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Clinical Trials

MainTitle

A Nurse Case Management Intervention to Improve MDR-TB/HIV Co-Infection Outcomes

This study is currently recruiting participants. (see Contacts and Locations)

Verified April 2017 by Jason Farley Ph.D., MPH, NP, FAAN, Johns Hopkins University

Sponsor
Johns Hopkins University

Collaborator
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Medical Research Council, South Africa

Information provided by (Responsible Party)
Jason Farley Ph.D., MPH, NP, FAAN, Johns Hopkins University

ClinicalTrials.gov Identifier
NCT02129244

First received: April 29, 2014
Last updated: April 7, 2017
Last Verified: April 2017
History of Changes
Purpose

Purpose

The researchers of this study are observing the treatment of multi-drug resistant Mycobacterium tuberculosis (MDR-TB) in South Africa. MDR-TB can not be treated with the usual TB drugs and needs to be treated with special drugs. The patients need to take these drugs for up to two years. Certain hospitals have already agreed to participate in this research project, half of the hospitals will be assigned a nurse case manager and the other half will not. The researchers are studying the benefits of having a nurse case manager to improve treatment response for patients with drug resistant TB. The researchers believe that nurse case management (NCM) in the intervention sites will increase MDR-TB cure and completion rates (i.e. treatment success) in comparison to usual care (UC), i.e. standardized programmatic management alone, in patients with and without HIV co-infection. To do this, the researchers will review the medical information collected at the hospital as part of the patient's treatment after obtaining the patient's permission.

Condition Intervention
MDR-TB
HIV

Other : NCM-Plus

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Nurse Case Management Intervention to Improve MDR-TB/HIV Co-Infection Outcomes

Further study details as provided by Jason Farley Ph.D., MPH, NP, FAAN, Johns Hopkins University:

Primary Outcome Measures

  • Proportion of patients who experience successful treatment outcomes [ Time Frame: 24-36 months ]
    General Estimating Equations (GEE) Regression Analysis
Secondary Outcome Measures:
  • Proportion of patients who experience successful treatment outcomes based on HIV co-infection [ Time Frame: 24 to 36 months ]
    Multivariate Analysis using binomial or Poisson-based GEE models
  • Proportion of patients who experience successful treatment outcomes based on sex and gender [ Time Frame: 24-36 months ]
    Multivariate Analysis using binomial or Poisson-based GEE models
  • Proportion of patients who experience successful treatment outcomes based on age [ Time Frame: 24-36 months ]
    Multivariate Analysis using binomial or Poisson-based GEE models

Estimated Enrollment: 3000
Study Start Date: October 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: NCM Plus Intervention
The researchers designed the NCM-Plus intervention by integrating the domains of the Chronic Care Model with added attention to linkage to care, building on evidence-based guidelines and the team's pilot findings. In the NCM bundle, the researchers provide extensive details on both proximal and distal outcome variables. Nurse case managers will be hired and trained to improve disease management for patients with MDR-TB and HIV. Specific measurable responsibilities will be implemented by each NCM at sites randomized to receive the intervention. The NCM-patient interaction will occur at the MDR-TB treatment inpatient or outpatient facility.
Other: NCM-Plus
    The NCM will follow the domains of the chronic care model by:
    • Assuring effective, efficient clinical care and self-management support
    • Promoting clinical care consistent with scientific evidence and patient preferences
    • Organizing data to facilitate efficient, effective care
    • Empowering and preparing patients to manage their health and health-care needs
    • Mobilizing community resources to meet the needs of patients

    No Intervention: Standard/Usual Care
    Usual care is defined as standardized programmatic management of MDR-TB/HIV without care coordination. Nurses are present as part of the team, but with no special coordination role, leaving the MDR-TB physician solely responsible for treatment outcomes with little support. Physicians see patients weekly during the intensive phase and the patient receives basic daily nursing care without coordination of care, active monitoring of Adverse Drug Reactions (ADR)s or HIV care integration. This care transitions to monthly visits with the physician in the continuation phase, again with very little nursing involvement in care coordination.

