African American Preference for Knee Replacement: A Patient-Centered Intervention (ACTION)

September 26, 2019 updated by: University of Pennsylvania

Behavioral & Social Science Research on Understanding and Reducing Health Disparities

A randomized, controlled design will be utilized to examine and compare the effectiveness of the proposed educational intervention, which includes an educational decision aid with attention control on select key patient-centered and process of care outcomes. The study sample will consist of approximately 300 African-American patients with osteoarthritis (OA) of the knee. Patients will be recruited from Pennsylvania Presbyterian Medical Center and the Philadelphia VA Medical Center and will be randomized to one of the two study arms.

The immediate goal of this randomized controlled trial is to assess the effect of a high-quality, evidence-based, patient-centered educational intervention on African American patient preferences, expectations, and the likelihood of receiving a recommendation for knee joint replacement surgery when clinically indicated. The long-term goal of this research is to implement effective strategies to improve minority patients' access to joint replacement and ultimately eliminate racial disparities in the utilization of this effective treatment for knee OA.

Study Aim: To examine the effect of the decision aid (DA) intervention on the likelihood of receiving a recommendation for knee joint replacement when clinically indicated. Hypothesis: The DA intervention will lead to higher rate of treatment recommendation within 6 months.

Secondary Aim: To examine the effect of the DA intervention on the rate of knee replacement receipt within 12 months. Hypothesis: Patients randomized to receive the intervention will undergo knee replacement within 12 months at a higher rate than those in the attention control group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study involves a baseline questionnaire, educational intervention, and follow-up questionnaire by phone 12 months after the intervention takes place. All eligible, consented patients will complete the baseline questionnaire, conducted by an ACTION research staff member. The baseline questionnaire (attached at end of protocol) will include the following instruments that have been field-tested by our team in previous and ongoing studies: 1.) Willingness to Consider Joint Replacement Question 2.)Knowledge Regarding Knee OA and Joint Replacement (developed by The Foundation for Informed Medical Decision Making) 3.) Hospital for Special Surgery Knee Expectations Survey 4.)Socioeconomic Survey 5.) Access to Health Care, Charlson Comorbidity Index 6.) Quality of Life Shortened Form-12v2. This survey can be done over the phone or in person. It should take approximately 30-40 minutes. At the completion of the baseline questionnaire, patients will be randomized into either study Decision Aid (DA) (hereafter referred to as DA intervention) arm or the attention control arm. Patient appointments for the DA intervention or attention control activity will be scheduled to occur 2 weeks prior to the patients appointment with an orthopedic specialist (up to the date of the appointment). The DA intervention (referred to as an information session in patient material) will be completed by an ACTION research study interventionist (the interventionist will not administer the baseline assessment). In the intervention arm, patients will be shown a decision aid video entitled, Treatment Choices for Knee Osteoarthritis. The patients are then given a brief education intervention called AskMe3, which is a brief communication skill-building intervention developed by the Partnership for Clear Health Communication. AskMe3 instructs patients 3 questions to ask their doctor: a) what is my main problem b) what do I need to do c) why is it important for me to do this? The completion time for the educational intervention will be approximately 1 hour. The attention control arm will be conducted by the ACTION research staff. Patients will be given written educational material adapted from the NIH/National Institute of Arthritis and Musculoskeletal and Skin Diseases publication Osteoarthritis to review at his/her leisure. (A copy of the information contained in the informational pamphlet is attached at end of protocol). The completion time for the attention control arm is approximately 10 minutes. Follow-up procedures will occur at the following time points: 1.) approximately 6 months after the participants intervention, an ACTION team staff member will review their medical chart to see if the participant had knee joint replacement surgery 2.)12-months post intervention participants will be contacted to find out if they had knee joint replacement surgery and a medical chart assessment will occur at this time as well. All follow-up procedures will be administered by an ACTION research team member that was not involved in the educational intervention. Participants in both the DA intervention and the attention control will complete a 12-month follow-up (completed approximately 12 months post intervention)survey over the phone. The survey will be comprised of the following: Willingness to consider joint replacement, Hospital for Special Surgery Knee Expectations Survey, Knowledge Regarding Knee OA and Joint Replacement, and a survey regarding surgery for joint replacement. At the time of the 12-month follow-up, the patient's medical record will be accessed to check for a joint replacement procedure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
340

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • African-American patient referred to orthopedic doctor
  • Age 50 or older
  • Presence of knee OA by American College of Rheumatology as evidenced by:
  • Chronic, frequent knee pain based on the NHANES questions.
  • Moderate to severe knee OA based on WOMAC index score 39.
  • Radiographic evidence of knee OA.

Exclusion Criteria:

  • Prior history of any major joint replacement.
  • Terminal Illness (e.g. end stage cancer).
  • Physician diagnosed inflammatory arthritis (i.e., rheumatoid arthritis, connective tissue disease, ankylosing spondylitis, or other seronegative Spondyloarthropathy.)
  • Contra-indications to replacement surgery (e.g., lower extremity paralysis as result of stroke).
  • Prosthetic leg
  • Cognitive impairment (e.g.,dementia)
  • No home telephone service.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Attention control
Subjects randomized to the attention control arm will receive an educational program (an NIH-developed booklet) that summarizes how to live with knee OA but does not specifically mention joint replacement. This booklet provides information about OA, examples of exercises one could do to improve pain and reduce stiffness, types of non-drug pain relief such as massage, and information about various medications. The interventionist will give the participant the booklet and describe what can be found inside. They are also encouraged to ask their doctor any questions they may have about the information in the booklet or questions they may have about their OA. The purpose of this educational program is to provide a tangible clinical incentive to the control group for participating in this additional component of the study.
Experimental: Decision Aid (DA) Intervention
Patients randomized to the DA Intervention will watch a Knee OA Decision Aid (DA) developed by the Foundation for Informed Medical Decision Making and then receive a brief counseling session called "AskMe3." The DA is a video that provides viewers with information about OA, treatment choices such as lifestyle changes, non-drug treatments, medication, injections, complementary therapies, and surgery, as well as the pros and cons of each type of treatment. The AskMe3 is a communication, skill-building intervention, which instructs patients to ask 3 questions to the doctor: 1) What is my main problem? 2) What do I need to do? 3) Why is it important for me to do this?
Behavioral: Decision Aid (DA) Intervention
Patients randomized to the DA Intervention will watch a Knee OA Decision Aid (DA) developed by the Foundation for Informed Medical Decision Making and then receive a brief counseling session called "AskMe3." The DA is a video that provides viewers with information about OA, treatment choices such as lifestyle changes, non-drug treatments, medication, injections, complementary therapies, and surgery, as well as the pros and cons of each type of treatment. The AskMe3 is a communication, skill-building intervention, which instructs patients to ask 3 questions to the doctor: 1) What is my main problem? 2) What do I need to do? 3) Why is it important for me to do this?

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recommendation of knee joint replacement
Time Frame: 6 months after intervention
Recommendation of knee joint replacement 6 months after intervention will be assessed for all patients by chart abstraction.
6 months after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Receipt of knee joint replacement
Time Frame: assessed for all patients 12 months post-intervention
Receipt of knee joint replacement will be assessed for all patients 12 months post-intervention initially through telephone survey and then validated by medical record review.
assessed for all patients 12 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Said A Ibrahim, MD, MPH, University of Pennsylvania
  • Principal Investigator: Gwo-Chin Lee, MD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 8, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5R01AR059615-03 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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