ReadmissionNCT04738669
Mhealth and Teach-Back Effectiveness In 30-Day Readmissions Reduction
A study testing mHealth and Teach-back in people with Readmission and mHealth, run by Health Services Academy, Islamabad, Pakistan at 1 site in Pakistan.
Trial summary
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)). Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Readmission, mHealth, Teach-Back Communication
- What is being tested?
- mHealth and Teach-back
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2020to Jun 2021
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients > 30 years of age
- Incident adult cases with index admission in PMNHP
- Ischemic Heart disease, Myocardial Infarction, Hypertension, Diabetes Mellitus, Bronchial Asthma
- Patients with a valid mobile number
- Able to read the SMS in Urdu
Who cannot join
- Serious mental illness such as schizophrenia,
- Are unable to use a telephone
- Are cognitively impaired during hospitalization as diagnosed by the consultant
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Alkhidmat AlRazi Hospital
Islamabad, Punjab Province, 46000
Usman Zafar, MBBS, FCPS, +923335723685, raazihospital.ms@gmail.com
About this study
Official title: Effectiveness of Mhealth and Teach-back Methods in Readmissions Reduction in Prime Minister's National Health Programme - A Feasibility Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
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
- Ethical approval from Institutional review Board of Health Services Academy Islamabad
- Permission from PMNHP to carry out a feasibility study
- Written consent from doctors and nurses to be enrolled in the teach-back process
- Informed verbal consent from all the selected patients to be enrolled in the PMNHP ii. Situation analysis The cross-sectional study will be conducted at the start of study prior to intervention to provide baseline data on selected variables. The baseline data will include sociodemographic status, diagnosis, comorbidities, length of stay in the hospital for the index admission.
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.
- 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:-
- Forward translation One translator, preferably a health professional, familiar with the terminology of the area covered by the instrument and with interview skills will be given this task.
- Expert panel A bilingual (in English and Urdu) expert panel will be convened. The goal in this step will be to identify and resolve the inadequate expressions/concepts of the translation, as well as any discrepancies between the forward translation and the existing or comparable previous versions of the questions if any. The result of this process will produce a complete translated version of the questionnaire
- Back-translation Using the same approach as that outlined in the first step, the instrument will then be translated back to English by an independent translator who has no knowledge of the questionnaire
- Pre-testing and cognitive interviewing. Pre-testing will be done on a sample of 10 - 18 patients and other discrepancies will be removed • Weekly Short text messages (SMS) from PMNHP staff will be sent to the enrolled patients about adherence to medication and follow up reminders
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
- In-depth Interviews and Focused Group Discussions from stakeholders at all three levels
- Post-intervention exploration of factors influencing implementation of the Interventions with identification of facilitators and barriers faced by stakeholders during the pilot implementation
- This will generate evidence to support up scalability of PMNHP
- Ten individuals from each level through purposive sampling will be selected for subjective perceptions and acceptability of the interventions
- Conditions
- Readmission, mHealth, Teach-Back Communication
- Being tested
- mHealth, Teach-back
- Keywords
- Readmission, Mobile health, mHealth, Teach-Back Communication
- Medical subject headings
- Teach-Back Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealthOther
The mHealth intervention includes telephonic call and SMS.
Teach-backBehavioural
While the teach-back includes counselling session related to discharge instruction including medication adherence.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: mHealth |
| 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. Receives: Behavioral: Teach-back |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission within 7 days post discharge
7 Days after discharge, participants were assessed for readmission.
Measured: 7 days post discharge.
Readmission within 14 days post discharge
14 Days after discharge, participants were assessed for readmission.
Measured: 14 days post discharge.
