About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older
living with HIV
admitted to internal medicine
has at least a cardiometabolic NCO as the primary or secondary reason for admission based on the HIV inpatient consultation
Disqualifiers
patients living beyond Lilongwe urban
Trial design
Single group
Treatments tested in this trial
Transition of Care Model (TCM)
BehavioralKey components of the TCM include discharge assessment, care planning, provider communication with outpatient follow-up teams, and community-based follow-up
Treatment groups
Trial outcomes
Primary outcomes
Post-discharge home visits
Proportion of discharged participants who have a home visit by a nurse within 1 week of 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
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.
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.
Secondary outcomes
The number of participants re-hospitalization after discharge
Proportion of participants who are discharged and then readmitted
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
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%
Control of hypertension
Among participants with hypertension, the proportion with blood pressure below 140/90
Sponsors and contacts
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University of North Carolina, Chapel Hill
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Fogarty International Center of the National Institute of Health
Collaborator