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Titrated Disease Management for Patients With Hypertension (TDM)

4 de setembro de 2018 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Real)

385

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27705
        • Durham VA Medical Center, Durham, NC

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Pesquisa de serviços de saúde
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comportamental: Booster/ low resource
A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months.
Outros nomes:
  • Intervention Arm - Booster
Comportamental: Medium/Level 1 resource intensity
Monthly tailored RN delivered calls + home BP monitoring.
Outros nomes:
  • Intervention Arm - Level 1
Comportamental: 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).
Outros nomes:
  • Intervention Arm - Level 2
Comparador Ativo: 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.
Comportamental: Booster/ low resource
A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months.
Outros nomes:
  • Intervention Arm - Booster

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Systolic Blood Pressure
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of Participants With Hypertension Control
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

VA Office of Research and Development

Investigadores

  • Investigador principal: George L Jackson, PhD MHA, Durham VA Medical Center, Durham, NC

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

27 de julho de 2012

Conclusão Primária (Real)

31 de outubro de 2016

Conclusão do estudo (Real)

31 de outubro de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

6 de julho de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de julho de 2011

Primeira postagem (Estimativa)

11 de julho de 2011

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de fevereiro de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de setembro de 2018

Última verificação

1 de setembro de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • IIR 10-383

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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