Does Inpatient Enrollment Into a Patient Communication App (Patient Gateway) Result in Improved Follow-up and Survey Completion Rates After Orthopaedic Trauma?
Phase: NA
Conditions: Orthopedic Disorder
Sponsor: Massachusetts General Hospital

Protocol Summary and  Statistical Analysis Plan 
Does inpatient enrollment into a patient communication app (Patient 
Gateway) result in improved follow-up and survey completion rates after 
orthopaedic trauma? 
 
NCT 2017P001594 
Version Date 03/07/2018 
 
 

PARTNERS HUMAN RESEARCH COMMITTEE 
PROTOCOL SUMMARY 
Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
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Answer all questions accurately and completely in order to provide the PHRC with the relevant 
information to assess the risk-benefit ratio for the study.  Do not leave sections blank. 
 
PRINCIPAL/OVERALL INVESTIGATOR 
Marilyn Heng, MD, MPH, FRCSC 
 
PROTOCOL TITLE 
Does inpatient enrollment into a patient communication app (Patient 
Gateway) result in improved follow-up and survey completion rates after 
orthopaedic trauma? 
 
FUNDING 
Department Funding  
 
VERSION DATE 
3/7/2018 
 
SPECIFIC AIMS 
Concisely state the objectives of the study and the hypothesis being tested. 
This study aims to:  
1. To determine if inpatient enrollment into a patient communication app 
(Patient Gateway) improves clinic follow-up of orthopaedic trauma patients. 
2. To determine if inpatient enrollment into a patient communication app 
(Patient Gateway) improves survey completion rates after orthopedic 
trauma. 
 
BACKGROUND AND SIGNIFICANCE 
Provide a brief paragraph summarizing prior experience important for understanding the 
proposed study and procedures. 
Follow-up in trauma is historically poor. As a result, outcomes from trauma 
are difficult to collect via surveys and are often significantly influenced by 
selection bias. Patient interaction apps like Patient Gateway are thought to 
facilitate greater participant involvement and adherence to treatment 
regimens. We explored if inpatient enrollment into Patient Gateway would 
improve clinic follow-up rates. Increasing follow-up rates could improve the 
quality of care delivered. 
 
In addition, self-administered survey questionnaires are an important data 
collection tool in clinical practice, public health research and epidemiology. 
However, survey completion rates are typically poor in orthopaedic trauma.  
 
With the evaluation of modern technology, electronic applications are being 
increasingly used in both hospital and personal settings. In our outpatient 
clinic, questionnaires to measure outcomes and monitor quality of care are 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
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administered by staff members using hospital owned tablet devices. 
Recently, applications to complete these surveys on personal devices have 
been developed. 
 
In a recent Cochrane review on the comparison of self-administered survey 
questionnaire responses collected using mobile apps versus other methods it 
was concluded that there are no data available on response rates. We will 
attempt to address this question. 
 
RESEARCH DESIGN AND METHODS 
Briefly describe study design and anticipated enrollment, i.e., number of subjects to be enrolled 
by researchers study-wide and by Partners researchers.  Provide a brief summary of the 
eligibility criteria (for example, age range, gender, medical condition).  Include any local site 
restrictions, for example, “Enrollment at Partners will be limited to adults although the sponsor’s 
protocol is open to both children and adults.”
All Patient Gateway naïve patients aged 18 years or older able to consent for 
themselves, admitted to the hospital for an orthopaedic condition with the 
need for outpatient follow-up and access to the internet or a smartphone will 
be invited to participate in this study. Exclusion criteria will be patients 
unable to consent for themselves, inability to communicate in English, and 
no possession of a smartphone. 
 
We will collect 240 patients; 120 in each group. Existing follow-up is 
assumed to be close to 70%, to detect a 15% difference at 95% CI, N=240.  
 
Briefly describe study procedures.  Include any local site restrictions, for example, “Subjects 
enrolled at Partners will not participate in the pharmacokinetic portion of the study.”  Describe 
study endpoints.
Eligible patients will be randomized into two groups; one group that is 
enrolled while an inpatient and another group that is just provided 
information about how to enroll. All patients eligible for participation will be 
approached during their hospital stay and asked for consent. Patients will be 
cluster randomized by week and after consenting, they will be assigned to 
the treatment arm randomized to that specific week. For intervention group, 
an explanation on the app will be provided by a trained research staff 
member and they will be fully enrolled in the app in the presence of this 
research staff member. In the period between hospital discharge and follow-
up, patients using the Gateway app will be requested to fill out a survey on 
their personal device and will receive a notification of their upcoming 
appointment. We will monitor when patients return to clinic for their first, 
90-day, and 1-year follow-up outpatient appointments. At 90 day and 1 year 
follow-up outpatient appointments, patients from both groups will be invited 
to complete a survey on a hospital owned tablet device per standard clinic 
protocol. In addition to the standard survey, two brief questionnaires on 
satisfaction with the electronic application and satisfaction with overall care 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
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will be provided at the end of the regular survey (if already completed over 
the app; just the satisfaction questions will be administered). 
 
