GUIDELINES FOR FOLLOW-UP/CORE OUTCOME TELEPHONE CALLS
It is vital for every trial to obtain as much data as possible to ensure valid statistical analyses
can take place. This may include obtaining data through postal questionnaires to
participants, and collecting data directly by telephone when questionnaires are not returned.
Chasing Strategy
A ‘chasing strategy’ for data collection should be defined for each trial to standardise and
maximise follow up. This should include details of specific activities i.e. how many contacts
should be made and at what time points. The strategy, including the number of reminder
questionnaires and chasing contacts must be consistent with the trial protocol, Patient
Information Leaflet and with ethical approval. It should be approved in its detail by the TMG
and may be included as part of the Trial Data Management Plan, or as a separate strategy.
Define in the chasing strategy





The criteria for determining classification of participants (i.e. responders, nonresponders, withdrawn).
The strategies for further calls e.g. call back at a pre-determined time; wait for the
participant to call back.
The maximum number of successful calls (i.e. Just calling the number and getting no
answer doesn’t count ) to be made before the participant is defined as lost to follow
up at that time point.
Which contact number to use in the first instance if more than one is held (e.g.
mobile, home, work, alternative contact person).
When messages can be left.
For example:
Week 0 - Questionnaire sent
Week 2 - 1st call. No message to be left
Week 3 - 2nd copy of questionnaire sent out
Week 4 - 2nd call to request questionnaire or collect core data if necessary. Brief message to
be left if applicable
Week 5 - final call to request questionnaire or collect core data if necessary.
Withdrawals
If the participant indicates that they do not wish to continue in the trial, a reason should be
obtained if possible (they are however under no obligation to give a reason). An explanation
to the participant of why it is so important for the trial to have as much data as possible may
be given – but we should not attempt to coerce the participant to remain in the trial if they are
unwilling for any reason (e.g. offering vouchers in the future).
WCTU Telephone guidelines
26 July 2012
Version 2.0
Voicemail messages
A decision will be needed as to whether it is appropriate to leave voice mail messages as
there may be issues around maintaining participant confidentiality. If messages are left, they
should not disclose that the person (for whom the message is intended) is taking part in a
clinical trial.
Text messages are another potential reminder but certainly not a replacement for talking to
someone. They may be useful for pre-notification of questionnaires for example.
Time of calls
In order to give the best chance of contacting people and thus ensure good follow-up rates it
may be necessary to be prepared to make calls out of usual office hours (e.g. evening calls).
Monetary incentives in the form of gift vouchers
Incentives and other evidence based strategies (e.g. for use with postal questionnaires)
should always be used to increase follow up unless there is a good reason not to.See
references below. The other main evidence based strategy is pre-notification i.e. letting
participants know that a questionnaire is coming and they should complete and return it
promptly.
Edwards PJ, Roberts I, Clarke MJ, Diguiseppi C, Wentz R, Kwan I, Cooper R, Felix LM,
Pratap S.
Methods to increase response to postal and electronic questionnaires.
Cochrane Database Syst Rev. 2009 Jul 8;(3):MR000008
Nakash RA, Hutton JL, Jørstad-Stein EC, Gates S, Lamb SE.
Maximising response to postal questionnaires--a systematic review of randomised trials in
health research.BMC Med Res Methodol. 2006 Feb 23;6:5.
Gates S, Williams MA, Withers E, Williamson E, Mt-Isa S, Lamb SE.
Does a monetary incentive improve the response to a postal questionnaire in a randomised
controlled trial? The MINT incentive study. Trials. 2009 Jun 22;10:44
Incorrect details
If the telephone number provided is incorrect or invalid, a procedure should be specified to
detail how to attempt to find the correct number. It may be worth considering, for example,
the use of the online service 192.com. It may be valuable to include ethical approval to
collect the details of another contact from the participant at recruitment.
Core data
If the participant indicates they have limited time (or interest), it may be appropriate to
concentrate on obtaining core outcome data only. This data set will need to be approved by
the CI and trial statistician.
