Home » Trials » SLCTR/2017/011
Improving health and well-being of elderly patients from a tertiary care hospital through nurse-led discharge plan and follow-up care: a Randomised Controlled Trial
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SLCTR Registration Number
SLCTR/2017/011
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Improving health and well-being of elderly patients from a tertiary care hospital through nurse-led discharge plan and follow-up care: a Randomised Controlled Trial
Public Title of Trial
Improving health and well-being of elderly patients through nurse-led discharge plan and follow-up care: a Randomised Controlled Trial
Disease or Health Condition(s) Studied
Well-being in the elderly
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1194-2789
Any other number(s) assigned to the trial and issuing authority
36/16 (ERC: Sri Jayewardenepura)
What is the research question being addressed?
Would the health and well-being of elderly patients improve to a greater extent by providing them with a nurse-led Post Discharge Plan (PDP) and follow-up care, compared to those who did not receive such care?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Health services research
Study Phase
Not Applicable
Intervention(s) planned
Study setting- Colombo South Teaching Hospital-Kalubowila, Medical Wards (Ward 1,3.4.5.7.9)
Participants will be randomized into the intervention and control arms using random block design; the computer generated randomization code will select randomly permuted blocks of 2 or 4.
Intervention Arm Participants in the intervention arm will receive
(i) a discharge plan meeting which will take 30-45 minutes with the PI (discharge planning nurse) and caregiver prior to discharge from the hospital.
(ii) a face-to-face education programme that will be included in information on adhering to medical treatment plan, follow-up clinics and appointments, self-care practices, life-style/behavior modifications, addressing patient specific educational needs, strategies to prevent complications, living environment modification prevent from social isolation, encourage spiritual activities, encourage leisure activities and promoting utilization of available community resources. This will last approximately 30-45 minutes and will take place on the day of discharge at the medical ward.
(iii) a telephone follow-up at three and six months (to assess the compliance to PDP and motivational short messages (SMS) on adhering to PDP)
(iv) Home visits at three months (phase II Assessment) and six months (Analysis)
Conducting discharge plan meeting, developing a tailor made PDP , telephone follow-up and home visits are included in the nurse-led discharge plan and follow-up care, which is a new intervention in addition to the standard discharge plan currently practiced in medical wards.
Control Arm Participants in the control arm will receive
(i) Usual care (current discharge plan implemented in medical wards)
(ii) Telephone calls to confirm discharge destination and participation in the study (done by Independent Research Assistant)
(ii) Home visits at three months (phase II Assessment) and six months (Analysis)
Single blinding will be achieved as participants will be selected by independent assessor (Research Assistant-RA) who will blind to the selection. Individual consultations will take place.
Data will be analyzed by independent analyst who will be provided with pre-entered coded responses, and therefore blinded to the intervention state of the participants.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Quality of life (using the World Health Organization Quality of Life - BREF instrument) |
[ Baseline, three months and six months ] |
|
2.
Number of hospital re-admissions (Interviewer Administered Questionnaire) |
[ Baseline, three months and six months ] |
|
3.
Health care utilization (Interviewer administer Questionnaire) |
[ Baseline, three months and six months ] |
|
4.
Level of self care (Instrumental Activities of Daily Living- Lawton and Brody- 1969 and Activities of Daily Living- Katz-1970) |
[ Baseline, three months and six months ] |
|
5.
Patient and caregiver satisfaction (Interviewer guide) |
[ Baseline, three months and six months ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
128 (64 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2017-06-01
Anticipated end date
2018-01-31
Date of first enrollment
2017-06-02
Date of study completion
Recruitment status
Recruiting
Funding source
University of Sri Jayewardenepura (Grant no. ASP/01/RE/MED/2016/54)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2016-08-26
Approval number
36/16
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura |
| Institutional Address: | Gangodawila, Nugegoda Sri Lanka |
| Telephone: | +94-112758000 (Extension: 4075) |
| Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Mrs. L.C. Damayanthi
Lecturer
B.Sc. Nursing Programme,
Department of Allied Health Sciences,
Faculty of Medical Sciences,
University of Sri Jayewardenepura,
Gagodawila, Nugegoda, Sri Lanka
Tel: +94-113182366
Mob: 0719844560/ 0769060563
damayanthi.chamila@ymail.com/ damayanthi.chamila@sjp.ac.lk
Contact Person for Public Queries
Dr. R.B. Marasinghe
Head, Department of Medical Education and Health Sciences
Faculty of Medical Sciences,
University of Sri Jayewardenepura,
Gagodawila, Nugegoda, Sri Lanka
Tel: +94-112758570
rohanabm@sjp.ac.lk
Primary study sponsor/organization
University of Sri Jayewardenepura
Research Council
University of Sri Jayewardenepura, Gangodawila, Nugegoda, Sri Lanka
Tel: +94-112803473
drasp@sjp.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
