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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21TW012647-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Fogarty International Center of the National Institute of Health | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transition of Care Model (TCM) | Experimental | Following hospitalization for comorbid HIV and non-communicable diseases, participants will be followed for 3 months post discharge using the adopted Transition of Care Model (TCM). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transition of Care Model (TCM) | Behavioral | Key components of the TCM include discharge assessment, care planning, provider communication with outpatient follow-up teams, and community-based follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Post-discharge home visits | Proportion of discharged participants who have a home visit by a nurse within 1 week of discharge | 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 | 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
| 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
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants re-hospitalization after discharge | Proportion of participants who are discharged and then readmitted | Through 3 months post-discharge |
| Dual control of HIV and hypertension |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chimwemwe Chawinga | Contact | 265884409026 | cchawinga@unclilongwe.org.mw |
| Name | Affiliation | Role |
|---|---|---|
| Cecilia Kanyama, MBBS | University of North Carolina at Chapel Hill (Project Malawi) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kamuzu Central Hospital | Recruiting | Lilongwe | Malawi |
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
More information provided by University of North Carolina, Chapel Hill
beginning 9 and continuing for 36 months following publication
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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| ID | Term |
|---|---|
| D000073296 | Noncommunicable Diseases |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The Transition of Care Model (TCM) is an evidence-based model in the United States of America (USA) focused on continuity of care for patients with complex needs, particularly mature adults, as they move through the health care system.
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| At 3 months post-discharge |
| 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 | At completion of enrollment |
| Acceptability of Intervention Measures(AIM) rating from patient and caregiver perspective | The AIM is a 4-item/ statement measure
| At 3 months post-discharge |
| Acceptability of Intervention Measures(AIM) rating from Healthcare Workers perspective | The AIM is a 4-item/ statement measure
| At 3 months post-discharge |
| Intervention Appropriateness Measure(IAM) rating from Healthcare Workers perspective | The IAM is a 4-item/ statement measure
| At 3 months post-discharge |
| Intervention Appropriateness Measure(IAM) rating for patient and caregiver | The IAM is a 4-item/ statement measure
| At 3 months post-discharge |
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
| 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% | At 3 months post-discharge |
| Control of hypertension | Among participants with hypertension, the proportion with blood pressure below 140/90 | At 3 months post-discharge |
| Control of diabetes | Among participants with diabetes, the proportion with hemoglobin A1C <7% | At 3 months post-discharge |
| HIV viral suppression | The proportion with HIV viral load below assay detection (<40 copies/ml) | At 3 months post-discharge |
| All-cause post-discharge mortality | The proportion with death after discharge from the index admission | Through 3-months post-discharge |