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Learning before leaping: integration of an adaptive study design process prior to initiation of BetterBirth, a large-scale randomized controlled trial in Uttar Pradesh, India.

Hirschhorn LR, Semrau K, Kodkany B, Churchill R, Kapoor A, Spector J, Ringer S, Firestone R, Kumar V, Gawande A - Implement Sci (2015)

Bottom Line: Checklists were used <25 % of observations.Revisions included change to peer-to-peer coaching (nurse to nurse, physician to physician); strengthened coach training on behavior and system change; adapted strategy for effective leadership engagement; and an explicit motivation strategy to enhance professional pride and effectiveness.These modifications resulted in improvement in multiple EBPs from baseline including taking maternal blood pressure (0 to 16 %), post-partum oxytocin (36 to 97 %), early breastfeeding initiation (3 to 64 %), as well as checklist use (range 32 to 88 %), all p < 0.01.

View Article: PubMed Central - PubMed

Affiliation: Ariadne Labs, Boston, MA, USA. lhirschhorn@ariadnelabs.org.

ABSTRACT

Background: Pragmatic and adaptive trial designs are increasingly used in quality improvement (QI) interventions to provide the strongest evidence for effective implementation and impact prior to broader scale-up. We previously showed that an on-site coaching intervention focused on the World Health Organization Safe Childbirth Checklist (SCC) improved performance of essential birth practices (EBPs) in one facility in Karnataka, India. We report on the process and outcomes of adapting the intervention prior to larger-scale implementation in a randomized controlled trial in Uttar Pradesh (UP), India.

Methods: Initially, we trained a local team of physicians and nurses to coach birth attendants in SCC use at two public facilities for 4-6 weeks. Trained observers evaluated adherence to EBPs before and after coaching. Using mixed methods and a systematic adaptation process, we modified and strengthened the intervention. The modified intervention was implemented in three additional facilities. Pre/post-change in EBP prevalence aggregated across facilities was analyzed.

Results: In the first two facilities, limited improvement was seen in EBPs with the exception of post-partum oxytocin. Checklists were used <25 % of observations. We identified challenges in physicians coaching nurses, need to engage district and facility leadership to address system gaps, and inadequate strategy for motivating SCC uptake. Revisions included change to peer-to-peer coaching (nurse to nurse, physician to physician); strengthened coach training on behavior and system change; adapted strategy for effective leadership engagement; and an explicit motivation strategy to enhance professional pride and effectiveness. These modifications resulted in improvement in multiple EBPs from baseline including taking maternal blood pressure (0 to 16 %), post-partum oxytocin (36 to 97 %), early breastfeeding initiation (3 to 64 %), as well as checklist use (range 32 to 88 %), all p < 0.01. Further adaptations were implemented to increase the effectiveness prior to full trial launch.

Conclusions: The adaptive study design of implementation, evaluation, and feedback drove iterative redesign and successfully developed a SCC-focused coaching intervention that improved EBPs in UP facilities. This work was critical to develop a replicable BetterBirth package tailored to the local context. The multi-center pragmatic trial is underway measuring impact of the BetterBirth program on EBP and maternal-neonatal morbidity and mortality.

Clinical trials identifier: NCT02148952 .

No MeSH data available.


Change in observed essential birth practices performed by birth attendants following implementation of the BetterBirth Program in the first two facilities in Uttar Pradesh following initial adaptation. Trained observers collected data at four predetermined observation time points (OPs) during the perinatal process (OP1: at admission; OP2: before pushing; OP3: immediate post-delivery; OP4: within 1 h post-delivery). Numbers observed OP1: pre 20, post 33; OP2: pre 23, post 23; OP3: pre 23, post 23; OP4: pre 23, post 23
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Fig1: Change in observed essential birth practices performed by birth attendants following implementation of the BetterBirth Program in the first two facilities in Uttar Pradesh following initial adaptation. Trained observers collected data at four predetermined observation time points (OPs) during the perinatal process (OP1: at admission; OP2: before pushing; OP3: immediate post-delivery; OP4: within 1 h post-delivery). Numbers observed OP1: pre 20, post 33; OP2: pre 23, post 23; OP3: pre 23, post 23; OP4: pre 23, post 23

Mentions: After introduction of the physician-led coaching and use of checklist in two phase I facilities, the site staff reacted positively to the concept of the checklist and its role in preventing harm and improving quality. However, system (staffing and supplies) and persistent motivational barriers were associated with limited observed behavior change (Fig. 1). The only substantial improvement across the labor and delivery period was seen in appropriate delivery of oxytocin immediately post-partum (22 to 74 %), with the SCC used between 10 % (at admission) and 39 % (within an hour of delivery) of observed care interactions. Based on discussions with coaches and study staff as well as observations of activities, a number of needed adaptations were identified. While engagement of the heads of the facilities was important, higher level engagement up to the district level and ongoing coaching at the facility management level were needed to address identified system-level issues such as supplies and equipment. Physicians also faced challenges in being effective and accepted coaches for nurses and auxiliary nurse midwives who comprised the overwhelming majority of the trained birth attendants. This was felt by the team as due in part to hierarchal rather than partnership interaction between physicians and nurses in the coaching relationship. Finally, the dose of coaching visits and strategy was inadequate to move beyond knowledge change to drive the needed behavior change to use the checklist and deliver essential birth practices.Fig. 1


Learning before leaping: integration of an adaptive study design process prior to initiation of BetterBirth, a large-scale randomized controlled trial in Uttar Pradesh, India.

