Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04436289 |
| Other study ID # |
IRB00214009 |
| Secondary ID |
5R34MH118998 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2020 |
| Est. completion date |
February 28, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Johns Hopkins University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: This is a pilot randomized clinical trial (RCT) to demonstrate the feasibility
and acceptability of a structural and behavioral intervention to reduce mortality following
hospital discharge for people with HIV (PWH) in South Africa. Investigators' prior study
showed that among 121 PWH discharged, 54% were readmitted and 26% had died by six months
following discharge. In the prior study, investigators identified that missing clinic visits
after discharge was associated with death. Here investigators are seeking to overcome key
barriers in piloting a home-based post-hospital care intervention. Investigators' approach is
informed by a conceptual model of key barriers to the care transition along with a behavioral
explanatory model, the Behavioral Model for Vulnerable Populations.
The overarching goal of this study is to tailor and pilot the intervention that shifts
initial post-discharge care from the out-patient clinic to the home and provides
patient-centered counseling (Home Link intervention). For the intervention to prove effective
it will need to substantially reduce post-discharge mortality. Specifically, in the Home Link
intervention, a team will conduct home visits to (1) provide a structured clinical
assessment; (2) reconcile medications, (3) provide psychosocial support through
patient-centered counseling, and (4) assess home needs (food security). These visits will
start one week after discharge and be repeated every two weeks until the participant is
stabilized and ready to initiate lower intensity clinic-based services or three months have
elapsed.
Aims: The aims of the study are to pilot a randomized clinical trial of home delivery of
health services during the post-hospital period for PWH.
Methods: This project is a pilot randomized clinical trial (RCT) to refine and test the
feasibility, acceptability, and preliminary effectiveness of the HomeLink intervention. At
the conclusion of the R34 grant period investigators will have a protocol and procedural
manual ready for a full RCT powered for effectiveness.
Significance: The proposed study is consistent with NIH HIV/AIDS highest priority research
and the South African National Strategic Plan on HIV, tuberculosis (TB), and sexually
transmitted infections (STIs) 2017-2022. The research addresses the HIV/AIDS Research
Priority of "retention and engagement in these services, and achievement and maintenance of
optimal prevention and treatment responses."
Description:
BACKGROUND
Sub-Saharan Africa HIV mortality:
In 2016 in South Africa approximately 154,000 PWH died. Of these deaths, 110,000 have been
characterized as excess mortality due to HIV (HIV associated deaths). Overall, HIV-associated
deaths are associated advanced disease defined by a low cluster of differentiation 4 (CD4)
count.
In-Hospital and Post-Hospital Mortality in Africa:
Inpatient mortality among people with HIV (PWH) in Africa is uniformly high ranging from 17.2
to 29.6% across the continent, including in South Africa. Following discharge from an index
hospitalization the mortality is also high. In investigators' preliminary work investigators
have observed a 26% mortality in the 6 months after hospital discharge. This observation is
consistent with mortality from other reports: 50% mortality at twelve months and 30% and 31%
at six months reported from Tanzania, Kenya, and South Africa, respectively.
Contribution of Post-Hospital Mortality to Overall Death among People with HIV:
In South Africa there are approximately 84,633 public sector acute care hospital beds of
which approximately 25% are adult medicine beds. By extrapolating the post-discharge
mortality investigators observed to all discharges among PWH in South Africa investigators
can estimate the annual mortality among PWH with a hospital discharge in the past six months.
Considering the national proportion of all admissions that are for PWH, the average length of
stay, and the annual readmission rate an estimated 240,000 PWH are admitted to medicine wards
in South Africa annually. A six-month post-hospital mortality of 26% suggests a total of
62,374 post-hospital deaths among PWH. This number of deaths represents 40% of the
approximately 154,000 total annual deaths among PWH in South Africa. A modest reduction in
post-hospital deaths could substantially reduce overall HIV mortality in South Africa.
Causes of Post-Hospital Death:
Some post-hospital deaths may be unavoidable due to advanced or incurable disease. Other
post-hospital deaths may be avoidable with improved retention in care. A study from
Johannesburg, South Africa assessed loss from care for HIV-TB co-infected patients; only 42%
of patients discharged were known to have been to an HIV clinic within 30 days of hospital
discharge [the time needed to obtain or refill antiretroviral therapy (ART) prescriptions at
the time of the study]. Similarly in Investigators' preliminary study, only 19% of
participants attended a scheduled follow-up visit. Failure to attend a scheduled visit was
associated with subsequent mortality in Investigators' preliminary study and in a report from
Tanzania. At present, there is limited research regarding approaches to retaining PWH in care
during the post-hospital transition.
STUDY OBJECTIVES
The overarching goal of this proposal is to demonstrate clinical trial feasibility,
acceptability, and preliminary efficacy of structured post-discharge medical home visits to
reduce mortality following the transition from the hospital to home. Investigators are
proposing a pilot randomized clinical trial (RCT) to determine preliminary efficacy,
feasibility of trial implementation and intervention delivery, acceptability of the
intervention, the effect of the intervention on barriers to care, and to obtain detailed
baseline psychosocial and medical needs to inform intervention refinement and explain
outcomes.
