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:BackgroundResearch is often undertaken using patient-reported outcomes from questionnaires. Achieving a high response rate demands expensive and time-consuming methods like telephone reminders. However, it is unknown whether telephone reminders change outcome estimates or only affect the response rate in research of populations with low back pain (LBP). The aim is to compare baseline characteristics and the change in outcome between patients responding before and after receiving a telephone reminder.MethodsThis is an ancillary analysis of data from a prospective cohort study employing questionnaires from 812 adults with LBP lasting more than 3 months. Patients not responding to the 52-week questionnaire were sent reminder emails after two and 3 weeks and delivered postal reminders after 4 weeks. Patients still not responding were contacted by telephone, with a maximum of two attempts. Patients were categorised into three groups: 1) patients responding before a telephone reminder was performed; 2) patients responding after the telephone reminder and 3) patients not responding at all. A positive outcome was defined as a 30% improvement on the Roland Morris Disability Questionnaire after 52 weeks.ResultsA total of 695 patients (85.2%) responded. Of these, 643 patients were classified in Group 1 and 52 patients were classified in Group 2. One hundred seventeen were classified in Group 3. No differences in outcome or baseline characteristics was found. In Group 1, 41.3% had a positive outcome, and in Group 2 48.9% had a positive outcome (P = 0.297). In group 3, non-respondents were younger, more often unemployed, more often smokers, more often reported co-morbidity, and reported higher depression scores than respondents.ConclusionsUsing a telephone reminder had no consequence on outcome estimates nor were there any differences in baseline characteristics between patients who responded before or after the telephone reminder.Trial registrationThe initial trial was registered in Clinicaltrials.gov ( NCT03058315 ).

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.

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.

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