Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

26 settembre 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

340

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • University of Pennsylvania

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

50 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: 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.
Sperimentale: 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?
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?

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Recommendation of knee joint replacement
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Receipt of knee joint replacement
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Said A Ibrahim, MD, MPH, University of Pennsylvania
  • Investigatore principale: Gwo-Chin Lee, MD, University of Pennsylvania

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2010

Completamento primario (Effettivo)

1 maggio 2015

Completamento dello studio (Effettivo)

8 luglio 2019

Date di iscrizione allo studio

Primo inviato

8 maggio 2013

Primo inviato che soddisfa i criteri di controllo qualità

8 maggio 2013

Primo Inserito (Stima)

10 maggio 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 ottobre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 settembre 2019

Ultimo verificato

1 settembre 2019

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 5R01AR059615-03 (Sovvenzione/contratto NIH degli Stati Uniti)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Artrosi al ginocchio

Prove cliniche su Decision Aid (DA) Intervention

Sottoscrivi