowa City VA Health Care System, Iowa City, IA
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246-2292
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Myrvik
Phone
319-339-7151
Email
Michele.Myrvik@va.gov
First Name & Middle Initial & Last Name & Degree
Hilary J Mosher, MD MFA BA
First Name & Middle Initial & Last Name & Degree
Katherine E Hadlandsmyth, PhD MA MS
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417-2309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana J Burgess, PhD
Phone
612-467-1591
Email
diana.burgess@va.gov
First Name & Middle Initial & Last Name & Degree
Diana J. Burgess, PhD
First Name & Middle Initial & Last Name & Degree
Joshua D Miller
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35660486
Citation
Hadlandsmyth K, Burgess DJ, Leparski RF, Odom AS, Campbell EJ, Obrecht AA, Adamowicz JL, Cho H, Steffensmeier KS, Johnson NL, Richards CC, Vander Weg MW, Lund BC, Yoon P, Mosher HJ. The Perioperative Pain Self-Management (PePS) randomized controlled trial protocol: Preventing chronic post-surgical pain and prolonged opioid use. Contemp Clin Trials. 2022 Jul;118:106810. doi: 10.1016/j.cct.2022.106810. Epub 2022 May 31.
Results Reference
result
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The Perioperative Pain Self-Management Program Trial
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