Effect of two different participant information sheets on recruitment to a falls trial

An embedded randomised recruitment trial

Miles D. Witham (Corresponding Author), Margaret M. Band, Rosemary J. G. Price, Roberta L. Fulton, Clare L. Clarke, Peter T. Donnan, Roy L Soiza, Vera Cvoro

Research output: Contribution to journalArticle

Abstract

Background/Aims: Recruitment to trials of intervention for older people who fall is challenging. Evidence suggests that the word falls has negative connotations for older people, and this may present a barrier to engaging with trials in this area. We therefore tested whether a participant information sheet that minimised reference to falls could improve recruitment rates.
Methods: We conducted a study within a trial, embedded within a randomised controlled trial of vitamin K versus placebo to improve postural sway in patients aged 65 and over with a history of falls. Potential participants were identified from primary care lists in 14 practices and were randomised to receive either a standard participant information sheet or an information sheet minimising use of the word falls, instead focussing on maintenance of health, fitness and balance. The primary outcome for this embedded trial was the proportion of responses expressing interest in participating received in each arm. Secondary outcomes were the proportion of those contacted attending a screening visit, consenting at screening, and the proportion contacted who were randomised into the main trial.
Results: In all, 4145 invitations were sent, with an overall response rate of 444 (10.7%). In all, 2148 individuals received the new information sheet (minimising reference to falls); 1997 received the standard information sheet. There was no statistically significant difference in response rate between those individuals sent the new information sheet and those sent the standard information sheet (10.1% vs 11.4%; difference 1.3% (95% confidence interval ?0.6% to 3.2%); p?=?0.19). Similarly, we found no statistically significant difference between the percentage of those who attended and consented at screening in the two groups (2.1% vs 2.7%; difference 0.6% (95% confidence interval: ?0.4% to 1.6%); p?=?0.20), and no statistically significant difference between the percentage randomised in the two groups (2.0% vs 2.6%; difference 0.6% (95% confidence interval ?0.4% to 1.6%); p?=?0.20)
Conclusions: Use of a participant information sheet minimising reference to falls did not lead to a greater response rate in this trial targeting older people with a history of falls.
Original languageEnglish
Pages (from-to)551-556
Number of pages6
JournalClinical Trials
Volume15
Issue number6
Early online date27 Sep 2018
DOIs
Publication statusPublished - 1 Dec 2018

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Confidence Intervals
Vitamin K
Primary Health Care
Randomized Controlled Trials
Placebos
Health

Keywords

  • Falls
  • study within a trial
  • participant information sheet
  • recruitment

Cite this

Witham, M. D., Band, M. M., Price, R. J. G., Fulton, R. L., Clarke, C. L., Donnan, P. T., ... Cvoro, V. (2018). Effect of two different participant information sheets on recruitment to a falls trial: An embedded randomised recruitment trial. Clinical Trials, 15(6), 551-556. https://doi.org/10.1177/1740774518803558

Effect of two different participant information sheets on recruitment to a falls trial : An embedded randomised recruitment trial. / Witham, Miles D. (Corresponding Author); Band, Margaret M.; Price, Rosemary J. G.; Fulton, Roberta L.; Clarke, Clare L.; Donnan, Peter T.; Soiza, Roy L; Cvoro, Vera.

In: Clinical Trials, Vol. 15, No. 6, 01.12.2018, p. 551-556.

Research output: Contribution to journalArticle

Witham, Miles D. ; Band, Margaret M. ; Price, Rosemary J. G. ; Fulton, Roberta L. ; Clarke, Clare L. ; Donnan, Peter T. ; Soiza, Roy L ; Cvoro, Vera. / Effect of two different participant information sheets on recruitment to a falls trial : An embedded randomised recruitment trial. In: Clinical Trials. 2018 ; Vol. 15, No. 6. pp. 551-556.
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abstract = "Background/Aims: Recruitment to trials of intervention for older people who fall is challenging. Evidence suggests that the word falls has negative connotations for older people, and this may present a barrier to engaging with trials in this area. We therefore tested whether a participant information sheet that minimised reference to falls could improve recruitment rates.Methods: We conducted a study within a trial, embedded within a randomised controlled trial of vitamin K versus placebo to improve postural sway in patients aged 65 and over with a history of falls. Potential participants were identified from primary care lists in 14 practices and were randomised to receive either a standard participant information sheet or an information sheet minimising use of the word falls, instead focussing on maintenance of health, fitness and balance. The primary outcome for this embedded trial was the proportion of responses expressing interest in participating received in each arm. Secondary outcomes were the proportion of those contacted attending a screening visit, consenting at screening, and the proportion contacted who were randomised into the main trial.Results: In all, 4145 invitations were sent, with an overall response rate of 444 (10.7{\%}). In all, 2148 individuals received the new information sheet (minimising reference to falls); 1997 received the standard information sheet. There was no statistically significant difference in response rate between those individuals sent the new information sheet and those sent the standard information sheet (10.1{\%} vs 11.4{\%}; difference 1.3{\%} (95{\%} confidence interval ?0.6{\%} to 3.2{\%}); p?=?0.19). Similarly, we found no statistically significant difference between the percentage of those who attended and consented at screening in the two groups (2.1{\%} vs 2.7{\%}; difference 0.6{\%} (95{\%} confidence interval: ?0.4{\%} to 1.6{\%}); p?=?0.20), and no statistically significant difference between the percentage randomised in the two groups (2.0{\%} vs 2.6{\%}; difference 0.6{\%} (95{\%} confidence interval ?0.4{\%} to 1.6{\%}); p?=?0.20)Conclusions: Use of a participant information sheet minimising reference to falls did not lead to a greater response rate in this trial targeting older people with a history of falls.",
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T1 - Effect of two different participant information sheets on recruitment to a falls trial

