This study evaluates a tailored-practice facilitation (PF) strategy for integrating a task strengthening strategy for hypertension control (TASSH) for the care of patients living with HIV (PWH) within primary health centers (PHCs) in Lagos, Nigeria.
Although access to antiretroviral therapy has led to increased survival among people living with HIV (PWH) in Africa, this population now has higher cardiovascular disease (CVD) - mortality than the general population largely due to an increased burden of hypertension. In Nigeria, the acute shortage of physicians limits the capacity to control hypertension among PWH at the primary care level where the majority receive treatment. This study proposes the use of practice facilitation (PF) - which will provide external expertise on practice redesign and a tailored approach to delivery of the evidence-based task strengthening strategy - to integrate hypertension into the HIV care model. Using a clinical-effectiveness implementation design, we will evaluate the effect of a PF strategy for integrating an evidence-based intervention for hypertension (HTN) control into HIV care among 960 patients with uncontrolled HTN in 30 primary health centers (PHCs) in Nigeria. Study is in 3 phases: 1) a pre-implementation phase that will develop a tailored PF intervention for integrating TASSH into HIV clinics; 2) an implementation phase that will compare the clinical effectiveness of PF vs. a self-directed condition (receipt of information on TASSH without PF) on BP reduction; and 3) a post- implementation phase to evaluate the effect of PF vs. self-directed condition on the adoption and sustainability of TASSH. The PF intervention comprises: (a) an advisory board to provide leadership support for implementing TASSH in HIV clinics; (b) training of the HIV nurses on TASSH protocol; and (c) training of practice facilitators, who will serve as coaches, provide support, and performance feedback to the HIV nurses
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
830
The TASSH protocol include the following 4 steps: 1). Identify HIV patients with uncontrolled HTN: trained HIV nurses will take patients' medical history (whether or not they have a diagnosis of diabetes, heart attack, stroke, heart failure, smoking). 2) Next, they will measure the patients' weight, height, waist circumference and BP with a valid automated device following standard procedures and then conduct lab tests with point-of-care testing on blood glucose, lipids and urine dip stick. 3) Initiate lifestyle counseling and medication treatment every 1-3 months: The nurses will next counsel eligible patients on lifestyle behaviors for 20 to 30 minutes (increased intake of fruits and vegetables, moderate physical activity and reduce salt intake). 4). Refer patients with complicated HTN to physicians for further care
Saint Louis University (SLU)
St Louis, Missouri, United States
Nigerian Institute of Medical Research (NIMR)
Yaba, Lagos, Nigeria
Change in Systolic Blood Pressure
The primary outcome is change in systolic blood pressure (SBP) from baseline to 12 months. Following the research investigators' existing TASSH protocol, the SBP reduction in patients will assessed as mean change in systolic BP from baseline to 12 months. Blood pressure will be taken with valid automated BP device from the existing TASSH protocol.
Time frame: Baseline, Month 12
Rate of Adoption of TASSH Across PHCs at 12 Months
Rate of adoption of TASSH is defined as the proportion of patients who were diagnosed with HTN by the HIV nurses; received lifestyle counseling and antihypertensive treatment from HIV nurses. For this purpose, adoption will be assessed as a composite of the following measures: 1) the number of hypertensive patients diagnosed by the nurses using the WHO CVD risk assessment; 2) proportion of patients with HTN who received lifestyle counseling from the nurses; and 3) proportion of patients for whom the HIV nurses initiated treatment with antihypertensive medications. In order to assess this measure, the nurses will complete a questionnaire inquiring about the number of patients with uncontrolled HTN who received medication treatment and lifestyle counseling.
Time frame: Month 12
Sustainability of TASSH Across PHCs at 24 Months
Sustainability of TASSH is defined as the maintenance of TASSH uptake at the HIV clinics at 24 months (one year after the end of the intervention). Sustainability will be assessed with a composite quantitative measure similar to adoption and qualitatively, based on interviews with nurses and clinic leadership at 24 months. For this purpose, two research coordinators will conduct the interviews with two nurses and one key leadership personnel at each primary health center (PHCs).
Time frame: Month 24
Implementation Climate Across PHCs at 12 Months
Implementation Climate will be assessed with the Implementation Climate Scale. It measures shared perceptions of policies, practices, procedures, and behaviors that are expected, supported, and rewarded to facilitate effective evidence-based practice (EBP) implementation. It is an 18-item questionnaire that comprises six subscales. Each item is rated on a 5-point Likert scale from 0-4; each subscale score is calculated as the mean score of the associated items; the total score is the average of the six subscale scores and ranges from 0-4. Higher scores indicate a climate that is highly supportive of implementing EBPs.
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Time frame: Month 12
Implementation Climate Across PHCs at 24 Months
Implementation Climate will be assessed with the Implementation Climate Scale. It measures shared perceptions of policies, practices, procedures, and behaviors that are expected, supported, and rewarded to facilitate effective evidence-based practice (EBP) implementation. It is an 18-item questionnaire that comprises six subscales. Each item is rated on a 5-point Likert scale from 0-4; each subscale score is calculated as the mean score of the associated items; the total score is the average of the six subscale scores and ranges from 0-4. Higher scores indicate a climate that is highly supportive of implementing EBPs.
Time frame: Month 24
Implementation Leadership Across PHCs at 12 Months
Implementation Leadership will be assessed with the Implementation Leadership Scale (ILS). It is a 12-item measure with four subscales: Proactive Leadership (α=.95), Knowledgeable Leadership (α=.96), Supportive Leadership (α=.95), and perseverant leadership (α=.96) and a total score (α=.98). Each item is rated on an item-specific Likert scale. Each subscale score is calculated as the mean score of the associated items; the total score is the average of the four subscale scores and ranges from 0-4. Higher scores indicate greater implementation leadership.
