- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01134887
Controlling Hypertension Outcomes by Improved Communication & Engagement (CHOICE)
Controlling Hypertension Outcomes by Improved Communication & Engagement (CHOICE)
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
The communication intervention had two goals; (a) coaching to enhance veteran's abilities to communicate their questions and concerns about self-management for hypertension to their physician; and (b) improving provider's communication skills for enhancing and encouraging self-management of hypertension.
A health educator met with each participating veteran in the intervention arm prior to the 2nd visit to develop a plan for enhancing communication about self-management of hypertension.
The PI provided the Four Habits communication training to the 5 primary care providers in the intervention arm. Two clinic visits between each participating provider-patient pair were videotaped and coded.
This project had a goal of enrolling 10 VA primary care providers to participate in the randomized control trial and 30 veterans (3 veterans from the panel of each of the 10 participating providers) who had a stroke and now demonstrated poorly controlled hypertension. The study evaluated the difference between the two groups, and compared the content of the provider-patient conversations around hypertension management.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Indiana
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Indianapolis, Indiana, Stati Uniti, 46202-2884
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
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Indianapolis, Indiana, Stati Uniti, 46202-2884
- Richard Roudebush VA Medical Center, Indianapolis
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Veteran:
- Veteran is a patient of the enrolled provider
- History of prior stroke
- Poorly controlled hypertension with at least one measurement >140/90 mm Hg in the past 12 months
- Complete a 6-item screen for cognitive and language impairment with a score of 3 or higher
- Sign the VA Media consent for use of picture and/or voice
Provider:
- Primary care provider, Medicine Service
- Sign VA media consent for use of picture and/or voice
Exclusion Criteria:
- Life expectancy is less than 6 months
- Non-English language patients
- Inability to provide informed consent
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Arm 1: Intervention-Veterans
Veterans enrolled in the "Intervention-Veterans" arm received a copy of the NIA guide for "Talking with Your Doctor" [Informational Guide for Patients].
Just prior to their next scheduled visit an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor [Educational Coaching].
To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit.
The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management.
|
Veterans received a copy of the NIA guide for "Talking with Your Doctor".
This pamphlet was specifically developed for this purpose (updated in 2002).
It has pictorials and is written at an 8th grade level.
an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor [Coaching].
To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit.
The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management.
|
Comparatore attivo: Arm 2: Control-Veterans
Veterans enrolled in the "Control-Veterans" arm received a copy of the NIA guide for "Talking with Your Doctor" [Informational Guide for Patients].
This pamphlet was specifically developed for this purpose (updated in 2002).
It has pictorials and is written at an 8th grade level.
|
Veterans received a copy of the NIA guide for "Talking with Your Doctor".
This pamphlet was specifically developed for this purpose (updated in 2002).
It has pictorials and is written at an 8th grade level.
|
Sperimentale: Arm 3: Intervention-Physicians
Primary care providers randomly assigned to the "Intervention-Physicians" arm of this study received a copy of the Four Habits of Highly Effective Physicians [Monograph for Physicians].
The Four Habits provided practical evidence-based advice for improving patient-physician communication.
Second, physicians participated in an audiotaped intensive 30 minute, one-on-one educational intervention with PI Frankel after their first set of visits from their three participating patients [Video-Assisted Coaching], but before seeing them for follow-ups.
The main goal of this meeting was to review and discuss the analysis of the physician's videotaped visits using the Four Habits framework, with a particular focus on improving communication about self-management.
|
Physicians participated in an audiotaped intensive 30 minute, one-on-one educational intervention with PI Frankel after their first set of visits from their three participating patients, but before seeing them for follow-ups.
The main goal of this video-assisted coaching session was to review and discuss the analysis of the physician's videotaped visits using the Four Habits framework, with a particular focus on improving communication about self-management.
Primary care providers randomly assigned to the "Intervention-Physicians" arm of this study received a copy of the Four Habits of Highly Effective Physicians.
The Four Habits provided practical evidence-based advice for improving patient-physician communication.
|
Comparatore attivo: Arm 4: Control-Physicians
Primary care providers randomly assigned to the "Control-Physicians" arm of the study did not receive coaching or additional resources, and conducted their primary care practice as usual [Control].
|
The primary care providers randomly assigned to the "Control-Physicians" arm did not receive any additional coaching or resources and conducted their practice as usual.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Patient Activation Measure
Lasso di tempo: 12 months
|
Veteran self-management of hypertension measured via the 13-item, (0-100 point range), Patient Activation Measure (PAM).
Administered at baseline (1st visit) and after each additional follow-up visit during the next 12-months (+2 max).
Rasch conversion changed raw scores to the PAM interval measure.
Reported outcome is difference in mean PAM scores at baseline and during 12-month follow-up.
If a participant had two PAM scores during the follow-up period, the average of the two was taken to calculate a combined follow-up score.
Higher PAM scores represent higher levels of self-activation.
Research on the PAM measure indicates that each point increase in PAM score correlates to a 2% decrease in hospitalization and a 2% increase in medication adherence.
Ranges for Baseline PAM scores: Intervention = 46.1 (min) to 84.3 (max); Control = 43.2
(min) to 77 (max).
Ranges for Follow-up PAM scores: Intervention = 48.4
(min) to 100 (max); Control = 45.1 (min) to 80.1 (max).
|
12 months
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Richard M. Frankel, PhD, Richard L. Roudebush VA Medical Center, Indianapolis, IN
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Primo inviato che soddisfa i criteri di controllo qualità
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Aggiornamenti dei record di studio
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RRP 09-190
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