Hirschhorn LR, Semrau K, Kodkany B, Churchill R, Kapoor A, Spector J, Ringer S, Firestone R, Kumar V, Gawande A - Implement Sci (2015)

Change in observed essential birth practices performed by birth attendants following implementation of the BetterBirth Program in the first two facilities in Uttar Pradesh following initial adaptation. Trained observers collected data at four predetermined observation time points (OPs) during the perinatal process (OP1: at admission; OP2: before pushing; OP3: immediate post-delivery; OP4: within 1 h post-delivery). Numbers observed OP1: pre 20, post 33; OP2: pre 23, post 23; OP3: pre 23, post 23; OP4: pre 23, post 23
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4536663&req=5

Fig1: Change in observed essential birth practices performed by birth attendants following implementation of the BetterBirth Program in the first two facilities in Uttar Pradesh following initial adaptation. Trained observers collected data at four predetermined observation time points (OPs) during the perinatal process (OP1: at admission; OP2: before pushing; OP3: immediate post-delivery; OP4: within 1 h post-delivery). Numbers observed OP1: pre 20, post 33; OP2: pre 23, post 23; OP3: pre 23, post 23; OP4: pre 23, post 23
Mentions: After introduction of the physician-led coaching and use of checklist in two phase I facilities, the site staff reacted positively to the concept of the checklist and its role in preventing harm and improving quality. However, system (staffing and supplies) and persistent motivational barriers were associated with limited observed behavior change (Fig. 1). The only substantial improvement across the labor and delivery period was seen in appropriate delivery of oxytocin immediately post-partum (22 to 74 %), with the SCC used between 10 % (at admission) and 39 % (within an hour of delivery) of observed care interactions. Based on discussions with coaches and study staff as well as observations of activities, a number of needed adaptations were identified. While engagement of the heads of the facilities was important, higher level engagement up to the district level and ongoing coaching at the facility management level were needed to address identified system-level issues such as supplies and equipment. Physicians also faced challenges in being effective and accepted coaches for nurses and auxiliary nurse midwives who comprised the overwhelming majority of the trained birth attendants. This was felt by the team as due in part to hierarchal rather than partnership interaction between physicians and nurses in the coaching relationship. Finally, the dose of coaching visits and strategy was inadequate to move beyond knowledge change to drive the needed behavior change to use the checklist and deliver essential birth practices.Fig. 1

Bottom Line: Checklists were used <25 % of observations.Revisions included change to peer-to-peer coaching (nurse to nurse, physician to physician); strengthened coach training on behavior and system change; adapted strategy for effective leadership engagement; and an explicit motivation strategy to enhance professional pride and effectiveness.These modifications resulted in improvement in multiple EBPs from baseline including taking maternal blood pressure (0 to 16 %), post-partum oxytocin (36 to 97 %), early breastfeeding initiation (3 to 64 %), as well as checklist use (range 32 to 88 %), all p < 0.01.

View Article: PubMed Central - PubMed

Affiliation: Ariadne Labs, Boston, MA, USA. lhirschhorn@ariadnelabs.org.

ABSTRACT

Background: Pragmatic and adaptive trial designs are increasingly used in quality improvement (QI) interventions to provide the strongest evidence for effective implementation and impact prior to broader scale-up. We previously showed that an on-site coaching intervention focused on the World Health Organization Safe Childbirth Checklist (SCC) improved performance of essential birth practices (EBPs) in one facility in Karnataka, India. We report on the process and outcomes of adapting the intervention prior to larger-scale implementation in a randomized controlled trial in Uttar Pradesh (UP), India.

Methods: Initially, we trained a local team of physicians and nurses to coach birth attendants in SCC use at two public facilities for 4-6 weeks. Trained observers evaluated adherence to EBPs before and after coaching. Using mixed methods and a systematic adaptation process, we modified and strengthened the intervention. The modified intervention was implemented in three additional facilities. Pre/post-change in EBP prevalence aggregated across facilities was analyzed.

Results: In the first two facilities, limited improvement was seen in EBPs with the exception of post-partum oxytocin. Checklists were used <25 % of observations. We identified challenges in physicians coaching nurses, need to engage district and facility leadership to address system gaps, and inadequate strategy for motivating SCC uptake. Revisions included change to peer-to-peer coaching (nurse to nurse, physician to physician); strengthened coach training on behavior and system change; adapted strategy for effective leadership engagement; and an explicit motivation strategy to enhance professional pride and effectiveness. These modifications resulted in improvement in multiple EBPs from baseline including taking maternal blood pressure (0 to 16 %), post-partum oxytocin (36 to 97 %), early breastfeeding initiation (3 to 64 %), as well as checklist use (range 32 to 88 %), all p < 0.01. Further adaptations were implemented to increase the effectiveness prior to full trial launch.

Conclusions: The adaptive study design of implementation, evaluation, and feedback drove iterative redesign and successfully developed a SCC-focused coaching intervention that improved EBPs in UP facilities. This work was critical to develop a replicable BetterBirth package tailored to the local context. The multi-center pragmatic trial is underway measuring impact of the BetterBirth program on EBP and maternal-neonatal morbidity and mortality.

Clinical trials identifier: NCT02148952 .

No MeSH data available.