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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 -

SLCTR Registration Number

SLCTR/2017/011


Date of Registration

12 May 2017

The date of last modification

Jun 02, 2017



Application Summary


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


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)


Trial Details


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


Assignment

Parallel


Purpose

Health services research


Purpose


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

  1. Male and female elderly patients (60 years or above)
  2. Needing follow up care and having caregivers (any family member, relative, neighbor, or friend who is willing and capable of looking after elderly person in the home)

Exclusion criteria

  1. Terminally ill
  2. No caregiver
  3. Declined to participate


Primary outcome(s)

  1. Quality of life (using the World Health Organization Quality of Life - BREF instrument)

  2. Number of hospital re-admissions (Interviewer Administered Questionnaire)

  3. Health care utilization (Interviewer administer Questionnaire)

  4. 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

None


Secondary outcome(s) - Time of assessment(s)

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


Recruitment status

Recruiting


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)


Funding source

University of Sri Jayewardenepura (Grant no. ASP/01/RE/MED/2016/54)



Contact & Sponsor Information


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

Secondary study sponsor (If any)

None