Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care (ICARE)
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
The use of clinical pharmacists in primary care has improved the control of several chronic cardiovascular conditions. However, many private physician practices lack the resources to implement team-based care with pharmacists. The purpose of this study was to evaluate whether a centralized, remote, clinical pharmacy service could improve guideline adherence and secondary measures of cardiovascular risk in primary care offices in rural and small communities.
This study was a prospective trial in 12 family medicine offices cluster randomized to either the intervention or usual care. The intervention was delivered for 12 months, and subjects had research visits at baseline and 12 months. The primary outcome was adherence to guidelines, and secondary outcomes included changes in key cardiovascular risk factors and preventative health measures. We enrolled 302 subjects.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Iowa
-
Akron, Iowa, Estados Unidos, 51001-0200
- Akron Mercy Medical Clinic
-
Belmond, Iowa, Estados Unidos, 50421
- Iowa Specialty Hospitals - Belmond Clinic
-
Cedar Rapids, Iowa, Estados Unidos, 52403
- Employee Health Clinic, Mercy Cedar Rapids
-
Clarion, Iowa, Estados Unidos, 50525
- Iowa Speciality Hospitals - Clarion Clinic
-
Davenport, Iowa, Estados Unidos, 52897
- Great River Medical Group
-
Des Moines, Iowa, Estados Unidos, 50312
- Des Moines University Family Medicine Clinic
-
Grinnell, Iowa, Estados Unidos, 50112-1833
- Grinnell Regional Family Practice
-
Knoxville, Iowa, Estados Unidos, 50138
- Knoxville Hospital Clinic
-
Newton, Iowa, Estados Unidos, 50208-3137
- Newton Clinic, P.C.
-
Riverside, Iowa, Estados Unidos, 52327
- UI Health Care-River Crossing
-
Sioux City, Iowa, Estados Unidos, 511105
- Siouxland Community Health Center
-
West Burlington, Iowa, Estados Unidos, 52655-1645
- Burlington Area Family Practice Center
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
INCLUSION CRITERIA
Section A: Demographic Criteria
- Patient was seen in your clinic or practice at least once in the past 24 months
- English-speaking male or female
Age is 50 or older at medical record screening
Section B: Risk Factors - Must have at least one of the following conditions
- Uncontrolled diabetes (Hemoglobin A1c > or + 7.5)
- Elevated LDL cholesterol > 110 for patients with PAD, CAD, stroke or diabetes or > 140 otherwise
Elevated blood pressure with:
- Systolic BP >= 140 or Diastolic BP >=90 in persons with diabetes or chronic kidney disease OR
- Systolic BP >= 150 in persons with uncomplicated hypertension
Section C: Cardiovascular Conditions - total number of risk factors in Section B (above) plus number of conditions Section C (below) must be THREE OR MORE
- History of coronary artery disease
- Previous Heart Attack
- History of Stroke
- History of Transient Ischemic Attack
- History of Atrial fibrillation
- History of Peripheral Vascular Disease / claudication
- History of carotid artery disease
- Current smoker
Obesity with BMI > 30
EXCLUSION CRITERIA
Section D: Exclusion Criteria - has NONE of the following:
- Inability to give informed consent
- Pregnant
- Diagnosis of pulmonary hypertension (Note: secondary pulmonary hypertension is OK)
- Cancer diagnosis with a life expectancy estimated less than 2 years
- Residence in a nursing home or diagnosis of dementia
- No telephone or a hearing impairment not allowing them to use a phone
- Refusal to consider attempting to use the internet at home, community center, library, medical office or other source to access the PHRM
- Patient has plans to move from the area or transfer care to a different clinic in the next 12 months
- Omron blood pressure cuff cannot be used on patient's arm for any reason
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: PHCVRS intervention
Each participant will receive communication with a clinical pharmacist for 12 months to decrease risk of developing cardiovascular disease.
|
A clinical pharmacist at the PHCVRS will follow each participant in the PHCVRS arm for 12 months, including:
Each participant in this arm will also have access to an online Personal Health Record that can be used to track medications, diagnosed conditions and laboratory values related to cardiovascular disease risk.
Participant will be able to access an online Personal Health Record for tracking medications and diagnosed conditions
|
|
Outro: Usual care/Personal Health Record
Will receive usual medical care plus access to an online Personal Health Record, where the participant can document medications and diagnosed conditions.
|
Participant will be able to access an online Personal Health Record for tracking medications and diagnosed conditions
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adherence of medical regimen/treatment to all of the Guideline Advantage criteria that apply.