Descriptive statistics will be used for demographic data. Logistic regression 
will be used for binary outcome data. 
 
For studies involving treatment or diagnosis, provide information about standard of care at 
Partners (e.g., BWH, MGH) and indicate how the study procedures differ from standard care.  
Provide information on available alternative treatments, procedures, or methods of diagnosis.
Not applicable as this study does not alter treatment or diagnosis in any 
way.  
 
Describe how risks to subjects are minimized, for example, by using procedures which are 
consistent with sound research design and which do not unnecessarily expose subjects to risk or 
by using procedures already being performed on the subject for diagnostic or treatment purposes.
The risk to subjects and their privacy is no more than minimal risk because 
all data that will be reviewed will be purely demographic and questionnaire 
data. Any protected (identifiable) health information will be de-indentified 
when the study has been completed. PHI will be stored on a password-
protected Partners network computer with access limited to study staff.  We 
will be using REDCap to collect survey responses, which is hosted behind the 
Partners Firewall.  
 
Describe explicitly the methods for ensuring the safety of subjects.  Provide objective criteria for 
removing a subject from the study, for example, objective criteria for worsening disease/lack of 
improvement and/or unacceptable adverse events.  The inclusion of objective drop criteria is 
especially important in studies designed with placebo control groups.
Subjects who indicate that they do not wish to participate will not be 
included in the study. 
 
FORESEEABLE RISKS AND DISCOMFORTS 
Provide a brief description of any foreseeable risks and discomforts to subjects.  Include those 
related to drugs/devices/procedures being studied and/or administered/performed solely for 
research purposes.  In addition, include psychosocial risks, and risks related to privacy and 
confidentiality.  When applicable, describe risks to a developing fetus or nursing infant.
The one risk we can foresee is a breach of patient confidentiality. We will 
take the utmost care to ensure that confidentiality is maintained. Patient 
specific identifiers will be erased once data is collected and verified. The 
identifiers will be assessable for the shortest duration of time possible.  
 
EXPECTED BENEFITS 
Describe both the expected benefits to individual subjects participating in the research and the 
importance of the knowledge that may reasonably be expected to result from the study.  Provide 
a brief, realistic summary of potential benefits to subjects, for example, “It is hoped that the 
treatment will result in a partial reduction in tumor size in at least 25% of the enrolled subjects.”  

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
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Indicate how the results of the study will benefit future patients with the disease/condition being 
studied and/or society, e.g., through increased knowledge of human physiology or behavior, 
improved safety, or technological advances. 
There is no direct benefit to subjects who participate in this study. At a 
societal level, it is hoped that the results of the study will help improve clinic 
follow-up rates. Increasing follow-up rates could improve the quality of care 
delivered. 
 
EQUITABLE SELECTION OF SUBJECTS 
The risks and benefits of the research must be fairly distributed among the populations that stand 
to benefit from it.  No group of persons, for example, men, women, pregnant women, children, 
and minorities, should be categorically excluded from the research without a good scientific or 
ethical reason to do so.  Please provide the basis for concluding that the study population is 
representative of the population that stands to potentially benefit from this research.
All Patient Gateway naïve patients aged 18 years or older admitted to the 
hospital for an orthopaedic injury with the need for outpatient follow-up will 
be invited to participate without regard to race, ethnicity, or gender. 
Vulnerable populations will not be recruited. 
 
When people who do not speak English are excluded from participation in the research, provide 
the scientific rationale for doing so.  Individuals who do not speak English should not be denied 
participation in research simply because it is inconvenient to translate the consent form in 
different languages and to have an interpreter present.
Individuals who do not speak English will be excluded from this study 
because the surveys have not been validated for use through an interpreter. 
 
For guidance, refer to the following Partners policy: 
          Obtaining and Documenting Informed Consent of Subjects who do not Speak English
          http://healthcare.partners.org/phsirb/nonengco.htm 
 
RECRUITMENT PROCEDURES 
Explain in detail the specific methodology that will be used to recruit subjects.  Specifically 
address how, when, where and by whom subjects will be identified and approached about 
participation.  Include any specific recruitment methods used to enhance recruitment of women 
and minorities.
Subjects will be will be screened for eligibility by the Research Coordinator in 
close collaboration with the surgeon investigators. Study staff familiar with 
the study inclusion and exclusion criteria will review the daily inpatient list to 
identify potential subjects. Subjects eligible for inclusion will be approached 
by research study staff.  
 