Readmission within 21 days post discharge
21 Days after discharge, participants were assessed for readmission
Measured: 21 Days post discharge
Readmission within 30 days post discharge
30 Days after discharge, participants were assessed for readmission
Measured: 30 Days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start1 Mar 2020
- Primary completionMar 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ReadmissionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Services Academy, Islamabad, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Fawad Mashhadi, Health Services Academy, Islamabad, Pakistan
- Investigators
- Assad Hafeez, PhD, Study director, Health Services Academy, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738669
- Sponsor's protocol ID
- No 1-07/14-HSA/2021
- Status last verified
- Feb 2021
- First submitted
- 21 Jan 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mhealth and Teach-back Methods in Readmissions Reduction in Prime Minister's National Health Programme - A Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04738669
- Acronym / sponsor ID
- No 1-07/14-HSA/2021
- Conditions
- Readmission, mHealth, Teach-Back Communication
- Keywords
- Readmission, Mobile health, mHealth, Teach-Back Communication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Health Services Academy, Islamabad, PakistanUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 4 Feb 2021 (actual)
- 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 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.
Detailed description
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
- Ethical approval from Institutional review Board of Health Services Academy Islamabad
- Permission from PMNHP to carry out a feasibility study
- Written consent from doctors and nurses to be enrolled in the teach-back process
- Informed verbal consent from all the selected patients to be enrolled in the PMNHP ii. Situation analysis The cross-sectional study will be conducted at the start of study prior to intervention to provide baseline data on selected variables. The baseline data will include sociodemographic status, diagnosis, comorbidities, length of stay in the hospital for the index admission.
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.
- 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:-
- Forward translation One translator, preferably a health professional, familiar with the terminology of the area covered by the instrument and with interview skills will be given this task.
- Expert panel A bilingual (in English and Urdu) expert panel will be convened. The goal in this step will be to identify and resolve the inadequate expressions/concepts of the translation, as well as any discrepancies between the forward translation and the existing or comparable previous versions of the questions if any. The result of this process will produce a complete translated version of the questionnaire
- Back-translation Using the same approach as that outlined in the first step, the instrument will then be translated back to English by an independent translator who has no knowledge of the questionnaire
- Pre-testing and cognitive interviewing. Pre-testing will be done on a sample of 10 - 18 patients and other discrepancies will be removed • Weekly Short text messages (SMS) from PMNHP staff will be sent to the enrolled patients about adherence to medication and follow up reminders
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
- In-depth Interviews and Focused Group Discussions from stakeholders at all three levels
- Post-intervention exploration of factors influencing implementation of the Interventions with identification of facilitators and barriers faced by stakeholders during the pilot implementation
- This will generate evidence to support up scalability of PMNHP
- Ten individuals from each level through purposive sampling will be selected for subjective perceptions and acceptability of the interventions
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: mHealthThis 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. |
| Teach back arm | Experimental | Behavioral: Teach-backThe 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients > 30 years of age
Key exclusion criteria (3 listed)
- Serious mental illness such as schizophrenia,
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 |
|---|---|---|
| mHealthThe mHealth intervention includes telephonic call and SMS. | Other | mHealth Arm |
| Teach-backWhile the teach-back includes counselling session related to discharge instruction including medication adherence. | Behavioural | Teach back arm |
Primary outcome
Readmission within 7 days post discharge
Time frame: 7 days post discharge.
7 Days after discharge, participants were assessed for readmission.
Readmission within 14 days post discharge
Time frame: 14 days post discharge.
14 Days after discharge, participants were assessed for readmission.
Readmission within 21 days post discharge
Time frame: 21 Days post discharge
21 Days after discharge, participants were assessed for readmission
Readmission within 30 days post discharge
Time frame: 30 Days post discharge
30 Days after discharge, participants were assessed for readmission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Assad Hafeez, PhD study director
Health Services Academy, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth and Teach-back in people with Readmission and mHealth, run by Health Services Academy, Islamabad, Pakistan at 1 site in Pakistan.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Syed Fawad Mashhadi, MPH, MPhil (+923218543782, phd15fawad@hsa.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission within 7 days post discharge (time frame: 7 days post discharge.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2021.