- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01851785
African American Preference for Knee Replacement: A Patient-Centered Intervention (ACTION)
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
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Stati Uniti, 19104
- University of Pennsylvania
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
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
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
Sponsor
Investigatori
- Investigatore principale: Said A Ibrahim, MD, MPH, University of Pennsylvania
- Investigatore principale: Gwo-Chin Lee, MD, University of Pennsylvania
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
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
-
University of GroningenCompletato
Prove cliniche su Decision Aid (DA) Intervention
-
Vanderbilt University Medical CenterAmerican Association for the Study of Liver DiseasesNon ancora reclutamento
-
Mayo ClinicPatient-Centered Outcomes Research Institute; Columbia University; Boston Children... e altri collaboratoriCompletatoFerita alla testaStati Uniti
-
Mayo ClinicCompletato
-
Washington University School of MedicineRobert Wood Johnson FoundationCompletatoCancro alla prostataStati Uniti
-
Emory UniversityNorthwestern University; Columbia University; Satellite Healthcare; Norman S. Coplon...CompletatoInsufficienza renale cronica | Trapianto di rene | Malattia renale allo stadio terminaleStati Uniti
-
Kaiser PermanenteFoundation for Informed Medical Decision MakingCompletatoObesità | Obesità, morboso | Chirurgia bariatrica | Aiuti decisionaliStati Uniti
-
Yale UniversityNational Cancer Institute (NCI)ReclutamentoGeriatria | Aiuto alla decisione | Screening mammograficoStati Uniti
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Attivo, non reclutanteCancro al seno in stadio anatomico I AJCC v8 | Cancro al seno in stadio anatomico IA AJCC v8 | Cancro al seno in stadio anatomico IB AJCC v8 | Cancro al seno in stadio anatomico II AJCC v8 | Cancro al seno in stadio anatomico IIA AJCC v8 | Cancro al seno in stadio anatomico IIB AJCC v8 | Cancro... e altre condizioniStati Uniti
-
Unity Health TorontoCompletato
-
Ottawa Hospital Research InstituteSconosciuto