Prazo: 12 months for each participant
|
The primary outcome measure was adherence to the GA criteria as a surrogate for quality of care because each subject had varying gaps in guideline-concordant care, depending on their specific cardiovascular conditions and preventative care needs.
|
12 months for each participant
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Control of blood pressure, low density lipoprotein cholesterol and hemoglobin A1c.
Prazo: 12 months for each participant
|
Secondary aims included control of BP, diabetes mellitus, and lipids for subjects whose conditions were not controlled at baseline.
|
12 months for each participant
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Barry L. Carter, Pharm.D., University of Iowa
- Investigador principal: Barcey T. Levy, M.D., Ph.D., University of Iowa
Publicações e links úteis
Publicações Gerais
- Carter BL, Ardery G. Avoiding Pitfalls With Implementation of Randomized Controlled Multicenter Trials: Strategies to Achieve Milestones. J Am Heart Assoc. 2016 Dec 19;5(12):e004432. doi: 10.1161/JAHA.116.004432. No abstract available.
- Carter BL, Levy BT, Gryzlak B, Chrischilles EA, Vander Weg MW, Christensen AJ, James PA, Moss CA, Parker CP, Gums T, Finkelstein RJ, Xu Y, Dawson JD, Polgreen LA. A centralized cardiovascular risk service to improve guideline adherence in private primary care offices. Contemp Clin Trials. 2015 Jul;43:25-32. doi: 10.1016/j.cct.2015.04.014. Epub 2015 May 4.
- Yang R, Carter BL, Gums TH, Gryzlak BM, Xu Y, Levy BT. Selection bias and subject refusal in a cluster-randomized controlled trial. BMC Med Res Methodol. 2017 Jul 10;17(1):94. doi: 10.1186/s12874-017-0368-7.
- Kennelty KA, Polgreen LA, Carter BL. Team-Based Care with Pharmacists to Improve Blood Pressure: a Review of Recent Literature. Curr Hypertens Rep. 2018 Jan 18;20(1):1. doi: 10.1007/s11906-018-0803-0.
- Carter BL. Will Team-Based Care Really be Implemented? J Clin Hypertens (Greenwich). 2015 Sep;17(9):692-3. doi: 10.1111/jch.12578. Epub 2015 Jun 1. No abstract available.
- Patel E, Pevnick JM, Kennelty KA. Pharmacists and medication reconciliation: a review of recent literature. Integr Pharm Res Pract. 2019 Apr 30;8:39-45. doi: 10.2147/IPRP.S169727. eCollection 2019.
- Carter BL. Collaborative care model for hypertension. J Clin Hypertens (Greenwich). 2018 Jan;20(1):96-97. doi: 10.1111/jch.13142. Epub 2017 Dec 13. No abstract available.
- Carter BL, Levy B, Gryzlak B, Xu Y, Chrischilles E, Dawson J, Vander Weg M, Christensen A, James P, Polgreen L. Cluster-Randomized Trial to Evaluate a Centralized Clinical Pharmacy Service in Private Family Medicine Offices. Circ Cardiovasc Qual Outcomes. 2018 Jun;11(6):e004188. doi: 10.1161/CIRCOUTCOMES.117.004188.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 201308707
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Individual, de-identified data will be shared with the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BIOLINCC).
Data and supporting materials will include:
- The analytic data set used in the main outcomes paper
- Source data sets used to create the analytic data set (for baseline and 12 month follow up data collection points)
- Informed consent document
- Study protocol and manuals
- Subject brochure and subject handout
- Case report forms (baseline and 12 month follow up)
- Summary of data redactions
- Summary of protocol changes over time
All dates will be converted to days or months from a reference event; no text will be included (e.g., comments).
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
All reviews for data are coordinated by BioLINCC and are performed by the NHLBI Data Repository Program Officer. The review includes:
- Appropriateness of the proposed research for the dataset(s) being requested
- Completion of the IRB requirements to obtain the datasets.
Requests that include datasets must have IRB approval (waiver, expedited review, convened review). Some datasets require that the researcher's IRB provide an expedited (Chairman) or convened review for the proposed project. In these cases, an IRB approval is needed because although obvious identifiers have been redacted, the wealth of individual level data that remain (demographic, anthropometric, medical history, personal history, outcomes) means that the possibility of direct identification of a study subject cannot be eliminated.
Consult the BIOLINCC website (https://biolincc.nhlbi.nih.gov/home/) or access the handbook at https://biolincc.nhlbi.nih.gov/media/guidelines/handbook.pdf for more information.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .