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The Study is a feasibility randomized controlled trial aiming to assess the feasibility of mHealth (voice call and SMS) and teach-back interventions on reducing the 30 days readmission rate in the patients enrolled in the Sehat Sahulat Programme (Prime Minister National Health Programme(PMNHP)).
The prime objective of this study was to generate a proof of concept for the conduct of a definitive trial for the reduction in readmissions in PMNHP.
A feasibility randomized controlled trial study consisted of three arms i.e intervention 1 (telephonic contact and text messages), intervention 2 (teach-back method) and control is planned in program beneficiaries of Islamabad, Pakistan.
The trial is being carried out in the three hospitals of Islamabad and patients are being recruited as per the inclusion and exclusion criteria.
Interventional Description of intervention(s) / exposure The study will comprise of three phases Phase I = Preparation Phase II= Implementation and monitoring Phase III = Evaluation Phase I (Preparation) i. Permissions
Phase II (Implementation) i) Team building This step shall include recruiting educated individuals for the survey. For this purpose selected PMNHP staff will be recruited for telephonic contact with the patients.
Researcher himself will brief and orient the team on background and objectives, the usefulness of the study and data recording and medication adherence scale to be used in the study, in a one day workshop comprising of one session of 3 hours.
ii) Validation of the Urdu translation of Medication Adherence Questionaire (MAQ) In order to address the validity and reliability of the MAQ translation and back translations of the questionnaire will be carried out. The questionnaire will be pretested on 10 patients by the staff for adaptability in accordance with the WHO guidelines.
iii) Developing text for SMS This shall comprise of developing easy and understandable text for SMS in English and Urdu for medication adherence and timely follow up to be delivered to the patients. For this purpose, Health communication experts and \ public health professionals will be contacted and involved. The developed SMS will be piloted among patients in a similar setting.
iv) Training of Data collectors for telephonic contact Selected PMNHP staff will be trained to contact the patients on their telephones and ask questions regarding their medication adherence and fill up the MAQ. Training sessions will be conducted by the researcher to carry out a telephonic survey and send SMS messages to the selected patients.
v) Training of doctors and nurses on the teach-back process Doctors and nurses from the selected empanelled hospitals will be trained on the teach-back process for better discharge communication with the patients. One day training session will be held in the Health Services academy vi) Assigning tasks and responsibilities All team members will be provided with a work-plan and agreed on responsibilities with timelines, in order to ensure timely and proper implementation of the various phases of the study.
vii) Intervention: Intervention - 1 (mhealth through a telephonic voice call and text messages) Telephonic voice calls for medication adherence using Morisky, Green and Levine (MGL) 4 items validated medication adherence scale at 7, (Baseline) 14, 21 and 30 days post index discharge. MGL is a validated tool for assessment of medication adherence with a Cronbach alpha = 0.61 in a European setting. The instrument will be translated in Urdu language and will be validated for linguistic and cultural adaptation using the following procedure:-
Intervention - 2 ( Teach-Back process) Teach-back is a simple mechanism by which a patient's understanding of a concept or topic may be assessed.
Society of Hospital Medicine (US) complete teach-back module will be used to train nurses and doctors of PMNHP empanelled hospitals in ICT in a one-day training session in Health Services Academy. This teach-back process intervention will be utilized in in group 2
viii) Monitoring the process: All steps and activities of the study will be monitored and spot-checked by the researcher Patients in the study will be contacted through telephone randomly in order to ensure that they are receiving teach-back, SMS and telephonic calls regarding medication adherence and follow up.
Phase III: Trial Acceptability
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | No Intervention | No intervention is being conducted in this arm. Routine care is being given to these patients. The patients will be followed up for any readmissions during the intervention period. | |
| mHealth Arm | Experimental | This arm will receive first receive weekly telephone call followed by the SMS in Urdu regarding medication adherence according to the discharge instructions. The calls and SMS will be sent on 7, 14, 21 and 30th day post-index discharge. The patients will be followed up for any readmissions during the intervention period. |
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| Teach back arm | Experimental | The trained doctors thoroughly explained the discharge instructions, medication schedule and any other self-care instructions to these participants and asked them to repeat what they have understood from the doctor verbal counselling. If the instructions were not clearly comprehended by the patients, then the same would be repeated by the consultant doctor. The patients will be followed up for any readmissions during the intervention period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mHealth | Other | The mHealth intervention includes telephonic call and SMS. |
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| Measure | Description | Time Frame |
|---|---|---|
| Readmission within 7 days post discharge | 7 Days after discharge, participants were assessed for readmission. | 7 days post discharge. |
| Readmission within 14 days post discharge | 14 Days after discharge, participants were assessed for readmission. | 14 days post discharge. |
| Readmission within 21 days post discharge | 21 Days after discharge, participants were assessed for readmission | 21 Days post discharge |
| Readmission within 30 days post discharge | 30 Days after discharge, participants were assessed for readmission | 30 Days post discharge |
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Inclusion Criteria:
Adult patients > 30 years of age
Exclusion Criteria:
Serious mental illness such as schizophrenia,
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Syed Fawad Mashhadi, MPH, MPhil | Contact | +923218543782 | phd15fawad@hsa.edu.pk |
| Name | Affiliation | Role |
|---|---|---|
| Assad Hafeez, PhD | Health Services Academy, Pakistan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkhidmat AlRazi Hospital | Recruiting | Islamabad | Punjab Province | 46000 | Pakistan |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2020 | Jan 21, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D064871 | Teach-Back Communication |
| ID | Term |
|---|---|
| D003142 | Communication |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Teach-back |
| Behavioral |
While the teach-back includes counselling session related to discharge instruction including medication adherence. |
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