Subjects will be given plenty of time to weigh the risks and benefits of 
participation in the study. Investigators will reinforce with their own patients 
that participation is voluntary, that they do not have to participate, and the 
decision not to participate will not affect their care, now or in the future. 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
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Provide details of remuneration, when applicable.  Even when subjects may derive medical 
benefit from participation, it is often the case that extra hospital visits, meals at the hospital, 
parking fees or other inconveniences will result in additional out-of-pocket expenses related to 
study participation.  Investigators may wish to consider providing reimbursement for such 
expenses when funding is available
Subjects will receive no remuneration. 
 
For guidance, refer to the following Partners policies: 
          Recruitment of Research Subjects 
          http://healthcare.partners.org/phsirb/recruit.htm
 
          Guidelines for Advertisements for Recruiting Subjects
          http://healthcare.partners.org/phsirb/advert.htm
 
          Remuneration for Research Subjects
          http://healthcare.partners.org/phsirb/remun.htm
 
CONSENT PROCEDURES 
Explain in detail how, when, where, and by whom consent is obtained, and the timing of consent 
(i.e., how long subjects will be given to consider participation).  For most studies involving more 
than minimal risk and all studies involving investigational drugs/devices, a licensed physician 
investigator must obtain informed consent.  When subjects are to be enrolled from among the 
investigators’ own patients, describe how the potential for coercion will be avoided.
We are requesting a waiver of written consent. Subjects will be given a fact 
sheet outlining study information. All subjects will be given ample time to 
read the fact sheet and consider participating. The PI will reinforce with the 
potential subjects that they don’t have to participate and that the decision to 
not participate will not affect their care at any time. When possible, if the PI 
is the treating physician, a Co-I, or experienced research coordinator will 
discuss the study with the subject and caregiver to avoid having the subject 
or caregiver feeling coerced. 
 
NOTE: When subjects are unable to give consent due to age (minors) or impaired decision-
making capacity, complete the forms for Research Involving Children as Subjects of Research 
and/or Research Involving Individuals with Impaired Decision-making Capacity, available on 
the New Submissions page on the PHRC website: 
http://healthcare.partners.org/phsirb/newapp.htm#Newapp
 
For guidance, refer to the following Partners policy: 
          Informed Consent of Research Subjects
          http://healthcare.partners.org/phsirb/infcons.htm
 
DATA AND SAFETY MONITORING 
Describe the plan for monitoring the data to ensure the safety of subjects.  The plan should 
include a brief description of (1) the safety and/or efficacy data that will be reviewed; (2) the 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
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planned frequency of review; and (3) who will be responsible for this review and for determining 
whether the research should be altered or stopped.  Include a brief description of any stopping 
rules for the study, when appropriate.  Depending upon the risk, size and complexity of the 
study, the investigator, an expert group, an independent Data and Safety Monitoring Board 
(DSMB) or others might be assigned primary responsibility for this monitoring activity.        
 
NOTE: Regardless of data and safety monitoring plans by the sponsor or others, the principal 
investigator is ultimately responsible for protecting the rights, safety, and welfare of subjects 
under his/her care. 
This is a non-invasive study and there will be no additional risk by 
participating in the study. 
 
The principal investigator will take responsibility for regular reviews of the 
study progress and any concerns regarding subject safety.  Study progress 
including data completion and entry will be discussed at protocol meetings to 
be held as needed during the duration of the protocol activity.  The principal 
investigator will report adverse events or other unanticipated problems to 
PHRC as described in the PHRC policy on Adverse Event Reporting and 
Unanticipated Problems Involving Risks to Subjects or Others. 
 
Describe the plan to be followed by the Principal Investigator/study staff for review of adverse 
events experienced by subjects under his/her care, and when applicable, for review of sponsor 
safety reports and DSMB reports.  Describe the plan for reporting adverse events to the sponsor 
and the Partners’ IRB and, when applicable, for submitting sponsor safety reports and DSMB 
reports to the Partners’ IRBs.  When the investigator is also the sponsor of the IND/IDE, include 
the plan for reporting of adverse events to the FDA and, when applicable, to investigators at 
other sites.   
 
NOTE: In addition to the adverse event reporting requirements of the sponsor, the principal 
investigator must follow the Partners Human Research Committee guidelines for Adverse Event 
Reporting
This is a non-invasive study involving administration of questionnaires only 
and there will be no additional risk by participating in the study; however, if 
adverse events and / or unexpected events are encountered, they will be 
reported immediately to the PI and to the IRB in accordance with the IRB 
adverse event reporting guidelines. 
 
