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Titrated Disease Management for Patients With Hypertension (TDM)

4. září 2018 aktualizováno: VA Office of Research and Development

Randomized Trial of Titrated Disease Management for Patients With Hypertension

This randomized clinical trial examines whether programs aimed at matching resources to patient hypertension (i.e. high blood pressure) control lead to greater reduction in systolic blood pressure (top number of blood pressure reading) than simply having maintenance phone calls in addition to usual care. Answering this question will provide important evidence concerning the overall goal of sustained long-term implementation of the disease management programs as part of patient aligned care teams in the Veterans Affairs and other healthcare systems.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Project Objectives: The investigators are conducting a two-arm 18-month randomized clinical trial for patients with pharmaceutically treated hypertension for which systolic BP is not controlled (>/=140 mmHg for non-diabetic or >/=130 mmHg for diabetic patients). The primary aim will be to compare two treatment arms/strategies in terms of impact on systolic BP control: Arm 1 - An intervention arm using titrated disease management in which patients' hypertension control, assessed at baseline, 6 and 12 months, will be used to decide the resource intensity of strategies: 1) Medium/level 1 resource intensity strategy: a registered nurse will provide monthly tailored behavioral support telephone calls + home BP monitoring; 2) High/level 2 resource intensity strategy: a pharmacist will provide monthly tailored behavioral support telephone calls + home BP monitoring + pharmacist-directed medication management; and 3) Booster (low) resource intensity strategy: a license practice nurse (LPN) will provide bi-monthly, non-tailored behavioral support telephone calls to patients whose systolic BP comes under control. Arm 2 - A control arm, in which an LPN will provide bi-monthly non-tailored behavioral support telephone calls (same procedures as the booster (low) resource intensity strategy component of the titrated intervention).

Typ studie

Intervenční

Zápis (Aktuální)

385

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • North Carolina
      • Durham, North Carolina, Spojené státy, 27705
        • Durham VA Medical Center, Durham, NC

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Age >= 18 years.
  • Assigned primary care provider in one of the clinics of the Durham VA Medical Center (VAMC) (including Community Based Outpatient Clinics for example - Hillandale Clinic and Greenville (CBOC)).
  • Had at least 1 primary care visit at the Durham VA or affiliated CBOC in the last year.
  • Diagnosis of hypertension requiring medication, as determined by: ICD 401.0, 401.1, or 401.9 for >= 2 outpatient encounters during the prior year and Received a prescription for at least 1 of the following classes of hypertensive medication in the previous year: 1) ACE inhibitors; 2) alpha blockers; 3) angiogenesis II inhibitors; 4) beta blockers; 5) calcium channel blockers; 6) diuretics; 7) antihypertensive combination; and/or 8) antihypertensives, other.
  • Out of control systolic blood pressure: Durham VAMC (including CBOCs or other affiliated clinics captured in the Durham VAMC electronic health record) outpatient BP measurements >= 150 mmHg for non-diabetic or >= 140 mmHg for diabetic patients over the last year and last systolic BP measurement >= 140 mmHg for non-diabetic or >= 130 mmHg for diabetic patients. If additional patients need to be approached to be offered the opportunity for further screening, non-diabetic patients with mean outpatient systolic BP of >= 140 mmHg or diabetic patients with mean outpatient systolic BP of >= 130 mmHg over the past year may be approached.

Patients must indicate that they both:

  • Have a VA or affiliated clinic provider that they consider to be their main PCP.
  • Receive the majority of healthcare at the Durham VA Medical Center (or affiliated clinic - such as Hillandale or Greenville).

Exclusion Criteria:

  • Active diagnosis of psychosis.
  • Diagnosis of metastatic cancer.
  • Type 1 diabetes
  • Class IV congestive heart failure (CHF).
  • Currently receiving kidney dialysis or if estimated glomerular filtration rate (eGFR) levels are <= 15.
  • Chronic obstructive pulmonary disease (COPD) requiring oxygen.
  • Resident in nursing home or receiving home healthcare.
  • Patient is pregnant or reports planning to become pregnant in the next two years
  • At the time of potential enrollment, participating in another ongoing hypertension, diabetes, cholesterol, or cardiovascular disease clinical trial.
  • Planning to leave the area prior to the anticipated end of participation.
  • Inability or unwillingness to come to the Durham VAMC or affiliated clinic such as Hillandale or Greenville for baseline-, 6-, 12-, and 18-month study visits.
  • Does not have reasonable access to a telephone.
  • Does not speak English.
  • Severely impaired hearing or speech (Patients must be able to respond to phone calls.).
  • Severely impaired vision (Patients must be able to read mailed material).
  • Refusal or inability to provide informed consent and HIPAA authorization form.
  • Arm size > 50 cm
  • Unable to obtain (including by arm) valid blood pressure readings
  • Inadequate mental status to complete the protocol, as judged by five or more errors on the Short Portable Mental Status Questionnaire (SPMSQ).
  • Former, current or pending solid organ or bone marrow transplant patient.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Titration Intervention

The intervention arm includes three levels of resource intensity targeted to improve patients' systolic blood pressure (SBP) [top number of blood pressure measurement].

Medium/level 1 resource intensity: a registered nurse (RN) will provide monthly tailored behavioral support telephone calls + home BP monitoring.

High/level 2 resource intensity: a pharmacist will provide monthly tailored behavioral support telephone calls + home BP monitoring + pharmacist-directed medication management.

