This is an implementation research study that will adapt and pilot test the Transitional Of Care Model (TCM), originally conceived and developed in the USA, for targeted use as a post-discharge intervention for adults hospitalized with comorbid HIV and NCDs in Malawi using a mixed methods approach.
This study will enroll 75 consecutive adults hospitalized with comorbid HIV and at least have one common cardiometabolic condition (e.g., hypertensive urgency, heart failure, stroke, or diabetes) and provide them with the adapted TCM according to the SOP developed in the prior phase. It is expected that 15-20% will also have comorbid opportunistic infections. The study will evaluate the acceptability and feasibility of the adapted intervention. Using mixed methods, including surveys and interviews, the study will evaluate the acceptability and feasibility of providing the inpatient and post-discharge components of the adapted TCM. The study will also describe key 3-month post-discharge clinical outcomes (mortality, readmission) and indicators that may mediate clinical outcomes (linkages/retention in care, adherence to antiretroviral therapy/non-communicable disease (ART/ NCDs) medications, dual control of HIV and NCDs, social demographic variables). Clinical outcomes and indicators in the pilot participants will be compared with a comparable historical control group of patients who had routine care at KCH in the recent past.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
75
Key components of the TCM include discharge assessment, care planning, provider communication with outpatient follow-up teams, and community-based follow-up
Kamuzu Central Hospital
Lilongwe, Malawi
RECRUITINGPost-discharge home visits
Proportion of discharged participants who have a home visit by a nurse within 1 week of discharge
Time frame: Through 3-months post-discharge
Completion of comprehensive needs assessment
Proportion of participants who have an assessment of social support, food insecurity, medication adherence self-efficacy during hospitalization or within 1 week of discharge
Time frame: Through 3-months post-discharge
Feasibility rating from health worker perspective.
Feasibility of intervention measure (FIM) score among health workers involved in the implementation of the post-discharge intervention.The FIM is a 4-item/ statement measure 1. The post-discharge intervention program seems implementable in our setting 2. The post-discharge intervention seems possible in our setting 3. The post-discharge intervention seems doable in our setting 4. The post-discharge intervention seems easy to use for our setting The FIM is measured on a five-point rating scale:( 1= completely disagree, 2= disagree,3=neither agree nor disagree, 4= agree, and 5 = completely agree) The mean score ranges from 1 to 5, with 1 indicating the least feasibility and 5 indicating the most feasibility.
Time frame: At 3 months post-discharge
Feasibility rating from patient and caregiver perspective
Feasibility of implementation measure (FIM) score among patients and caregivers who were assigned to receive the post-discharge intervention.The FIM is a 4-item/ statement measure 1. The post-discharge intervention program seems implementable in our setting 2. The post-discharge intervention seems possible in our setting 3. The post-discharge intervention seems doable in our setting 4. The post-discharge intervention seems easy to use for our setting The FIM is measured on a five-point rating scale:( 1= completely disagree, 2= disagree,3=neither agree nor disagree, 4= agree, and 5 = completely agree) The mean score ranges from 1 to 5, with 1 indicating the least feasibility and 5 the most feasibility.
Time frame: At 3 months post-discharge
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Reach among eligible hospitalized adults with HIV/NCD comorbidity
Proportion of eligible adults admitted with HIV/NCD comorbidity who participate in the study during the enrollment period
Time frame: At completion of enrollment
Acceptability of Intervention Measures(AIM) rating from patient and caregiver perspective
The AIM is a 4-item/ statement measure 1. The post-discharge intervention implementation program meets my approval 2. The post-discharge intervention is appealing to me 3. I like the post-discharge intervention 4. I welcome the post-discharge intervention The AIM is measured on a five-point rating scale:( 1= completely disagree, 2= disagree,3=neither agree nor disagree, 4= agree, and 5 = completely agree) The mean score ranges from 1 to 5, with 1 indicating poorly acceptable and five highly acceptable
Time frame: At 3 months post-discharge
Acceptability of Intervention Measures(AIM) rating from Healthcare Workers perspective
The AIM is a 4-item/ statement measure 1. The post-discharge intervention implementation program meets my approval 2. The post-discharge intervention is appealing to me 3. I like the post-discharge intervention 4. I welcome the post-discharge intervention The AIM is measured on a five-point rating scale:( 1= completely disagree, 2= disagree,3=neither agree nor disagree, 4= agree, and 5 = completely agree) The mean score ranges from 1 to 5, with 1 indicating poorly acceptable and 5 highly acceptable.
Time frame: At 3 months post-discharge
Intervention Appropriateness Measure(IAM) rating from Healthcare Workers perspective
The IAM is a 4-item/ statement measure 1. The post-discharge intervention program seems fitting in our setting 2. The post-discharge intervention seems suitable for our setting 3. The post-discharge intervention seems applicable to our setting 4. The post-discharge intervention seems a good match in our setting The IAM is measured on a five-point rating scale:( 1= completely disagree, 2= disagree,3=neither agree nor disagree, 4= agree, and 5 = completely agree) The mean score ranges from 1 to 5, with 1 indicating the least appropriate and 5 the most appropriate
Time frame: At 3 months post-discharge
Intervention Appropriateness Measure(IAM) rating for patient and caregiver
The IAM is a 4-item/ statement measure 1. The post-discharge intervention program seems fitting in our setting 2. The post-discharge intervention seems suitable for our setting 3. The post-discharge intervention seems applicable to our setting 4. The post-discharge intervention seems a good match in our setting The IAM is measured on a five-point rating scale:( 1= completely disagree, 2= disagree,3=neither agree nor disagree, 4= agree, and 5 = completely agree) The mean score ranges from 1 to 5, with 1 indicating the least appropriate and 5 the most appropriate.
Time frame: At 3 months post-discharge
The number of participants re-hospitalization after discharge
Proportion of participants who are discharged and then readmitted
Time frame: Through 3 months post-discharge
Dual control of HIV and hypertension
Among participants with hypertension and HIV, the proportion with both HIV viral load below assay detection (\<40 copies/ml) and blood pressure below 140/90
Time frame: At 3 months post-discharge
Dual control of HIV and diabetes
Among participants with diabetes and HIV, the proportion with HIV viral load below assay detection (\<40 copies/ml) and hemoglobin A1C \<7%
Time frame: At 3 months post-discharge
Control of hypertension
Among participants with hypertension, the proportion with blood pressure below 140/90
Time frame: At 3 months post-discharge
Control of diabetes
Among participants with diabetes, the proportion with hemoglobin A1C \<7%
Time frame: At 3 months post-discharge
HIV viral suppression
The proportion with HIV viral load below assay detection (\<40 copies/ml)
Time frame: At 3 months post-discharge
All-cause post-discharge mortality
The proportion with death after discharge from the index admission
Time frame: Through 3-months post-discharge