Clinical trial NCT03021863: How Frequently and in What Format Are Research Trial Results Disseminated to Participants (ResponseQT)
Official title: How Frequently and in What Format Are Research Trial Results Disseminated to Participants? A Survey of Trialists and Response Questionnaire Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motivation
Keywords: Dissemination
Tone
Survey reminders
Questionnaires
Lead sponsor: ThinkWell
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: The BMJ
name: Queen's University, Belfast
First posted: 2017-01-16
Enrollment: 1198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Questionnaires are frequently used in online research, however recruiting, and completion rates of online participants from a variety of cultures and demographic backgrounds can be challenging. The challenge is greater in an online cohort because there is no way to observe the participant beyond what is contributed online. Poor recruiting and completion can result in underpowered research that may not be representative of the sample population. This can trigger an increase in costs as the recruitment period may have to be extended until sample size is reached. When recruiting and completion rates are inadequate studies may have to be terminated and the answer to the research question can remain unknown.

To mitigate these challenges, reminder emails are sent to questionnaire respondents. There is uncertainty about how the tone of the email reminder affects the proportion of recruitment rates.

A nested randomized trial will be used to test the intervention of tone delivery in survey email reminders to establish an evidence base. This study (ResponseQT) proposes to link with the anticipated 20,000 person international cohort study, (How Frequently and in What Format are Research Trial Results Disseminated to Participants: A Survey of Trialists (ResponseQT) to explore the evidence of effect for the research question, "Does the tone of a survey email reminder affect the proportion of survey participants recruited. The population will consist of researchers who have published a clinical trial indexed in Pub Med in 2014-15.The intervention is the tone of questionnaire email reminders and the outcomes will be the proportion of participants recruited after invitation (partial plus complete responses) following reminder 1 and 2.

Detailed description: RATIONALE

Dissemination is the planned process by which results of studies are communicated to the stakeholders of that research. Stakeholders can include health policy makers, academics, practicing clinicians and other health service workers, patients, the general public, and research funders. There are multiple ways to disseminate research findings and it is often considered a shared responsibility between funders and research investigators. Traditionally, the focus has targeted healthcare professionals, policy makers, and academics through journal publications and conference presentations. However, optimal knowledge translation depends on disseminating results to all stakeholders in a way that enables them to consider the implications of the results.

Effective communication and active dissemination of research results to patients and the lay public is essential for making informed decisions and choices, but it is sometimes considered as an afterthought. Furthermore, there is no consensus on what dissemination to patients or members of the lay public means, what is the most effective dissemination process and whether research results should be disseminated to relevant patient groups and the wider public as well as the patients who took part in the studies.

Only clinical trials indexed in PubMed 2014-15 where participants were enrolled into the study will be included. We will include screening questions at the start of the survey to exclude authors of non-randomised controlled trials, preclinical, and first-in-human trials and trials where there were no study participants.

AIM

To identify frequency and format of dissemination of clinical trial results to participants and to identify barriers to dissemination.

OBJECTIVES

1. To identify frequency of dissemination of recently published clinical trial results to participants;
2. To explore the format of results disseminated to participants and describe researchers' perceived appropriateness and accessibility of the format;
3. To identify how frequently research results are disseminated to patients beyond those taking part in the trials such as via advocacy groups;
4. To explore the frequency of public/patient involvement for determining the format, content, and extent of the dissemination plans;
5. To determine researchers' perceived confidence in disseminating results to participants and other patients.

This research will contain a study within a study (SWAT) also known as a nested trial (ResponseQT).

SWAT RATIONALE

Written communication in questionnaire email reminders are without verbal or sensory cues and it is difficult to modify reminders without feedback from respondents. It would be helpful to know what kind of tone the researcher can take to increase recruitment rates.

In questionnaires, the tone could be perceived as the perception of the researcher's attitude toward the reader and the subject of the message. The overall tone of a questionnaire reminder message may affect the reader just as one's tone of voice affects the listener in a verbal exchange. This could influence response and completion rates. Added to the complexity, tone can be interpreted differently by different individuals. Survey communications about reminders suggest two approaches appealing to a team victory with a sense of duty and benefit for others by participating or by building a sense of encouragement for participation. In addition, we will test whether introducing duty or encouragement in the second reminder (after a generic first reminder) makes a difference and whether someone who was exposed to duty or encouragement in the first reminder benefits from the reinforcement of a "nudge" from a generic reminder.

METHODS

This research involves exploring ways to increase recruitment rates through reminder emails that will be sent to those who were invited but have not yet responded to the questionnaire. A reminder will be sent to all non-respondents by email 14 days following the initial mailing. An additional reminder will be sent to all non-respondents by email 28 days following the first reminder. The nested trial (ResponseQT) will examine the evidence of effect for tone used within the questionnaire reminder emails. The group to which a participant is randomized will determine the tone of the questionnaire reminder emails.

All potential respondents will be randomized to one of nine groups. They will receive the same questionnaire invitation email. Reminders for non-responders be assigned according to the group they were randomized to:

Group A Tone = Duty x 2

Group B Tone = Encourage x 2

Group C Tone = Encourage + Duty

Group D Tone = Duty + encourage

Group E Tone = Generic tone reminders X 2

Group F Tone = Generic + Duty

Group G Tone = Generic + Encouragement

Group H Tone = Duty + Generic

Group I Tone = Encouragement + Generic

All non-responders will receive a reminder to complete the questionnaire at fourteen days according to the group they are randomized to. At twenty-eight days remaining non-responders will receive the second reminder email.

The outcomes of recruitment will be compared at three stages: initial response, following the first reminder and following the second reminder.

Eligibility criteria: Inclusion Criteria:

* reports of clinical trials with human participants indexed in PubMed 2014-15

Exclusion Criteria:

* reports of laboratory or animal studies,
* reports of preclinical trials,
* reports of trials where there were no study participants

Primary outcomes:
measure: Recruitment
timeFrame: Duration of study up to 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: ThinkWell
state: Oxfordshire
Study officials:
affiliation: ThinkWell
name: Amy I Price, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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