Booster (low) resource intensity: a licensed practical nurse (LPN) will provide non-tailored behavioral support telephone calls every two months to patients whose SBP comes under control.
Behaviorální: Booster/ low resource
A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months.
Ostatní jména:
  • Intervention Arm - Booster
Behaviorální: Medium/Level 1 resource intensity
Monthly tailored RN delivered calls + home BP monitoring.
Ostatní jména:
  • Intervention Arm - Level 1
Behaviorální: High/Level 2 resource intensity
Pharmacist delivered telephone behavioral self-management support + Home BP monitoring with feedback to pharmacist + Algorithmic medication changes directed by pharmacist (with physician backup).
Ostatní jména:
  • Intervention Arm - Level 2
Aktivní komparátor: LPN Control
A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months (identical to booster (low) resource intensity component of the titrated intervention). The control arm will utilize the same procedures as the booster level for intervention patients for whom SBP comes under control.
Behaviorální: Booster/ low resource
A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months.
Ostatní jména:
  • Intervention Arm - Booster

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Systolic Blood Pressure
Časové okno: Baseline
Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the baseline study visits.
Baseline
Systolic Blood Pressure
Časové okno: 6 months
Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the 6- month study visits.
6 months
Systolic Blood Pressure
Časové okno: 12 months
Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the12-month study visits.
12 months
Systolic Blood Pressure
Časové okno: 18 months
Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the18- month study visits.
18 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With Hypertension Control
Časové okno: Baseline
The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms. Control was defined as SBP < 130mmHg for hypertensive patients with diabetes and < 140mmHg for patients without diabetes. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the baseline study visit.
Baseline
Number of Participants With Hypertension Control
Časové okno: 6 months
The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms. Control was defined as SBP < 130mmHg for hypertensive patients with diabetes and < 140mmHg for patients without diabetes. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the 6-month study visit.
6 months
Number of Participants With Hypertension Control
Časové okno: 12 months
The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms. Control was defined as SBP < 130mmHg for hypertensive patients with diabetes and < 140mmHg for patients without diabetes. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the 12-study visit.
12 months
Number of Participants With Hypertension Control
Časové okno: 18 months
The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms. Control was defined as SBP < 130mmHg for hypertensive patients with diabetes and < 140mmHg for patients without diabetes. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the18- month study visit.
18 months
Cost Effectiveness
Časové okno: Over 18 months of study intervention

One of our secondary research questions was: "If the intervention results in greater reduction in SBP than the control group, is it cost effective?"

Intervention results did not show statistically significant differences between arms, therefore cost effectiveness analysis was not appropriate.

While cost effectiveness was not analyzed because it was a null trial, the investigators would have used resource utilization and cost data from VA data sets to measure VA outpatient and inpatient utilization and costs by arms over 18 months. The investigators would have examined hypertension-related outpatient pharmacy prescription counts and costs in order to compare them to total outpatient pharmacy costs and the investigators would have examined inpatient utilization and costs.
Over 18 months of study intervention
Number of Participants Who Did Not Achieve Medication Adherence
Časové okno: Baseline

The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:

  • Do you ever forget to take your blood pressure medicine?
  • Are you careless at times about taking your blood pressure medicine?
  • When you feel better do you sometimes stop taking you blood pressure medicine?
  • Sometimes if you feel worse when you take your blood pressure medicine, do you stop taking it? The scale is a Yes(0) or No (1) answer.

A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence.

The numbers in the descriptive tables reflect number non-adherent.
Baseline
Number of Participants Who Did Not Achieve Medication Adherence
Časové okno: 6 months

The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:

  • Do you ever forget to take your blood pressure medicine?
  • Are you careless at times about taking your blood pressure medicine?
  • When you feel better do you sometimes stop taking you blood pressure medicine?
  • Sometimes if you feel worse when you take your blood pressure medicine, do you stop taking it? The scale is a Yes(0) or No (1) answer.

A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence.

The numbers in the descriptive tables reflect number non-adherent.
6 months
Number of Participants Who Did Not Achieve Medication Adherence
Časové okno: 12 months

The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:

  • Do you ever forget to take your blood pressure medicine?
  • Are you careless at times about taking your blood pressure medicine?
  • When you feel better do you sometimes stop taking you blood pressure medicine?
  • Sometimes if you feel worse when you take your blood pressure medicine, do you stop taking it? The scale is a Yes(0) or No (1) answer.

A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence.

The numbers in the descriptive tables reflect number non-adherent.
12 months
Number of Participants Who Did Not Achieve Medication Adherence
Časové okno: 18 months

The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:

  • Do you ever forget to take your blood pressure medicine?
  • Are you careless at times about taking your blood pressure medicine?
  • When you feel better do you sometimes stop taking you blood pressure medicine?
  • Sometimes if you feel worse when you take your blood pressure medicine, do you stop taking it? The scale is a Yes(0) or No (1) answer.

A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence.

The numbers in the descriptive tables reflect number non-adherent.
18 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

VA Office of Research and Development

Vyšetřovatelé

  • Vrchní vyšetřovatel: George L Jackson, PhD MHA, Durham VA Medical Center, Durham, NC

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

27. července 2012

Primární dokončení (Aktuální)

31. října 2016

Dokončení studie (Aktuální)

31. října 2016

Termíny zápisu do studia

První předloženo

6. července 2011

První předloženo, které splnilo kritéria kontroly kvality

6. července 2011

První zveřejněno (Odhad)

11. července 2011

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. února 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

4. září 2018

Naposledy ověřeno

1. září 2018

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • IIR 10-383

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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