Impact of Medical Follow-up Discharge Package

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised Controlled Trial of an Integrated Post-discharge Transitional Care Package for General Medical In-patients in Cape Town, South Africa

Conditions
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Follow-up Study, Medical In-patients

Intervention / Treatment
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* Other: Integrated medical follow-up package


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients referred for admission to general medical wards (including within hospital transfer e.g. ICU discharge) >18 years and willing to give informed consent Exclusion Criteria: Patient admitted directly to intensive care unit Patient refusing consent or <18 years old Patients electively admitted Patients without phone numbers who cannot provide any telephone contact details for a co-habitant, relative or neighbour.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>At discharge, patients will be given a discharge plan by their attending caregiver as deemed appropriate. | |
| Other: Integrative medical follow-up package<br>At discharge, patients will receive a discharge plan by their attending caregiver. Thereafter, if randomised to this study arm they will receive the intervention as outlined elsewhere. Integrated Medical Follow-up package | Other: Integrated medical follow-up package<br>* At discharge, patients will receive a discharge plan by their attending caregiver. On day 3 they will be contacted telephonically to: i) Discuss their discharge diagnosis and medications ii) Arrange specialist clinic follow-up booking for 2 weeks iii) Reemphasise drug compliance Reminders via SMS to attend there OPD appointment(s) Medical out-patient review at 2-weeks and 6 weeks if required Medical telephonic hot-line for advice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | All cause 12-month mortality will be evaluated at 12-months post enrolment. Data on mortality will be acquired through telephonic patient/family contact and review of provincial death registry | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | 6-month mortality will be evaluated in a similar way to 12-month mortality. | 6 months | 
| Hospital readmission rate | Readmission to secondary, tertiary hospitals or emergency units will be included. | 12 months | 
| Bartel index | The change in functional outcome between discharge and 12-months will be measured using the Bartel index. | 12 months | 
| Karnofsky performance score | Changes in functional outcomes will be assessed by measuring the change in Karnofsky performance scores between 12-months and pre-admission. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medical in-patients, follow-up care, developing country