Dataset Information

Professionally designed information materials and telephone reminders improved consent response rates: evidence from an RCT nested within a cohort study.

ABSTRACT:

Objectives

To investigate whether different study-to-participant communication methods increase response, increase response from hard-to-engage individuals, and influence participants' consent decisions.

Study design and setting

A randomized controlled trial within the Avon Longitudinal Study of Parents and Children. Cohort members were invited to re-enroll at age 18 and consent to linkage to their health and administrative records. Participants were randomized to receive one of eight combinations of three interventions: a prior-notification postcard or no contact, a standard or professionally designed consent pack, and a phone or postal reminder. The primary outcome was return of the consent form ("response"), with consent decision being the secondary outcome.

Results

Of 1,950 participants, 806 (41%) responded. Response rates were 2.7% higher (95% confidence interval: -0.06, 5.5%; P = 0.06) among those receiving designed packs than among those receiving standard packs and 6.4% higher (2.3, 10.6%; P = 0.002) among those receiving phone reminders (compared with postal reminders). The prior-notification postcard did not influence response rates [difference = 0% (-2.8, 2.8%; P = 1.0)], and we found no evidence that the communication method influenced consent decision.

Conclusion

This trial provides evidence that communication material design can influence response rates and that phone reminders have superior cost/benefit returns over designed materials. Experimental evaluation of communications strategies and dissemination of findings may benefit cohort studies.

SUBMITTER: Boyd A

PROVIDER: S-EPMC4503222 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

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Publications

Professionally designed information materials and telephone reminders improved consent response rates: evidence from an RCT nested within a cohort study.

Boyd Andy A Tilling Kate K Cornish Rosie R Davies Amy A Humphries Kerry K Macleod John J

Journal of clinical epidemiology 20150331 8

<h4>Objectives</h4>To investigate whether different study-to-participant communication methods increase response, increase response from hard-to-engage individuals, and influence participants' consent decisions.<h4>Study design and setting</h4>A randomized controlled trial within the Avon Longitudinal Study of Parents and Children. Cohort members were invited to re-enroll at age 18 and consent to linkage to their health and administrative records. Participants were randomized to receive one of e ...[more]

PMID: 25920944

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Project description:ObjectiveTo assess whether customised mobile phone reminders would improve adherence to therapy and thus decrease virological failure among HIV infected patients starting antiretroviral treatment (ART).DesignRandomised controlled trial among HIV infected patients initiating antiretroviral treatment.SettingThree diverse healthcare delivery settings in south India: two ambulatory clinics within the Indian national programme and one private HIV healthcare clinic.Participants631 HIV infected, ART naïve, adult patients eligible to initiate first line ART were randomly assigned to mobile phone intervention (n=315) or standard care (n=316) and followed for 96 weeks..InterventionThe intervention consisted of customised, interactive, automated voice reminders, and a pictorial message that were sent weekly to the patients' mobile phones for the duration of the study.Main outcome measuresThe primary outcome was time to virological failure (viral load >400 copies/mL on two consecutive measurements). Secondary outcomes included ART adherence measured by pill count, death rate, and attrition rate. Suboptimal adherence was defined as mean adherence <95%.ResultsUsing an intention-to-treat approach we found no observed difference in time to virological failure between the allocation groups: failures in the intervention and standard care arms were 49/315 (15.6%) and 49/316 (15.5%) respectively (unadjusted hazard ratio 0.98, 95% confidence interval 0.67 to 1.47, P=0.95). The rate of virological failure in the intervention and standard care groups were 10.52 and 10.73 per 100 person years respectively. Comparison of suboptimal adherence was similar between both groups (unadjusted incidence rate ratio 1.24, 95% CI 0.93 to 1.65, P=0.14). Incidence proportion of patients with suboptimal adherence was 81/300 (27.0%) in the intervention arm and 65/299 (21.7%) in the standard care arm. The results of analyses adjusted for potential confounders were similar, indicating no significant difference between the allocation groups. Other secondary outcomes such as death and attrition rates, and subgroup analysis also showed comparable results across allocation groups.ConclusionsIn this multicentre randomised controlled trial among ART naïve patients initiating first line ART within the Indian national programme, we found no significant effect of the mobile phone intervention on either time to virological failure or ART adherence at the end of two years of therapy.Trial registration Current Controlled Trials ISRCTN79261738.

Project description:Can reproductive life plan (RLP)-based information in contraceptive counselling before pregnancy increase women's knowledge of reproduction, and of the importance of folic acid intake in particular?The RLP-based information increased women's knowledge of reproduction including knowledge of folic acid intake.Many women have insufficient knowledge of reproduction, including a health-promoting lifestyle prior to conception, and highly educated women in particular postpone childbearing until an age when their fertile capacity has started to decrease.The study was an randomized controlled trial with one intervention group (IG) and two control groups (CG1, CG2). A sample size calculation indicated that 82 women per group would be adequate. Recruitment took place during 3 months in 2012 and 299 women were included. The women were randomized in blocks of three. All groups received standard care (contraceptive counselling, Chlamydia testing, cervical screening). In addition, women in the IG were given oral and written RLP-based information about reproduction.A total of 299 out of 338 (88%) Swedish-speaking women visiting a Student Health Centre were included (mean age 23 years); response rate was 88%. Before the counselling, women in the IG and the CG1 completed a baseline questionnaire, including questions about lifestyle changes in connection to pregnancy planning, family planning intentions and knowledge of reproduction (e.g. the fecundity of an ovum). At follow-up 2 months after inclusion, a structured telephone interview was performed in all groups (n = 262, 88% participation rate).There was no difference between the groups regarding the mean knowledge score at baseline. The IG scored higher at follow-up than at baseline (P < 0.001); the mean increased from 6.4 to 9.0 out of a maximum 20 points. The women in the CG1 scored no differently at follow-up than at baseline. The difference in the knowledge score between the IG and the two CGs was significant (P < 0.001), whereas no difference was shown between the two CGs. There was no difference between the groups at baseline regarding how many women could mention folic acid intake among the things to do when planning to get pregnant. At follow-up, 22% in the IG, 3% in CG1 and 1% in CG2 mentioned folic acid intake (P < 0.001). At follow-up, more women in the IG also wished to have their last child earlier in life (P < 0.001) than at baseline, while there was no difference in the CG1.As the study sample consisted of university students, it is possible that the effect of the intervention was connected to a high level of education and conclusions for all women of reproductive age should be drawn with caution.The provision of RLP-based information seems to be a feasible tool for promoting reproductive health.Study funding was received from the Faculty of Medicine, Uppsala University, Sweden. There are no conflicts of interest.ClinicalTrial.gov Identifier NCT01739101.

Dataset Information

Professionally designed information materials and telephone reminders improved consent response rates: evidence from an RCT nested within a cohort study.

Objectives

Study design and setting

Results

Conclusion

Publications

Professionally designed information materials and telephone reminders improved consent response rates: evidence from an RCT nested within a cohort study.

Similar Datasets

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