Clinical trial NCT01916876: Impact of Medical Follow-up Discharge Package
Official title: A Randomised Controlled Trial of an Integrated Post-discharge Transitional Care Package for General Medical In-patients in Cape Town, South Africa
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Follow-up Study
Medical In-patients
Keywords: medical in-patients
follow-up care
developing country
Lead sponsor: University of Cape Town
Sponsor class: OTHER
First posted: 2013-08-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The post discharge time is a vulnerable time for general medical in-patients, with high rates of adverse events that may cause unnecessary readmissions and even death. A recent study of 415 patients discharged from the general medical wards at Groote Schuur Hospital, demonstrated a very high 12 month mortality of 35%. The majority of these deaths were classified as "unexpected". The reasons for this were not further examined, but it was speculated, given the authors' knowledge of the public sector in Cape Town, that three related factors contribute significantly to this early mortality: i) a lack of continuity of care, with patients not necessarily accessing the primary care support treatment that they need or being able to access early post discharge follow-up (for example for anti-retroviral or anti-tuberculous care); ii) the inability of primary care to deal with the complex nature of the discharged patients, most whom have significant co-morbid disease; iii) A lack of optimisation of therapy for chronic disease after acute discharge.

The investigators hypothesise that an integrated post-discharge transitional care package, which includes an early medical specialist follow-up in the first 3 months after hospital discharge will decrease the 6- and 12-month mortality and re-admission rate amongst general medical hospital admissions in Cape Town, South Africa. Our study will compare an integrated package, suitable to implementation if effective, with current standard discharge packages.


Eligibility criteria: Inclusion Criteria:

1. Patients referred for admission to general medical wards (including within hospital transfer e.g. ICU discharge)
2. \>18 years and willing to give informed consent

Exclusion Criteria:

1. Patient admitted directly to intensive care unit
2. Patient refusing consent or \<18 years old
3. Patients electively admitted
4. Patients without phone numbers who cannot provide any telephone contact details for a co-habitant, relative or neighbour.

Primary outcomes:
measure: All cause mortality
timeFrame: 12 months
Secondary outcomes:
measure: All cause mortality
timeFrame: 6 months
measure: Hospital readmission rate
timeFrame: 12 months
measure: Bartel index
timeFrame: 12 months
measure: Karnofsky performance score
timeFrame: 12 months
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
city: Cape Town
country: South Africa
facility: Victoria Hospital
Study officials:
affiliation: University of Cape Town
name: Jonathan Peter
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stuart-Clark H, Vorajee N, Zuma S, Van Niekerk L, Burch V, Raubenheimer P, Peter JG. Twelve-month outcomes of patients admitted to the acute general medical service at Groote Schuur Hospital. S Afr Med J. 2012 May 23;102(6):549-53. doi: 10.7196/samj.5615.