Controlling Hypertension Outcomes by Improved Communication & Engagement (CHOICE)
maanantai 26. kesäkuuta 2017 päivittänyt: VA Office of Research and Development
Controlling Hypertension Outcomes by Improved Communication & Engagement (CHOICE)
This randomized control study tested the feasibility of two communication enhancement interventions: one with veterans who had a stroke and demonstrated poorly controlled hypertension; the other with VA primary care providers who provided routine outpatient medical care to these veterans.
This study intervened with both members of the provider-patient dyad in an attempt to improve the self-management of hypertension by improving communication during visits to the VA outpatient clinic, specifically by enabling veterans to communicate their questions and concerns about chronic disease self-management to their providers more effectively, and to help providers improve their ability to communicate more effectively with this population of veterans.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
26
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
-
Indiana
-
Indianapolis, Indiana, Yhdysvallat, 46202-2884
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
-
Indianapolis, Indiana, Yhdysvallat, 46202-2884
- Richard Roudebush VA Medical Center, Indianapolis
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 99 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
|
Active Comparator: 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.
|
|
Kokeellinen: 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.
|
|
Active Comparator: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Patient Activation Measure
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Tutkijat
- Päätutkija: Richard M. Frankel, PhD, Richard L. Roudebush VA Medical Center, Indianapolis, IN
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Tiistai 1. syyskuuta 2009
Ensisijainen valmistuminen (Todellinen)
Sunnuntai 30. syyskuuta 2012
Opintojen valmistuminen (Todellinen)
Maanantai 30. tammikuuta 2017
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Perjantai 28. toukokuuta 2010
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Tiistai 1. kesäkuuta 2010
Ensimmäinen Lähetetty (Arvio)
Keskiviikko 2. kesäkuuta 2010
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Tiistai 1. elokuuta 2017
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 26. kesäkuuta 2017
Viimeksi vahvistettu
Torstai 1. kesäkuuta 2017
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- RRP 09-190
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
EI
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Yhdysvalloissa valmistettu ja sieltä viety tuote
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .