SLCTR Registration Number
Date of Registration
The date of last modification
Jun 02, 2017
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 of Health Condition(s) Studied
Well-being in the elderly
Universal Trial Number
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
Randomized controlled trial
Health services research
Study setting- Colombo South Teaching Hospital-Kalubowila, Medical Wards (Ward 1,22.214.171.124.9)
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.
Quality of life (using the World Health Organization Quality of Life - BREF instrument)
Number of hospital re-admissions (Interviewer Administered Questionnaire)
Health care utilization (Interviewer administer Questionnaire)
Level of self care (Instrumental Activities of Daily Living- Lawton and Brody- 1969 and Activities of Daily Living- Katz-1970)
5.Patient and caregiver satisfaction (Interviewer guide)
Primary outcome(s) - Time of assessment(s)
Baseline, three months and six months
Secondary outcome(s) - Time of assessment(s)
Target number/sample size
128 (64 in each arm)
Countries of recruitment
Anticipated start date
Anticipated end date
State of ethics review approval
Approved by the Ethics Review Committee of the Faculty of Medical Sciences, University of Sri Jayewardenepura on 26th August 2016 (Ref 36/16)
University of Sri Jayewardenepura (Grant no. ASP/01/RE/MED/2016/54)
Contact person for Scientific Queries/Principal Investigator
Mrs. L.C. Damayanthi
B.Sc. Nursing Programme, Department of Allied Health Sciences, Faculty of Medical Sciences, University of Sri Jayewardenepura, Gagodawila, Nugegoda, Sri Lanka
Mob: 0719844560/ 0769060563
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
Primary study sponsor/organization
University of Sri Jayewardenepura
University of Sri Jayewardenepura, Gangodawila, Nugegoda, Sri Lanka