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. 2020 Jul 14;2020(8):CD013679. doi: 10.1002/14651858.CD013679

Hannan 2016.

Study characteristics
Methods Aim: to test the effects of a NP 2‐way communication mobile phone and texting follow‐up intervention for the first 6 months postbirth in low‐income first‐time mothers and their healthy full‐term infants.
Study design: parallel individual RCT
Recruitment: first‐time low‐income mothers were enrolled from the Mother Baby Unit at Jackson Memorial Hospital in Miami, FL.
Study duration: 6 months
Study dates: not reported
Participants Inclusion criteria: first‐time mothers, aged 18 years, any racial/ethnic group, low‐income, understood spoken English or Spanish, access to a mobile phone, delivered a singleton healthy full‐term infant, only infants with limited access to health care were included.
Sample size (n): 141 (intervention: 63; control: 66)
Age (mean): mothers: 25.3 (SD 5.6) years
Sex (male): infants: 55%
Country: USA (high‐income)
Setting: community, linked to hospital mother and baby unit
Interventions Intervention: 2‐way NP mobile phone intervention that included calls and SMS messages
Content: calls and text messages assessing health problems or concerns regarding the infant
Frequency and intensity: mobile phone contact and texting on posthospital discharge days 3, 7, 14, 21, then monthly for 6 months. Additionally, intervention group mothers were able to contact the NPs by mobile phone or texting Monday to Saturday
Control: standard care/no intervention. Routine hospital discharge care
Co‐interventions: if a healthcare concern was stated, the NP followed US paediatric protocols to implement care. If the mother voiced a serious infant complaint such as fever, excessive crying, vomiting, lethargy, or seizure‐like activity, the mother was instructed to contact the 911 emergency systems. Backup paediatricians were available to the NPs for consultation on infant health concerns.
Outcomes 1. Immunisations up to date (at 2, 4, 6 months – we included data for the longest time point (6 months)); 2. Infant emergency room attendance (6 months)
Outcomes reported but not included in review:
1. Infant hospitalisations (6 months) (outcome not included, for healthcare attendance we included immunisations and emergency department visits); 2. Infant urgent care seeking (6 months) (outcome not included, for healthcare attendance we included immunisations and emergency department visits); 3. Time in days to first well visit (postnatal care appointment) – outcome not eligible for inclusion; 4. Mothers' perceived stress (posthospital discharge) – outcome not eligible for inclusion; 5. Mothers' perceived social support (posthospital discharge) – outcome not eligible for inclusion; 6. Infant well visits received late (first visit, month 1, month 2, month 4, month 6) – outcome not eligible for inclusion
Outcome assessment time point: specified above after each outcome
Funding/declarations of interest Funding: funded by MBRS Score National Institute of Health; Eunice Kennedy Shriver National Institute of Child Health & Human Development.
Conflicts of interest: author(s) declared no potential conflicts of interest.
Notes Trial ID: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "mothers were randomized to a control or intervention group using a table of random numbers."
Allocation concealment (selection bias) Unclear risk No information on allocation concealment.
Blinding of participants and personnel (performance bias)
All outcomes High risk Not possible to blind participants, no information on blinding of study personnel.
Blinding of subjective outcome assessment (detection bias) High risk Measures collected from mothers were at high risk of detection bias since the study was not blinded.
Incomplete outcome data (attrition bias)
All outcomes High risk 12 mothers were lost to contact postdischarge due to disconnected mobile phones. It is not reported how many from each group.
Selective reporting (reporting bias) Unclear risk All expected outcomes and all outcomes listed in the methods section were reported, but no protocol or online trial record available to check against.
Other bias Unclear risk There were no significant differences in the demographic characteristics between the groups except for the number of years in the US.