Impact of Medical Follow-up Discharge Package

NCT01916876 | Withdrawn

• 1 other identifier: UCT 148.2/2013
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Follow-up Study; Medical In-patients

Keywords

medical in-patients; follow-up care; developing country

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• All cause mortality

  6 months

• Hospital readmission rate

  12 months

• Bartel index

  12 months

• Karnofsky performance score

  12 months

Study Arms (2)

Standard Care

NO INTERVENTION

At discharge, patients will be given a discharge plan by their attending caregiver as deemed appropriate.

Integrative medical follow-up package

OTHER

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

Interventions

Integrated medical follow-up package OTHER

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

Integrative medical follow-up package

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cape Town: lead

Study Sites (2)

Groote Schuur Hospital

Cape Town, 8001, South Africa

Location

Victoria Hospital

Cape Town, 8001, South Africa

Location

Related 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. doi: 10.7196/samj.5615.

  PMID: 22668961 BACKGROUND

Study Officials

• Jonathan Peter

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Consultant, Department of Medicine

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: August 6, 2013
• Study Start: March 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2016
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

ZA (2)