- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07925710
Osteoarthritis Care Tools for Primary Care Providers in Family Medicine and Geriatrics Clinics
OACareTools PLUS (OACareTools Primary Care-Led Usability & Scalability Study): Aim 3 Implementation and Evaluation
The purpose of this study is to test the implementation of OACareTools+, a program designed to help healthcare providers connect adults with arthritis to physical activity programs. OACareTools+ includes provider training, patient resources, and tools to make referrals easier. The goal is to increase awareness of programs like Walk With Ease and help more people with arthritis participate in them.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants will be clinicians (n= 165) in geriatrics and family medicine clinics and a subset of patients (n=30). The study team will deliver education and resources to providers in a training session about Walk With Ease. After the provider training, providers will use the study resources to refer patients with arthritis to Walk With Ease. Healthcare provider participants will complete surveys after their first referral and at the end of the study (12-months). Patient participants who are referred to Walk With Ease through the OACareTools+ intervention will be invited to participate in interviews about their experience (6-weeks) with the referral process. Primary endpoints of the study will be 1) number of healthcare providers that referred patients to Walk With Ease 2) number of Walk With Ease patient participants 3) healthcare provider acceptability and feasibility 4) patient acceptability of the intervention.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Katie Huffman
- Phone Number: 919-962-5145
- Email: katie_huffman@med.unc.edu
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC Thurston Arthritis Research Center
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Contact:
- Katie Huffman
- Phone Number: 919-962-5145
- Email: katie_huffman@med.unc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthcare provider participants: currently a healthcare provider or staff person in the UNC study clinics (Geriatrics and Family Medicine)
- Patient participants: 18 years or older; received a referral to Walk With Ease from a provider at a UNC study clinic or used clinic flyers to register for Walk with Ease and agreed to participate in the phone interview on the post-Walk With Ease evaluation form
Exclusion Criteria:
- Both: non-English speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healthcare providers
Healthcare providers will receive the intervention, OACareTools+, which involves a training session on, patient resources about, and provider referral to Walk With Ease. |
OACareTools+ is a healthcare provider intervention that combines healthcare provider education, customized patient and clinical resources, and technical support from a national organization to facilitate provider counseling on and referral to as well as patient engagement in Walk With Ease. There are 2 main parts to this intervention: 1) Healthcare provider education: The study team will deliver the provider education and resources (including information about Walk With Ease and the established referral process/smartphrase) in live and recorded presentations and in follow-up emails. 2) Implementation: Providers will use the resources to briefly counsel patients about physical activity and Walk With Ease and use the smartphrase to refer patients to Walk With Ease. Patients will register for and participate in the online Walk With Ease program. Patients and providers can seek assistance from the national organization as needed during these processes.
Other Names:
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Experimental: Patients
A subset of patients who are referred through OACareTools+ to Walk With Ease will provide feedback on their experience with the referral process to Walk With Ease. |
OACareTools+ is a healthcare provider intervention that combines healthcare provider education, customized patient and clinical resources, and technical support from a national organization to facilitate provider counseling on and referral to as well as patient engagement in Walk With Ease. There are 2 main parts to this intervention: 1) Healthcare provider education: The study team will deliver the provider education and resources (including information about Walk With Ease and the established referral process/smartphrase) in live and recorded presentations and in follow-up emails. 2) Implementation: Providers will use the resources to briefly counsel patients about physical activity and Walk With Ease and use the smartphrase to refer patients to Walk With Ease. Patients will register for and participate in the online Walk With Ease program. Patients and providers can seek assistance from the national organization as needed during these processes.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthcare provider acceptability
Time Frame: Measure collected up to 2 months after provider's first referral
|
The Acceptability of Intervention Measure is a measure of implementation outcomes, including 4 items ranked on a Likert scale of 1 (completely disagree) to 5 (completely agree), with a summed total ranging from 4-20 where higher scores indicate greater acceptability; measured via electronic survey. |
Measure collected up to 2 months after provider's first referral
|
|
Healthcare provider feasibility
Time Frame: Measure collected up to 2 months after provider's first referral
|
The Feasibility of Intervention Measure is a measure of implementation outcomes, including 4 items ranked on a Likert scale of 1 (completely disagree) to 5 (completely agree), with a summed total ranging from 4-20 where higher scores indicate greater feasibility; measured via electronic survey. |
Measure collected up to 2 months after provider's first referral
|
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Patient acceptability
Time Frame: 6-weeks post- Walk With Ease registration
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The Acceptability of Intervention Measure is a measure of implementation outcomes, including 4 items ranked on a Likert scale of 1 (completely disagree) to 5 (completely agree), with a summed total ranging from 4-20 where higher scores indicate greater acceptability; measured via telephone interview. |
6-weeks post- Walk With Ease registration
|
|
Patient usefulness: clinician referral to Walk With Ease
Time Frame: 6-weeks post- Walk With Ease registration
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During a phone interview, patients will be asked, "How helpful was it to talk with healthcare provider about physical activity and Walk With Ease?" They will be asked to use a scale, 0-10, where 0 is not helpful at all and 10 is extremely helpful. Higher scores indicate greater levels of helpfulness. |
6-weeks post- Walk With Ease registration
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|
Number of healthcare providers who referred patients
Time Frame: 12 months
|
Healthcare providers in the study clinics who refer patients to the Walk With Ease program using the study referral process and resources |
12 months
|
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Number of patients who registered for Walk with Ease
Time Frame: 12 months
|
Patients from the study clinics who register in the Walk With Ease program |
12 months
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Patient usefulness: educational resources
Time Frame: 6-weeks post-Walk with Ease registration
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During a phone interview, patients will be asked, "How helpful were the education materials given to you by your healthcare provider?" They will be asked to use a scale, 0-10, where 0 is not helpful at all and 10 is extremely helpful. Higher scores indicate greater levels of helpfulness. |
6-weeks post-Walk with Ease registration
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Leigh Callahan, PhD, UNC Thurston Arthritis Research Center
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26-2715
- 1U48DP006837-01 (U.S. NIH Grant/Contract)
- 1 U48DP006837-01-03 (Other Grant/Funding Number: Centers for Disease Control and Prevention)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Deidentified individual data that support the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC. Data collected include: pre/post walking program assessments, referral count, patient engagement metrics, arthritis outcomes, satisfaction (provider and patient). Qualitative data will be available in the form of a summary.
IPD Sharing Time Frame
Beginning 9 and continuing for 36 months following publication.
IPD Sharing Access Criteria
Approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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