    Detailed Description:

    Mycobacterium tuberculosis (TB) remains the leading cause of death among persons living with Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) in southern Africa. This syndemic places an overwhelming burden on healthcare workers and the health system. Drug-resistant TB remains a growing threat to public health despite advances in treatment and diagnosis over the past decade. South Africa has the world's highest rate of TB/HIV co-infection and ranks fourth worldwide for both multi-drug resistant (MDR) TB incidence and HIV prevalence. Treatment of MDR-TB, defined as resistance to isoniazid and rifampin, remains challenging and its treatment course complex. Success of second line treatment regimens is considerably less likely than first line treatment with significantly more adverse drug reactions (ADRs). Prospective cohort studies from South Africa report less than 50% treatment success (i.e. cure or completion) and significant differences in patients with and without HIV are noted. Differences in sex and gender as well as age are rarely evaluated. In addition to the management complexity and length of treatment, systems level factors such as access to care and healthcare capacity contribute to poorer treatment outcomes. Insufficient numbers of trained physicians capable and clinically competent to manage the challenges of integrated MDR-TB/HIV care are commonplace. These circumstances place a heavy burden on the most abundant healthcare resource in South Africa, the nurse. Nurses with proficiency in care models for both diseases are essential to improve treatment outcomes. The investigators experience dictates, however, that patients endure lengthy treatment with little assessment, support or guidance from nursing professionals due to a lack of training as well as lack of evidence-based interventions and delineated models of care for MDR-TB patients.
    Nurse case management (NCM) models in which a registered nurse facilitates and coordinates treatment plans to ensure that timely, evidence-based care is given improves treatment outcomes. Presently, there is little evidence to describe such models in TB/HIV co-infected patients globally, and specifically less evidence for MDR-TB/HIV in sub-Saharan Africa. Many studies, however, have demonstrated substantial improvements in disease outcomes utilizing nurse case managers. Complex diseases such as heart failure, diabetes, HIV and drug susceptible TB are among these. Substantial gaps remain, however, in the investigators understanding of the impact of such interventions among co-infected patients, the influence of such models among different age groups or the cost-benefit in under resourced settings. Prior studies provide strong evidence that interventions must be multi-faceted and foster system level approaches to improve treatment outcomes (i.e. NCM patient-centered care services coupled with systems level approaches to care coordination). The Chronic Care Model identifies essential elements of a health care system that encourage high-quality chronic disease care in such a systems approach. These elements provide the conceptual model and implementation structure for the proposed NCM plus health systems strengthening (i.e. NCM-plus) intervention, a multi-faceted health systems and patient-centered intervention to improve MDR-TB/HIV treatment outcomes. The proposed 5-year cluster randomized trial, will evaluate the NCM-plus intervention on MDR-TB treatment outcomes in South Africa, the epicenter of the MDR-TB/HIV epidemic.
    Primary Aim:
    To determine the impact of a NCM model (i.e. NCM-Plus) on MDR-TB outcomes in patients with and without HIV co-infection in South Africa through a cluster randomized trial.
    Hypothesis:
    Nurse case management (NCM) in intervention sites will increase MDR-TB cure and completion rates (i.e. treatment success) in comparison to usual care (UC), i.e. standardized programmatic management alone, in patients with and without HIV co-infection.
    Secondary Aims:

    1. To conduct sub-group analysis by a) HIV co-infection; b) sex and gender; and c) age
    2. To compare the frequency and time to identification of adverse drug events between intervention and control sites.
    uct a costing analysis and a cost-effectiveness evaluation of the intervention.