The primary objectives of this study are:
1. To estimate 6 month mortality rates and assess for evidence of efficacy of the Home Link
intervention compared to care as usual.
2. To determine the feasibility, acceptability, and effect of the Home Link intervention on
identified barriers to care.
3. To characterize medical and behavioral needs among participants in the study.
The secondary objectives of this study are:
1. Determine post-hospital health care out-of-pocket costs for participants
2. Assess re-admission
3. Estimate 12 month mortality by study arm
SIGNIFICANCE
This study fits with the South African National Strategic Plan to increase effective HIV
treatment. The study is also consistent with NIH HIV/AIDS highest priority research and the
South African National Strategic Plan on HIV, TB, and STIs 2017-2022. Given the high
post-discharge mortality findings from this study could contribute to approaches to reduce
mortality for PWH.
METHODS
Study design:
This is a pilot randomized clinical trial (RCT) to refine and test the feasibility,
acceptability, and preliminary effectiveness of Home Link.
Study setting:
This pilot operational research study will be conducted in Matlosana. All participants will
be recruited from Tshepong Hospital. Eligibility will include residing within Matlosana
sub-district.
Tshepong Hospital: Tshepong Hospital is a tertiary care hospital in Matlosana. An average of
30 patients are admitted to medicine wards daily. Nearly 50% are PWH.
Description of the geographical areas of study implementation:
The proposed study will be conducted at the 500 bed Tshepong Hospital in the Northwest
Province. Tshepong Hospital is one of 5 hospitals in Kenneth Kaunda District and the single
tertiary care public hospital serving the population of 400,000 in Matlosana. This hospital
was selected due to its size, heterogeneous catchment area (rural to urban), and
long-standing working relationships with the research team. Tshepong Hospital currently
provides discharge services that include (1) discharge counseling and education provided by
counselors and (2) a medical record notebook with a discharge summary for the patient to take
to his or her clinic visits.
Rationale for selecting geographical areas of study implementation:
Investigators selected Tshepong Hospital based on a long-standing working relationship
between the PI, the Perinatal HIV Research Unit (PHRU), and the Tshepong Hospital. This has
included a prior study of post-hospital outcomes.
Study Population:
The study population is comprised of adults (≥18 years old), either male or female, spending
at least two nights in a medical ward of Tshepong Hospital. Investigators will only include
individuals with known HIV status, either HIV-positive or HIV-negative. Investigators propose
to recruit up to 180 HIV-positive and 60 HIV-uninfected participants. Randomization to the
intervention vs control arms will be stratified by HIV status.
Pre-discharge study procedures:
All participants will have a baseline demographic health and psychosocial questionnaire
(E001, E002).
Care-as-usual (CAU) study arm:
Participants will receive standard discharge care as provided at Tshepong Hospital during the
study. This currently includes discharge counseling from a trained discharge counselor and
will be provided with a follow-up return date (usually two weeks post-hospital). Discharge
counseling will include a review of discharge medications and instructions regarding
follow-up care visits.
Home Link study arm:
The Home Link intervention will be delivered by a home visit team including a primary care
nurse and counselor trained in patient-centered. A rotating hospital-based doctor will be
available for pre-home visit clinical file review and post-visit discussion, via cell phone,
for decision making and input on patient care during a household visit. Investigators have
termed this individual a "discharge officer". The discharge officer will be a Tshepong
clinician who is working in the hospital. Supporting Home Link is expected to take <30
minutes of the physician's time during the day. For study-specific concerns, the team will
consult with a Good Clinical Practice (GCP)-trained, PHRU research doctor based at the
Tshepong Hospital.
Post-discharge follow-up:
The primary outcome is mortality six months after hospital discharge. Secondary outcomes
include mortality 12 months after hospital discharge, number of nights spent in a hospital,
number of ambulatory clinical encounters after the index hospitalization, and patient
out-of-pocket costs for medical care. Outcomes will be assessed through scheduled contact and
completion of a structured questionnaire with the participant or designated next of kin
(either telephonic or in person if telephonic fails) at 8, 12, 26, and 52 weeks. Mortality
will be further ascertained through a 26 and 52 week review of the Tshepong Hospital file
(including the affiliated Klerksdorp hospital files) and matching of participant national
identification numbers to the vital statistics register through consultation with the
Department of Home Affairs. Repeat hospitalization will be ascertained using self-report /
next of kin report and hospital records. Most subsequent hospitalizations can be expected to
be at Tshepong Hospital due to the substantial distance to reach the next nearest hospital
(>50 km to a lower level facility). In Investigators' prior experience investigators have
observed rare use of alternative hospitals. Clinic visit data will be ascertained by
self-report followed by verification through review of clinic paper or electronic (tier.net)
records and National Health Laboratory Service electronic records (TrackCare).