MONITORING AND QUALITY ASSURANCE 
Describe the plan to be followed by the principal investigator/study staff to monitor and assure 
the validity and integrity of the data and adherence to the IRB-approved protocol.  Specify who 
will be responsible for monitoring, and the planned frequency of monitoring.  For example, 
specify who will review the accuracy and completeness of case report form entries, source 
documents, and informed consent.   
 
NOTE: Regardless of monitoring plans by the sponsor or others, the principal investigator is 
ultimately responsible for ensuring that the study is conducted at his/her investigative site in 

Partners Human Subjects Research Application Form 
  
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Version Date:  June 1, 2005 
 
  
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accordance with the IRB-approved protocol, and applicable regulations and requirements of the 
IRB.
The principal investigator and site responsible investigator are responsible 
for adherence to all IRB rules and guidelines. The research coordinator will 
be responsible for the accuracy and completeness of all forms, entries, and 
informed consent.  
 
As an added quality assurance measure, study staff will hold weekly 
meetings to ensure adherence to protocol is maintained by all of the study 
staff as well as to monitor the status and quality of the study. A data audit of 
25% of the data will be performed by either a research coordinator or an 
investigator to verify the accuracy of the data. 
 
For guidance, refer to the following Partners policies: 
          Data and Safety Monitoring Plans and Quality Assurance
          http://healthcare.partners.org/phsirb/guidance.htm#13
 
          Reporting Unanticipated Problems (including Adverse Events)
          http://healthcare.partners.org/phsirb/guidance.htm#7
 
PRIVACY AND CONFIDENTIALITY 
Describe methods used to protect the privacy of subjects and maintain confidentiality of data 
collected.  This typically includes such practices as substituting codes for names and/or medical 
record numbers; removing face sheets or other identifiers from completed 
surveys/questionnaires; proper disposal of printed computer data; limited access to study data; 
use of password-protected computer databases; training for research staff on the importance of 
confidentiality of data, and storing research records in a secure location.   
 
NOTE: Additional measures, such as obtaining a Certificate of Confidentiality, should be 
considered and are strongly encouraged when the research involves the collection of sensitive 
data, such as sexual, criminal or illegal behaviors.
Care will be taken to preserve the confidentiality of patient information.  
Information specific to the study (the questionnaires and scores) will be 
maintained in a private database on a secure network, to which access is 
limited. Subject data will be kept on a protocol-specific, password-protected, 
Partners Healthcare System-maintained computer that is kept in a locked 
office. PHS computers maintain the latest anti-virus software and firewall 
protections. Only IRB approved staff will have access to these data. 
 
SENDING SPECIMENS/DATA TO RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
Specimens or data collected by Partners investigators will be sent to research collaborators 
outside Partners, indicate to whom specimens/data will be sent, what information will be sent, 
and whether the specimens/data will contain identifiers that could be used by the outside 
collaborators to link the specimens/data to individual subjects.

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
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None of the information collected will be sent to research collaborators 
outside of Partners.      
 
Specifically address whether specimens/data will be stored at collaborating sites outside 
Partners for future use not described in the protocol.  Include whether subjects can withdraw 
their specimens/data, and how they would do so.  When appropriate, submit documentation of 
IRB approval from the recipient institution.
No specimens/data will be stored at sites outside of partners for future use. 
 
RECEIVING SPECIMENS/DATA FROM RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
When specimens or data collected by research collaborators outside Partners will be sent to 
Partners investigators, indicate from where the specimens/data will be obtained and whether the 
specimens/data will contain identifiers that could be used by Partners investigators to link the 
specimens/data to individual subjects.  When appropriate, submit documentation of IRB 
approval and a copy of the IRB-approved consent form from the institution where the 
specimens/data were collected.
No specimens/data will be received from sites outside of partners for future 
use. 

 
Statistical analysis, study size 
Descriptive statistics were used for demographic data. Differences between groups were assed 
using the chi-square or Fisher’s exact test for categorical variables and the t-test and/or analysis 
of variance (ANOVA) for continuous variables. Demographic or treatment factors associated 
with improved follow-up or EPP use were assessed using forward stepwise logistic regression 
modeling to avoid overfitting. We also performed a sub-group analysis assessing the the effect of 
patient race and average median income. A robustness analysis exploring the likelihood of 
enrolling in an EPP or completing follow-up in all patients was also performed. Significance was 
set at P < 0.05. Stata software, version 14 (StataCorp), was used for all analyses. 
 
An a priori power analysis was completed to determine sample size, we assumed an existing 
follow-up rate of 70%, and to detect an ~10 % difference in follow-up with an alpha of 0.05, we 
calculated an approximate sample size of 200 patients distributed equally between both groups.