    Eligibility

    Eligibility

    Ages Eligible for Study: 13 Years and older  
    Sexes Eligible for Study: All  
    Accepts Healthy Volunteers: No  

    Criteria

    Inclusion Criteria:

    • Center (Cluster Level)
      1. MDR-TB Centers in KwaZulu-Natal (KZN) or Eastern Cape (EC), South Africa providing standardized
      2. MDR-TB regimen according to National Department of Health guidelines
      3. Facility has provided MDR-TB care for a minimum of 6 months at study initiation
      4. MDR-TB Centers with facility-based access to anti-retroviral therapy
      5. Facility willingness to participate in the study
    • Individual (Patient Level)
      1. Patients 18 years of age and older, with microbiologically confirmed MDR- TB, admitted to receive inpatient care at a participating hospital who signs informed consent within 7 days of admission.
      2. Patients 13 - 17 years of age, with microbiologically confirmed MDR- TB, who provide consent for study team to contact parent or legal guardian and when patient is willing and parent or legal guardian provides approval for study participation within 7 days of admission.

      Exclusion Criteria (Individual Patient Level):
    • Persons who present to the MDR-TB ward who have started MDR-TB treatment prior to admission.
    • Children, less than 13 years of age; only one participating center has an MDR-TB wards for children under 13.
    • Persons who are unable or unwilling to provide informed consent for participation
    • Any patient enrolled in another clinical trial that changes standard MDR- TB or HIV
    care.

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT02129244

    Contacts

    Contact:   Kelly Lowensen, RN, MSN 410-502-3101 klowens1@jhu.edu

    Locations

    South Africa
    Regus Primary Office Not yet recruiting
    Westville, Durban, South Africa, 3629
    Contact: Kelly Lowensen, RN, MSN    410-502-3101    klowens1@jhu.edu
    Principal Investigator: Jason E Farley, PhD, MPH, NP
    Catherine Booth Hospital Recruiting
    Amatikulu, KwaZulu-Natal, South Africa
    King George V Hospital Recruiting
    Durban, South Africa
    Fort Gray Hospital Active, not recruiting
    East London, South Africa
    Don McKenzie Recruiting
    Ethekwini, South Africa
    Dunstan Farrell Hospital Not yet recruiting
    Hibberdene, South Africa
    Hlabisa Hospital Recruiting
    Hlabisa, South Africa
    Manguzi Recruiting
    Manguzi, South Africa
    Nkqubela Recruiting
    Mdantsane, South Africa
    Fosa Hospital Not yet recruiting
    Newlands West, South Africa
    Doris Goodwin Hospital Recruiting
    Pietermaritzburg, South Africa
    Marjorie Parrish Hospital Recruiting
    Port Alfred, South Africa
    Jose Pearson Hospital Recruiting
    Port Elizabeth, South Africa
    Murchison Hospital Recruiting
    Port Shepstone, South Africa
    St Margaret's MDR-TB Hopsital Recruiting
    Umzimkulu, South Africa

    Sponsors and Collaborators

    Johns Hopkins University
    National Institutes of Health (NIH)
    National Institute of Allergy and Infectious Diseases (NIAID)
    Medical Research Council, South Africa

    Investigators

    Principal Investigator: Jason E Farley, PhD, MPH, NP Johns Hopkins University
    More Information

    More Information


    Responsible Party: Jason Farley Ph.D., MPH, NP, FAAN, Associate Professor, Johns Hopkins University  
    ClinicalTrials.gov Identifier: NCT02129244   History of Changes  
    Other Study ID Numbers: 104488-01A1  
      RO1 104488-01A1  
    Study First Received: April 29, 2014  
    Last Updated: April 7, 2017  
    Individual Participant Data    
    Plan to Share IPD: No  

    Keywords provided by Jason Farley Ph.D., MPH, NP, FAAN, Johns Hopkins University:

    MDR-TB
    HIV
    Nurse Case Management (NCM)

    Additional relevant MeSH terms:
    Coinfection
    Tuberculosis, Multidrug-Resistant

    ClinicalTrials.gov processed this data on October 20, 2017
    This information is provided by ClinicalTrials.gov.