Time frame: Month 12
Implementation Leadership Across PHCs at 24 Months
Implementation Leadership will be assessed with the Implementation Leadership Scale (ILS). It is a 12-item measure with four subscales: Proactive Leadership (α=.95), Knowledgeable Leadership (α=.96), Supportive Leadership (α=.95), and perseverant leadership (α=.96) and a total score (α=.98). Each item is rated on an item-specific Likert scale. Each subscale score is calculated as the mean score of the associated items; the total score is the average of the four subscale scores and ranges from 0-4. Higher scores indicate greater implementation leadership.
Time frame: Month 24
Change in Proficiency Across PHCs at 12 Months
Proficiency will be assessed using the Organizational Culture domain of the Organizational Social Context Scale, a 15-item Proficiency subscale used to evaluate the practice capacity proficiency level of the primary health centers (PHCs). Proficient Organizational Cultures are those characterized by shared norms and expectations that the nurses are skilled service providers, and have current knowledge of the TASSH protocol. Items are completed using a 5-point rating scale ranging from 1 (never) to 5 (always) with measures such as responsiveness (e.g., 'members of my organizational unit are expected to be responsive to the needs of each patient') and competence (e.g., 'members of my organizational unit are expected to have up-to-date knowledge'). The total score is the sum of responses and ranges from 15-75; higher scores indicate more proficient organizational cultures. Alpha reliability for the proficient culture scale is .89.
Time frame: Month 12
Change in Proficiency Across PHCs at 24 Months
Proficiency will be assessed using the Organizational Culture domain of the Organizational Social Context Scale, a 15-item Proficiency subscale used to evaluate the practice capacity proficiency level of the primary health centers (PHCs). Proficient Organizational Cultures are those characterized by shared norms and expectations that the nurses are skilled service providers, and have current knowledge of the TASSH protocol. Items are completed using a 5-point rating scale ranging from 1 (never) to 5 (always) with measures such as responsiveness (e.g., 'members of my organizational unit are expected to be responsive to the needs of each patient') and competence (e.g., 'members of my organizational unit are expected to have up-to-date knowledge'). The total score is the sum of responses and ranges from 15-75; higher scores indicate more proficient organizational cultures. Alpha reliability for the proficient culture scale is .89.
Time frame: Month 24
Change in Organizational Readiness to Change - Evidence Across PHCs at 12 Months
Organizational Readiness to Change - Evidence is assessed with the 12-item Evidence Scale, which evaluates the strength of the evidence for the proposed change/innovation. It will be used to evaluate intervention process measures focused on CFIR's Evidence Strength \& Quality and Relative Advantage construct. Each item measures the extent to which a respondent agrees or disagrees with the item statement on a 5-point Likert- type scale (1 = strongly disagree; 5 = strongly agree) and the Cronbach α=0.74. The total score is the sum of responses and ranges from 12 to 60; higher scores indicate greater strength of the evidence for the proposed change/innovation.
Time frame: Month 12
Change in Organizational Readiness to Change - Evidence Across PHCs at 24 Months
Organizational Readiness to Change - Evidence is assessed with the 12-item Evidence Scale, which evaluates the strength of the evidence for the proposed change/innovation. It will be used to evaluate intervention process measures focused on CFIR's Evidence Strength \& Quality and Relative Advantage construct. Each item measures the extent to which a respondent agrees or disagrees with the item statement on a 5-point Likert- type scale (1 = strongly disagree; 5 = strongly agree) and the Cronbach α=0.74. The total score is the sum of responses and ranges from 12 to 60; higher scores indicate greater strength of the evidence for the proposed change/innovation.
Time frame: Month 24
Change in External Change Agent Support Across PHCs at 12 Months
External change agent support is assessed using a 3-item tool that evaluates support provided by external facilitators, the expectations about performance and improvement, and the ways to achieve the goal of the project. Items are scored on a 5-point Likert scale from 1-5 and the Cronbach α=0.77. The total score is the sum of responses and ranges from 3-15; higher scores indicate greater external change agent support.
Time frame: Month 12
Change in External Change Agent Support Across PHCs at 24 Months
External change agent support is assessed using a 3-item tool that evaluates support provided by external facilitators, the expectations about performance and improvement, and the ways to achieve the goal of the project. Items are scored on a 5-point Likert scale from 1-5 and the Cronbach α=0.77. The total score is the sum of responses and ranges from 3-15; higher scores indicate greater external change agent support.
Time frame: Month 24
Change in Organizational Readiness to Change - Facilitation Across PHCs at 12 Months
Organizational Readiness to Change - Facilitation is measured using the Facilitation Scale (8-items) evaluates organizational capacity to facilitate change will be used to evaluate implementation process measures focused on CFIR Engaging construct. Each item measures the extent to which a respondent agrees or disagrees with the item statement on a 5-point Likert-type scale (1 = strongly disagree; 5 = strongly agree). It has Cronbach α=0.95. The total score is the sum of responses and ranges from 8-40; higher scores indicate greater organizational capacity to facilitate change.
Time frame: Month 12
Change in Organizational Readiness to Change - Facilitation Across PHCs at 24 Months
Organizational Readiness to Change - Facilitation is measured using the Facilitation Scale (8-items) evaluates organizational capacity to facilitate change will be used to evaluate implementation process measures focused on CFIR Engaging construct. Each item measures the extent to which a respondent agrees or disagrees with the item statement on a 5-point Likert-type scale (1 = strongly disagree; 5 = strongly agree). It has Cronbach α=0.95. The total score is the sum of responses and ranges from 8-40; higher scores indicate greater organizational capacity to facilitate change.
Time frame: Month 24