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Titrated Disease Management for Patients With Hypertension (TDM)

4 settembre 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Effettivo)

385

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

  • Stati Uniti
    • North Carolina
      • Durham, North Carolina, Stati Uniti, 27705
        • Durham VA Medical Center, Durham, NC

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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

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: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: Booster/ low resource
A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months.
Altri nomi:
  • Intervention Arm - Booster
Comportamentale: Medium/Level 1 resource intensity
Monthly tailored RN delivered calls + home BP monitoring.
Altri nomi:
  • Intervention Arm - Level 1
Comportamentale: 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).
Altri nomi:
  • Intervention Arm - Level 2
Comparatore attivo: 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.
Comportamentale: Booster/ low resource
A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months.
Altri nomi:
  • Intervention Arm - Booster

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Systolic Blood Pressure
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Hypertension Control
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

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

Sponsor

VA Office of Research and Development

Investigatori

  • Investigatore principale: George L Jackson, PhD MHA, Durham VA Medical Center, Durham, NC

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.

Pubblicazioni generali

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 (Effettivo)

27 luglio 2012

Completamento primario (Effettivo)

31 ottobre 2016

Completamento dello studio (Effettivo)

31 ottobre 2016

Date di iscrizione allo studio

Primo inviato

6 luglio 2011

Primo inviato che soddisfa i criteri di controllo qualità

6 luglio 2011

Primo Inserito (Stima)

11 luglio 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 febbraio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 settembre 2018

Ultimo verificato

1 settembre 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IIR 10-383

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

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