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

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ClinicalTrials.gov Identifier: NCT01916876
Recruitment Status : Withdrawn (Funding shortage)
First Posted : August 6, 2013
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Jonathan Peter, University of Cape Town

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.


Condition or disease Intervention/treatment Phase
Follow-up Study Medical In-patients Other: Integrated medical follow-up package Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Health Services Research
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 Start Date : March 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : May 2016

Arm Intervention/treatment
No Intervention: Standard Care
At discharge, patients will be given a discharge plan by their attending caregiver as deemed appropriate.
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.

  1. 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

  2. Reminders via SMS to attend there OPD appointment(s)
  3. Medical out-patient review at 2-weeks and 6 weeks if required
  4. Medical telephonic "hot-line" for advice




Primary Outcome Measures :
  1. All cause mortality [ Time Frame: 12 months ]
    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


Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 6 months ]
    6-month mortality will be evaluated in a similar way to 12-month mortality.

  2. Hospital readmission rate [ Time Frame: 12 months ]
    Readmission to secondary, tertiary hospitals or emergency units will be included.

  3. Bartel index [ Time Frame: 12 months ]
    The change in functional outcome between discharge and 12-months will be measured using the Bartel index.

  4. Karnofsky performance score [ Time Frame: 12 months ]
    Changes in functional outcomes will be assessed by measuring the change in Karnofsky performance scores between 12-months and pre-admission.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01916876


Locations
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South Africa
Groote Schuur Hospital
Cape Town, South Africa, 8001
Victoria Hospital
Cape Town, South Africa, 8001
Sponsors and Collaborators
University of Cape Town
Investigators
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Principal Investigator: Jonathan Peter University of Cape Town
Publications:
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Responsible Party: Jonathan Peter, Honorary Consultant, Department of Medicine, University of Cape Town
ClinicalTrials.gov Identifier: NCT01916876    
Other Study ID Numbers: UCT 148.2/2013
First Posted: August 6, 2013    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014
Keywords provided by Jonathan Peter, University of Cape Town:
medical in-patients
follow-up care
developing country