Impact of Medical Follow-up Discharge Package (RECALL-CT)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Follow-up Study; Medical In-patients
• Intervention / Treatment: Other: Integrated medical follow-up package

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa, 8001
    • Groote Schuur Hospital
  • Cape Town, South Africa, 8001
    • Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care; At discharge, patients will be given a discharge plan by their attending caregiver as deemed appropriate.
Other: Integrative medical follow-up package; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Cape Town
• Investigators: Principal Investigator: Jonathan Peter, University of Cape Town

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: August 1, 2013
• First Submitted That Met QC Criteria: August 5, 2013
• First Posted (Estimate): August 6, 2013

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: developing country; follow-up care; medical in-patients
• Other Study ID Numbers: UCT 148.2/2013