Impact of Medical Follow-up Discharge Package

Follow-up Study Clinical Trial

— RECALL-CT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01916876
• Other study ID #: UCT 148.2/2013
• Status: Withdrawn
• Phase: N/A
• First received: August 1, 2013
• Last updated: December 2, 2014
• Start date: March 2015
• Est. completion date: May 2016

Study information

• Verified date: December 2014
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Follow-up Study
• Medical In-patients

Intervention

Other:
• Integrated medical follow-up package
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

Locations

Country	Name	City	State
South Africa	Groote Schuur Hospital	Cape Town
South Africa	Victoria Hospital	Cape Town

Sponsors (1)

Lead Sponsor	Collaborator
University of Cape Town

Country where clinical trial is conducted

South Africa, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	All cause mortality	6-month mortality will be evaluated in a similar way to 12-month mortality.	6 months	No
Secondary	Hospital readmission rate	Readmission to secondary, tertiary hospitals or emergency units will be included.	12 months	No
Secondary	Bartel index	The change in functional outcome between discharge and 12-months will be measured using the Bartel index.	12 months	No
Secondary	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	No