Follow-up StudyRECALL-CTNCT01916876
Impact of Medical Follow-up Discharge Package
A study testing Integrated medical follow-up package in people with Follow-up Study and Medical In-patients, run by University of Cape Town at 2 sites in South Africa.
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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follow-up Study, Medical In-patients
- What is being tested?
- Integrated medical follow-up package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesSouth Africa
- Study dates
- Mar 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for admission to general medical wards (including within hospital transfer e.g. ICU discharge)
- >18 years and willing to give informed consent
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Groote Schuur Hospital
Cape Town, 8001
Victoria Hospital
Cape Town, 8001
About this study
Official title: 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.
- Conditions
- Follow-up Study, Medical In-patients
- Being tested
- Integrated medical follow-up package
- Keywords
- medical in-patients, follow-up care, developing country
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated medical follow-up packageOther
At discharge, patients will receive a discharge plan by their attending caregiver.
- On day 3 they will be contacted telephonically to:
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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" Receives: Other: Integrated medical follow-up package |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (4)
All cause mortality
6-month mortality will be evaluated in a similar way to 12-month mortality.
Measured: 6 months
Hospital readmission rate
Readmission to secondary, tertiary hospitals or emergency units will be included.
Measured: 12 months
Bartel index
The change in functional outcome between discharge and 12-months will be measured using the Bartel index.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startMar 2015
- Primary completionDec 2015 (estimated)
- Study completionMay 2016 (estimated)
Why it stopped: Funding shortage
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Follow-up StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Peter, University of Cape Town
- Investigators
- Jonathan Peter, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916876
- Sponsor's protocol ID
- UCT 148.2/2013
- Acronym
- RECALL-CT
- Status last verified
- Dec 2014
- First submitted
- 1 Aug 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22668961
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of an Integrated Post-discharge Transitional Care Package for General Medical In-patients in Cape Town, South Africa
- ClinicalTrials.gov ID
- NCT01916876
- Acronym / sponsor ID
- RECALL-CT / UCT 148.2/2013
- Conditions
- Follow-up Study, Medical In-patients
- Keywords
- medical in-patients, follow-up care, developing country
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding shortage
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 6 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Integrated medical follow-up packageAt 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" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients referred for admission to general medical wards (including within hospital transfer e.g. ICU discharge)
- >18 years and willing to give informed consent
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated medical follow-up packageAt 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 | Other | Integrative medical follow-up package |
Primary outcome
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
4 secondary outcomes
All cause mortality
Time frame: 6 months
Hospital readmission rate
Time frame: 12 months
Bartel index
Time frame: 12 months
Karnofsky performance score
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Background: PubMed 22668961Stuart-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Peter principal investigator
University of Cape Town
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated medical follow-up package in people with Follow-up Study and Medical In-patients, run by University of Cape Town at 2 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01916876, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.