T2 - An embedded randomised recruitment trial

AU - Witham, Miles D.

AU - Band, Margaret M.

AU - Price, Rosemary J. G.

AU - Fulton, Roberta L.

AU - Clarke, Clare L.

AU - Donnan, Peter T.

AU - Soiza, Roy L

AU - Cvoro, Vera

N1 - The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Chief Scientist Office, Scottish Government grant number CZH/4/1100.

PY - 2018/12/1

Y1 - 2018/12/1

N2 - Background/Aims: Recruitment to trials of intervention for older people who fall is challenging. Evidence suggests that the word falls has negative connotations for older people, and this may present a barrier to engaging with trials in this area. We therefore tested whether a participant information sheet that minimised reference to falls could improve recruitment rates.Methods: We conducted a study within a trial, embedded within a randomised controlled trial of vitamin K versus placebo to improve postural sway in patients aged 65 and over with a history of falls. Potential participants were identified from primary care lists in 14 practices and were randomised to receive either a standard participant information sheet or an information sheet minimising use of the word falls, instead focussing on maintenance of health, fitness and balance. The primary outcome for this embedded trial was the proportion of responses expressing interest in participating received in each arm. Secondary outcomes were the proportion of those contacted attending a screening visit, consenting at screening, and the proportion contacted who were randomised into the main trial.Results: In all, 4145 invitations were sent, with an overall response rate of 444 (10.7%). In all, 2148 individuals received the new information sheet (minimising reference to falls); 1997 received the standard information sheet. There was no statistically significant difference in response rate between those individuals sent the new information sheet and those sent the standard information sheet (10.1% vs 11.4%; difference 1.3% (95% confidence interval ?0.6% to 3.2%); p?=?0.19). Similarly, we found no statistically significant difference between the percentage of those who attended and consented at screening in the two groups (2.1% vs 2.7%; difference 0.6% (95% confidence interval: ?0.4% to 1.6%); p?=?0.20), and no statistically significant difference between the percentage randomised in the two groups (2.0% vs 2.6%; difference 0.6% (95% confidence interval ?0.4% to 1.6%); p?=?0.20)Conclusions: Use of a participant information sheet minimising reference to falls did not lead to a greater response rate in this trial targeting older people with a history of falls.

AB - Background/Aims: Recruitment to trials of intervention for older people who fall is challenging. Evidence suggests that the word falls has negative connotations for older people, and this may present a barrier to engaging with trials in this area. We therefore tested whether a participant information sheet that minimised reference to falls could improve recruitment rates.Methods: We conducted a study within a trial, embedded within a randomised controlled trial of vitamin K versus placebo to improve postural sway in patients aged 65 and over with a history of falls. Potential participants were identified from primary care lists in 14 practices and were randomised to receive either a standard participant information sheet or an information sheet minimising use of the word falls, instead focussing on maintenance of health, fitness and balance. The primary outcome for this embedded trial was the proportion of responses expressing interest in participating received in each arm. Secondary outcomes were the proportion of those contacted attending a screening visit, consenting at screening, and the proportion contacted who were randomised into the main trial.Results: In all, 4145 invitations were sent, with an overall response rate of 444 (10.7%). In all, 2148 individuals received the new information sheet (minimising reference to falls); 1997 received the standard information sheet. There was no statistically significant difference in response rate between those individuals sent the new information sheet and those sent the standard information sheet (10.1% vs 11.4%; difference 1.3% (95% confidence interval ?0.6% to 3.2%); p?=?0.19). Similarly, we found no statistically significant difference between the percentage of those who attended and consented at screening in the two groups (2.1% vs 2.7%; difference 0.6% (95% confidence interval: ?0.4% to 1.6%); p?=?0.20), and no statistically significant difference between the percentage randomised in the two groups (2.0% vs 2.6%; difference 0.6% (95% confidence interval ?0.4% to 1.6%); p?=?0.20)Conclusions: Use of a participant information sheet minimising reference to falls did not lead to a greater response rate in this trial targeting older people with a history of falls.

KW - Falls

KW - study within a trial

KW - participant information sheet

KW - recruitment

U2 - 10.1177/1740774518803558

DO - 10.1177/1740774518803558

M3 - Article

VL - 15

SP - 551

EP - 556

JO - Clinical Trials

JF - Clinical Trials

SN - 1740-7745

IS - 6

ER -