Training for core outcome data collection should be given, such as about reading the
questions exactly, not interpreting them for the participant, and not swaying people towards
a value – for example with the EQ5D thermometer where someone should provide a
number, they should not say “that feeling fairly good is a 70”.
Call log
A record/log of each call made should be completed to record the date, time name of caller
and result of the call - a template is available. Where possible for accuracy build into any
WCTU Telephone guidelines
26 July 2012
Version 2.0
database application, reports on who to call and when so that they could be automatically
run.
Call procedure:
Anyone making calls should have received appropriate training, e.g. sensitive conversations
for critical care studies, and have sufficient knowledge about the study to be able to respond
to basic questions.
For each call ensure you speak clearly and in a polite, respectful manner – this may
necessitate using a quiet room with no distractions.
A script should be produced for callers to follow (some examples used previously are
available).
Items to include in script:
1. Introduce yourself (who you are, who you work for).
2. Confirm you are speaking to the correct person.
3. Check that it is a convenient time to call - you should give an idea of how long the
call may last and if it’s not convenient at that time, arrange another date/time to call.
4. Explain the purpose of your call/ key points to cover (participants may not realise the
importance of returning their questionnaires) and what actions are needed – this may
be requesting the return of an outstanding form or asking if the participant would be
willing to respond to questions over the phone.
5. Include prompts for common queries / scenarios that may arise for the trial.
6. If you are unable to answer any questions they have, you should explain the situation
and transfer the call to another appropriate person or arrange for someone to call
them back at a convenient time (e.g. trial coordinator). If you are transferring the call,
always explain exactly what you are doing.
7. At the end of each call, thank the participant for their time/assistance and ask if they
have any further questions.
Note: You may need to adjust your tone of voice according to the mood of the participant,
e.g. if they are angry or upset; avoid humour, keep calm and show empathy towards them. If
they are obviously in a good mood, then you can match them to some extent but always
remain professional.
Where it is considered appropriate to leave a voice mail message, a script/standard text to
use should be produced.
Training and QA:
All staff making calls should be trained in call procedures prior to taking on this role. This
should include, where possible, scenario based training - which could be done, for example,
by running a “mock call” to collect core data. A record of this training should be added to the
trainee’s PDF. After training the Trial Coordinator should follow up regularly (at least 6
monthly) with those who make calls to review the procedure and confirm that it is being
followed. If any issues or problems come to light during these meetings or it becomes clear
that follow up rates are falling, the TC may arrange for further training to be undertaken.
WCTU Telephone guidelines
26 July 2012
Version 2.0
Some calls may lead to potentially challenging conversations:
Handling potentially challenging conversations on the phone
Top Tips:






LISTEN – allow participant / patient representative to talk (or shout!) to say what they
need to get off their chest without interruption
TAKE A DEEP BREATH and take a few seconds before responding
SHOW THAT YOU HAVE BEEN LISTENING by repeating back what has been said
e.g. “It sounds like ….you are very angry to have received this letter / you are very
concerned about your participation in this study…” USE THE PERSON’S OWN
WORDS
At some point you may need to interject – perhaps by saying “I’m afraid I need to
interrupt you..”
If you feel unable to deal with the conversation then TRANSFER THE CALL to the
appropriate person e.g. Trial Coordinator or lead clinician, or arrange for the person
to be called back (as soon as possible) by the most appropriate person.
ASK FOR SUPPORT from colleagues if you want to talk about a difficult
conversation that has left you feeling emotional or that may not have gone as well as
you would have liked.
Phonetic Alphabet
Sometimes, especially if the line is bad, you may find it difficult to obtain information clearly.
In this situation, it may be useful to confirm any spellings using the phonetic alphabet:
WCTU Telephone guidelines
26 July 2012
Version 2.0
Telephone Communication Record Log for <<Name>> Trial
Date
Time
TNO
(24 hr
clock)
WCTU Telephone guidelines
Caller’s name
Outcome: Resolved;
Outcome: On-going;
Agreed to return form / completed via No answer / Message left / Call again
phone
(date/time agreed?) / Another copy requested
& sent
26 July 2012
Version 2.0